ispor connections vol. 14 no 1

IN THIS ISSUE

CONNECTIONSCONNECTIONSUNITING SCIENCE AND PRACTICEISP R

JANUARY / FEBRUARY 2008 VOL. 14, NO. 1

INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH

LETTER FROM THE EDITOR

PRESIDENT’S MESSAGE

Translational Research and the Value Equation

POLICY ANALYSIS

The Age of Health Economics: The Impact of IQWIG on the GermanPharmaceutical Market

Levels of Association Between Health Care Expenditure and Health CareIndicators in Economically Developed Countries

OUTCOMES

Raising the Bar in the USA: The Impact of Heightened Awareness of the Needfor Health-Economic Data in the Absence of a Regulatory Mandate

POLICY ANALYSIS

Commentary: Reflections on “Sicko” by Michael Moore from a European Pointof View

ISPOR CORNER

Board of Directors Take Action in 2007

ISPOR Board of Directors Election Candidates 2008

ISPOR Student Corner: Authorship Declines in Economic Evaluations

Recently Published Works: Using Pharmacoeconomics Innovatively

ISPOR 3rd Asia-Pacific Conference Call for Abstracts

ISPOR 13th Annual International Meeting Program

ISPOR 13th Annual International Meeting Short Courses

ISPOR 13th Annual International Meeting Promotional Information

ISPOR 13th Annual International Meeting Registration

Copyright © 2008 International Society of Pharmacoeconomics and Outcomes Research (ISPOR) All rights reserved under International and Pan-AmericanCopyright Conventions. Published in the United States of America by the International Society for Pharmacoeconomics and Outcomes Research. No part ofthis publication may be used or reproduced in any manner whatsoever or by any means – graphic, electronic, or mechanical, including photocopying, taping,or information storage and retrieval systems without express written permission of the International Society for Pharmacoeconomics and Outcomes Research.ISPOR and ISPOR CONNECTIONS are trademarks of the International Society for Pharmacoeconomics and Outcomes Research. Inquiries should be addressedto: International Society for Pharmacoeconomics and Outcomes Research, 3100 Princeton Pike, Building 3, Suite E, Lawrenceville, NJ 08648 USA

ISPOR 2007-2008 BOARD OF DIRECTORS

PRESIDENT – Diana Brixner PhD, RPh, University ofUtah/Pharmacotherapy, [email protected]

PAST PRESIDENT – Michael F. Drummond PhD, University ofYork, [email protected]

PRESIDENT-ELECT – Chris L. Pashos PhD, HERQuLES,[email protected]

DIRECTORS – Marc Berger MD, Eli Lilly and Company, [email protected]; Lou Garrison, PhD, University ofWashington, [email protected]; Shu-Chen Li PhD,University of Newcastle, [email protected]; UweSiebert MD, University of Health Sciences, Medical Informatics& Technology, [email protected]; Richard J. Willke PhD,Pfizer, [email protected]

TREASURER – Karen Rascati RPh, PhD, University of Texas,[email protected]

FOUNDING EXECUTIVE DIRECTOR – Marilyn Dix Smith RPh,PhD, ISPOR, [email protected]

ISPOR CONNECTIONS EDITOR & EDITORIAL BOARDEDITOR-IN-CHIEF – Steven E. Marx PharmD, MS, AbbottLaboratories, [email protected]

ASSOCIATE EDITORS-IN-CHIEF – Thomas Mittendorf PhD,University of Hannover, [email protected]; DavidThompson PhD, i3 Innovus, [email protected]

EDITORIAL BOARD – Rajesh Balkrishnan PhD, MS, Ohio StateUniversity; Benjamin Craig PhD, University of South Florida;Bonnie M. Korenblat Donato PhD, Bristol Myers Squib; MarcNuijten PhD, MD, MBA, Imta, Erasmus University; MichaelWonder BSc, BPharm, Novartis Pharmaceuticals Australia; Peter Wong RPH, MS, MBA, PhD, Good Samaritan Hospital

ISPOR CONNECTIONS PUBLISHING, SUBSCRIPTION,AND ADVERTISING OFFICE: ISPOR CONNECTIONS (ISSN 1538-5108) (USPS 019121) is published bi-monthly by the International Society forPharmacoeconomics and Outcomes Research, 3100 PrincetonPike, Building 3, Suite E, Lawrenceville, NJ 08648 USA. Phone: 609-219-0773 Toll Free: 1-800-992-0643Fax: 609-219-0774 Website: www.ispor.orgAnnual membership dues include $30 for regular members and$15 for student members for a 1-year subscription to ISPORCONNECTIONS.

Periodicals Postage paid at Trenton, New Jersey and at additional mailing offices. POSTMASTER: Send address changesto ISPOR CONNECTIONS, 3100 Princeton Pike, Building 3, SuiteE, Lawrenceville, NJ 08648 USA.Managing Editor: Stephen L. Priori, email: [email protected] Advertising Manager: Danielle Mroz, email: [email protected]

Direct advertising, photocopy permission, and reprint requests,to Managing Editor.

All members of the Board of Directors serve in their personal capacity and do notrepresent the views of their organization during Board activities. All members of theBoard of Directors annually disclose any conflicts of interest concerning businessrelationships with the Society. See: http://www.ispor.org/board/index.asp.

2 January/February 2008 ISPOR CONNECTIONS

LETTER FROM THE EDITOR

Ten Most Influential Authors in 2007: Steve Marx's Picks

At the end of the year, we read about the ten best and worst

of movies, dressed, jobs, etc. But who in health econom-

ics & outcomes research were the most influential authors

to you? Well, I attempted again to identify them by

conducting a Medline search using the following search terms: cost-effectiveness

or quality of life from January 1, 2007 through December 31, 2007. There were

3,005 articles sited under cost-effectiveness and 10,686 articles under quality of

life, which are both slightly higher from last year. The initial screening criteria

requirement was first author of at least 3 articles that resulted in 20 cost-

effectiveness authors, and 62 quality of life authors. Of the 82 authors identified a

search of each authors name and articles related to cost-effectiveness or quality

of life were quantified and weighted for each term. The following top ten authors in

alphabetical order were identified:

2007 TOP TEN AUTHORS Samuel Aballea Dennis Revicki *

David Cella * Thomas Rosemann

Greg de Lissovoy Michael Schatz

Michael Drummond * Andrew Shorr

Barbara Murphy Kenneth Smith

* Last year winners

Congratulations to all the movers and shakers or the Chubby Checkers of health

economics & outcomes research for making a difference in 2007. Let's start doing

some of our own twisting and shouting, by presenting and authoring our own stud-

ies to demonstrate the value of health economics for decision makers. Again, these

are my picks, not the association. If you have suggestions on improving

the methodology to identify these authors next year, I look forward to your

suggestions.

On behalf of the editorial members and ISPOR staff, we look forward to and inform-

ative and productive New Year.

Steve Marx, Editor-in-Chief

ISPOR CONNECTIONS

Arecent commentary published in the Journalof the American Medical Association

addressed the “Meaning of TranslationalResearch and Why it Matters” [1]. In light ofISPOR related topics such as outcomesresearch, comparative effectiveness, cost-effec-tiveness, and pharmacoeconomics, it seemstimely to consider where these disciplines fit inthe continuum of translational research.

As Woolf acknowledges in his article, translation-al research means different things to differentpeople. The more traditional definition of “bench

to bedside” encompasses drug discovery(medicinal chemistry), drug formulation (phar-maceutics), drug testing (pharmacology andclinical development), and patient care (pharma-cotherapy). These definitions align particularlywell with the Departments in our own College ofPharmacy at the University of Utah, and, mostlikely, with various other colleges and pharma-ceutical companies across the globe. TheInstitute of Medicine (IOM) Clinical ResearchRoundtable has labeled this definition as “trans-lational block one”, or T1 [2]. The componentsof T1 have been traditionally funded by individualNational Institutes of Health (NIH) institutes andnow collectively through the NIH roadmap initia-tive [3] and by the launch of the Clinical andTranslational Science Award (CTSA) with a goalof $500 million in funding across 60 academiccenters by 2012.

An alternative definition of translational research,perhaps more relevant to the disciplines repre-sented by ISPOR and other population-basedorganizations such as the International Society ofPharmacoepidemiology, Academy Health,Society for Medical Decision Making and others,would be “translating research into practice”.Here the disciplines of epidemiology, evidence-based synthesis, economics, public policy,behavioral science, and biostatistics play a muchlarger role in understanding how the real world ofclinical practice, patient behaviors, and concomi-tant disease can impact the predictions of thehighest quality research produced by randomizedclinical trials. The IOM Clinical ResearchRoundtable labeled this as ”translational blocktwo” or T2 [2]. The challenges of this type ofresearch abound. In specific research on how anew technology can be introduced into practice,one must consider the nuances of a health caresystem that has previously operated in theabsence of such technology. Treatment guide-lines are reviewed and revised, systematicreviews are redone, and documentation, such asthe Academy of Managed Care Pharmacy(AMCP) Dossier and dossiers for other globalregion reimbursement agencies, is prepared andupdated. The evidence that is created to supportthese documents is largely conducted in patientpopulations from primary care physician prac-tices, integrated health care systems, and nation-al administrative claims databases. This “realworld” research can include assessment of the

impact of therapeuticguidelines on thetreatment and out-comes of disease, theimpact of disease ormedication therapymanagement inter-vention programs,and health services research to evaluate the ben-efit of vaccination or diagnostic screening pro-grams. The practice-based component of thisresearch is primarily conducted in community orambulatory settings to provide insight on theimpact and outcomes of implementing new tech-nologies. The practice-based research waspotentially referred to as T3 by Westfall and col-leagues [4] to more specifically acknowledgethis practice-based approach. Either way thedynamics of funding research in the T-2 T-3arena is far different than the funding of the moretraditional T1 translational research. The adapta-tion of the NIH towards translational research haddedicated $787 million of a $22.1 billion budgetto health services research, and the previouslymentioned resources have been directed towardsthe CTSA, however, with a focus on T1. In factacademic centers across the U.S have struggledwith how to incorporate community-based primary care research and pharmacotherapy out-comes research into CTSA grant applications. Amore likely source for practice-based researchhas been the Agency for healthcare Research andQuality (AHRQ) with the charge that researchresults are widely disseminated and used inhealthcare decision making [5]. However, thefunding for this mission is sparse with roughly a$300 million budget initially targeted at transla-tional research in practice grants with a shifttoward special project research on patient safetyand informatics.

A larger concern is that the conversation of defin-ing translational research largely stops here.Although we can study the implementation oftechnologies into practice, we have neither dis-cussed research that is focused on studying thecomparative effectiveness of different technolo-gies nor the associated costs. Yet these two disciplines are the core principles of ISPOR. Thebenefit and limitations of conducting practicebased research have been largely recognized andmany of these same limitations apply to realworld effectiveness studies; however, there is

PRESIDENT’S MESSAGE

Translational Research and the Value EquationDiana Brixner PhD, 2007-2008 ISPOR President and Associate Professor and Chair of the Department of Pharmacotherapy and

Executive Director of the Pharmacotherapy Outcomes Research Center at the University of Utah College of Pharmacy, Salt Lake

City, UT, USA

January/February 2008 ISPOR CONNECTIONS 3

>

IN THIS ISSUELETTER FROM THE EDITOR 2

PRESIDENT’S MESSAGETranslational Research and the Value Equation 3

POLICY ANALYSISThe Age of Health Economics: The Impact ofIQWIG on the German Pharmaceutical Market 4

Web Connections

Levels of Association Between Health CareExpenditure and Health Care Indicators inEconomically Developed Countries 7

OUTCOMES

Raising the Bar in the USA: The Impact ofHeightened Awareness of the Need for Health-Economic Data in the Absence of a RegulatoryMandate 9

POLICY ANALYSIS

Commentary: Reflections on “Sicko” by MichaelMoore from a European Point of View 13

ISPOR CONNECTIONS Editorial Policy 14

ISPOR CORNER

Board of Directors Take action in 2007 15

ISPOR Board of Directors Election Candidates 2008 16

ISPOR Student Corner: Authorship Decisions in Economic Evaluations 23

Recently Published Works: UsingPharmacoeconomics Innovatively 26

ISPOR 3rd Asia-Pacific Conference Call for Abstracts 28

ISPOR 13th Annual International Meeting Program 31

ISPOR 13th Annual International Meeting Short Courses 36

ISPOR 13th Annual International MeetingPromotional Information 38

ISPOR 13th Annual International MeetingRegistration 39


Starting in February 2006, a wave of health carecost-containment reforms swept throughGermany, designed to deliver Û1.0 billion in2006, rising to Û1.3 billion in 2007 and 2008. Afurther far-reaching package was agreed in July2006 to restructure the financing of health careand create a more cohesive, uniform system.

These reforms impact the German pharmaceuti-cal market in a number of ways and include astronger role for IQWiG (Institut für Qualität undWirtschaftlichkeit im Gesundheitswesen) in theevaluation of new drugs and technologies.Frank-Ulrich Fricke, Principal, HEOR at IMSHealth, examines the implications of this changeand unfolds the new map that may help to guidepharma across an unfamiliar landscape.

From 2008, after the amendment of its method-ologies IQWiG - an independent foundation broad-ly equivalent to England's NICE (National Institutefor Health and Clinical Excellence) - will be able toconduct cost-benefit assessments, initially on

drugs considered 'high-profile'. This is in additionto its previous remit for evaluating clinical benefit.

From that point on, Germany will join a growingnumber of countries - the USA included - wherepharmaceutical products are measured with aneconomic slide-rule before a penny of statutoryhealth insurance funds is made available to pro-cure them. The only difference being that inGermany a product will gain market access firstand then be assessed for subsequent restrictionsor withdrawal of prescribability. IMS currentlyestimates that up to Û140bn of annual globalpharmaceutical sales are subject to some form ofeconomic evaluation.

By satisfying IQWiG's criteria, a drug can be pre-scribed via the statutory health insurance therebyallowing access to a wider prescription market.Failure to demonstrate efficiency gains is likely tolimit the market to those citizens and privatehealth funds that are willing and able to pay up tothe full prescription price.

IQWiG carries out its work at the behest of DerGemeinsame Bundesausschuss or Federal JointCommittee (G-BA). The G-BA - part of the self-governing body that oversees the German healthcare system - is institutionalized as a legal entityunder public law. However, it does not haveresponsibility for the licensing of drugs, which isthe preserve of the Federal Institute for Drugs andMedical Products (BfArM). G-BA likens its role tobeing the "eye of the needle" through which a newdrug or method must pass to gain a positive eval-uation in terms of benefit and efficiency, beforequalifying for reimbursement in outpatient carefrom the statutory health insurance (SHI) funds.

Together IQWiG and the G-BA act as the musculargatekeepers of the health care market in Germany.Convincing these organisations that a new treatmentoffers improved value for money over existing interven-tions has become the key to commercial success.

IQWiG assessments of new drugs, other inter-ventions, current marketed drugs and additional

POLICY ANALYSIS

The Age of Health Economics: The Impact of IQWIG OnThe German Pharmaceutical MarketFrank-Ulrich Fricke PhD, MSc, Principal, IMS Health Economics & Outcomes Research, Nuremburg, Germany

also acknowledged benefit of this information tothe payer. Drugs and/or other technologiesshould not be expected to act the same waywhen patient behaviors, disease states, and otherfactors are not controlled as they are in random-ized trials, and these differences can be impor-tant in making coverage decisions. The processof rational health care resource allocation shouldinclude economics, but how this information iscollected and how it is interpreted are importantconsiderations. These ongoing debates are alsoreflected in the associated funding sources, bothfor comparative and cost effectiveness, which atthis juncture are largely absent outside of thosevested in the results.

In summary, there is a continuum of researchfrom bench to bedside to practice to resourceallocation where the clarity of definition seems towane and the funding sources seem to diminish.However, in all likelihood, this is a reflection ofthe societal changes in how medicines are dis-covered, applied, and paid for to prevent diseaseand improve human health. If we include com-parative effectiveness and cost-effectiveness aslogical next steps in the continuum of transla-tional research, we should be pleased to know

there is room for many more transitional states inthe future.

References1. Woolf SH. The meaning of translational research and why itmatters. JAMA 2008;299:211-13.

2. Sung NS, Crowley EFJr., Genel M, et al. Central Challengesfacing the national clinical research enterprise. JAMA2003;289:1278-87.

3. http://nihroadmap.nih.gov/ Accessed January 16, 2008.

4. Westfall JM, Mold J, Fagnan L. Practice Based research -“blue highways” on the NIH roadmap. JAMA 2007;297:403-6.

5. Agency for Healthcare Research and Quality. Budget esti-mates for appropriations committees, fiscal year (FY) 2008:performance budget submission for congressional justification.Performance budget overview 2008http://www.ahrq.gov/about/cj2008/cjweb08a.htm#statementAccessed November 17, 2007.

continued from page 3...

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measures that may have a relevant budgetaryimpact on the SHI, are typically commissioned bythe G-BA and serve as a basis for a number ofimportant decisions. These include whether toinclude a drug in a reference pricing group, theprescribability of drugs for SHI members, andtreatment guidelines. In addition, based on anIQWiG assessment and according to the law, thehead association of the sick funds must set amaximum reimbursement price.

The IQWiG assessment will be based on its ownpre-defined criteria which together with its datasources will be set out early on in the process ina 'report plan'. This is published as part ofIQWiG's operational procedures which alsoinvolve a 'draft report' ahead of a 'final report' forthe G-BA. To complete the process the G-BA thenconveys its recommendations to the Ministry ofHealth (BMG). The role of the Ministry is only toconsider whether the decisions taken by the G-BA are legally robust.

The Current Situation IQWiG is currently preparing its new assessmentmethodology paper and is expected to finallyannounce the selected methodologies, (Version3) in Q4 2007. This will allow pharma companies

very little time to prepare for assessments begin-ning in 2008.

Statements emanating from IQWiG and G-BA offi-cials suggest that the new process may involve ahealth benefit assessment as the first step (asbefore). If no such benefit is perceived, then nocost-benefit assessment will be conducted. If,however, there is believed to be benefit overexisting treatments then a cost-effectivenessanalysis will be conducted as the next step.

To determine whether any new drug offers ahealth benefit gain, comparisons will be madewith the current care regimen for patients withinthe SHI sector defined in the report plan. Basedon current IQWiG practice, many health benefitassessments, but only a few cost-benefitassessments, can be expected - mainly becauseso far very few evaluations have revealed addi-tional benefits from new therapies.

New treatments that are innovative, high-profile,expensive, and likely to be in demand by a largenumber of patients are the most likely G-BA tar-gets for an IQWiG assessment. Staying 'off theradar screen' of the G-BA and other institutionalplayers in health care may therefore become a

strategic necessity for some pharma companiesin Germany. Quite what constitutes 'expensive' isnot defined by IQWiG, but it is likely to be a high-ly moveable threshold.

Cost-effectiveness According toIQWiGAlso unclear is what form IQWiG's technical cost-benefit analysis will take. However, the following'good practice' guidelines can be expected toinfluence its final shape:

• Recommendations of the Panel on Cost-effectiveness in Health and Medicine

• Published guidelines for authors and peerreviewers of economic submissions to theBritish Medical Journal

• New England Journal of Medicine policy oncost-effectiveness analyses

• Set of German recommendations on the con-duct of economic evaluations

IQWiG is also consulting a number of internation-al experts regarding the potential methodology -although again it is unclear on what basis these'experts' were selected. >


New Imperative: Demonstratingthe Value of MedicinesTo succeed in the reformed German health caremarket pharma companies must focus on arange of short- and long-term solutions that pro-vide a clear pathway through an IQWiG assess-ment. In particular, they will need to revisit reim-bursement and market access processes.

In the past, pharma companies could, followingmarket authorization, market their product, setthe price and receive full reimbursement. This willchange. With the new processes in place theycan still set the price but they will need to assessthe likelihood of an IQWiG/G-BA approval.Developing health economic information, includ-ing a health technology evaluation, and preparingthoroughly for an IQWiG assessment is thereforeessential. For some companies it will call for anew set of skills and techniques.

What is also emerging is the opportunity for phar-ma managers to engage with IQWiG during theassessment process which will begin with IQWiGconducting a scoping workshop and invitingstakeholders to comment on the extent of theassessment. As a next step, consultations on thereport plan will be held, followed by hearings onthe draft reports. In between, evidence availableto be included in the assessments will be dis-cussed informally. To be prepared for these“encounters” pharmaceutical companies shouldcompile the evidence available and potentiallyproduce a parallel Health TechnologyAssessment (HTA) of their own, based on inter-nationally accepted standards (INAHTA orDAHTA) and written by specialist authors.

Judging by the proposed IQWiG 'report plan' forthe assessment of a particular treatment, pharmamanagers will need to compare the suggestedpopulation, intervention, comparator and out-comes of mortality, morbidity and quality of lifewith their own notions about their product. Theyshould also evaluate the criteria for study/articleevaluation selected, as well as the deployedsearch algorithm. This can be done best by com-paring the report plan with an HTA.

IQWiG's assessment process may last 12months or longer and managers will need to fol-low this closely, especially with regard to publica-tion of the draft report. This is issued with aninvitation for comments which will be subse-quently discussed at a private hearing withIQWiG. Thorough preparation is essential, basedon available evidence, but the timescale for turn-around is short - a mere four weeks.

IQWiG's final report should take into account revi-sions agreed at the draft report stage but there

will be no scope at this point for a further appealto IQWiG regarding the final report it submits tothe G-BA.

The next opportunity for an appeal is directly tothe G-BA once their decision has been made.Appeals can challenge the reference pricinggroup set, the treatment guidelines laid down andany prescribing exclusions from SHI funds. If thisproves unsuccessful, a final challenge can bemade and the case heard before the SocialCourts. A successful challenge may mean refer-ral back to the G-BA for reconsideration. In themeantime, the product in question remains on themarket and the manufacturer can establish thebrand. Thus, although the delay of the assess-ment can benefit the product, the process willnevertheless incur additional costs.

Early Planning Critical Companies hoping to supply pharma products inGermany need to start looking for the positiveeconomic impact of their new healthcare inter-vention, early in their development process. Indoing so, they should consider patient potential,current pathways of care, and the financialimpact of the illness. From this analysis they willneed to develop strong value hypotheses as wellas demonstrate the clinical difference their newtreatment will make. All this will need to be trans-lated into financial terms.

For the major international Pharma companiessuch a process is likely to fit in with current bestpractice; for others some procedural adjustmentswill be required. But even such a rigorousapproach might not be sufficient to secure pre-scribability, potentially resulting in the need toconsider discount pricing. However, this may notbe quite as damaging as it first sounds.

DiscountingThe Social Code makes provision for manufactur-ers and sickness funds to agree discount con-tracts and most of the statutory health insurancefunds have these contracts in place. For Pharma,an attractive feature of this scheme is that dis-count contracts do not affect public or referenceprices across the rest of Europe. In other words,a discount in Germany does not mean a discountelsewhere in Europe.

Recent experience in Germany shows that suchdiscount contracts can be an effective way ofeither staying on the market (short acting insulinanalogues) or entering the market (generics). Byestablishing a discount contract with a sicknessfund, those companies marketing generics havebeen able to gain market share and, in somecases, gained a handsome dividend.

Patients, too, benefit from the discount schemesnot only in terms of access to treatments theywould not otherwise have but also because thepresence of a discount contract enables sickfunds to release their patients from co-payments.

Patients and Prescribers - AnAlternative ScenarioWhere pharma companies are unwilling or unableto negotiate a discount contract, one effect of theeconomic belt-tightening reforms may be to limitthe toolkit available for prescribers and reduce thechoice of treatment for patients. This, in turn,may further differentiate the quality and quantityof care, with those who are privately insured and/or willing to pay more out of pocket havingaccess to those treatments which are more in linewith their individual preferences and potentiallymore expensive.

Public reaction to this will in part depend on themedia attention attracted by IQWiG's work andthe strength of the patient lobby. The patient'sperspective - particularly in terms of health end-points that describe a patient 'feeling better' - isnot fully considered by IQWiG. Over time suchneglect may lead to public dissatisfaction withthe changes to the health care system puttingreforms once again on the German health policyagenda.

WEB CONNECTIONS

Does your research warrant an understandingof existing hospitals within a certain area (with-in the United States). Do you need to controlfor number of beds, discharges or total patientrevenue? Do you want to know the number ofhospitals available within a certain region?Free hospital information is available throughthe American Hospital Directory,at:www.ahd.com/freesearch.php3.

What if your data needs for hospital informationgoes beyond what is available at:www.ahd.com/freesearch.php3? Visit anothersite on ahd.com, the hospital statistics by statesite: www.ahd.com/state_statistics.html.Here one can find, for each state, the numberof hospitals, staffed beds, total discharges,patient days and gross patient revenue. Alldata is for non-federal, short term, acute carehospitals.

Do you know of any websites that youwould like to share with the ISPOR community?

If so, contact Bonnie M. KorenblatDonato PhD, at [email protected].

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Different health care systems with similar levels of resources per capitaoften show wide variations in population health outcomes. One possible

explanation for this is that different health care systems choose to use theresources available to them in different ways, some of which may be sub-optimal. Sub-optimal resource use can lead to inefficiencies in health careprovision and poorer health outcomes. In an attempt to address the questionof quality of care, the WHO [1] and the OECD [2] both published reportsfocusing on assessing the performance of health care systems in differentcountries. However, neither addressed the issue of cost-effectiveness, or,more specifically, which countries had the more cost-effective health caresystems. Using data published by the WHO relating to health care outcomesand expenditure, we attempt to assess how health care performance indica-tors are related to wealth and health care expenditure, and to provide an indi-cation of which countries may be providing the most cost-effective care.

Data from the OECD and WHOThe WHO has recently made publicly available an extensive database con-taining a range of health-related, demographic and economic variablesacross a number of years [3]. The World Health statistics 2007 presents themost recent health statistics for the WHO's 193 member states and are col-lated from publications and databases produced by the WHO's technical pro-grammes and regional offices. A core set of health-related indicators wasselected for the database on the basis of their relevance to global health, theavailability and quality of the data, and the accuracy and comparability ofestimates. The statistics for the indicators are derived from an interactiveprocess of data collection, compilation, quality assessment and estimationoccurring among WHO's technical programmes and its member states.

The health care indicators (HCIs) that were collated for use in this study arelisted in Table 1. These were chosen as they can be viewed as representingquality of life, and less subject to endogenous factors within particular coun-tries. Male-to-female ratios were used to aggregate the health care indicators(HCI) across gender. In addition, values for the per capita gross domesticproduct (GDP), and the per capita health-care expenditure (HCE) in both USand international dollars were also collated. An International dollar is thehypothetical unit of currency which locally has the same purchasing powerthat one US dollar has in the US.

Data were collated for the 30 OECD countries listed in Table 2 [2]. Thesecountries were chosen as they represented the countries which are mosteconomically developed and likely to have the most advanced health caresystems. They also represented countries for which the full range of datawas available. Including data from less developed countries would haveintroduced unreasonable heterogeneity.

Once the data was collated, a series of analyses were performed. Univariableregression analyses was conducted to explore the linear association betweeneach HCI and either GDP or HCE. This was repeated using the logarithms ofGDP and HCE, in US and international dollars. The proposed explanatory vari-able with the best predictive power was then used as a predictor of the HCI.

Correlations Between Health Care Indicators AndEconomic Data The correlation coefficients (r) between the HCIs and the logged economicvariables in US dollars are shown in Table 3. Correlation with internationaldollar economic variables was generally less statistically significant than withUS dollars, and these results are not shown. The correlations shown are allstatistically significant after adjusting for multiplicity (P<0.05). The HCIswhich were more strongly correlated with GDP than HCE were infant mortal-ity rates, maternal mortality ratios, neonatal mortality rates and the probabil-ity of dying under five years of age. HCE was more strongly correlated thanGDP with healthy life expectancy (HALE) at birth, average life expectancy atbirth and the probability of dying between ages 15 and 60 years old.

POLICY ANALYSIS

Levels Of Association Between Health Care ExpenditureAnd Health Care Indicators In Economically DevelopedCountriesRay Gani PhD, Heron Evidence Development Ltd, Letchworth Garden City, Hertfordshire, UK

> TABLE 1 Health-care indicators used to assess the quality of health-care in each country

Healthy life expectancy (HALE) at birth (years) Infant mortality rate Life expectancy at birth (years)Maternal mortality ratio Neonatal mortality rate Probability of dying between 15 and 60 yearsProbability of dying under five years of age

> TABLE 2 The 30 member countries of the Organisation for EconomicCo-operation and Development (OECD)

Australia Denmark Hungary Luxembourg Poland SwedenAustria Finland Iceland Mexico Portugal SwitzerlandBelgium France Ireland Netherlands Republic Turkey

of KoreaCanada Germany Italy New Zealand Slovakia United

KingdomCzech Greece Japan Norway Spain United StatesRepublic of America

> TABLE 3 Correlation coefficients between health-care indicators andthe logarithms of GDP and HCE

Health care indicator GDP HCEHealthy life expectancy (HALE) at birth 0.81*** 0.83***Infant mortality rate -0.73*** -0.65**Life expectancy at birth 0.74*** 0.77***Maternal mortality ratio -0.59** -0.53*Neonatal mortality rate -0.72*** -0.62***Probability of dying (15 to 60 years old) -0.74*** -0.77**Probability of dying (under five years old) -0.73*** -0.63**GDP = Per capita gross domestic product; HCE = Per capita health-careexpenditure. P-values are adjusted using Bonferroni method for multiplecomparisons. * P<0.05; ** P<0.01; ***P<0.001.

>


The strongest correlation found was between healthy life expectancy (HALE)and the logarithm of HCE, for which the correlation coefficient was 0.83(P<0.001, Table 3). A regression model fitted to the logarithm of the HCE datais shown in Figure 1. The mean cost was US$2400 and the mean health lifeexpectancy at birth was 69.1 years. The majority of data from countries fallwithin the 95% confidence intervals. Outliers in this correlation were Japan,Spain and Sweden, which have a higher than expected HALE, and the USAand Hungary which have a lower than expected HALE for their given HCE.

Discussion and ConclusionsIn general there are high levels of correlation between economic and healthcare indicators in economically developed countries. In particular there is a

strong correlation between total per capita health care expenditure andhealthy life expectancy, with lower than expected values of healthy lifeexpectancy given the health-care expenditure in Hungary and the USA. Whilstthis might indicate that the health care systems in these countries are underperforming, this does not imply a causal relationship.

There are a number of other factors that may influence health care indicators,such as education, nutrition or public spending. To derive robust estimatesof the cost-effectiveness of different health care systems, these factorswould need to be accounted for. In effect this would require deriving a stan-dardised control group against which the health-care systems within differ-ent countries could be compared.

Further data and analysis would help identify the costs and benefits of differ-ent health care systems to estimate the cost-effectiveness of health caresystems between countries. Such an analysis would be technically challeng-ing, but potentially yield huge benefits. By identifying the most cost-effectivehealth care system, best practice could be identified and replicated, therebypotentially leading to improvements across different health care systemswithin different countries.

References1. The World Health Report 2000: Health Systems: Improving Performance, Geneva, WHO, 2000http://www.who.int/whr/2000/en/ Last accessed September 2007.

2. Smith P (ed). Measuring up: Improving health system performance in OECD countries, Paris,OECD, 2002.

3. World Health Statistics 2007, Geneva, WHO, 2007 http://www.who.int/whosis/en/index.html Lastaccessed September 2007.

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IC

> FIGURE 1 Per capita health care expenditure and healthly lifeexpectancy for the 30 OECD copuntries


Economic assessment of new health care technologies is practiced amongan increasing number of countries around the world. Today, the United Statesis taking steps in requiring economic evaluation for new healthcare technolo-gies. Michael E. Minshall and John Watkins consider some of the issues.

Health Technology Assessments (HTAs) are increasing in countries aroundthe world. To date, HTA requirements exist in about 30 countries, includingAustralia, Canada, Germany, The Netherlands, Spain, Sweden and the UK.There are discussions within a number of other countries, including Chinaand Korea, to add health economics and outcomes research (HEOR) datainto HTAs, making them requirements for formulary approval and access tomedical technologies, drugs and other kinds of medical treatment.

In the United States, the environment for health-economic data is changing.The US health care market contains two major segments: the public payerand the private payer groups, both representing about 50% of the market.While most HTA work completed in the United States over the past 15 to 17years has been in the private sector, the public sector, including governmententities such as Medicare and Medicaid, has initiated steps to consider HTAsfor technology adoption.

Two entities in the private sector that provide a good indication of whereHTAs are moving within the United States are the Academy of Managed CarePharmacy (AMCP) Guidelines and the more recently published WellpointGuidelines. Additionally, USHTA requirements focus more on the budgetaryimpact and less on the cost-effectiveness of new health technologies.Moving forward, companies will be required to perform HTA analyses to getnew technologies on formulary and covered by private and public plans.

HTA in the USA: What Led us to this Point?The managed care revolution of the late-1980s and 1990s produced ademand for evidence-based formulary placement. Additionally, it called forthe pharmaceutical and biotechnology industries to provide information onbudget impact and to establish the “value” of new medicine, including clini-cal, economic and humanistic ideals.

Today there are about 600 different health care providers in the US privatesector. Theoretically, all of them could have their own HTA requirements, asthere are no mandatory national guidelines within the United States.However, when segmented by larger groups, it's evident that about 40 pay-ers, or about 40 managed care plans, represent about 80 percent of the mar-ket.

HTA in the USA: The Existing GuidelinesAMCP GuidelinesThe AMCP Guidelines are the first widely-followed and utilized guidelines forHTA in the United States. They include explicit mentions of non-U.S. bodies,

such as the National Institute for Health and Clinical Excellence (NICE) in theUK, and are required by many managed care plans across the United States.

With three versions, including the latest, Version 2.1 (April 2005), which clar-ified the differences between budget-impact and cost-effective models, theAMCP Guidelines are an invaluable tool for referencing the appropriate stepsto prepare dossiers for submissions. While not mandatory, the AMCPGuidelines are known and followed by many industry professionals for HTAs.

Wellpoint Guidelines (Version 5.1, October 2005) Wellpoint Health Networks, with about 32 million covered lives, is currentlythe largest HMO in the US. The Wellpoint Guidelines establish two sets ofrequirements - one for new products and the other for existing products, aswell as a reevaluation process and guidelines for assessing clinical perform-ance, cost-effectiveness and system impact versus comparators.

Of particular note in the Wellpoint Guidelines is the distinction between newand existing products. The Wellpoint Guidelines call for a reevaluationprocess after several years, which represent a true departure from the AMCPGuidelines and other guidelines' directives.

Seven Key Elements of the Wellpoint GuidelinesEvidentiary and Analytical Standards - While the Wellpoint Guidelines statethat evidence must meet accepted standards, what's of special interest isWellpoint's position that “claims made for treatment effect, cost-effective-ness and budget impact” must be done within the Wellpoint treating environ-ment. This demonstrates that Wellpoint is initiating an analytical standardscomponent, monitoring clinical evidence, cost-effectiveness and budgetimpact over time for verification.

OUTCOMES

Raising the Bar in the USA: The Impact of HeightenedAwareness of the Need for Health-Economic Data in theAbsence of a Regulatory MandateMichael E. Minshall, Principal Health Economics and Outcomes Research, IMS Health®, and Adjunct Professor, Indiana University

School of Medicine, Department of Public Health, Noblesville, IN, USA; and John Watkins RPh, MPH, BCPS, Pharmacy Manager,

Formulary Development, Premera Blue Cross, and Clinical Associate Professor of Pharmacy, University of Washington, Seattle, WA, USA

> FIGURE 1 Wellpoint Evidentiary and Analytical Standards

>


For example, if a company indicates the ICER for a new product is $20,000per life year gained, Wellpoint will revisit this claim in three, four and five yearspans to determine if its standard is met. If not, renegotiations could occurbetween the company and Wellpoint. For pharmaceutical and biotechnologycompanies, this approach suggests that cost-effectiveness claims will needto be reevaluated and verified after a given time period.

Outcomes Assessments - Wellpoint states that “where a previous submissionhas been made detailing the epidemiology of the disease state and the product'splace in therapy, it is important to revisit this claim and confirm its relevance.”This is significant regarding the verification of claims on a cost-effective, budg-et-impact basis. Comparators may “shift” to different products since the firstHTA was performed, potentially requiring pharmaceutical and biotechnologycompanies to run comparative analyses again in three to five years time.

Comparator Therapies - The Wellpoint Guidelines state that companies maybe asked to revisit their choice of comparator if after several years there's adifferent, most-common comparator.

Outcomes Claims - The Wellpoint Guidelines set a “gold standard” withregards to randomized, comparative trials with a randomized, active com-parator, as opposed to randomized controlled trials (RCTs) with a placebocomparator. Additionally, its verbiage “with particular emphasis on welldesigned pragmatic trials and their outcomes” is significant considering thepush by pharmaceutical and biotechnology firms over the last 10 to 14 yearsfor Phase IIIb and Phase IV trials, which are more naturalistic in design.

Quality Adjusted Life Years (QALY) - While the Wellpoint Guidelines do notmandate a generic cost-per-QALY, Wellpoint is encouraging companies topresent this information, which may help bring the U.S. guidelines into align-ment with other global HTA groups, such as NICE and the PharmaceuticalBenefits Advisory Committee (PBAC) in Australia.

New Data/Claims - Wellpoint favors a “Probabilistic Sensitivity Analysis” for-mat related to cost-effectiveness analysis (CEA). This format is well knownto those in the UK and academics in the United States. Many HTA bodiesaround the world require this technique to be used in comparative cost-effec-tive analyses.

Budget Impact Analysis (BIA) - The Wellpoint Guidelines request that manufac-turers “provide forecasts of the impact of the product on resource utilization, thepharmacy budget, the medical budget and the total costs of treating the patientsin that disease or therapy area” and state that Wellpoint will assess such fore-casts as part of ongoing product reevaluation. This is the largest departure oradvance from the AMCP Guidelines and will necessitate extra effort andthoughts around the design, analysis, and interpretation of HTAs.

Centers for Medicare & Medicaid Services (CMS)In the public sector, several significant issues relate to the CMS. Regardingcost effectiveness, a legislative mandate to incorporate HTA into the formu-lary process is possible, but its outcome is unclear at this time. CMS will

likely issue guidance in the next one to two years, but there is no mandato-ry time table.

The role of CEA has long been at issue. In 1989, Medicare formally pro-posed to include CEA as one of several criterions for approving new medicaltechnologies, but was turned away due to tremendous political opposition.Reasons for the failure included:

• Americans desire and appetite for new medical technology,• Distaste for setting coverage limits,• U.S. population's sense of entitlement for Medicare funds,• Wealthy country with a shortage in health care dollars,• Special interest groups with political influence,• A fragmented U.S. health care system with multiple payers.

The Medicare Modernization Act (MMA) of 2003 contains a provision callingon the Agency for Healthcare Research and Quality (AHRQ) to conductresearch on outcomes, comparative clinical effectiveness, and appropriate-ness of healthcare, including prescription drugs.

CMS released a Guidance document on April 11, 2006 on the NationalCoverage Determination (NCD) process stating, “Cost-effectiveness is not afactor CMS considers in making NCDs.” Additionally, MMA contains lan-guage forbidding Medicare from applying a “functional equivalence” stan-dard to drugs or biologic agents, thereby eliminating the concept of “refer-ence pricing” for drugs in the same class, which is widely practiced inEurope.

Finally, CMS encourages the use of data from practical clinical trials. Thisincludes increasing emphasis on health outcomes actually experienced bypatients, such as quality of life, functional status, duration of disability, andmorbidity and mortality, as well as decreasing emphasis on outcomes thatpatients do not experience directly, such as changes in laboratory values,radiographic response, sensitivity/specificity, physiologic parameters, andother intermediate/surrogate outcomes.

Toward More Rigorous Health-Economic Decision-Making: One Payer's ExperiencePremera Blue Cross, a Blue Cross Blue Shield affiliate, is a commercial PPOoperating primarily in the Pacific Northwest and covering 1.6 million lives(1.2 million pharmacy lives). Premera recognizes that HTA is necessarytoday because of rising health care spending as a percentage of US grossdomestic product (GDP) and a realization that this trend simply cannot con-tinue, as it is becoming increasingly difficult for employers to provide fulldrug coverage for their employees.

HTA in the U.S. private sector is extremely varied, however much is beingdone to advance the concept of value-based technology assessment.Compared to Wellpoint, Premera Blue Cross is much smaller and has fewerinternal resources to support HTA, but it deals with the same basic issues.These include data limitations and evidence gaps caused by factors such asethical limitations on study design, industry sponsorship of clinical trials, andthe time and logistics required to conduct large-scale, long-term outcomestudies. To best handle these gaps, most organizations in the U.S. follow apure evidence-based medicine (EBM) doctrine, focusing exclusively on theclinical evidence and often limited to large-scale, well-designed RCTs andrigorous meta-analyses.

Like other organizations, Premera focuses on high-quality, RCT evidence andtries to incorporate best available evidence, which sometimes includes obser-

HTA in the U.S. private sector is extremely varied,

however much is being done to advance the

concept of value-based technology assessment.

Compared to Wellpoint, Premera Blue Cross is much

smaller and has fewer internal resources to support

HTA, but it deals with the same basic issues.


vational study results. Since 2001, Premera has been considering CEA whensuch information is available. Best available evidence implies a willingness totrade a certain amount of rigor for speed. This more pragmatic approachincludes modeling data, CEA and BIA, when reasonable models are available.

Burden of Proof Always Lies with the New TechnologyA cardinal principle of EBM is that the burden of proof always lies with thenew technology. This is contrary to predominant U.S. cultural assumptions.There is a very strong sense in the United States that newer is always better,unless proven otherwise. But in EBM, older is generally better, in that moreis known about the older product, such as its weak points and strengths.Given the choice, Premera will usually choose the proven, older technologiesversus newer ones.

Figure 2 outlines the general thought process Premera pharmacy and thera-peutics (P&T) committee members use to evaluate a new product. Theproduct must be safe, effective and cost-effective for the new technology tobe adopted. The first three steps with drugs are in the realm of Premera'sP&T, an external committee on which no Premera staff are allowed to vote.The fourth step, BIA, is done internally on the business side.

Premera uses the term “value” in its public statements, which essentially isa lay term for incremental cost-effectiveness. If the new product costs morethan the comparator, adoption requires demonstration of a clinically mean-ingful improvement in outcome and offsetting cost savings - usually from thepayer perspective. However, if the new product costs less than the compara-tor, adoption requires a lesser standard of clinical evidence, assuming thereare no hidden costs to offset savings and basic safety and effectiveness areachieved.

Figure 3 outlines Premera's HTA drug review process, which was created forpharmaceutical products. This process is now being expanded to includeother technologies.

Three Examples regarding the Need for Targeted DiagnosticsGleevec (imatinib) and Iressa (gefitinib) - Lowering the number needed totreat (NNT) improves cost-effectiveness. To do this effectively, more respon-sive and sicker patients must be targeted, which becomes increasinglyimportant as the cost of the technology increases.

For example, in the case of Gleevec (imatinib) and Iressa (gefitinib), smallmolecule, targeted oncology therapies, Gleevec came to market with genet-ic markers that identify the responders; Iressa did not. A review of patientswho received each of these drugs through Premera in 2006 found that 364individuals had received Gleevec, while only 11 were treated with Iressa.These numbers suggest that both physicians and payers respond favorablyto specific markers that guide them in patient selection.

Drug Example: Exenatide (Byetta) - Exenatide is a new diabetes drug with acompletely new harmacology. While it is fairly expensive compared to alterna-tives, when Premera first examined it, the company consulted with local opin-ion leaders who thought that it would have a place in therapy but had difficultyin defining the most cost-efficient patient population. To aid in determining themost efficient patient population for treatment with exenatide, Premera utilizedthe CORE Diabetes Model, which was licensed by the drug manufacturer,Amylin Pharmaceuticals. The information Premera sought included:

• What is its place in therapy?- New mechanism, costs more than alternatives- No long-term clinical endpoint trials- Probably a good drug, But for whom?

• CORE Diabetes Model- Markov model structure using Monte Carlo simulation and tracker vari-

ables- Submodels account for comorbidities and interactions between comor-

bidities- Very flexible user inputs for cohort and treatment characteristics

• Test case (Hypothesis: change in patient weight would affect diabetesoutcomes)- Assume cohort on Metformin- Baseline HbA1c = 8.5% + 1- BMI = 35 kg/m2 + 5 (base case = 27.5 kg/m2)- Add exenatide vs. comparator agent or vs. continuing metformin

monotherapy

Exenatide was compared to generic glyburide, which costs about 5%asmuch as exenatide, pioglitazone (Actos), insulin glargine (Lantus), and con-tinuation of metformin. (Note: the metformin only treatment is referred to as“placebo” in Table 1 that follows.)

> FIGURE 2 Premera's Thought Process for Technology Review

> FIGURE 3 Premera's HTA Review Process

>


Table 1 lists the results for the above treatment options, modeled over a 30-year time horizon. All comparisons yielded incremental cost-utility ratios ofless than $50,000 per QALY for all treatments.

Diagnostic Example: Oncotype DX - In this test for early-stage breast cancer,a 21-gene panel gives a risk score that correlates with the likelihood of distant recurrence of disease after surgery.

Details of the test include:• 21 gene diagnostic panel for estrogen receptor positive, node negative

breast cancer- Risk score (range 0-100) predicts likelihood of distant recurrence- Stratified risk: low (<18), med (18-30) high (>30)

• Draft guidance document for dossier submission was provided to themanufacturer• Resulting submission was reviewed for medical policy determination

- Should Premera cover this test?- If so, for which patients?

The proposed rationale for cost-effectiveness is Chemotherapy (CT) avoid-ance in low-risk patients and the basing of treatment strategies on testresults can lead to more informed decisions, improved outcomes and apotential to reduce overall cost of care. In the Premera evaluation, the keyquestion was whether the results would be actionable for providers. WhenPremera consulted the Premera Oncology Advisory Panel, a representativegroup of community-based oncologists, the vast majority of them said theywould probably not advise their patients to forego chemotherapy simplybecause of this test result. As a result of this evaluation, Premera approvedthe test under very limited conditions in a subgroup of patients who wouldbe on the borderline and for whom the test might actually make a difference.This exercise reaffirmed the principle that test results must be actionable inorder to be eligible for coverage.

SummaryThe United States is moving, albeit slowly, towards some type of national-ized, cost-effectiveness requirement. What form that takes, whether it will bea QALY format or straight mortality, is unclear at this time. Moreover, it is

highly likely that the requirements for private payers and public payers willremain disparate and a multi-faceted approach to value determination willremain a necessity in the US marketplace for manufacturers.

CEA will be rated at varying degrees of importance by major coveragegroups in the United States, including: the private sector, with HMOs andPPOs; the public sector, with the CMS and government systems; and fee forservice, which is a smaller part. It's inevitable that CMS becomes moreinvolved in HTA processes. As part of the MMA of 2002, the U.S. Congressmandated that CMS incorporate a technology assessment process based oneconomics. Since CMS oversees a tremendous part of the medical marketin the United States, CMS can be considered a “bell-weather” entity thatother groups may follow in both the public and private sectors; however, onlytime will tell.

It may take many years for the United States to achieve a nationalized, cost-effectiveness requirement, and the country may never get there. The UnitedStates spends about 14% of its GDP on healthcare, a tremendous part of itsentire GDP, and there are many competing interests with input into theprocess. In short, a great number of people have a say about what happenswith U.S. health care dollars.

> TABLE 1 Exenatide vs. Treatment Alternatives

IC

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The documentary film Sicko by Michael Moore gives us a very grim insightinto the American health care system. A variety of individuals speak to the

audience, all of them having major problems as necessary health care serv-ices (like bone marrow transplantation) were denied to them by their healthcare insurances in the past. The more urging problem in the United States,namely its over 45 million uninsured citizens is very strikingly represented bya man stitching an open wound on his leg by himself just like SylvesterStallone already showed us some 25 years ago in the film “Rambo: FirstBlood”. Seeing all the sad and horrible cases some of the American viewersmay very well lower their heads in shame, some may be outraged. For oth-ers it also may only be an anecdotal line up of short glimpses at countriesaround the world with a more or less 'socialized medicine'.

But one question remains: Do Europeans smile while watching this film?

Michael Moore has not been known in the past to present a completely bal-anced and unbiased picture of the given situation. He intelligently uses fastcuts and a satirical undertone while commenting the pictures we see on thebig screen. In doing so he plays with the emotions of the audience aiming toreach his goal of gaining attention for a specific element going wrong in theongoing development process of the American society. In this film especial-ly Europeans are attracted to the content because Moore goes oversees toFrance and the UK to search for the Holy Grail in solving the problems of theUS health care system. As much as we Europeans would like to sit backknowing that we possess this final recipe for the perfect health care system,we have to reflect for one moment if we actually are entitled to laugh and topoint our finger over the Atlantic.

The image of the American health care system sketched in the film needs asecond look at. It is true, that the health care market in the US compared toother industrialized countries is the one with the highest rate of un- or under-insured citizens, having in mind that over 15% of the American public isaffected by this. Adding to that, in the European understanding of the phrase'health insurance' this figure definitely will be much higher. Even public cov-erage schemes like Medicaid or Medicare bear a high financial risk topatients, as drug costs and co-payments may be substantial. On the otherhand one has to keep in mind that the US health care system has high inher-ent innovative powers and a high rate and speed in the diffusion of treatmentinnovations. So it may be that the overall life expectancy, which often is citedin the film, isn't as high as in most European countries (but as in Cuba look-ing at WHO figures), on the other hand the survival rate after cancer treat-ment rather might be higher. Furthermore, the majority of developments inorganizational or funding issues in health care finally are to some extent root-ed in the US market. Topics from recent European history include diseasemanagement programs for chronic conditions, managed care or integratedhealth care concepts. Another example is diagnosis related group (DRG) sys-tems for hospital services which were enacted in most European counties(like Germany) very recently. Europeans, especially German health politi-cians, tend to look exclusively to the US for new concepts having cost con-tainment in the back of their head. The United States in the 80’s and 90’s

undoubtedly was the laboratory for new health care concepts for the rest ofthe world.

The multilayered structure of the US health care market makes it a very com-petitive system, which is good, speaking as a health economist. But it alsobecomes very non-transparent to consumers and the general public. Thisproblem is touched by Moore when he presents the tragic case of a motherloos-ing her young daughter after urgent treatment is denied by a hospitalonly because the health insurance insists on referral to another hospital thecompany has a contract with. This case cannot be typical and must not hap-pen in the US simply because any hospital is obliged to offer life-saving serv-ices regardless of insurance coverage. Showing this as an example of profitmaximizing insurance companies is unfair, since this simply seems to be asound legal case the mother should fight in the name of her daughter. Onething this example does make crystal clear to a European, is that, in the US,not every hospital or physician is there to treat every single citizen. We aresimply not used to the idea to be only entitled to go to those service providersour health insurance has a contract with. This non-transparency would pres-ent a major problem in our perception of the system as a whole.

One approach to tackle non-transparent treatment processes is to base deci-sions on treatment alternatives on scientific medical and health economicevidence and research. This trend has been and will be one of the mostimportant political topics in Europe and definitely will be one of the topics inthe US in the coming years. Some patients in the film do not receive specif-ic treatments because supposedly no efficacy has been shown by scientificresearch up to that point. The assessment if there is scientific proof or not isvery problematic in the hand of a single employee of an insurance, especial-ly if this employee has an incentive to deny treatments simply because hecan raise his salary by doing so. But looking at medical benefits as well ascost benefit ratios has been and must be an issue not only in Europe becom-ing more and more attractive in a world with budgetary constraints whereeverybody has the vision of 'value for money'. For some treatments someEuropean countries (e.g. drugs for loosing weight in obese patients) reacheddifferent conclusion for their decision on re-imbursement. This urges theneed for every health care system to evaluate innovations within its specificcontext and to define an optimal level of 'adequate' health care.

Looking over to Europe, Moore speaks with an English hospital physicianwho explains that he chooses a therapy only looking at the specific healthcare need of a patient and not at funding issues. The film is blanking out thelong and painful time period the National Health Service (NHS) fought withsubstantial under-funding making no investments in the infrastructure. Thesedays' problems with e.g. waiting lists for treatment are not so huge any moreand salaries of physicians have gone up. To reach this goal Great Britain hadto reach a broad societal consensus to spend a higher proportion of tax rev-enues on health care. This process was furthermore aided by the fact thatGreat Britain was lucky to find itself in an economically prosperous phase. Ifthe stream of financial resources continues to flow in a recession stillremains to be seen.

POLICY ANALYSIS

Commentary: Reflections on 'Sicko' by Michael Moorefrom a European Point of ViewWolfgang Greiner PhD, Health Economist, University of Bielefeld, Bielefeld, Germany, and Thomas Mittendorf PhD, Health

Economist, University of Hanover, Hanover, Germany

>

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In wrapping things up, what implications does this filmhave to a European audience? We have the fear that a lotof Europeans only will experience a comforting but creepysensation looking at this bizarre health care system whichluckily seems to be very distant from ones own experi-ence and beliefs. But we shouldn't make ourselves toocomfortable in our cinema seat: An orientation of theEuropean health care systems towards a more competi-tive approach seems inescapable with a much worsedemographic change in Europe than in the United Statesas well as rising costs for health care due to the progressin medical technology. The vision at the end of the movieeverybody should be nice and help one another and notonly look at financial profits definitely cuts a long story tooshort. Individuals who use wrongly set incentives withinthe system for their own advantage exist everywhereregardless of the underlying system. The conflict of goalsbetween general (and affordable) health care for all and ahealth care system that searches for efficiency via sub-stantial competition between its participants is not solvedas easily as Moore implies with his film.

With this in mind the scarecrow of 'socialized medicine'existing in all its different facets in Europe surely is not theHoly Grail for the US as their health care system isn't theone and only blueprint for health care systems in Europe. IC

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ISPOR CONNECTIONS Editorial Policy


ISPOR Vision Implementation• To address new initiatives identified at the2007 ISPOR Leadership Retreat:

Research Excellence: the Health SciencePolicy Council should consider the following top-ics in the development of new ISPOR initiatives[comparative effectiveness; methods for extrapo-lating beyond data (lifetime) and validating phar-macoeconomic models; better analysis of co-morbidities & impact of disease; developing aninventory of methods from other disciplinesincluding partnering with other disciplines;patient advocacy council]

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ISPOR CONNECTIONS, the following benefitswere approved for the ISPOR CONNECTIONSEditor-in-Chief: complimentary registration forthe ISPOR Annual International Meetings andAnnual European Congresses and travel reim-bursement per ISPOR Travel ReimbursementPolicy and hotel room reimbursement for 4 days.• The Board approved that annual meeting /congress invited issue panelists and moderator(except individuals employed by industry)receive a complimentary registration, hotel room(one night stay for intra-continental and twonights for transcontinental travel), travel expensereimbursement per ISPOR TravelReimbursement Policy.• The Board confirmed the appointment ofKaren Rascati as the 2007-2010 ISPORTreasurer.

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Award Actions: • The ISPOR International Fellowship Awarddescription, nature of the awards, awardrequirements, selection criteria, and selectionprocess were approved including a follow-upreport after the Fellowship experience and 2years later.• The Board recommended that “financial needmay be considered” is added to the selectioncriteria for the ISPOR International FellowshipAward.

• The deadline for candidate submission for theISPOR International Fellowship Award ischanged from September 30th to November30th of each year.• The Board approved Dr. David Eddy as the2007 Avedis Donabedian Lifetime AchievementAwardee, Dr. Todd Lee as the 2007 Bernie J.O'Brien New Investigator Awardee; the ISPORBoard of Directors Service Awardees (PeterNeumann, 2005-2006 President; Joyce Cramer,2005-2007 Director, Scott Ramsey, 2005-2007Director; Lorne Basskin, 2004-2007 Treasurer)and the ISPOR Distinguished Service Awardees(Scott Ramsey, 12th Annual InternationalMeeting Program Committee Chair; MichaelBarry and Michael Drummond, 10th AnnualEuropean Congress Program Committee Chairs;Joyce Cramer, ISPOR Medication Complianceand Persistence SIG Chair; and the 2006-2007ISPOR Student Chapter Presidents); the recipientof the 2007 ISPOR Research ExcellenceAwardee in Methodology Anirban Basu, PhD, forhis paper "Scale of Interest vs. Scale ofEstimation: Comparing Alternative Estimators forthe Incremental Costs of a Co-morbidity," HealthEcon 2006:15:1091-107; and the recipient ofthe 2007 ISPOR Research Excellence Awardeein Practical Application John Hsu MD, MBA,MSCE for his paper "Unintended Consequencesof Caps on Medicare Drug Benefits", N Engl JMed 2006;54:349-59. • The Board approved that the Value in HealthCo-editors, with 4 or more years of service andwho have resigned or whose term has ended,receive an ISPOR Distinguished Service Awardduring the Annual Meeting Awards Program• The Board approved that the Chair and Vice-Chair of the ISPOR 1st Latin AmericaConference, Diana Pinto and Rafael Alfonso, asrecipients of the ISPOR Distinguished ServiceAwards.

ISPOR CORNER

Boards of Directors Take Action in 2007Marilyn Dix Smith PhD, ISPOR Founding Executive Director

ISPOR 2006-2007 Board of Directors (June 1-December 31, 2007): President - Michael Drummond, PhD, University of York; Past- President - Peter J.Neumann, ScD, Tufts University School of Medicine; President-elect - Diana Brixner PhD, University of Utah, College of Pharmacy; Directors - Joyce Cramer,Yale University School of Medicine; Scott Ramsey, MD, PhD, Fred Hutchinson Cancer Research Center; Shu Chuen Li PhD, National University of Singapore,Department of Pharmacy Science; Uwe Siebert MD, ScD, University of Health Sciences, Medical Informatics & Technology; Marc Berger MD, OutcomesResearch & Management, Merck & Company, Inc.; Treasurer- Lorne Basskin, PharmD, Healthsouth Sunrise Rehabilitation Hospital; Executive Director - MarilynDix Smith, RPh, PhD, ISPOR.ISPOR 2007-2008 Board of Directors (July 1-December 31, 2007): President - Diana Brixner PhD, RPh, University of Utah, College of Pharmacy, President;Past-President - Michael Drummond, PhD, University of York; President-elect - Chris L. Pashos, Abt Associated, HERQuLES; Directors - Marc Berger, MD, EliLily and Company; Lou Garrison, PhD, University of Washington; Shu Chen Li, PhD, University of Newcastle; Uwe Siebert, MD, ScD, University of HealthSciences, Medical Informatics & Technology; Richard Willke, PhD, Pfizer; Treasurer-Karen Rascati, PhD, RPh, University of Texas; Executive Director - MarilynDix Smith, RPh, PhD, ISPOR.

The ISPOR 2006-2007 and 2007-2008 Boards of Directors had yet another busy year in 2007. The Boards met six times (4 teleconferences and 2 face-to-facemeetings). The Board approved the following:

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ISPOR CORNER

ISPOR Board of Directors Elections 2008


The International Society for Pharmacoeconomics and OutcomesResearch is a member-driven organization. Your participation is critical.

The activities of the organization are response to member needs. As a mem-ber-driven organization, its governance is determined by the membership.

The ISPOR BOARD OF DIRECTORS is responsible for the general supervisionand management of the Society. The Board of Directors consists of theOfficers (President, President-Elect, Immediate Past President) and now

seven Directors. The term of office is July 1 to June 30. The term of officefor the President is one year. The term of office for the Directors is two years.In this election, the president-elect (term of office: president-elect 2008-2009 and as president 2009-2010) and five Directors' term of office will beelected.

The Nominations Committee has paired the Director positions to assure abalanced representation of the ISPOR membership on the Board of Directors

Publication - Value in HealthActions:• The Board supported the recommendations ofthe Value in Health Management Advisory Boardthat Value in Health Editor-in-Chief, Editorial(Co-editors) Board, and Editorial Advisory Boardpolicies and procedures are developed to defineresponsibilities, term and criteria for termrenewal. The Board also recommended that co-editors receive a financial reward if 80% of thetime to first decision is <30 days each year;provide honorarium to reviewers and providefinancial rewards to reviewers if the review iscompleted in < 30 days.• The Board approved the Value in HealthEditor-in-Chief, Editorial Board, and EditorialAdvisory Board polices & procedures.• The Board approved the Value in HealthEditorial Board (Co-Editors) purpose, term, andresponsibilities• The Board approved the Value in HealthEditorial Advisory Board purpose, term, andresponsibilities.• The Board agreed with the increase in thenumber of co-editors from 11 to 12 as recom-mended by the Editor-in-Chief.• The Board approved Andrea Manca, PhD, SeniorResearch Fellow, Centre for Health Economics,University of York as Value in Health Co-editor.• The Board approved Paul Schuffham as aValue in Health Co-editor.

Publication - ISPOR CONNECTIONSActions:• The Board approved Thomas Mittendorf PhD,MSc, Universität Hannover, Hannover, Germanyand David Thompson PhD, Vice President,Global Health Economics, Medford, MA, USA as2008-2012 Co-Editors-in-Chief for ISPOR CON-NECTIONS. The Co-Editors-in-Chief, along withcurrent Editor-in-Chief Steven Marx, and ISPORCONNECTIONS Managing Editor, Stephen Priori,will develop the roles of each Editor-in-Chief.

Organizational/Policies andProcedures Actions:• The Board approved that the number ofDirectors on the Board of Directors is increased

from 5 to 7 Directors and the NominationsCommittee is responsible to assure that theBoard is a balanced representation of the ISPORmembership with respect to education, profes-sional interests, work experience, geographiclocation, and gender.• The Board approved the policies and proceduresfor the ISPOR Health Science Policy Council.• The Board approved the policies & proce-dures for formation and naming of a task force.• The Board approved the 2007-2008 Boardsub-Committee chairs and members.

Meeting Actions:• The ISPOR Annual Meeting/Congress ProgramCommittee Chairs Standard Operating Procedure(SOP) was approved with the recommendationthat in a teleconference, ISPOR staff, using theSOP questionnaire, interview and summarize theProgram Committee Chairs issues and sugges-tions for improving the ISPOR Annual Meetings.It was suggested that the next year's ProgramChair(s) also attend this teleconference.• The Board acknowledged the new category ofabstract submissions for the ISPOR 12th AnnualInternational Meeting - Case Studies in HealthCare Decision using Costs and OutcomesResearch Data. This initiative is to address theVision 2010 goal to reach out to health caredecision-makers [i.e.:. .include individuals inter-ested in the use of information on the costs andconsequences of health care interventions aswell as the processes by which health caredecisions are made]. These case studies are tobe submissions from health care decisionmaker that describe situations where organiza-tions attempted to integrate cost and outcomeinformation into their processes and proce-dures. Submissions describing successes,works in progress, or failures are encouraged..

Special Interest Group/Committee/Task Force/Council/Consortium Actions:• The Board approved Patient ReportedOutcomes (PRO) Good Research Practices TaskForces to address the following topics: Use ofExisting PRO Instruments and their Modification,PRO Instrument Creation, Changing Culture or

Language of PRO Application, Changing Modeof Administration of PRO Instrument includingePRO, and Development of PRO Instruments forChildren and Youth as recommended by theHealth Science Policy Council.• The Board endorsed the ISPOR FellowshipStandards Task Force initiative of publishingguidelines for groups interested in developingpost-graduate pharmacoeconomic fellowshipprograms and for students interested in pursu-ing such programs; 2) encouraged the collabo-ration of ISPOR Fellowship Standards TaskForce with the American College of ClinicalPharmacy in the development of a joint state-ment to be published in Pharmacotherapy; and3) recommended that the Task Force considersubmitting a Letter to the Editor to Value inHealth referencing the Pharmacotherapy article.[Note: An article on the PharmacoeconomicFellowship Guidelines could also be published inISPOR CONNECTIONS and at the ISPOR websitewith a link to Pharmacotherapy. It was also sug-gested that an article on historical trends in thetypes of training & implications for outcomesresearch would be of interest.]• The Board approved a RetrospectiveDatabase Good Research Practice Task Forcewith the goal to define good research practicesfor longitudinal data analysis with time-varyingmeasures including time-dependent confound-ing variables and ensure internal validity andimprove causal inference from observationalstudies using retrospective databases.• The Board approved that the Health CareStrategy Council is renamed the HealthTechnology Assessment Council to be consis-tent with current initiatives of the Society andthat this Council continue to address the missions as stated at: http://www.ispor.org/councils/HTA_council.asp

ISPOR Comments on Public Policy:• The Board approved that ISPOR provide comments to the EUnetHTA Core Model. In thisapproval the Board is not supporting any specif-ic recommendation, but the process of provid-ing comments to EUnetHTA. The approvedISPOR Letter of Comments and the EUnetHTAHTA Core Model is at: http://www.ispor.org/workpaper/ispor_comments/index.asp.


Michael Barry MD, PhD, FRCPI For 10 years Dr. Michael Barry has been a Consultant ClinicalPharmacologist and Senior Lecturer in Clinical Pharmacologyat the University of Dublin, Trinity College, Dublin, Ireland, andhead of the Irish National Centre for Pharmacoeconomicswhich advises the Department of Health in relation to the pric-ing and reimbursement of pharmaceuticals in addition to con-ducting health technology assessments (HTAs). Dr. Barry has served on national advi-sory groups and is a board member of the newly formed Health Information & QualityAuthority (HIQA) whose remit includes HTA.

As a clinician he works at St. James's Hospital, Dublin performing both inpatientand outpatient duties. He runs weekly clinics in cardiovascular and internal medicineand lectures on clinical pharmacology and internal medicine to undergraduate medicalstudents at Trinity College. As a Royal College of Physicians of Ireland specialist train-er, he is actively involved in post-graduate medical teaching. He has been chair of localresearch ethics committees.

Dr. Barry, a graduate of University College Cork, Ireland, qualified in medicine in1984. He obtained a 1st honours BSc degree in pharmacology in 1981 and complet-ed a PhD in pharmacology at Trinity College in 1990. He became a member and Fellowof the Royal College of Physicians of Ireland in 1988 and 1995 respectively. Prior tohis current post, Dr. Barry was Consultant Pharmacologist and Senior Lecturer at theUniversity of Liverpool, UK, from 1990 -1998.

He has over 100 peer-reviewed publications on clinical pharmacology, generalmedicine, HTA and pharmacoeconomics. Recent publications relate to the cost effec-tiveness of universal hepatitis B and pneumococcal vaccination strategies in the Irishhealth care setting. As a member of ISPOR he co-chaired the 10th Annual EuropeanCongress held in Dublin in October 2007.

ISPOR Vision Statement by Michael Barry MD, PhD, FRCPIThe 10th Annual European ISPOR Congress in Dublin 2007 hailed the health technol-ogy assessment (HTA) “revolution” and a future of great promise for our discipline.Any vision for ISPOR must continue to place scientific excellence at its core as quali-ty science is essential for the continued success of this international society. Comingfrom a country that has recently embraced HTA, certain challenges are evident, andthese shape my vision for ISPOR. I have little doubt that “capacity” is one of the majorissues and a rate-limiting step. Therefore ISPOR should continue to identify, encour-age and support the training and development of the next generation of researchers inpharmacoeconomics and outcomes research. The support of regional ISPOR groupswould provide the organisational structure to deliver on this vision, particularly in theresource limited setting.

In Ireland working closely with decision-makers frequently translates our work intohealth policy bringing pharmacoeconomics 'to life' once again highlighting the impor-tance of engaging decision-makers who still number too few in our organisation. Asthe largest net exporter of pharmaceuticals worldwide, we appreciate the balancebetween achieving value for money and supporting industry innovation; hence animportant component of my ISPOR vision is continuing our development of a multidis-ciplinary society. This includes reaching out to fellow clinicians who may not alwaysembrace our ideals.

Following the ISPOR European Congress in Dublin, I have witnessed the significantimpact on all stakeholders across the country and such meetings are central to myvision for ISPOR. An essential component to deliver on any ISPOR vision is the excel-lent ISPOR team who I came to know very well whilst co-chairing the Dublin meeting.The prospect of working with such colleagues and fellow members in contributing tothe future of ISPOR is a real honour for me.

Lorenzo Giovanni Mantovani PhDLorenzo Giovanni Mantovani was born in Milan, Italy. CurrentlyDr Mantovani is Director of CIRFF, Center of Pharma-coeconomics, Federico II University of Naples, Naples, Italy. Hewas Director and Co-founder of the Center of Pharmaco-economics of the University of Milan. He has been coordinatorof the Master of Science in Pharmacoeconomics since 2001.

Dr. Mantovani holds a Degree in Economics from Bocconi University of Milan, Italy.He has a Doctor of Science in Epidemiology from Erasmus University of Rotterdam,the Netherlands, and received the ISPOR Distinguished Service Award in 2005 for hisservice to ISPOR as the ISPOR 8th Annual European Meeting Program Committee Co-chair. The main interests of Lorenzo are the economic and outcomes evaluation in rarediseases, especially haemophilia, and, in general practice, with a focus on evaluationof adherence and persistence to chronic therapies. He is member of the HaemophiliaInternational Prophylaxis Study Group, of the European Heamophilia TherapyStandardisation Board, and Coordinator of the Health Economics Committee of theItalian Society of General Practice. Lorenzo was President of the Italian Group forPharmacoeconomics Studies Executive Board (2002-2004).

He is field editor for pharmacoeconomics for the journal, PharmacologicalResearch. He is author or co-author of more than 90 papers published on several jour-nals including Value in Health, Pharmacoeconomics, Blood, European Journal ofCancer, Human Reproduction, European Heart Journal, American Journal of KidneyDiseases, Canadian Medical Association Journal, Haemophilia, Journal ofHypertension, Allergy.

Beyond his academic activity, Dr. Mantovani is advisor for pharmacoeconomics forseveral Italian regional health authorities, covering more than 16 millions enrollees.Within this activity he is co-founder of DENALI, a data warehouse project collectingand managing health care events of more than 9 millions citizens of the Lombardyregion in Italy.

ISPOR Vision Statement by Lorenzo Giovanni Mantovani PhDIn recent years ISPOR has invested much energy into scientific development, and into thefurthering of scientific understanding among members. While these efforts are acknowl-edged within the society, they are not fully recognised by decision-makers at large.

The ISPOR name quite literally stands for the synthesis of evidence related to costs,clinical effects, and the health status of patients as follows: Costs: a major consider-ation for healthcare providers and payers; Clinical Effects: the primary focus for clini-cians; Health Status: the foremost concern of patients. We must assert our collectiveknowledge and experience of these three domains, and of the interconnectionsbetween them. In order to fulfil the ISPOR mandate, we must become more visible,more credible, and more influential within national and international healthcaredebates. This is fundamental to ISPOR's existence. To achieve this we must furtherdevelop our collaborations with the three key decision-making bodies: 1) clinical decision-makers; 2) payers; and 3) patients.

ISPOR and its members can be the catalyst that brings these three stake-holderstogether, with ISPOR acting as a developer, guardian and guarantor of methods. It ismy vision that ISPOR should tighten its educational and research links with other med-ical scientific societies, with national/regional and local payers' associations, and withpatient advocacy groups. Joint sessions at major conferences, and multidisciplinaryresearch groups, can be the starting point to raise the ISPOR profile, and to developcommon dialogue with those who can benefit from the message of ISPOR and itsmembers.

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PRESIDENT-ELECT CANDIDATES

and to complement the professional and experience backgrounds of theincumbent Board members. The candidates for the Board of Directors bringdiverse professional training and work experiences in clinical practice, out-comes research, health economics, pharmacoeconomics, and health tech-nology assessment from the United States, Canada, Europe, and Asia.

You, as an ISPOR member, have an opportunity to choose the leadership ofthis organization from the distinguished candidates.

MAKE YOUR VOICE HEARD. PLEASE VOTE.

YOUR BALLOT MUST BE RECEIVED BY April 4, 2008

To vote, go to the ISPOR website at: www.ispor.org


Dyfrig Hughes BPharm MSc, PhD,MRPharmSDr. Dyfrig Hughes is Senior Research Fellow inPharmacoeconomics and Deputy Director of the Centre forEconomics and Policy in Health, Bangor University, Bangor,Wales. He was previously at the University of Liverpool,where he was lecturer at the Department of Pharmacologyand Therapeutics. He is a pharmacist and pharmacologist by training, havingcompleted his PhD in cardiovascular pharmacology. He was subsequentlyawarded a National Health Service Post-Doctoral Fellowship in Health Economics,and gained an MSc in Health Economics at the University of York.

His research interests include the assessment of the impact of non-compli-ance on the effectiveness and cost-effectiveness of pharmaceuticals, and eco-nomic evaluations of medicines and of pharmacogenetic testing. Dr. Hughes hasauthored or co-authored over 60 articles and book chapters, including 20 phar-macoeconomic assessment reports that have directly informed national policy.He received the 2004 Galen Award from the Royal Pharmaceutical Society ofGreat Britain for pharmacy practice research.

Dr. Hughes is a member of the National Institute for Health and ClinicalExcellence (NICE) technology appraisal committee, and Deputy Health Economistfor the All Wales Medicines Strategy Group. In addition, Dr. Hughes is a memberof the British Pharmacological Society and the International Health EconomicsAssociation, as well as a frequent reviewer for peer-reviewed journals in healtheconomics, clinical pharmacology and health services research. He serves onthe editorial boards of the journals PharmacoEconomics and Pharmaco-epidemiology & Drug Safety.

Dr. Hughes is an enthusiastic member of ISPOR and has contributed to theSociety's activities in many capacities, including Chair of the ISPOR MedicationCompliance and Persistence Special Interest Group (SIG). He previously chairedthis SIG's Economics of Compliance & Persistence Working Group, and has con-tributed to the work of the ISPOR Drug Costs Standards Task Force.

ISPOR Vision Statement by Dyfrig Hughes BPharm MSc PhD MRPharmSISPOR's vision for 2010 includes building on past achievements by reaching outto existing and new members to enhance its reputation through education, fos-tering of research and growth. As an ISPOR Board member, I will take an activerole to help ISPOR achieve the excellence for which it stands.

As a member of two national health care decision-making bodies, I am onlytoo aware of the importance of pharmacoeconomic evaluations and patient-reported outcomes in informing challenging decisions on health technologies. Inthe cost-conscious world that we live in, a greater understanding of the conceptsand methods involved is essential. For non-specialists, and for professionals incountries with less experience in these fields, ISPOR can play a leading role, andI will prioritise education by promoting the expansion of our local chapters, shortcourses, student networks, and workshops.

I have a track record of leading international collaborative research throughISPOR's Special Interest Groups. The Medication Compliance and PersistenceSIG has become the most active of ISPOR's SIGs, with over 40 members, sever-al publications in Value in Health, and a number of ISPOR presentations andworkshops. ISPOR's SIGs are an excellent platform for fostering research excel-lence, and promoting collaborations. I will encourage the development of newSIGs wherever possible.

I am delighted to have been nominated as a candidate for the ISPOR Board ofDirectors, and if elected, I will strive to achieve ISPOR's vision for the future, andserve its members honourably.

Paul Kind Paul has a wide-ranging, multidisciplinary background anda research career that spans more than 30 years duringwhich he has majored in the development and applicationof health status measures for use in clinical and economicevaluation. Paul combines academic research with consul-tancy in the field of health-related quality of life measure-ment. He has provided expert advice to government, international agencies andthe pharmaceutical industry throughout the world. Until this year, he wasProfessor of Health Economics in the Centre for Health Economics at theUniversity of York, York, UK and Principal Investigator in the Outcomes ResearchGroup, but has taken early retirement to concentrate on his consultancy, QualityOutcomes, and its specialist services for the pharmaceutical industry. He hasheld a number of academic positions across Europe and North America, includ-ing at the University of Uppsala, Sweden, McGill University, Montreal, Canada,and the University of Wisconsin, Madison, Wisconsin, USA. He has been a fac-ulty member of the Netherlands Institute for Health Sciences and an HonoraryFellow of the National Centre for Quality of Life Research, St. Petersburg. He hasbeen an elected Board member of ISOQOL and played an active part in the for-mation of the ISPOR Quality of Life Special Interest Group, receiving aDistinguished Service Award in 2001. He was ISPOR's representative on the FDA“Harmonisation” Project that established the PRO. Paul is a regular contributor toISPOR meetings in Europe and the US, having first presented at APOR,Philadelphia in 1997. He has participated in regional ISPOR meetings in Russia,South America, and China. Paul is a Founder Member and past-President of theEuroQoL Group and was centrally involved in the development of EQ-5D.; he cur-rently Chairs the EuroQoL Group's Scientific Executive Committee. He serves onthe editorial advisory boards of several academic journals including Value inHealth and PharmacoEconomics.

ISPOR Vision Statement by Paul KindISPOR is now the leading organisation in the field of outcomes measurement,representing a natural locus between health care decision-makers, policy ana-lysts and research scientists from both the public and private sectors. For thoseof us who recall the pre-ISPOR days, there has been a considerable shift in itsstructures, processes and outcomes. APOR (the original name of our Society)naturally attracted a largely US membership with pharmacy or industry back-ground. As the rebranded International Society, ISPOR sought to widen its geo-graphical catchment area to embrace a worldwide audience - an objective thathas been emphatically achieved. The ISPOR Annual European Congress nowcompetes in scale with the ISPOR Annual International Meeting held in NorthAmerica; regional meetings provide access to a global membership. By wideningthe scope of the research, applications and methods that are recognised throughits programme of meetings, ISPOR has moved away from its original pharmaceu-tical base. Diagnostics, devices and other technologies now form a legitimatepart of the ISPOR mainstream. This is not a rejection of the past - merely a reflec-tion of a future in which research methods and their implementation have grownbeyond the boundaries of pharmacoeconomics.

For ISPOR to maintain its lead role it must continue to foster the practice ofhigh quality science and the communication of that product to patients, providersand other relevant stakeholders - including national governments. It is not enoughto undertake technically competent work - having a leadership role means inter-preting that knowledge for a wider, non-technical audience. That ethos extends tothe creation of an internationally recognised curriculum that ensures new entrantsto the field are properly qualified to meet the standards we have set. I wouldmake the achievement of these goals my personal priority and would be hon-oured to serve on the Board if so elected by the Society's membership.

CANDIDATES FOR DIRECTOR (POSITION 1)


Penny Mohr MAPenny Mohr, MA, is the Director of the Division of Researchon Health Plans and Drugs within the Office of Research,Development, and Information at the Centers for Medicareand Medicaid Services (CMS), Baltimore, MD, USA. Thedivision is responsible for conducting research and over-sight of demonstration evaluations per taining to theMedicare prescription drug benefit, Medicare managed care, and the end-stagerenal disease program. In addition to her management responsibilities, Ms. Mohrserves as a technical authority within the Agency on issues pertaining to theadoption, diffusion, and cost-effectiveness of health care technology in theMedicare program. She is a member of CMS' Council for Technology andInnovation, charged with coordinating coverage, coding and payment processesfor new medical technologies, as well as promoting the exchange of informationon new technologies between CMS and other entities. She holds advisory boardpositions on the National Institute of Diabetes, Digestive and Kidney Diseases' USRenal Data System, the American Journal of Managed Care, and Tufts-NewEngland Medical Centers' Center for Value and Risk in Health Care, and serveson the Steering Committee for Academy Health's economic interest group.

She has been a member of ISPOR for eight years, and is the Issues PanelReview Committee Co-chair for the upcoming ISPOR 13th Annual InternationalMeeting in Toronto, Canada. Prior to joining CMS, she was a Senior ResearchDirector at Project HOPE's Center for Health Affairs, and outcomes research man-ager at MedSTAT, where she pursued longstanding interests in medical technolo-gy policy and cost-effectiveness research. She has published widely on a vari-ety of health services research topics. Pertinent to this society, Ms. Mohr hasextensive international experience, having worked in more than a dozen countriesin Africa, Asia, the Caribbean, South America, and Eastern Europe. Ms. Mohrreceived a Master's degree at the University of Sussex, England where she stud-ied economics.

ISPOR Vision Statement by Penny Mohr, MAThe rapid growth of ISPOR's membership is testament to the central place it hasassumed among pharmacoeconomics and outcomes researchers, and I am hon-ored to have been nominated to serve on its Board of Directors. Since ISPOR'sinception, I have seen continual improvement in the scientific rigor of articlespublished in its journal, Value in Health, and the caliber of presentations andkeynote addresses at its meetings. ISPOR has also been successful in helpingto enhance the scientific methods underpinning outcomes research, and educat-ing its membership about cutting-edge techniques to measure the comparativevalue of medical technology. I would like to see continuing improvement in theseareas, particularly in the quality of the peer review process for its scientific meet-ings, which is essential for its credibility.

ISPOR has not performed as well in reaching out to decision and policy-mak-ers, although this is part of the organization's long-term vision. Users of out-comes research, including physicians, managed care representatives, and gov-ernment decision-makers still represent only five percent of total membership. Ifthe ISPOR membership were to elect me to the Board, my key focus would be toexpand ISPOR's global reach among decision and policy-makers. I would encour-age the Society to increase its efforts to engage in meaningful dialog betweenindustry, researchers, and decision-makers, enhance the ways in which researchcan be translated into practice, and become an essential reference for policy-makers interested in comparative effectiveness research. My previous involve-ment in organizations such as the International Society for TechnologyAssessment in Health Care, which attracted a high proportion of public policy-makers, past experience conducting outcomes research for private industry, andcurrent position working within the federal government afford me unique perspec-tives that can help ISPOR bridge the communication gap between research andpolicies relating to medical technology.

Dennis W. Raisch, PhD, RPhDennis W. Raisch, PhD, RPh is Associate Center Director forScientific Affairs at the Veterans Affairs (VA) CooperativeStudies Program Clinical Research Pharmacy (CSPCRP)and Research Associate Professor at the University of NewMexico College of Pharmacy, Albequerque, New Mexico,USA. After practicing as a hospital pharmacist for nineyears, he earned his Masters and PhD degrees from University of Arizona. As afaculty member of the University of New Mexico, he teaches graduate and under-graduate courses and mentors graduate students. He developed and supervisesa post-graduate pharmacoeconomics research fellowship at the VA CSPCRP.

His research endeavors involve performing health services research, assess-ing adverse drug reactions, and providing pharmaceutical support for large,multi-center clinical trials. He participates on numerous national and internation-al clinical trial executive committees. Currently, he is performing retrospectivepharmacoeconomic research of drug therapies using the national VA databasesand collaborating with the Research on Adverse Drug Reactions and Reports(RADAR) team. RADAR's primary research objective is to identify, assess, anddescribe rare, serious adverse drug reactions. He has numerous scientific pre-sentations and over 75 research publications.

As an ISPOR member since 1998, he has served as a member of the Legislativeand Governmental Affairs Committee, the Heath Care Strategy Council, and theConsensus Development Workshop “Building a Pragmatic Road Forward: An ISPORWorkshop on the Future of the QALY”. In 2005, he received an ISPOR DistinguishedService Award for coordinating the development of the ISPOR Managed CareResearch Digest, which was accomplished through the ISPOR ManagedCare/Pharmacy Benefits Management Special Interest Group. Since 2004 he haschaired the Risk Benefit Management Special Interest Group (RBM-SIG). The RBM-SIG conducted a members-based risk/benefit of medications survey, published inISPOR CONNECTIONS and presented at several ISPOR Annual meetings. He is alsoco-faculty of an ISPOR Short Course on risk-benefit management.

ISPOR Vision Statement by Dennis W. Raisch, RPh, PhDISPOR is an organization that has incredible insight into the future of patient out-comes research and its application in health care delivery and decision-making.This strength is related to the diversity of ISPOR membership, offering perspec-tives from industry researchers to academicians and from USA to world-wide.Furthermore, ISPOR has consistently promoted cutting-edge debates from allviewpoints of controversial issues relevant to patient outcomes research and itsapplication. As a member of the Board, my efforts will be to continue to pro-mote these efforts as well as the Vision 2010 goals of education, internationalgrowth, research excellence, and reaching out to decision-makers.

No matter how elegant patient outcomes research methodology is, if results donot ring-true to decision-makers, our efforts are futile. In order to expand theimpact of our research and ISPOR activities, major emphasis must continue to bedirected toward communication with decision-makers; from the patient to theprovider to health care payers to society. The Board has already approved sev-eral strategies directed at assuring relevance of research findings to decision-makers. I have a particular interest in achieving them and helping to develop newstrategies. We need to consider the continually increasing role of patients inhealth care decision-making, both at an individual level and a political level.Patients and providers are appropriately represented at the outer rings of influ-ence in the ISPOR vision diagram. An important future direction of ISPOR is todevelop communication strategies that promote the relevance of our researchfindings to those groups. Establishing new relationships and alignments withpatient and provider organizations will help strengthen ISPOR and augment theapplication of patient outcomes research.

I am honored to be nominated for ISPOR Board membership and if elected, Ihope to provide a perspective that enhances the achievement of Vision 2010 TaskForce Recommendations.


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Zeba M. Khan RPh, PhDZeba Khan is currently Executive Director and Head of U.S.Pricing, Pricing Strategy & Policy at Novartis PharmaceuticalsCorporation based in East Hanover, New Jersey, USA. Sheleads the development and implementation of pricing and con-tracting strategy for general medicines. Dr. Khan joinedNovartis in January 2003 as Global Head of Pricing and HealthEconomics Strategy, CVM, working and living in Basel, Switzerland for three yearsprior to moving to the USA. Prior to joining Novartis, Dr. Khan was employed atGlaxoSmithKline (GSK), Research Triangle Park, North Carolina, USA, for six years invarious leadership roles in health care management, managed markets and was SeniorHealth Outcomes Scientist in North America, Department of Medical Affairs, whereshe developed and implemented health economics and outcomes strategies to sup-port market access. Prior to joining the pharmaceutical industry in 1997, Dr. Khanwas a clinical pharmacist at University Hospital, University of Utah Health SciencesCenter and Poison Center Specialist at the Intermountain Regional Poison ControlCenter, both based in Salt Lake City, Utah, USA.

Dr. Khan earned her pharmacy degree from the University of Utah and her MS andPhD in Pharmacy Administration, Pharmacoeconomics/Health Outcomes from TheUniversity of Texas at Austin. Over her 18-year career, she has gained both USA andglobal experience in strategic pricing and contracting, health economics, outcomesresearch, managed markets, health care management, and clinical pharmacy. She hasauthored/co-authored over 90 publications, patents, and podium/poster presentations.

Dr. Khan has been a member of ISPOR since 1996, and has served in many capac-ities, including membership on the ISPOR Vision 2005 Committee, ISPOR FellowshipCommittee, ISPOR Awards Committee, and ISPOR Program/Planning Committee.Most recently, she serves as the Co-Chair of the ISPOR Short Course Committee andhas served over 8 years as the ISPOR Student Network Faculty Advisor.

ISPOR Vision Statement by Zeba M. Khan RPh, PhDISPOR has grown to become a strong, international organization in a short time. Myvision is to evolve an organization that is sustainable in an ever changing environment.That evolution can only be accomplished through globalization, international growth,collaboration and teamwork locally, regionally, and globally. Given the industry chal-lenges, ISPOR must be the leader in establishing guidelines/standards that foster bet-ter research, leading to better decision-making and improved patient care. We mustalso lead in developing and communicating health outcome and scientific informationwhile fostering continued education and shaping the future. These challenges can beaddressed by: 1) Strengthening educational activities, distance learning programs, andshort courses by considering feasibility of certification, leveraging the ISPOREducator's Toolkit, tapping into the ISPOR Speaker's Bureau, and reaching out to newgroups in our discipline globally; 2) Empowering our task forces and work groups toadvance the science, methods, interpretation, and their application; 3) Understandingpayer needs since the economic evidence required for decision-making may varydepending on geography, regulations, and country-specific needs. ISPOR must reachout to decision-makers at all levels to build partnerships; and 4) Supporting studentinitiatives to ensure student representation in all ISPOR committees. Since studentsare the future of ISPOR, they should be engaged early to develop future leaders andprovide growth for the organization.

My professional experience in the US and Europe and my active involvement withISPOR has prepared me to see this vision through to realization. Since 2004, I haveserved as Co-Chair of the Short Course Committee which has focused on developingcontent, building new courses, and evaluating courses for quality assurance. As aresult, attendance and the number of short courses have tripled since 1998. As theISPOR Student Advisor, I am proud of the accomplishments of the Student Network.We have grown from 5 members in 1995 to over 400, comprising 15% of the ISPORmembership with 38 ISPOR Student Chapters in the USA, Canada, Europe, and Asia.I welcome the opportunity to work with you to continue to build a future ISPOR organ-ization that is sustainable and recognizable across all scientific disciplines.

Hong Li PhD, MPHWorking out of Singapore, Dr. Li is Group Director, Departmentof Global Epidemiology and Outcomes Research, Bristol-MyersSquibb (BMS) Company. In this role, he supports and coordi-nates outcomes research activities for BMS products of multi-ple therapeutic areas in the Asia Pacific region. In addition tothe responsibilities in BMS, Dr. Li is an Adjunct AssociateProfessor of University of Cincinnati. Furthermore, Dr. Li is a founding member of theISPOR Asia Consortium. From 2005 to 2007, Dr. Li served the role of the first Chair ofthe Advisory Committee of the ISPOR Asia Consortium.

Dr. Li holds a Ph.D. degree in Health Services Research/Epidemiology and a Masterof Public Health (MPH) degree in International Health Policy from School of PublicHealth, University of North Carolina at Chapel Hill, USA. His major academic researchinterests are health care project evaluation, international health care policy evaluation,and applied epidemiology methodology in health services research, such as drug uti-lization evaluation, evidence-based medicine, and naturalist study design.

Since mid-1990s, Dr. Li has publications in journals of JAMA, Value in Health,Journal of Clinical Psychology, and Psychiatry Research. In addition, Dr. Li has co-authored in proceedings of various international conferences such as AmericanPsychiatry Association, European College of Neuropsychopharmacology (ECNP),Collegium International Neuro-Psychopharmacologicum (CINP), International Society ofPharmacoepidemiology (ISPE), and ISPOR conferences. Dr. Li has given presentationson an array of topics to different audience including the World Health Organization,China Ministry of Labor and Social Security, Thailand Food and Drug Administration,Medical Association of Macau, Seoul National University, Beijing University, FudanUniversity, the National Health Research Institute of Taiwan, the Bureau of NationalHealth Insurance of Taiwan, the Regional Conference of Health Care Cost Effectivenessin Singapore, and Seoul International Digest Disease Symposium (SIDDS).

ISPOR Vision Statement by Hong Li PhD, MPHI envision ISPOR advancing the practice of pharmacoeconomics and outcomes researchglobally and enabling decision-makers to best utilize health care resources locally.

A decade ago, the ISPOR annual conference in the USA was the only ISPOR meet-ing for members to attend; now, ISPOR conferences are also held in Europe, AsiaPacific, and Latin America. I believe this is not simply a geographic expansion of theorganization but an evolution of outcomes research across the globe. As ISPOR isengaged in more international activities, the issues that we face become more com-plex in terms of different health care systems, variable health care resources, cultures,and values. Ideally, pharmacoeconomic and outcomes research methodologies willcontinue being enhanced at the global level in a way that use of scientific evidence canbe translated into the best decision-making for health care resource utilization; yet, itremains the critical challenge for all of us. To me and many ISPOR members as well,however, the vision of ISPOR can turn this challenge into an opportunity and reality.


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Don Husereau BScPharm, MScDon Husereau is Director of Health TechnologyAssessment Development at the Canadian Agency forDrugs and Technologies in Health (CADTH), Ottawa, ON,Canada. He received his Bachelor of Science inPharmacy in 1993 at the University of Alberta andworked in community pharmacy practice until 1996. Hecompleted his MSc in Pharmacy and PharmaceuticalSciences (Biotechnology) in 2000, where he also served as a lecturer andcourse facilitator for graduate and undergraduate courses. Prior to working atCADTH, he worked as a consultant for both the International Atomic EnergyAgency and Canadian International Development Agency. He joined CADTH (for-merly CCOHTA) in January, 2001. At CADTH, he has overseen the developmentof several programs, including a rapid assessment service for policy-makers. In2005, he led the completion of the 3rd edition of the CADTH Health TechnologyAssessment (HTA) Guidelines for the Economic Evaluation of HealthTechnologies: Canada. These guidelines represented the first attempt to createa Canadian national health economic evaluation guideline that extended beyondpharmaceutical interventions. In his current role at CADTH, he leads the identi-fication and assignment of policy research. In this role, he acts as a convenorfor discussions among health care researchers, health program managers (policy-makers), assessors, manufacturers, clinicians, and communicationsspecialists with the aim of meeting decision-maker needs through the optimalapplication of research.

Don Husereau has led and served on several national and international com-mittees. He is currently the chair of the Health Technology Analysis Exchange, anetwork of Canadian Health Technology Assessors. He has also served as anadvisor for the development of the US Agency for Healthcare Research andQuality Developing Evidence to Inform Decisions about Effectiveness (DEcIDE)network.

Don Husereau has successfully fostered international HTA collaborationswith both the National Institute for Health Research HTA program (UK) andDAHTA@DIMDI (Germany). Through his more recent involvement with ISPOR,he has contributed to Health Technology Assessment Advisory Council discus-sions. He is also an academic editor for the Public Library of Science ONE jour-nal and a member of the Cochrane Hypertension Review Group. His interestsinclude health economic evaluation and scientific epistemology.

ISPOR Vision Statement by Don Husereau BScPharm, MSc It is an honour to be asked to contribute to the leadership of ISPOR, an organi-zation with esteemed and enthusiastic membership motivated by mass collabo-ration. Through transparency, education, sharing and acting globally, ISPORmembers are committed to applying their unique expertise to optimizing the careof patients worldwide. It is clear that continued excellent leadership is requiredto both achieve and go beyond ISPOR VISION 2010. I believe that ISPOR cancontinue to be a model social network and reach its goals by providingincreased attention to several key areas:

Promoting health-focused research: ISPOR members represent a wide-rang-ing set of perspectives, spanning across key players and jurisdictions that areresponsible health delivery. Members know that excellent health, rather thanexcellent health science is their ultimate goal. The shift of focus from health sci-ence to health requires continued promotion of methods of valuation of uncer-tainty, rational priority setting, and ideas sharing in Society meetings and com-munications.

Promoting health-focused judgement and decision-making: ISPOR has fos-tered growth in the area of judgement and decision-making through groups suchas the "Health Technology Assessment In Evidence-Based Decisions Group" and"HTA in Reimbursement Economics Working Group". The complexity of healthdecisions requires ISPOR members to increase their use of reliable knowledgetransfer and decision science methods to maximize health impact.

Promoting health beyond interventions: New service and delivery paradigmsfor health mean decision-makers must consider organizational, health humanresources, environmental risk management and information technology issuesmore than they have in the past. By furthering its Good Research PracticeStandards, ISPOR is in a position to lead future health research in these areas.I believe I could quite effectively contribute to the ISPOR Board of Directors andI look forward to your vote and working with you.


Hans-Peter Dauben MDDr. Hans-Peter Dauben, born in Moenchengladbach, Germany, is acivil servant at the German Institution for Medical Documentation andInformation (DIMDI), Cologne, Germany, an institution within thescope of the federal ministry of health. After finalizing his training asa cardiac surgeon at the University of Duesseldorf, Germany, hemoved to DIMDI to establish the German Agency for HTA at DIMDIon behalf of the federal ministry in 2000 and to develop a structureto access HTA information, set priorities in HTA and monitor new technology developmentsto establish a broad consensus on HTA in Germany. The experiences of information systemsdevelopments lead to the nomination of Dr. Dauben as the national representative for infor-mation system development at the European medicine agency (EMEA) in London, UK. Since2004 he is involved in different working groups developing information principles and sys-tems in cooperation with public agencies and pharmaceutical companies. Since 2006 Dr.Dauben is also working as a consultant for the public health institution (LIGA) of Northrhine-Westfalia in Bielefeld, Germany, a public institution within the scope of the state ministry ofhealth. Out of this activity he is involved in describing the need and requirements on how thestate government can set up a system to support innovations in health care environment.Since 2006 he is also a member of the National Task Force for Public Health Genomic man-aged by LIGA.

At the University of Cologne he is giving lectures on HTA and evidence-based medicinesince 2002. In addition, he is mainly involved in courses on HTA with dedicated user groupsin the field of health quality assurance and control, pharmacists and physicians in coopera-tion with different professional organizations. His research interests are mainly focused oninformed decision-making processes, including the methodology development of HTA, sys-tematic evaluation of health needs in health care systems, support systems for innovationsin health care management and improving knowledge management in evidence-based healthcare systems.

Since 2000 Dr. Dauben is involved in different European projects. These projects arerelated to HTA (ECHTA/ECAHI-EUnetHTA), to pharmaceutical information systems (PPRI)and to regional implementation of informed decision-making processes (EUREGIO II).Internationally, Dr. Dauben is a well-known speaker and organizer of conferences, work-shops, and educational courses within his areas of experience and interests. He is a mem-ber of the ISPOR HTA Council.

ISPOR Vision Statement by Hans-Peter Dauben MDISPOR's development over the years has shown the need and the acceptance of the actualgoals described in the ISPOR vision 2010. I feel honoured to be selected as a candidate forthe ISPOR Board of Directors, and if elected, I will be involved in working towards thesegoals. My personal experiences and actual work is focussed on three main topics: 1)Knowledge sharing; 2) Methodology developments focussed on the assessment and sup-port of innovations; and 3) Education and training. Living in Europe and working forEuropean institutions and projects, the need to learn from each other, the need for clear com-munication, and the need for requirements to overcome misunderstanding depending onwordings is a daily challenge. Therefore, my vision for ISPOR is to aim for communicationand knowledge sharing.

Communication - regional growth and collaboration: The spread of our Society to all areasof the world leads to new challenges in the sense of understanding, knowledge and accept-ance of different cultures and health care systems. Regional growth of the Society will requireseveral efforts to form a basis for common understanding. Within the field of HTA, the ISPORHTA Council Roundtable discussions initiated by ISPOR are a first step to promote global evi-dence and to support and learn from the experience of the local implementation of this. As partof this process the communication of the three main groups, the scientific community, theindustry and the decision-makers has to be promoted. Additionally topics as equity and fair-ness have to be integrated within the communication out of different cultures and societies.

Knowledge sharing: Scientific developments transfer and education: The exchange ofglobal evidence, based on clear and robust scientific methodologies and data is, for allinvolved groups, of the highest importance to gain the efficiency needed. These scientificdevelopments within the different ISPOR work groups have to be transferred and implement-ed within the existing education institutions. Besides promoting the actual ISPOR courses,the integration of this knowledge into academic curriculum is needed. Students are not onlya good basis for the future of the Society, but better training and education will also help toovercome the lack of trained staff in many health management areas.

The scientific developments supported by ISPOR have to focus on feasible and reliablemethods. In the field of HTA, new ways have to be described on how institutions, groups,members can be supported in implementing innovative technologies not only for pharma-ceuticals, but also medical devices and health care management. Based on transparencyand standardization, actual resistance within the different groups can be overcome. I wouldvery much welcome the opportunity and challenge to work with and for you to foster oursociety, to promote the excellence of the knowledge within the Society and to make ISPORthe basis for including scientific work in daily life.

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Vithaya Kulsomboon PhDDr. Vithaya Kulsomboon received the Bachelor ofSciences degree in Pharmacy from the Faculty ofPharmacy, Mahidol University, Bangkok, Thailand, in1980 and Master Degree in Primary Health CareManagement in 1989 from ASEAN Institute for HealthDevelopment (AIHD), Mahidol University. Dr. Kulsomboonearned the Doctor of Philosophy degree in PharmacyPractice and Administrative Sciences from the University of Maryland atBaltimore, Baltimore, Maryland, USA, in 2000, where he specialized in pharma-ceutical policy and pharmacoeconomics. In 2007, he received the DistinguishedAlumni Award for Distinguished Research from the AIHD. Presently, Dr.Kulsomboon is an Associate Professor in the Department of Social Pharmacy andDirector of the International Graduate Program in Social and AdministrativePharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University,Bangkok, Thailand, where he teaches graduate course in pharmacoeconomicsand pharmacoepidemiology.

Dr. Kulsomboon is one of the leaders in Thailand who introduced the conceptof pharmacoeconomics at the national level. In 2007 he was appointed Chiefof the Advisory Committee on Health Economics, National Essential DrugCommittee. The Committee has been instrumental in introducing, for the firsttime, the pharmacoeconomic principles and pharmacoeconomic evaluation tothe drug approval and selection process at the national level. The Committeealso introduced national guidelines for pharmacoeconomic evaluation and thecriteria establishing government willingness to pay for pharmaceuticals to theNational Essential Drug Committee.

Dr. Kulsomboon is one of the founding members of the ISPOR ThailandChapter, and has served as President of the Chapter since it was established in2005. He is a member of the 2006-2008 Executive Committee of the ISPORAsia Consortium, founded in 2004. He, with other members of the AsiaConsortium, is helping to organize the ISPOR 3rd Asia-Pacific Conference inSouth Korea, and along with the Thailand Chapter members, is organizing the4th Asia-Pacific Conference to be held in Phuket, Thailand.. ISPOR Vision Statement by Vithaya Kulsomboon PhDThe global movement of economic evaluation in pharmaceutical health caresystems has encouraged us to recognize the critical importance of pharma-coeconomics. ISPOR's mission will foster the understanding of the disciplinesthe Society represents and will bring the principles of pharmacoeconomics andrigorous pharmacoeconomic analysis to the forefront in decision-making andpromulgation of health care policy worldwide.

To strengthen the Society as a premier leader in the field of pharmacoeco-nomics, the Board of Directors must vigorously promote ISPOR to recruit activemembers from academia, industry, government and practice in the local,national and international communities. I hereby propose that the Board adoptthe following five key strategies as the framework of our future endeavors.These five strategies referred to as ISPOR are: 1) Strong Initiative; 2) FirmSupport; 3) Willing Participation; 4) Equal Opportunity; and 5) Utmost Respect.

ISPOR will identify and promote strong initiatives to make the Society vitaland dynamic. ISPOR will provide firm support to and encourage active partici-pation of its members by sponsoring local chapters, seminars, workshops,short courses, informal and formal publications as well as effective networking.ISPOR will make it clear that there is equal opportunity for all of its members tocontribute to the Society and reap important benefits as a member of theSociety. Finally, ISPOR will respect the importance of its individual members,recognize their personal aspirations as members of the Society, and assist themto meet their goals regardless of their role, rank or status within their respectiveinstitutions or practices. My devotion to the Society, which has already beenclearly demonstrated, will be further realized as a Member of the Board ofDirectors of this august body. Thank you for your kind consideration of my nom-ination to the ISPOR Board.

CANDIDATES FOR DIRECTOR (POSITION 5)Shanlian Hu MD, MScShanlian Hu is Professor of Health Economics. Director of TrainingCenter for Health Management and Director of PharmacoeconomicsResearch and Evaluation Center at School of Public Health, FudanUniversity, Shanghai, China. At present, he is the Chair of ISPORChina Doctor Association Chapter. He is elected as Chair of 2008-2010 ISPOR Asia Consortium Executive Committee as well. Hemade great contributions to ISPOR as the ISPOR 2nd Asia-Pacific(AP) Conference Program Committee Co-Chair in Shanghai, China, in 2006, and is playinga role in the planning of the upcoming ISPOR 3rd AP conference as Short CourseCommittee Co-Chair. He helped to organize a delegation of 30 policy-makers' from China,with Novo Nordisk Pharmaceutical Co., to attend ISPOR 10th Annual European Congress inDublin, Ireland in 2007.

He graduated from School of Public Health, Shanghai First Medical College, and furtherpursued his Master Degree in Epidemiology in Shanghai Medical College, and MSc ofMedical Microbiology in the London School of Tropical Medicine and Hygiene, London, UK.In 1980-1982, he was a WHO Fellow pursuing health service studies in UCLA, UC Berkeley,and at Harvard in 1986. He has been a member of several China's Ministry of Health (MOH)Advisory Committees, such as Health Policy and Management, New Type Rural CooperativeMedical System and Urban Community Health Care. Recently, he is also appointed asDirector of Shanghai Health Development Research Center, under the leadership of ShanghaiBureau of Health. He uses these platforms to conduct pharmacoeconomics and drug policyresearch in China. In his career, he was the Deputy Director of National Health EconomicInstitution in MOH and the Coordinator of China Network of Training and Research in HealthEconomics and Financing between 1991 and 2005. He received several national advancedscience and technology awards in 1990s. Over the past decade, he was a consultant for theWorld Bank, UNICEF, UNDP and AUSAID in China and several Asian countries. In the recentyears, he has been working in pharmacoeconomics education, compiling reference books,disseminating pharmacoeconomics and outcomes research (PE & OR) knowledge to thepolicy-makers, pharmacoeconomic analyses and disease management for several pharma-ceutical companies, such as Merck International Foundation, Pfizer, Sanofi-Aventis, GSK,Janssen. He is interested in drug pricing and reimbursement, national essential drug policyand systematic reviews on health reform and development.

ISPOR Vision Statement by Shanlian Hu MD, MScUnder the transition of demographic, epidemiologic and risk factors, disease pattern hasbeen changed through out the world. The quality and safety of medical services and univer-sal coverage of health care and health insurance become the priorities of government healthreform agenda. The accessibility and affordability of health service are being ranked as thefirst priority by the policy-makers. On the one hand, they are dealing with innovation of med-icines and health technology which is essential for improving health status of population.On the other hand, the value of money and its cost-effectiveness should be consideredbecause of the budget constraint. When searching all themes at ISPOR meetings in NorthAmerica, Europe and Asia-Pacific regions, evidence-based health care decision-making hasdominated. The new discipline of PE & OR are the tools to solve these problems. I ampleased to see that ISPOR plays a great role in this field. Now promoting education andactively reaching out to decision-makers is one of ISPOR's Vision 2010.

My professional experience is to disseminate PE & OR and health technology assess-ment knowledge in academic and education environment. Pharmacoeconomics and out-comes research have been placed in the education curriculum as a core or elective coursein the medical colleges and universities. In the policy research study, I have many chancesto work with policy-makers. I do think capacity building and leadership development are soimportant that can make big change in the excellence of ISPOR.

It is a great honor to be recommended by the Board of Directors Nominations Committeeas a candidate to serve on the ISPOR Board of Directors. Actually, it is really a challenge forme. I believe I will help the Society succeed in the following areas: 1) Working closely withdifferent stakeholders, including academia, policy-makers and pharmaceutical industry inannual ISPOR activities; 2) Searching opportunities and funding from government andindustry side to conduct capacity building programs to develop pharmacoeconomics andoutcomes research and health technology assessment; and 3) Promoting PE & OR in theAsia-Pacific region during my term as a Chair of 2008-2010 Asia Consortium ExecutiveCommittee of ISPOR.

IC

MAKE YOUR VOICE HEARD. PLEASE VOTE. YOUR BALLOT MUST BE RECEIVED BY APRIL 4, 2008TO VOTE, GO TO THE ISPOR WEBSITE AT: www.ispor.org


ISPOR STUDENT CORNER

Authorship Decisions in Economic EvaluationsBenjamin M Craig PhD, ISPOR CONNECTIONS Editorial Advisory Board member and Assistant Professor, University of Wisconsin,

Department of Family Medicine, Madison, WI, USA

Among the research trades, authorship is a profes-sional currency in addition to the trappings of

intellectual self worth. Ambiguities concerning author-ship needlessly damage collaborations, impede pub-lication, and deter career development. Whileresearchers are required to meticulously describetheir budgets, some fail to equally clarify ownership ofscientific spoils, proving detrimental for both theauthors and the research community.

To the best of my knowledge, no guidance has yetbeen published in pharmacoeconomics and out-comes research regarding authorship decisions.Naturally, our field requires the integration of clinicalexpertise and research training, most often fulfilled byinterdisciplinary teamwork. Among the articles listedin 2006 Recently Published Works section of ISPORConnections, 88% are multi-author publications, aproportion which has changed little since 2000. Forour field, the mixing of expertise can be troublesome,because conventions on authorship vary greatly bydiscipline [1].

This paper outlines common guidance on authorshipand establishes three rules for streamlining the deci-sion process. Because these rules are based on first-hand experience in pharmacoeconomics and out-comes research, they should be taken with a grain ofsalt. Dilemmas regularly faced by seasoned and jun-ior investigators are described not to provide a defini-tive statement on authorship; instead, their purpose isto introduce issues surrounding authorship for refer-ence by junior researchers and for discussion amongmore seasoned ones.

Three Rules of AuthorshipThe person with the authority to determine authorshipis typically the lead author or the principle investigatorof the project. Regardless, these three rules are rec-ommended:

Rule #1 Ask potential authors about their author-ship expectations before the first meetingBefore a job begins, employees typically have somesense of salary. “Everybody needs money. That's whythey call it money!” (Danny DeVito as MickeyBergman in "Heist”). In research, authorship is a com-modity: it speaks to the intellectual caliber of investi-gators, and researchers who contribute to a projectwill expect to be paid. As with salaries, authorshipnegotiations are best handled one-on-one prior to thestart of the research activities.

These negotiations entail a summary of the researchproject, emphasizing the contributions and expecta-tions of each author. Every contributor should receivea list of expected tasks with an initial timeline for com-pletion. Planning far in advance is often difficult, evenimpractical, but it begins a discussion of reasonable

expectations. For example, tasks such as modeling,literature review, and editing can be assigned in tradefor a particular rank in authorship based on the effortthey require. Effort asked of a senior person is givenmore weight, because they typically have greateropportunity costs (i.e., higher wage rates), but theyare often more productive because of their wealth ofexperience and training. A verbal description of otherauthor contributions may help calibrate evaluationsover rank. Consistent verbal repetition of these con-tracts helps to set precedent, so that later misunder-standings can be avoided.

How many authors does the paper merit? This num-ber varies greatly by discipline. In economics, articlesgenerally have up to three authors, but the averagenumber of authors is increasing [2]. In the 2006issues of the Journal of Health Economics, 23% of thearticles were sole authored and only 10.5% had overthree authors. On the contrary, epidemiology and clin-ical papers typically have over three authors. In the2006 issues of New England Journal of Medicine,98.1% of the original research articles had over threeauthors, and most of those with fewer authors werewritten by health economists.

Clinical articles increasingly use group titles (e.g.,Clinical Trial Writing Group) instead of listing allauthors, which may be in response to Journal require-ments and referencing rules. Because the value ofauthorship may depend on whether the authors'names are listed, discussions of a group name mayelicit varying responses. Health technology assess-ments do not require primary data collection, so themanuscripts typically have less than four authors.However, if an article will have more than six authors,a group name may be substituted for the sixth or moreauthors. Otherwise, these remaining coauthors maybe left out of the reference section under the defaultconvention of “et al.” in future references to the work.

Although clinical-economic trials are increasinglyprevalent, health technology assessment are usuallybased on parameters taken from the literature or sec-ondary data. When a primary researcher providesparameters or data to another, authorship may beexpected in trade, even if the primary researcher doesnot contribute further to the paper. Journals frown onthis bartering, but it is a known practice. Barteringover data must be clarified before the project is initiat-ed; otherwise, the primary author may rightfully with-draw their data from the paper, essentially gutting themanuscript.

Some project staff and educators are paid for theirefforts, and while they contribute to the project, theirefforts may not merit authorship. Such staff includesinterviewers, editors, professional writers, data entrypersonnel, and librarians. Difficulties persist when

thesis advisors or supervisors expect authorshipregardless of their contributions, because they con-tributed toward the funding of the project or super-vised the career development of the lead author. Whilethey should be rewarded for these contributions, interms of salary and promotion, their support alonedoes not necessitate authorship.

Rule #2 Clearly define the authorship order at thefirst meetingEconomic evaluations usually order the authors byamount of contribution, which is more similar to epi-demiology than economics. Because the conventionsof authorship order vary by discipline, open commu-nication seems to be the best strategy [3]. In tradi-tional economics, authors are arranged in alphabeticalorder, and arrangement outside of alphabetical orderimplies secondary authorship [4]. In epidemiologyand clinical research, however, authorship order isbased on contribution, except for the last author whomay be the senior investigator on a multi-paper proj-ect [1]. Frank discussions with administrators con-cerning the “last authorship” position may preventlater confusion, particularly when two seniorresearchers might assume this privileged post.

Recently, a new pattern is emerging, where seniorcoauthors who once coveted the last position requestsecond authorship. Journals, in the name of space,have shortened the list of authors in the referencesections. The 2004 Uniform Requirements ofManuscripts do not limit the number of authors on anysubmitted manuscript; however, when the article isreferenced only the first six authors will be listed fol-lowed by “et al.” If the manuscript has seven or moreauthors, the last author may be removed automatical-ly by reference software applications, much to thedisappointment and detriment of the senior coauthor.

After introducing the preliminary order and contribu-tions of each author, your collaborators may respondby asking to do more or less, changing authorshiptoward a preferred order. My experience suggests thatsuch discussions work well as a team building exer-cise and help legitimize the distribution of tasks. Thisopen formality may seem awkward, but it saves thegroup time and improves the likelihood of a success-ful project.

Rule #3 Once written, submit the paper to a jour-nal that matches the authorshipAt the first meeting, it is prudent to discuss potentialjournals for the manuscript submission. Journalshave particular requirements for authorship bestknown at the beginning of the project, such as themaximum number of authors, authorship require-ments, and rules on conflicts of interest. Thus, earlyjournal identification is good practice as it gives pur-pose to a research project and motivates authors >


toward a common goal and audience.

The maximum number of authors varies by journal.For example, the Lancet editorial board set a maxi-mum of eight authors in 1997, which was heavily crit-icized at the time (Johnstone 1997). Journals suchas the Journal of Health Economics do not list a for-mal limit, but the infrequency of more than threeauthors might indicate multi-author rejections or, atleast, insistent requests for authorship reductions(e.g., dropping research assistants).

For most journals, every author must participate inwriting the manuscript and insist that the specific con-tributions of each contributor be identified. Discussingthese requirements at the very beginning of a projectmay simplify the later removal of authors who fail tocontribute in a timely fashion.

Authors are also required to list all potential conflictsof interest at time of submission [6]. For example, theNew England Journal of Medicine will not publish aneconomic evaluation if an author has financial interestin the study results. Authors may privately inform youof their potential conflicts, which may either affect thejournal selection or, if caught early, the authorshipdecision.

Lastly, if the paper's authorship does not fit the jour-nal, the paper should be submitted to a more appro-priate publication. It is unfair to both the journal andthe paper's authors to change authorship for the pur-poses of submission to a particular publication. Foradditional guidance, Harvard Medical School hasposted further authorship advice (http://www.hms.harvard.edu/integrity/ authorship.html).

Common DilemmasAll researchers experience dilemmas in authorship.These cases describe possible responses to threecommon dilemmas: Removal of a co-author, changein author order, and quid pro quo.

Removal of an authorEvery seasoned investigator has experienced a col-laborative effort where a member of the original teamis unable or unwilling to complete their pre-definedresponsibilities in a timely fashion. Often the investi-gator remains interested, but has experienced achange in position or shift in work loads. After miss-ing the predefined deadlines, the first step is to talkwith the collaborator, so that you can identify the rea-son behind their lack of contribution. Options includean extension of the deadline, a change in authorshiporder, or the removal of the author.

If you have little interest in keeping the author, a cor-dial dismissal that preserves good feeling and thepossibility of future collaboration is the next goal. Asa result of this discussion, the author may bow out ofthe project, in hopes that they may preserve their rep-utation and collaborate with you sometime in thefuture. If this offer is not made, you may outwardlyempathize with the author and ask to decrease theirworkload by removing the responsibilities (and

authorship) of this project. Most removal cases in myexperience have ended in this fashion.

Some cases are not as simple, and involve an authorwith insufficient motivation to complete the work in atimely fashion, but expects to maintain authorship. Aslead author, you must balance the welfare of theunproductive authors with those of the more produc-tive authors, including yourself. One strategy is tostrike a deal with the unproductive authors. You mightoffer authorship on a future paper, if they relinquishthe current project. Most authors wish to maintain theappearance of collaboration; therefore offer a sched-ule of work, forcing the author to choose whether ornot to remain an author through delivering the sched-uled effort. If the effort is not realized, the lead authorhas legitimate grounds for removal. Such assertivebehavior may render respect of your collaborators.

Regardless, the removal of a disgruntled author isrisky, and is best avoided. In most cases, it leaves ablack on the reputations of all those involved. Someauthors have gone to court to squash manuscripts onthe principle of the issue. Sadly, these manuscriptsrarely merit the exchange of blows. If the situationworsens to this point, it may be best to drop the man-uscript. You can likely significantly change the paperand begin with a new team instead of proceedingunder malignant circumstances.

Change in Author OrderLess extreme than the removals, changes in author-ship order are common. After a project begins,authors may ask for a change in the authorship order,because the assigned tasks required more effort thanexpected or because they were unable to completethe assigned tasks. This process of renegotiationrequires the open participation of all authors, becauseit may change the ranking. A common tragedy iswhen collaborators are surprised by a re-ordering attime of publication.

Disagreements over authorship order most oftenoccur because of unexpected work needed to com-plete the project. For example, a referee may requestfor a substudy requiring further data collection or anadditional analysis. To prevent the arguments, care isneeded not to unduly assignment of unpredicted workto the third or four authors. At the top, author contri-butions may appear more similar, because their tasksinclude dissimilar activities (e.g., data analysis andsite administrator). When the extra work is assign,best practice suggests that the authorship order isclarified.

Quid Pro QuoThe demands of academic research have renderedgreater rigor as well as a Pandora's box of unethicalpractices. As a graduate student, a well known pro-fessor of labor economics once told me that if I didnot want my manuscript refereed by particular col-leagues that I should discuss the paper with them andinclude them in the acknowledgements. In the author-ship decision, questionable tactics include 'guest' and'ghost' authorship [7].

'Guest' authorship is the inclusion of an individual in theby-line who does not meet the authorship criteria. Inthe end, the journal, editorial board and publisher havelittle choice but to trust the corresponding author, whomay be at the mercy of local influences (`pressured'authorship) or perceive improved publication potentialwith the inclusion of a noteworthy 'guest' who may noteven know about their inclusion. The most challengingcases of 'guest' authorship are when members of athesis committee or course instructors require author-ship of all graduate student submission under theirdirection, which demoralizes the better students andhurts reputations and student recruitment.

Manuscripts may benefit greatly from the swift pen ofa professional writer. 'Ghost' authorship is moretreacherous, because the manuscript may be writtenby another and gifted to the corresponding author,which is obviously incongruent with journal guideline.However, it is also well understood that evidence fromparticular messengers may be more or less persua-sive. These cases also occur in reverse where aca-demic researcher consults on a manuscript under thecondition of anonymity, because he or she does notwish attribution for the study results.

Reputation and loyalty are also commodities inresearch, which may be traded for money, author-ship and professional advancement. The authorshipdecision includes a balance of multiple interestsacross all those involved. Compared to scientificmisconduct (e.g., falsifying results), the trade ofauthorship for money, reputation, loyalty and profes-sional advance, instead of contribution, is a lessersin, which may explain why quid pro quo seemsincreasingly prevalent.

A research project is like starting a new business:choose your coauthors wisely. Look through their CV.If they write many papers with persons under theirauthority (i.e., junior faculty, graduate students), askwhy. The researcher is either exceptionally generouswith their time or an unscrupulous leech. Contactingpeople who have worked with the authorship candi-dates and checking your authors references beforehiring them is simply good practice in academicresearch.

References1. Savitz DA. Invited Commentary: What can we infer fromauthor order in epidemiology? Am J Epidemiol 1999;149:5.

2. Sutter M, Kocher M. Patterns of co-authorship among eco-nomics departments in the USA. App Economics 2004;36:327-33.

3. Stokes TD, Hartley JA. Coauthorship, social structure, andInfluence within specialties. Soc Stud Sci 1989;19:1.

4. Engers M, Gans JS, Grant S, King SP. First author conditions.J Pol Econ 1999;107:4

5. Laband D, Tollison R. Alphabetized coauthorship. AppEconom 2006;38:1649-53.

6. Barnes R and Heaton A. Panel 6: Addressing questions ofbias, credibility, and quality in health economic evaluations.Value in Health 1999;2:99-102.

7. Bennett DM, Taylor DM. Unethical practices in authorship ofscientific papers. Emergency Med 2003;15:263-70.

IC


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Disease Related ResearchCARDIOVASCULAR DISEASE• Colgan R, Johnson JR, Kuskowski M, Gupta K. A

prospective study of risk factors for trimethoprim-sul-famethoxazole resistance in acute uncomplicated cysti-tis. Antimicrob Agents Chemother 2007 Dec [Epubahead of print]

• Hill RA, Boland A, Dickson R, Dundar Y, Haycox A,McLeod C, Mujica Mota R, Walley T, Bagust A. Drug-eluting stents: a systematic review and economic eval-uation. Health Technol Assess 2007;11:1-242.

• Nichol MB, Knight TK, Dow T, Wygant G, Borok G,Hauch O, O'Connor R. Quality of anticoagulation moni-toring in nonvalvular atrial fibrillation patients:Comparison of Anticoagulation Clinic versus usual care(January). Ann Pharmacother 2007 Dec [Epub aheadof print]

• Velazquez EJ, Lee KL, O'Connor CM, Oh JK, BonowRO, Pohost GM, Feldman AM, Mark DB, Panza JA,Sopko G, Rouleau JL, Jones RH; STICH Investigators.The rationale and design of the surgical treatment forischemic heart failure (STICH) trial. J ThoracCardiovasc Surg 2007;134:1540-7.

• Vats V, Nutescu E, Blackburn JC, Ansell J, WittkowskyA, Shapiro N, Schumock GT. Efficacy and safety ofwarfarin management in US anticoagulation clinic. JThromb Thrombolysis 2007 Nov [Epub ahead of print]

DERMATOLOGY• Arcury TA, Feldman SR, Schulz MR, Vallejos Q, Verma

A, Fleischer AB Jr, Rapp SR, Davis SF, Preisser JS,Quandt SA. Diagnosed skin diseases among migrantfarmworkers in North Carolina: prevalence and riskfactors. J Agric Saf Health 2007;13:407-18.

• Carroll CL, Lang W, Snively B, Feldman SR, Callen J,Jorizzo JL. Development and validation of the dermato-myositis skin severity index. Br J Dermatol 2007 Dec[Epub ahead of print]

• Housman TS, Hancox JG, Mir MR, Camacho F,Fleischer AB, Feldman SR, Williford PM. What special-ties perform the most common outpatient cosmeticprocedures in the United States? Dermatol Surg 2007Dec [Epub ahead of print]

ENDOCRINOLOGY, METABOLISM & DIABETES• Bloem CJ, Chang AM. Short-term exercise improves

{beta}-cell function and insulin resistance in olderpeople with impaired glucose tolerance. J ClinEndocrinol Metab 2007 Nov [Epub ahead of print]

• Cramer JA, Benedict A, Muszbek N, Keskinaslan A,Khan ZM. The significance of compliance and persist-ence in the treatment of diabetes, hypertension anddyslipidaemia: a review. Int J Clin Pract 2007 Nov[Epub ahead of print]

• Hughes MC, Girolami TM, Cheadle AD, Harris JR,

Patrick DL. A lifestyle-based weight management pro-gram delivered to employees: examination of healthand economic outcomes. J Occup Environ Med2007;49:1212-7.

• McCollum M, Hansen LB, Ghushchyan V, Sullivan PW.Inconsistent health perceptions for US women andmen with diabetes. J Womens Health (Larchmt)2007;16:1421-8.

GASTRO-INTESTINAL• Brun-Strang C, Dapoigny M, Lafuma A, Wainsten JP,

Fagnani F. Irritable bowel syndrome in France: qualityof life, medical management, and costs: the Encolistudy. Eur J Gastroenterol Hepatol 2007;19:1097-103.

• Lee CC, Lee VW, Chan FK, Ling TK. Levofloxacin-resistant helicobacter pylori in Hong Kong.Chemotherapy 2008;54:50-3. Epub 2007 Dec.

• Marchack BW, Chen LB, Marchack CB, Futatsuki Y.Fabrication of an all-ceramic abutment crown under anexisting removable partial denture using CAD/CAMtechnology. J Prosthet Dent 2007;98:478-82.

• Symms MR, Rawl SM, Grant M, Wendel CS, CoonsSJ, Hickey S, Baldwin CM, Krouse RS. Sexual healthand quality of life among male veterans with intestinalostomies. Clin Nurse Spec 2008;22:30-40.

• Wahlqvist P, Brook RA, Campbell SM, Wallander M-A,Alexander AM, Smeeding JE, Kleinman NL. Objectivemeasurement of work absence and on-the-job produc-tivity: a case-control study of US employees with andwithout gastroesophageal reflux disease. J OccupEnviron Med 2008;50:25-31

INFECTIOUS DISEASE• Cranny G, Elliott R, Weatherly H, Chambers D, Hawkins

N, Myers L, Sculpher M, Eastwood A. A systematicreview and economic model of switching from non-glycopeptide to glycopeptide antibiotic prophylaxis forsurgery. Health Technol Assess 2008;12:1-168.

• Kaskel P, Tuschy S, Wagner A, Bannert C, Cornely OA,Glasmacher A, Lipp HP, Ullmann AJ.Economic evalua-tion of caspofungin vs liposomal amphotericin B forempirical therapy of suspected systemic fungal infec-tion in the German hospital setting.Ann Hematol; Epubahead of print 2007 Oct.

• Scherer P, Penner IK, Rohr A, Boldt H, Ringel I, Wilke-Burger H, Burger-Deinerth E, Isakowitsch K,Zimmermann M, Zahrnt S, Hauser R, Hilbert K, Tiel-Wilck K, Anvari K, Behringer A, Peglau I, Friedrich H,Plenio A, Benesch G, Ehret R, Nippert I, Finke G,Schulz I, Bergtholdt B, Breitkopf S, Kaskel P, ReischiesF, Kugler J.The Faces Symbol Test, a newly developedscreening instrument to assess cognitive decline relat-ed to multiple sclerosis: first results of the Berlin Multi-Centre FST Validation Study. Mult Scler 2007;13:402-11. Epub 2007 Jan.

• Simpson KN, Jones WJ, Rajagopalan R, Dietz B. Cost

effectiveness of lopinavir/ritonavir tablets comparedwith atazanavir plus ritonavir in antiretroviral-experi-enced patients in the UK, France, Italy and Spain. ClinDrug Investig 2007;27:807-17.

NEUROLOGY & MENTAL HEALTH• Sentell T, Shumway M, Snowden L. Access to mental

health treatment by English language proficiency andrace/ethnicity. J Gen Intern Med 2007;22(Suppl.2):S289-93. Epub 2007 Oct.

• Brown CM, Richards K, Rascati KL, Gavaza P, CorbellZ, Zachry W, Phillips GA. Effects of a psychotherapeu-tic drug prior authorization (pa) requirement onpatients and providers: A providers' perspective. AdmPolicy Ment Health 2007 Dec [Epub ahead of print]

• Getsios D, Migliaccio-Walle K, Caro JJ. NICE Cost-effectiveness appraisal of cholinesterase inhibitors:Was the right question posed? Were the best toolsused? Pharmacoeconomics 2007;25:997-1006.

• Haycox A. When NICE says No! Pharmacoeconomics2007;25:995-6.

• Krystal JH, Gueorguieva R, Cramer J, Collins J,Rosenheck R; The VA CSP No. 425 Study Team.Naltrexone is associated with reduced drinking by alco-hol dependent patients receiving antidepressants formood and anxiety symptoms: Results from VA cooper-ative study No. 425, "Naltrexone in the Treatment ofAlcoholism" Alcohol Clin Exp Res 2007 Dec [Epubahead of print]

• Kunze AM, Gunderson BW, Gleason PP, Heaton AH,Johnson SV. Utilization, cost trends, and member cost-share for self-injectable multiple sclerosis drugs--phar-macy and medical benefit spending from 2004 through2007. J Manag Care Pharm 2007;13:799-806.

• Liu DT, Lee VY, Chi-Lai L, Lam DS. Stenotrophomonasmaltophilia and Mycobacterium chelonae Coinfectionof the Extraocular Scleral Buckle Explant. OculImmunol Inflamm 2007;15:441-2.

• Morlock RJ, Williams VS, Cappelleri JC, Harness J,Fehnel SE, Endicott J, Feltner D. Development andevaluation of the daily assessment of symptoms -Anxiety (DAS-A) scale to evaluate onset of symptomrelief in patients with generalized anxiety disorder. JPsychiatr Res 2007 Nov [Epub ahead of print]

• Newcomer KL, Vickers Douglas KS, Shelerud RA,Long KH, Crawford B. Is a videotape to change beliefsand behaviors superior to a standard videotape inacute low back pain? A randomized controlled trial.Spine J 2007 Nov [Epub ahead of print]

ONCOLOGY• Bottomley A, Coens C, Efficace F, Gaafar R, Manegold

C, Burgers S, Vincent M, Legrand C, van MeerbeeckJP; EORTC-NCIC. Symptoms and patient-reportedwell-being: do they predict survival in malignant pleuralmesothelioma? A prognostic factor analysis of EORTC-

This column includes books, articles, and abstracts recently published by ISPOR members. To ensurethat your published work in pharmacoeconomic or outcomes research is reported here, please keepyour contact information up to date with the Society. Any questions, comments, or submissions concerning this review can be directed to Stephen Priori at [email protected].

ISPOR CORNER

Recently Published Works: Using Pharmacoeconomics InnovativelyBy Stephen Priori, Director, ISPOR Publications


NCIC 08983: randomized phase III study of cisplatinwith or without raltitrexed in patients with malignantpleural mesothelioma. J Clin Oncol 2007;25:5770-6.

• Gondek K, Sagnier PP, Gilchrist K, Woolley JM. Currentstatus of patient-reported outcomes in industry-spon-sored oncology clinical trials and product labels. J ClinOncol 2007;25:5087-93.

• He Z, Tang F, Ermakova S, Li M, Zhao Q, Cho YY, MaWY, Choi HS, Bode AM, Yang CS, Dong Z. Fyn is anovel target of (-)-epigallocatechin gallate in the inhibi-tion of JB6 Cl41 cell transformation. Mol Carcinog2007 Dec [Epub ahead of print]

• Jeruss JS, Mittendorf EA, Tucker SL, Gonzalez-AnguloAM, Buchholz TA, Sahin AA, Cormier JN, Buzdar AU,Hortobagyi GN, Hunt KK. Combined use of clinical andpathologic staging variables to define outcomes forbreast cancer patients treated with neoadjuvant thera-py. J Clin Oncol 2007 Dec [Epub ahead of print]

• Li Q, Iuchi T, Jure-Kunkel MN, Chang AE. Adjuvanteffect of anti-4-1BB mAb administration in adoptive Tcell therapy of cancer. Int J Biol Sci 2007;3:455-62.

• Northouse LL, Mood DW, Schafenacker A, Montie JE,Sandler HM, Forman JD, Hussain M, Pienta KJ, SmithDC, Kershaw T. Randomized clinical trial of a familyintervention for prostate cancer patients and theirspouses. Cancer 2007;110:2809-18.

• Owusu C, Buist DS, Field TS, Lash TL, Thwin SS,Geiger AM, Quinn VP, Frost F, Prout M, Ulcickas YoodM, Wei F, Silliman RA. Predictors of tamoxifen discon-tinuation among older women with estrogen receptorpositive breast cancer. J Clin Oncol 2007 Dec [Epubahead of print]

• Sukel MP, Breekveldt-Postma NS, Erkens JA, van derLinden PD, Beiderbeck AB, Coebergh JW, Herings RM.Incidence of cardiovascular events in breast cancerpatients receiving chemotherapy in clinical practice.Pharmacoepidemiol Drug Saf 2007 [Epub ahead ofprint]

• Weycker D, Malin J, Edelsberg J, Glass A, Gokhale M,Oster G. Cost of neutropenic complications ofchemotherapy. Ann Oncol 2007 Dec [Epub ahead ofprint]

PEDIATRICS• Golicki DT, Golicka D, Groele L, Pankowska E.

Continuous Glucose Monitoring System in childrenwith type 1 diabetes mellitus: a systematic review andmeta-analysis. Diabetologia 2008;51:233-40.

• Pradel FG, Obeidat NA, Tsoukleris MG. Factors affect-ing pharmacists' pediatric asthma counseling. J AmPharm Assoc 2007;47:737-46.

• Winterstein AG, Gerhard T, Shuster J, Zito J, JohnsonM, Liu H, Saidi A. Utilization of pharmacologic treat-ment in youths with attention deficit/hyperactivity dis-order in medicaid database (January). AnnPharmacother 2007 Nov [Epub ahead of print]

• Winterstein AG, Gerhard T, Shuster J, Johnson M, ZitoJM, Saidi A. Cardiac safety of central nervous systemstimulants in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics2007;120:e1494-501.

RESPIRATORY DISORDERS• Quint LE, Cheng J, Schipper M, Chang AC,

Kalemkerian G. Lung lesion doubling times: values andvariability based on method of volume determination.Clin Radiol 2008;63:41-8. Epub 2007 Oct.

SKELETAL/ARTHRITIS• Difrancesco MW, Holland SK, Ris MD, Adler CM,

Nelson S, Delbello MP, Altaye M, Brunner HI. Functional

magnetic resonance imaging assessment of cognitivefunction in childhood-onset systemic lupus erythe-matosus: A pilot study. Arthritis Rheum 2007;56:4151-63.

• Brunner H, Das L, Passo M, Koneru S, Mongey AB.Reply. Arthritis Rheum 2007;59:153-4. [Epub ahead ofprint]

• Jonsson B, Kobelt G, Smolen J. Patient access torheumatoid arthritis treatments. Eur J Health Econ2007 Dec [Epub ahead of print]

• Jonsson B, Kobelt G, Smolen J. The burden ofrheumatoid arthritis and access to treatment: uptake ofnew therapies. Eur J Health Econ 2007 Dec [Epubahead of print]

• Khanna R, Smith MJ. Utilization and costs of medicalservices and prescription medications for rheumatoidarthritis among recipients covered by a state medicaidprogram: A retrospective, cross-sectional, descriptive,database analysis. Clin Ther 2007;29:2456-67.

• Sosroseno W, Sugiatno E, Samsudin AR, Ibrahim MF.The effect of nitric oxide on the production of cyclicAMP by a human osteoblast (HOS) cell line stimulatedwith hydroxyapatite. Biomed Pharmacother 2007 Oct[Epub ahead of print]

• Wijbrandts CA, Dijkgraaf MG, Kraan MC, Vinkenoog M,Smeets TJ, Dinant H, Vos K, Lems WF, Wolbink GJ,Sijpkens DE, Dijkmans BA, Tak P. The clinical responseto infliximab in rheumatoid arthritis is in part depend-ent on pre-treatment TNF{alpha} expression in thesynovium. Ann Rheum Dis 2007 Nov [Epub ahead ofprint]

• Zethraeus N, Strom O, Borgstrom F, Kanis JA, JonssonB. The cost-effectiveness of the treatment of high riskwomen with osteoporosis, hypertension and hyperlipi-daemia in Sweden. Osteoporos Int 2007 Dec [Epubahead of print]

SURGERY• Salem L, Devlin A, Sullivan SD, Flum DR. Cost-effec-

tiveness analysis of laparoscopic gastric bypass,adjustable gastric banding, and nonoperative weightloss interventions. Surg Obes Relat Dis 2007 Dec[Epub ahead of print]

• Varghese TK Jr, Marshall B, Chang AC, Pickens A, LauCL, Orringer MB. Surgical treatment of epiphrenicdiverticula: a 30-year experience. Ann Thorac Surg2007;84:1801-9; discussion 1801-9.

• Vartak S, Ward MM, Vaughn TE. Do postoperativecomplications vary by hospital teaching status? MedCare 2008;46:25-32.

General InterestHEALTH SERVICES• Fargher EA, Eddy C, Newman W, Qasim F, Tricker K,

Elliott RA, Payne K. Patients' and healthcare profes-sionals' views on pharmacogenetic testing and itsfuture delivery in the NHS. Pharmacogenomics2007;8:1511-9.

• Joyner PU, Cox WC, White-Harris C, Blalock SJ. Thestructured interview and interviewer training in theadmissions process. Am J Pharm Educ 2007;71:83.

• Leblanc JM, Seoane-Vazquez EC, Arbo TC, Dasta JF.International critical care hospital pharmacist activities.Intensive Care Med 2007 Nov [Epub ahead of print]

• Lee VH. A Personal tribute to Joseph R. Robinson-Aninspiration for all generations. Pharm Res 2007 Dec[Epub ahead of print]

• Nuckols TK, Paddock SM, Bower AG, Rothschild JM,Fairbanks RJ, Carlson B, Panzer RJ, Hilborne LH.Costs of intravenous adverse drug events in academicand nonacademic intensive care units. Med Care2008;46:17-24.

• Parshuram CS, To T, Seto W, Trope A, Koren G,Laupacis A. Systematic evaluation of errors occurringduring the preparation of intravenous medication.CMAJ 2008;178:42-8.

METHODOLOGY• Chi CL, Street WN, Ward MM. Building a hospital refer-

ral expert system with a Prediction and Optimization-Based Decision Support System algorithm. J BiomedInform 2007 Oct [Epub ahead of print]

• Clauson KA, Polen HH, Marsh WA. Clinical DecisionSupport Tools: Performance of personal digital assis-tant versus online drug information databases.Pharmacotherapy 2007;27:1651-8.

• Dijkstra BA, Jong CA, Bluschke SM, Krabbe PF, Staakvan der CP. Does naltrexone affect craving in abstinentopioid-dependent patients? Addiction Biology2007;12:176-82.

• Krabbe PFM, Salomon JA, Murray CJL. Quantification ofhealth states with rank-based nonmetric multidimension-al scaling. Med Decision Making 2007;27:395-405.

• Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP,Dawisha S, O'Neill R, Kennedy DL. Patient-reportedoutcomes to support medical product labeling claims:FDA perspective. Value Health 2007;10(Suppl.2):S125-37.

• Stalmeier PFM, Lamers LM, Busschbach van JJ, KrabbePFM. On the assessment of preferences for health andduration: Maximal Endurable Time and Better than Deadpreferences. Med Care 2007;45:835-41. IC

Pharmacoeco-comic Relief


Evidence-Based Health Care Decision Making In Asia Pacific: The Application of Pharmacoeconomics and Outcomes Research

Co-organized by:ISPOR Asia Consortium

Seoul National University

The Korean Association of Health Technology Assessment (KAHTA)

On-line Abstract Submission Ends: 17 March 2008

Acceptance Notification: 15 June 2008

Early Registration Deadline: 15 July 2008

ISPOR 3rdAsia-PacificConference7-9 September 2008 Grand Hilton Seoul Seoul, South Korea

Conference Program Committee ChairBong-Min Yang PhD, Professor of Economics, School of Public Health, Seoul National University, Seoul, South Korea

• • •Conference Program Committees and Conference Advisory Committee are available at www.ispor.org

Conference Co-sponsors and Supporting Media are available at www.ispor.orgInformation of support opportunities and support organizations are available at www.ispor.org

Research Abstracts Outcomes research on all health care interventions (including drugs, devices, behavioral modification programs, surgery, disease prevention, gene thera-py, screening, diagnostic procedures health education) on all diseases or health disorders are considered. Research abstracts (except for conceptualpapers) must be organized by OBJECTIVES, METHODS, RESULTS, CONCLUSION. All accepted research abstracts are published in Value in Health as sub-mitted. Accepted research is presented as a 15 minute podium presentation or poster presentation (with an author discussion hour). Abstracts are evalu-ated on the quality of the study (or concept) and quality of the abstract presentation.

Research topics: Clinical Outcomes Studies, Cost Studies, Patient-Reported Outcomes Studies, Health Care Use & Policy Studies, Methods/Health PolicyConcepts and Research on Methods.See the ISPOR website for research subtopics.

Workshop Proposals Workshop proposals should show novel and innovative experiences in the conduct of outcomes research (including, but not limited to, experiences withconjoint analysis, large database analysis, modeling, observational studies, record review, surveys, sensitivity analysis, patient registries) or novel andinnovative experiences in the use of outcomes research (clinical, economic, or patient-reported/preference-based outcomes) in health care policy develop-ment. Workshop proposals must be organized by DISCUSSION LEADERS, PURPOSE, and DESCRIPTION. Accepted workshops are one hour with no morethan four presenters (from more than one organization). An audience interactive element must be included in the proposal and during the workshop.

Workshop topics: Clinical Outcomes Research, Economic Outcomes Research, Patient-Reported/Preference-based Outcomes Research, Use of Real World Data,Education/Communications in Outcomes Research, Health Policy Development Using Outcomes Research.See the ISPOR website for workshop subtopics.

Issue Panel ProposalsIssue Panel proposals should show real debate on new or controversial issues in health economic/pharmacoeconomics and outcomes research or realdebate on the use of outcomes research in health care decision-making. An accepted Issue Panel is one hour with a moderator and 2-3 panelists (prefer-ably from different organizations). Panelists should present distinct views about the topic. Issue Panel proposals must be organized MODERATOR, PAN-ELISTS, ISSUE, OVERVIEW.

Issue Panel topics: Clinical Outcomes Research Issues, Economic Outcomes Research Issues, Patient-Reported Outcomes Research Issues, Health PolicyDevelopment Using Outcomes Research Issues.See the ISPOR website for issue panel subtopics.

CALL FOR ABSTRACTSOn-line Abstract Submission Ends 17 March 2008 • Acceptance Notification: 15 June 2008

Early Registration Deadline is 15 July 2008

Abstract submissions are invited for Contributed Researches, Workshops and Issue Panels. Abstract submitted to the ISPOR or 13th Annual International Meeting, or the 10th Annual European Congress,

and abstracts that will be submitted to the 11th Annual European Congress CAN be submitted to this Conference. To submit abstracts, go to www.ispor.org.


ISPOR 3RD ASIA-PACIFIC CONFERENCE 7-9 September 2008 • Seoul, South Korea

SHORT COURSE PROGRAMSunday, 7 September 2008

8:00AM-12:00PM MORNING COURSEIntroduction to Quality of Life AssessmentBruce Crawford MA, MPH, Mapi Values Asia, Japan; Watcharee LeurmarnkulPhD, Family Health International, ThailandCourse Description: This course is to provide methods that may help to solvecommon problems encountered with quality of life / patient-reported outcomes,including an overview of psychometric validation methods, missing data analy-sis techniques, and a variety of methods to assess minimally clinically impor-tant differences. - designed for individuals with little experience with qualityof life studies.

Introduction to Decision AnalysisShu-Chuen Li PhD, University of Newcastle, AustraliaCourse Description: participants will learn to evaluate the appropriateness ofdecision analysis in different settings, construct simple decision trees, under-stand the basic mechanics of tree evaluation and sensitivity analysis, andacquire skill in the interpretation of a published decision analysis. - Suitable forthose with little experience with decision analysis.

Meta-Analysis and Systematic Literature ReviewNathorn Chaiyakunapruk PharmD, PhD, Naresuan University, Thailand; Suk-kyung Hahn PhD, Seoul National University, South KoreaCourse Description: This course highlights and expounds upon four key areas:1) impetus for meta-analysis and systematic reviews, 2) basic steps to performa quantitative systematic review, 3) statistical methods of combining data, and4) appraisal and use of meta-analytic reports. - designed for those with littleexperience with meta-analysis.

Introduction to Biostatistics in Clinical Trials andEconomic StudiesIsao Kamae MD, PhD, Keio University, Japan; Guk-Hee Suh MD, PhD,Hangang Sacred Heart Hospital, South KoreaCourse Description: Providing an introduction to biostatistics and PE analysis inclinical trials, the course will include elementary probability theory, basic con-cepts of statistical inference, sampling theory, hypothesis tests for randomizedcontrolled trials, etc. - to familiarize new researchers or managers interest-ed in research with current statistical techniques.

Pharmacoeconomics for Health Care Decision-makersKenneth KC Lee PhD, The Chinese University of Hong Kong, ChinaCourse Description: Participants will learn the basic concepts and tools forconducting PE & OR. Different assessment methods including cost-effective-ness, cost-minimization, cost of illness, cost-utility and cost-benefit analysis willbe discussed. The applications of PE and OR data will be covered and illustratedby practical examples. - designed to assist decision-making for health careworkers.

Formulary DevelopmentKenneth Hartigan-Go PhD, The Zuellig Foundation, Philippines; Shawn Hsiang-Yin Chen, PharmD, Taipei Medical University, TaiwanCourse Description: This course will describe the organizational structure of theP&T committee, the new drug application and review procedures, the prepara-tion of drug monographs and description of the one-in and one-out process witha discussion of the evidence-based practices with PE consideration put intopractice, the enforcement of drug formulary, etc. - designed for those with lit-tle experience in developing a formulary.

1:00PM-5:00PM AFTERNOON COURSEBudget Impact and Cost AnalysisGordon G. Liu PhD, Peking University, ChinaCourse Description: This course will describe methods to determine the cost-of-illness of a health condition. Participants will learn how to estimate the

impact of new healthcare technologies on disease-specific costs from differentdecision-maker perspectives. Actuarial methods using straight-line projectionsand nonlinear trends will be described. - designed for those with some experi-ence with pharmacoeconomic analysis.

Retrospective Data AnalysisJeff J. Guo, PhD, University of Cincinnati Medical Center, USA; Eui-Kyung LeePhD, Sookmyung University, South KoreaCourse Description: Large administrative claims databases provide a uniqueopportunity to examine retrospectively the effects of drug use on clinical andeconomic outcomes in the “real world” settings. Retrospective data analysis,such as data from medical claims or the other health databases will be dis-cussed. The advantages and disadvantages of using these datasets to performeconomic analyses and epidemiologic studies will be outlined. - designed forthose with little experience with database analysis.

Modeling: Structure and Design of a ModelTony Hsiu-Hsi Chen PhD, National Taiwan University, Taiwan; Tae-Jin Lee PhD,Hallym University, South KoreaCourse Description: This course will present pharmacoeconomic modellingtechniques such as Monte Carlo Simulation, Markov modelling, discrete eventmodels, and other modelling techniques and their appropriate use. The stepsinvolved with model structure, data inputs, data validation will be discussed.This intermediate course requires basic understanding of decision analysis.

Pharmacoeconomic Guidelines for Health CareDecision-makersShanlian Hu MD, Fudan University, China; Tony Yen-Huei Tarn PhD, Center forDrug Evaluation, Taiwan; Alison Tan-Mulligan PhD, GlaxoSmithKlinePharmaceuticals (China) Investment Co. Ltd, ChinaCourse Description: Participants will learn the main contents and analytic tech-niques in PE guideline, the differences between PE guidelines around the worldand some country-specific PE guidelines, the political and technical process ofits formulation and implementation. - designed to teach researchers, clini-cians, drug manufacturers and policy makers.

Reimbursement System and MethodologiesMadeleine R. Valera MD, Philippine Health Insurance Corporation, Philippines;Eduardo Banzon MD, World Bank-Manila Office, Philippines; Christian Gericke,MD, The University of Adelaide, AustraliaCourse Description: This course is designed to provide the participants withunderstanding for the basic principles of reimbursement systems and method-ologies. Recent pharmaceutical spending patterns , trends and cost-containmentmeasures will be discussed taking account of the wider policy context. -designed for those with little experience in pharmaceutical pricing andreimbursement.

Applied Modeling - Use of Decision AnalysisSoftware TreeAgeCourse Description: This course is a hands-on introduction to the use of soft-ware in the creation and analysis of cost-effectiveness decision models. Thebasics of cost-effectiveness decision-making, building and analyzing a simpledecision tree, Markov modeling and Monte Carlo simulation will be introduced.All participants must bring a Windows laptop computer with a copy of TreeAgePro Suite installed and running and receive a CD-rom at the training. Downloadand installation instructions will be provided when you pre-register for thecourse.

Sunday, 7 September 2008, 5:30PM-8:30PM Educational SymposiaSunday, 7 September 2008, 8:30PM-10:30PM Welcome Reception sponsoredby Novartis


ISPOR 3RD ASIA-PACIFIC CONFERENCE 7-9 September 2008 • Seoul, South Korea

Monday, 8 September 2008

8:00AM-8:20AM WELCOME AND INTRODUCTIONBong-Min Yang PhD, Program Chair, Professor, Seoul National University and President, The KoreanAssociation of Health Technology Assessment, South Korea

President of Seoul National University (Invited)

8:20AM-8:40AM WELCOME FROM SOUTH KOREA GOVERNMENT AND GUEST PRESENTATIONMinster of Health and Welfare, South Korea (invited) or Chairman of Health Insurance Review Agency,South Korea (Invited)

8:40AM-9:00AM WELCOME FROM ISPOR & ISPOR ASIA CONSORTIUM

9:00AM-9:15AM BREAK, EXHIBIT & CONTRIBUTED POSTER PRESENTATION VIEWING

9:15AM-11:15AM FIRST PLENARY SESSIONEVIDENCE-BASED DECISION MAKING IN ASIA-PACIFIC: HEALTH CARE SYSTEMS OF CHINA MAIN-LAND, INDIA, SOUTH KOREA, JAPAN, MALAYSIA, PAKISTAN, PHILIPPINES, SINGAPORE, TAIWANAND THAILAND

A panel discussion on evidence-based health care decision making adapted in above health care sys-tems, focusing on health technology (drug and medical device & diagnostics) approval policies, pric-ing policies, reimbursement policies and financial control policies

Moderator: Kenneth KC Lee PhD, The Chinese University of Hong Kong, China

Panelists:Systems Rapidly Changing: Thailand, South Korea and Taiwan

Suwit Wibulpolprasert PhD, Senior Advisor on Disease Control, Ministry of Health, Thailand; Tae-JinLee PhD, Associate Professor of Health Economics, Hallym University, South Korea; Ming-Chin YangPhD, Associate Professor, National Taiwan University, Taiwan

Systems Moderately Changing: China mainland, Japan and Singapore

Gordon G. Liu PhD, Professor and Chair, Peking University, China; Takashi Fukuda PhD, AssociateProfessor, The University of Tokyo, Japan; Lee Chien Earn PhD, Senior Director, HealthcarePerformance Group, Ministry of Health, Singapore

Systems Gradually Changing: India, Pakistan, Malaysia and Philippines

Urmila Mukund Thatte PhD, MD, Professor and Head, Topiwala National Medical College, and BYLNair Charitable Hospital Mumbai Central, India; Anwarul Hassan Gilani PhD, National Professor ofPharmacology & Director, Aga Khan University, Pakistan, and WHO Advisor on Drug Policy andManagement; Samsinah Hussain PhD, Associate Professor and Head, University of Malaya, stry ofHealth, Malaysia, and Member of the Drug Control Authority (DCA) and Pharmacy Board, Ministry ofHealth, Malaysia; Madeleine R. Valera MD, Officer-in-Charge, Health Finance Policy and ServicesSector, and Vice President, Quality Assurance Research and Policy Development Group, PhilippineHealth Insurance Corporation, Philippines

Respondents:Sandeep Duttagupta PhD, Regional Director, Asia & Latin America, Global Outcomes Research,Pfizer Inc., USA; Sheldon Kong PhD, Executive Director, Global Outcomes Research, Reimbursement,and Health Technology Assessment, Merck & Company, Inc., USA; Hong Li PhD, MPH, GroupDirector, Outcomes Research - Asia Pacific, Department of Global Epidemiology and OutcomesResearch, Bristol-Myers Squibb Company, Singapore; Mingliang Zhang PhD, Director, HealthEconomics, Pricing and Market Access, Asia Pacific and Japan, PGSM, Johnson & Johnson, USA


11:30AM-12:30PM CONTRIBUTED PODIUM PRESENTATION-SESSION I Research studies on the following topics may be presented: Arthritis, Cancer, CardiovascularDisease, Diabetes, and GI Disorders

12:30PM-2:00PM LUNCH, EXHIBIT & CONTRIBUTED POSTER PRESENTATION VIEWING

1:00PM-2:00PM EDUCATIONAL SYMPOSIUM sponsored by IMS Health

2:00PM-3:00PM CONTRIBUTED WORKSHOP-SESSION I

3:00PM-3:15PM BREAK, EXHIBIT & CONTRIBUTED POSTER PRESENTATION VIEWING

3:15PM-4:15PM ISSUE PANEL


4:30PM-6:00PM SECOND PLENARY SESSIONDEVELOPING EVIDENCE USING HEALTH TECHNOLOGY ASSESSMENT (HTA)

Activities and achievements of the European Network for Health Technology Assessment (EUnetHTA)and Canadian Agency for Drugs and Technologies in Health (CADTH) will be presented. Asian HTA

initiatives in Taiwan and South Korea will be introduced. Issues on how the exiting HTAs can beadapted globally will be discussed.

Moderator:Isao Kamae MD, DrPH, Professor and Chair, Graduate School of Health Management, KeioUniversity, Japan

Speakers:Harmonize HTA Globally - Activities and achievements of EUnetHTA & CADTH

Finn Boerlum Kristensen MD, PhD, Director & Professor, Danish Centre for Health TechnologyAssessment, National Board of Health, Copenhagen, Denmark, Adjunct Professor, University ofSouthern Denmark, and Project Leader, European Network for HTA (EUnetHTA); Jill M. Sanders PhD,President and CEO, Canadian Agency for Drugs and Technologies in Health (CADTH)

HTA Initiatives in Asia - Cases of Taiwan and South Korea

Tony Yen-Huei Yarn PhD, Senior Researcher, Health Technology Assessment Task Force, Center forDrug Evaluation, Taiwan; Eui-Kyung Lee PhD, Professor, Sookmyung Women's University, SouthKorea

6:00PM-8:00PM RECEPTION, EXHIBIT & CONTRIBUTED POSTER PRESENTATION VIEWING

6:00PM-7:00PM POSTER PRESENTATION AUTHOR HOUR

7:00PM-8:00PM EDUCATIONAL SYMPOSIUM sponsored by Bristol-Myers Squibb Company

VALUE OF ANTIVIRAL TREATMENTS FOR CHRONIC HEPATITIS B

Tuesday, 9 September 2008

8:00AM-9:00AM EXHIBIT & CONTRIBUTED POSTER PRESENTATION VIEWING

9:00AM-9:15AM ISPOR SERVICE AWARDS PRESENTATION

9:15AM-10:45AM THIRD PLENARY SESSIONDEVELOPING AND IMPLEMENTING PHARMACOECONOMIC GUIDELINES: LESSONS LEARNED FROMAUSTRALIA AND SOUTH KOREA

This session will give an overview of experience and lessons learned in developing and implementingpharmacoeconomic guidelines in Australia, and in South Korea, where the pharmacoeconomic guide-lines was issued in 2006, and in 2008 the decision is expected being made on whether and how theguidelines will be officially implemented countrywide.

Moderator:Bong-Min Yang PhD, Professor of Economics, Seoul National University, South Korea

Speakers:Rosalie Viney PhD, Associate Professor and Deputy Director, Centre for Health Economics Research& Evaluation, Australia

Eun-Young Bae PhD, Senior Researcher, Health Insurance Review Agency, South Korea


11:00AM-12:00PM CONTRIBUTED WORKSHOP-SESSION II

12:00PM-1:30PM LUNCH, EXHIBIT & CONTRIBUTED POSTER PRESENTATION VIEWING

12:30PM-1:30PM EDUCATIONAL SYMPOSIUM Sponsored by Korean Research-basedPharmaceutical Industry Association

1:30PM-2:30PM CONTRIBUTED PODIUM PRESENTATION-SESSION II

2:30PM-2:45PM BREAK, EXHIBIT AND CONTRIBUTED POSTER PRESENTATION VIEWING

2:45PM-3:45PM SPECIAL SESSION Invited Organizations or Topics:Health Insurance Review Agency, Seoul, South Korea

Developing and Implementing PE Guidelines in China and Thailand

ASEAN Harmonization and Improving Drug Access: Where are the Benefits and Risks

Pharmacoeconomics and Outcomes Research in, Joan, Indonesia, Mongolia, and Vietnam

Health Technology Assessment Application in Medical Device & Diagnostics


4:00PM-5:00PM CONTRIBUTED WORKSHOP-SESSION III

5:00PM-5:15PM BREAK

5:15PM-6:00PM ISPOR CONTRIBUTED RESEARCH AWARDS PRESENTATIONISPOR 4th ASIA-PACIFIC CONFERENCE ANNOUNCEMENTCLOSING REMARKS

PRELIMINARY PROGRAM


ISPOR 13th Annual International MeetingSheraton Centre Toronto Toronto, Ontario, Canada May 3 -7, 2008

PROGRAMFRIDAY, MAY 2, 200810.00AM-5:00PM EDUCATIONAL SYMPOSIUM (Presented by Oxford Outcomes & Axia Research, supported by Amgen Canada)International Experiences of Centralized Reimbursement Reviews – Identifying Best Practices This symposium will focus on experiences in countries that routinely use centralized reimbursement reviews fornew medicines and other health technologies. Through presentations and dialogue, recommendations for bestpractices in reimbursement decision-making will be identified for practitioners and decision-makers. Panelistswill be thought leaders representing the perspectives of academia, the decision-making community and industry,and from disciplines including economic appraisal, patient-reported outcomes and epidemiology.

SATURDAY, MAY 3, 20088:00AM-5:00PM PRE-MEETING SHORT COURSES

SUNDAY, MAY 4, 20088:00AM-5:00PM PRE-MEETING SHORT COURSES5:00PM-7:00PM EDUCATIONAL SYMPOSIUM (Co-Sponsored by PhRMA Health Outcomes Committee & ISPOR)Evolving Evidence Requirements in the Changing Global Landscape of Payer-Decision MakingEver changing evidence requirement by payers in North America, Europe and Asia Pacific have enormous implica-tions for submissions by the pharmaceutical industry. The symposium will review the latest changes in thedemand for value evidence by these decision-makers, and its implications for health economics and industry.

7:00PM-7:30PM SYMPOSIUM RECEPTION6:30PM-8:30PM STUDENT RESEARCH COMPETITION8:30PM-10:00PM STUDENT ICEBREAKER RECEPTION

MONDAY, MAY 5, 20087:30AM-8:30AM ISPOR FORUMS (Open forum with buffet breakfast)ISPOR Digest of International Databases ForumThe use of the ISPOR Digest of International Databases will be discussed. The forum will provide an opportunityfor researchers to provide input and insight to the effectiveness of the ISPOR Digest.

Patient Registry Taxonomy, Good Research and Operational Issues ForumThis session will focus on the ISPOR Taxonomy of Patient Registries book as well as good research principles,practical design and operational considerations in developing and using patient registry information.

8:30AM-8:45AM WELCOME & INTRODUCTIONAdrian Levy PhD and C. Daniel Mullins PhD, Program Committee Co-Chairs

8:45AM-9:00AM PRESIDENTIAL ADDRESSDiana Brixner PhD, 2007-2008 ISPOR President and Associate Professor and Chair, Department ofPharmacotherapy, Executive Director, Pharmacotherapy Outcomes Research Center, University of Utah, Salt LakeCity, UT, USA

9:00AM-10:15AM FIRST PLENARY SESSION: New Evidence on Evidence-BasedTechnology Assessment in the USA vs. CanadaThe requirement for evidence when performing technology assessments is viewed by some as a logical process formaking decisions and by others as an impossible hurdle and a moving target. Technology assessment occurs quitedifferently across public and private payers in Canada and the United States, yet all agree that credible evidenceis needed for technology assessment and adoption. Panelists representing public and private payers will discusshow they currently assess evidence and conduct technology assessments and how this may change in the future.Moderator/Speaker: Mark Sculpher PhD, Professor of Health Economics, Centre for Health Economics,University of York, York, UKSpeakers: Leslie Levin MB, MD, FRCP, FRCPC, Senior Medical, Scientific and Health Technology Advisor, Head,Medical Advisory Secretariat, Ministry of Health and Long Term Care, Toronto, ON, Canada; Sean Tunis MD, MSc,Executive Director, Center for Medical Technology Policy, Baltimore, MD, USA; David Yoder PharmD, MBA,Divisional Vice President Pharmacy, Bravo Health, Baltimore, MD, USA

10:15AM-10:45AM BREAK, EXHIBITS & POSTER PRESENTATIONS VIEWING - SESSION I10:45AM-11:45PM PODIUM PRESENTATIONS - SESSION I Health Care Decisions Using Outcomes Research Information Case Studies ICASE 1: AN INTEGRATED PILOT PROJECT UTILIZING AN INTERNAL HTA PROCESS TO SET MEDICAL ANDPAYMENT POLICY IN A U.S. COMMERCIAL HEALTH PLANWatkins J1, Choudhury S1, Sturm L2, Bresnahan B3, Sullivan S3, 1Premera Blue Cross, Mountlake Terrace, WA, USA;2Formulary Resources, LLC, Issaquah, WA, USA; 3University of Washington, Seattle, WA, USACASE 2: DRUG ELUTING STENTS - AN EXAMPLE OF THE TRANSITION FROM EVIDENCE TO POLICYTHROUGH THE ONTARIO COMPREHENSIVE APPROACH TO THE DIFFUSION OF HEALTH TECHNOLOGIESLevin L1, Goeree R2, 1Ontario Ministry of Health and Long-Term Care, Toronto, ON, Canada; 2McMaster University,Hamilton, ON, CanadaCASE 3: REVIEWING AND ADAPTING A LOCAL HEALTH TECHNOLOGY ASSESSMENT PROGRAM TODEPARTMENTS WITHIN A CANADIAN HEALTH REGIONAusten L, Poulin P, Calgary Health Region, Calgary, AB, Canada

Outcomes Research in Canada CA1: ECONOMIC ANALYSIS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS IN THE PRIMARY PREVEN-TION OF SUDDEN CARDIAC DEATH - A CANADIAN PERSPECTIVE Deniz B1, Sadri H2, 1United BioSource Corporation, Concord, MA, USA, 2Medtronic of Canada Ltd, Toronto, ON, CanadaCA2: THE USE OF RESEARCH ABSTRACTS IN FORMULARY DECISION MAKING BY THE ONTARIO CANCERDRUG APPROVAL COMMITTEE Weizman A1, Bell C2, 1University of Toronto, Toronto, ON, Canada, 2Department of Medicine, St. Michael’s Hospital,Toronto, ON, Canada CA3: A COST-EFFECTIVENESS ANALYSIS OF HEPATITIS C SCREENING AMONG IMMIGRANTS IN CANADA. Chen W1, Dinner K2, Wong T2, Heathcote J3, Krahn MD3, 1University of Toronto, Toronto, ON, Canada, 2Public HealthAgency of Canada, Ottawa, ON, Canada, 3University Health Network, Toronto, ON, Canada CA4: THE EARLY CLINICAL AND ECONOMIC BENEFITS OF ATORVASTATIN IN A CANADIAN SETTING Merikle E1, Ramos É1, Kuznik A2, Botteman MF3, 1Pfizer Canada Inc, Kirkland, QC, Canada, 2Pfizer Inc, New York, NY,USA, 3PharMerit North America LLC, Bethesda, MD, USA

Drug and Health Services Use Research DH1: FOLLOW-UP VISITS FOR PATIENTS WITH MAJOR DPRESSIVE DISORDER DURING INITIATION OFANTIDEPRESSANT TREATMENT Chen SY, Hansen R, Maciejewski ML, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA DH2: IMPACT OF ADHERING TO LIPID MANAGEMENT NATIONAL GUIDELINE RECOMMENDATIONS ONCARDIOVASCULAR EVENTS AND COSTS IN A MANAGED CARE POPULATION Balu S1, Simko RJ1, Burge RT1, Quimbo R2, Cziraky MJ2, 1Abbott Laboratories, Abbott Park, IL, USA, 2HealthCore, Inc,Wilmington, DE, USA DH3: THE IMPACT OF DRUG VINTAGE ON PATIENT SURVIVAL: A PATIENT-LEVEL APPROACH USING QUE-BEC’S PROVINCIAL HEALTH PLAN DATA Lichtenberg F1, Van Audenrode M2, Grootendorst P3, Latremouille-Viau D2, Lefebvre P2, 1Columbia University, NewYork, NY, USA, 2Groupe d’analyse, Ltee, Montreal, QC, Canada, 3University of Toronto, Toronto, ON, Canada DH4: MARKET DISCONTINUATION OF PHARMACEUTICALS IN THE UNITED STATES: ANALYSIS OF NEWDRUGS APPROVED FROM 1980 TO 2007 Qureshi ZP, Szeinbach SL, Seoane-Vazquez E, The Ohio State University, Columbus, OH, USA

Mental Health Outcomes Research MH1: REAL WORLD ASSOCIATION BETWEEN ANTIPSYCHOTIC TREATMENT AND WEIGHT GAIN IN ANADOLESCENT POPULATION Ghate SR1, Said Q2, Rosenblatt LC3, Kim E3, Pikalov A4, Brixner D1, 1The University of Utah College of Pharmacy, SaltLake City, UT, USA, 2University of Arkansas for Medical Sciences, Little Rock, AR, USA, 3Bristol-Myers Squibb,Plainsboro, NJ, USA, 4Otsuka America Pharmaceuticals, Rockville, MD, USA MH2: ECONOMIC AND CLINICAL CONSEQUENCES ASSOCIATED WITH POTENTIAL DRUG-DRUG INTERAC-TIONS BETWEEN ANTIPSYCHOTICS AND CONCOMITANT MEDICATIONS IN PATIENTS WITH SCHIZOPHRENIA Guo JJ1, Kelton CM1, Patel NC1, Wu JH2, Jing Y1, Fan H3, Keck P1, 1University of Cincinnati, Cincinnati, OH, USA,2Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA, 3Covance Inc, Sun Prairie, WI, USA


ISPOR 13th Annual International MeetingSheraton Centre Toronto, Toronto, Ontario, Canada, May 3 -7, 2008

MH3: WORK ABSENTEEISM AND BED DAYS IN CHRONIC MEDICAL DISORDER PATIENTS WITH AND WITH-OUT DEPRESSION IN THE UNITED STATES, 2004-2005 Sankaranarayanan J, Smith LM, Meza J, Burke WJ, University of Nebraska Medical Center, Omaha, NE, USA MH4: TREATMENT COST AND COMORBIDITIES ASSOCIATED WITH OBESITY AMONG CHILDREN AND ADO-LESCENTS WITH BIPOLAR DISORDER Guo JJ1, Kelton CM1, Jing Y1, Patel NC2, 1University of Cincinnati, Cincinnati, OH, USA, 2University of Georgia,Augusta, GA, USA

Research on Medicare Part D and Reimbursement Policies I MD1: MEDICARE PART D: EARLY EVIDENCE ON PRESCRIPTION DRUG TREATMENT PATTERNS, HOSPITAL-IZATION OFFSETS AND MEDICARE SPENDING Zhang Y1, Newhouse JP2, Hanlon J1, Lave J1, Donohue JM1, 1University of Pittsburgh, Pittsburgh, PA, USA, 2HarvardUniversity, Boston, MA, USA MD2: THE IMPACT OF MEDICARE PART D ON THE PERCENT GROSS MARGIN EARNED BY TEXAS INDEPEN-DENT PHARMACIES FOR DUAL ELIGIBLE BENEFICIARY CLAIMS Winegar AL, Shepherd MD, Lawson K, Richards KM, University of Texas at Austin, Austin, TX, USA MD3: IMPACT OF MEDICARE PART D DOUGHNUT ON THE USE OF MEDICATIONS BY THERAPEUTIC CLASS-ES FOR STANDARD BENEFICIARIES Sun SX, Lee KY, Walgreens Health Services, Deerfield, IL, USA MD4: IMPACT OF THE MEDICARE MODERNIZATION ACT OF 2003 ON PART B DRUG USE AND SPENDING:A CASE STUDY OF BIOLOGICALS FOR RHEUMATOID ARTHRITIS Doshi JA, Li P, Puig A, University of Pennsylvania, Philadelphia, PA, USA

12:00PM-1:00PM PODIUM PRESENTATIONS - SESSION II Health Care Decisions Using Outcomes Research Information Case Studies IICASE 4: THE IMPACT OF THE PROJECT OF ENHANCING COVERAGE RATE FOR PATIENTS WITH CANCERLee SM, Nam MH, Yoon SH, Kim BY, Choi MR, Cho HS, Lee KD, Health Insurance Review & Assessment Services,Seoul, South KoreaCASE 5: THE CENTER FOR DRUG POLICY: PARTNERS HEALTHCARE Reddy P1, Yeh Y1, Clapp M2, Churchill W3, 1Partners Healthcare, Charlestown, MA, USA; 2Massachusetts GeneralHospital, Boston, MA, USA; 3Brigham and Women’s Hospital, Boston, MA, USACASE 6: THE USE OF AN EVIDENCE-BASED PRACTICE STRATEGY TO IMPROVE QUALITY IN THE ACUTECARE SETTINGMutnick AH, Wong PK, Hanseman DJ, Mercy Health Partners, Southwest Ohio, Cincinnati, OH, USA

Cancer Outcomes Research CN1: TRENDS IN TREATMENT AMONG ELDERLY COLORECTAL CANCER PATIENTS IN THE US: EVIDENCEFROM LINKED SEER-MEDICARE DATA Lang K1, Lines LM1, Lee DW2, Korn JR1, Vanness DJ3, Earle C4, Menzin J1, 1Boston Health Economics, Inc, Waltham,MA, USA, 2GE Healthcare, Waukesha, WI, USA, 3University of Wisconsin-Madison, Madison, WI, USA, 4HarvardUniversity, Boston, MA, USA CN2: ECONOMIC EVALUATION OF EGFR-GUIDED TREATMENT IN ADVANCED REFRACTORY NON SMALL-CELL LUNG CANCER Carlson JJ1, Garrison L1, Ramsey S2, Veenstra DL1, 1University of Washington, Seattle, WA, USA, 2Fred HutchinsonCancer Research Center, Seattle, WA, USA CN3: COMPARISON OF THE COST-EFFECTIVENESS OF SIX CYCLES OF TAXOTERE, DOXORUBICIN,CYCLOPHOSPHAMIDE (TAC) VERSUS SIX CYCLES OF FLUOROURACIL, DOXORUBICIN, CYCLOPHOSPHAMIDE(FAC) IN THE ADJUVANT SETTING OF NODE POSITIVE BREAST CANCER WITH PRIMARY AND SECONDARYG-CSF PROPHYLAXIS Mittmann N1, Koo M1, Alloul K2, Trudeau M3, 1Sunnybrook Health Sciences Centre, Toronto, ON, Canada, 2sanofi-aventis Canada, Montreal, QC, Canada, 3Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON,Canada CN4: COSTS ASSOCIATED WITH NEUTROPENIA IN ELDERLY PATIENTS TREATED FIRST-LINE FORADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) Stokes ME1, Muehlenbein CE2, Marciniak MD2, Faries D2, Motabar S3, Buesching DP2, Gillespie TW4, Lipscomb J4,Knopf KB5, 1United BioSource Corporation, Dorval, QC, Canada, 2Eli Lilly and Company, Indianapolis, IN, USA,3United BioSource, Bethesda, MD, USA, 4Emory University and Veterans Affairs Medical Center, Atlanta, GA, USA,5California Pacific Medical Center, San Francsico, CA, USA

Health Policy Research HP1: A COMPARISON OF THREE TECHNOLOGY APPRAISAL SYSTEMS; NICE, SMC AND CADTH Karia R1, Gani R2, Perard R1, Cann K2, 1Heron Evidence Development Ltd, Letchworth Garden City, Hertfordshire, UK,2Heron Evidence Development Ltd, Hertfordshire, UK HP2: NHS REIMBURSEMENT OF NEW CANCER DRUGS: IS NICE GETTING NASTIER? Mason AR1, Drummond M2, 1University of York, York, N. Yorkshire, UK, 2University of York, York, Heslington, UK HP3: PRIORITY SETTING FOR NEW TECHNOLOGIES: POSSIBLE DETERMINANTS AMONG THE WORKINGPOPULATION Derycke H, Annemans L, Ghent University, Gent, Belgium HP4: 25 YEARS OF THE ORPHAN DRUG ACT: ANALYSIS OF THE NEW ORPHAN DRUGS APPROVEDBETWEEN 1983 AND 2007 Rodriguez-Monguio R1, Visaria J2, Seoane-Vazquez E2, 1University of Massachusetts, Amherst, MA, USA, 2The OhioState University, Columbus, OH, USA

Research on Medicare Part D and Reimbursement Policies II MD5: HEALTH CARE UTILIZATION BY MEDICARE ADVANTAGE BENEFICIARIES IN THE ERA OF THEMEDICARE PART D DRUG BENEFIT COVERAGE GAP Delate T1, Raebel MA2, Ellis JL2, Bayliss EA2, 1Kaiser Permanente Colorado, Aurora, CO, USA, 2Kaiser PermanenteColorado, Denver, CO, USA MD6: INFLUENCE OF MEDICARE CLAIM-PAYING AGENTS’ REIMBURSEMENT POLICY ON G-CSF CHOICEDURING FIRST CYCLE OF CHEMOTHERAPY FOR NON-HODGKIN’S LYMPHOMA PATIENTS Pan X1, Brooks JM2, Wright KB1, Voelker MD1, 1University of Iowa, Iowa City, IA, USA, 2USRDS Economic SpecialStudy Center, The University of Iowa, Iowa City, IA, USA MD7: DIFFERENTIAL TAKE-UP OF THE MEDICARE PART D PRESCRIPTION DRUG BENEFIT Rabbani A1, Yin W1, Zhang JX1, Sun SX2, Alexander GC1, 1University of Chicago, Chicago, IL, USA, 2Walgreens HealthServices, Deerfield, IL, USA

MD8: THE IMPACT OF MEDICARE NEW DRUG BENEFIT (PART D) ON THE UTILIZATION OF PSYCHOTROPICMEDICATIONS AND CONSEQUENT OUT OF POCKET EXPENDITURE FOR ELDERLY Chen H1, Nwangwu A1, Aparasu R1, Sun SX2, Lee KY2, 1University of Houston, Houston, TX, USA, 2Walgreens HealthServices, Deerfield, IL, USA

Research on Patient Reported Outcomes Methods PM1: RASCH RATING SCALE ANALYSIS OF THE EQ-5D USING THE 2003 MEDICAL EXPENDITURE PANELSURVEY (MEPS) Gu NY, Doctor JN, University of Southern California, Los Angeles, CA, USA PM2: WHAT PATIENTS SAY VS. WHAT PATIENTS MEAN: QUALITATIVE RESEARCH IN PRO DEVELOPMENT Lasch KE1, Marquis P1, Vigneux M2, Abetz L3, Arnould B2, Bayliss MS1, Crawford B1, Rosa K1, Scott J1, 1Mapi Values,Boston, MA, USA, 2Mapi Values, Lyon, France, 3Mapi Values Limited, Bollington, UK PM3: THE VALIDITY AND RELIABILITY OF A PARENT-CHILD DYAD APPROACH TO UTILITY AND QUALITY-OF-LIFE ASSESSMENT IN CHILDREN Ungar WJ1, Boydell K1, Dell S1, Feldman BM1, Marshall DA2, Willan AR1, Wright J1, 1The Hospital for Sick Children,Toronto, ON, Canada, 2McMaster University, Hamilton, ON, Canada PM4: EVALUATION OF A THEORY OF GLOBAL HEALTH PREFERENCE FORMATION Shaw JW1, Pickard AS1, Lin HW1, Cella D2, Trask PC3, 1University of Illinois at Chicago, Chicago, IL, USA, 2EvanstonNorthwestern Healthcare, Evanston, IL, USA, 3Pfizer, Inc, New London, CT, USA

1:00PM-2:45PM LUNCH, EXHIBITS & POSTER PRESENTATIONS VIEWING - SESSION I1:30PM-2:30PM EDUCATIONAL SYMPOSIUM (Sponsored by IMS Health)Why Does Medication Noncompliance Persist? Noncompliance with prescribed medicines contributes to over 125,000 deaths each year, costing the health caresystem more than $175 billion annually. Yet, despite the nearly 40,000 articles published on the subject, non-compliance still persists. In this session, IMS will feature a dynamic and interactive discussion that offers newperspectives on the problem of noncompliance, the breadth and quality of current compliance literature, andinsights into the design and evaluation of evidence-based compliance programs.

2:45PM-3:45PM ISSUE PANELS - SESSION I CLINICAL OUTCOMES RESEARCH ISSUESIP1: COMPARATIVE EFFECTIVENESS RESEARCH: BREAKING THE METHODS MOLDModerator: Sean Tunis MD, MSc, Executive Director, Center for Medical Technology Policy, Baltimore, MD,USA.Panelist(s): Bryan Luce PhD, MBA, Senior Vice President, Science Policy, United BioSource Corporation,Bethesda, MD, USA; Scott Berry PhD, President, Berry Consultants, College Station, TX, USA; Michael Krams MD,Asst. Vice President, Wyeth Research, Collegeville, PA, USA.

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUESIP2: IS NICE ALL THAT NASTY? COMPARISONS OF ACCESS TO CANCER THERAPY IN UK AND US HEALTHCAREModerator: Lee N Newcomer MD, Senior Vice President, Oncology, UnitedHealthcare, Edina, MN, USA.Panelist(s): Mike F Drummond PhD, Professor of Health Economics, University of York, Centre for HealthEconomics, York, Heslington, UK; Scott Ramsey MD, PhD, Associate Member, Fred Hutchinson Cancer ResearchCenter, Seattle, WA, USA; Dennis W Raisch PhD, Associate Center Director, Department of Veterans AffairsCooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA.IP3: ESTABLISHING KEY PRINCIPLES FOR HEALTH TECHNOLOGY ASSESSMENTModerator: Sean D Sullivan PhD, RPh, Professor of Pharmacy and Public Health and Director, University ofWashington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA.Panelist(s): Naomi Aronson PhD, Executive Director, Blue Cross-Blue Shield Technology Evaluation Center,Chicago, IL, USA; Peter J. Neumann ScD, Professor, Tufts-New England Medical Center, Institute for ClinicalResearch and Health Policy Studies, Boston, MA, USA; Jill M. Sanders PhD, President and CEO, Canadian Agencyfor Drugs and Technologies in Health, Ottawa, ON, Canada.IP4: WHAT DID THE MEDICARE REPLACEMENT DRUG DEMONSTRATION TEACH US ABOUT THE ROLE OFCOST-EFFECTIVENESS ANALYSES IN PUBLIC POLICY?Moderator: Penny E Mohr MA, Director, Division of Research on Health Plans and Drugs, Centers for Medicare andMedicaid Services, Office of Research, Development and Information, Baltimore, MD, USA.Panelist(s): William Lawrence MD, MS, Research Fellow, Agency for Healthcare Research and Quality, Center forOutcomes and Effectiveness Research, Rockville, MD, USA; Allan Wailoo BSc, MA, PhD, Senior Lecturer in HealthEconomics, The University of Sheffield, Health Economics and Decision Science, School of Health and RelatedResearch, Sheffield, UK; Martin Zagari MD, Global Health Economics Head, Amgen, Thousand Oaks, CA, USA.

PATIENT-REPORTED OUTCOMES RESEARCH ISSUESIP5: PATIENT-REPORTED OUTCOMES, HEALTH-STATE UTILITIES, OR STATED-PREFERENCES? SIMILARITIES,DIFFERENCES AND ROLES IN DEMONSTRATING PRODUCT VALUEModerator: A. Brett Hauber PhD, Senior Economist and Head, RTI Health Solutions, Health Preference Assessment,Research Triangle Park, NC, USA.Panelist(s): Paul Kind PhD, Professor of Economics, University of York, Centre for Health Economics, York,Heslington, UK; William Furlong MSc, Research Coordinator, McMaster University and Health Utilities Inc,Hamilton, ON, Canada; F. Reed Johnson PhD, Senior Fellow and Principal Economist, RTI International, ResearchTriangle Park, NC, USA.

3:45PM-4:00PM BREAK, EXHIBITS & POSTER PRESENTATIONS VIEWING - SESSION I4:00PM-5:00PM PODIUM PRESENTATIONS - SESSION III Research On Adherence and Compliance I AC1: THE ASSOCIATION BETWEEN IMPROVEMENTS IN DRUG ADHERENCE AND SHORT-TERM SERVICEUTILIZATION AND COSTS IN A MEDICAID POPULATION Thiebaud P, Pfizer Health Solutions, New York, NY, USA AC2: PATTERNS OF DIABETES MEDICATION AND TEST ADHERENCE IN A MEDICAID DISEASE MANAGE-MENT PROGRAM Demand M, Gutierrez PR, Thiebaud P, Pfizer Health Solutions, New York, NY, USAAC3: DEPRESSIVE SYMPTOMATOLOGY, MEDICATION PERSISTENCE, AND ASSOCIATED HEALTH CARECOSTS IN OLDER ADULTS WITH INSOMNIA Kulkarni AS1, Patel I2, Anderson RT3, Balkrishnan R1, 1The Ohio State University College of Pharmacy, Columbus,OH, USA, 2The Ohio State University, Columbus, OH, USA, 3Wake Forest University School of Medicine, WinstonSalem, NC, USA

PROGRAM continued



AC4: THE COST OF NON-ADHERENCE TO ASTHMA TREATMENT GUIDELINES AMONG A LOW-INCOMECOHORTSaid Q1, Waitzman NJ2, 1University of Arkansas for Medical Sciences, Little Rock, AR, USA, 2University of Utah, SaltLake City, UT, USA

Cardiovascular Disease Outcomes Research CV1: EFFECTIVENESS OF COMBINED BETA-BLOCKER AND ACEI OR ARB THERAPY IN CHRONIC HEARTFAILURE Sharma M1, Deswal A2, Henderson L3, Desai R1, Chitnis A1, Petersen N4, Ashton C5, Johnson M4, 1University ofHouston, Houston, TX, USA, 2Baylor College of Medicine; Michael E. DeBakey Veterans Affairs Medical Center,Houston, TX, USA, 3University of Texas M.D.Anderson Cancer Center, Houston, TX, USA, 4Michael E. DeBakeyVeterans Affairs Medical Center, Houston, TX, USA, 5University of Alabama, Birmingham, AL, USACV2: THE COST-EFFECTIVENESS OF CANDESARTAN IN THE TREATMENT OF CHRONIC HEART FAILURE (HF)- AN ASSESSMENT OF THE LOW LEFT VENTRICULAR EJECTION FRACTION (LOW-LVEF) TRIALS IN THECANDESARTAN-IN-HEART-FAILURE-ASSESSMENT-OF-REDUCTION-IN-MORTALITY-AND-MORBIDITY(CHARM) TRIAL PROGRAMME Levin LÅ1, Jørgensen E2, Eriksson B3, Swedberg K4, Paulsson T3, 1Linköping University, Linköping, Sweden,2AstraZeneca, Oslo, Norway, 3AstraZeneca, Södertälje, Sweden, 4Sahlgrenska Academy, Göteborg University,Gothenburg, Sweden CV3: CLINICAL AND ECONOMIC OUTCOMES ASSOCIATED WITH BLEEDING DURING CORONARY ARTERYBYPASS GRAFT SURGERY AMONG ELDERLY AMERICANS Ganz ML1, Joshi AV2, Wang Q3, Wilke CT4, Lee WC3, Pashos CL1, 1Abt Associates, Inc, Lexington, MA, USA, 2NovoNordisk Inc, Princeton, NJ, USA, 3Abt Associates, Inc, Bethesda, MD, USA, 4University of Illinois at Chicago,Chicago, IL, USA CV4: CAN TWO A’S RESULT IN A FAILURE?: EFFECT OF ASPIRIN ON THE RISK OF HEART FAILURE HOSPI-TALIZATIONS IN CHF PATIENTS ON ACE INHIBITORS. Shah DH, Parikh NM, Kamble PS, Chen H, Johnson M, University of Houston, Houston, TX, USA

Diabetes Outcomes Research DB1: REAL-WORLD SIX MONTH OUTCOMES OF PATIENTS INITIATING EXENATIDE IN A PRIMARY CAREELECTRONIC MEDICAL RECORD DATABASE Brixner D1, McAdam-Marx C1, Ye X1, Boye KS2, Schroeder B3, Fabunmi R3, 1The University of Utah College ofPharmacy, Salt Lake City, UT, USA, 2Eli Lilly and Company, Indianapolis, IN, USA, 3Amylin Pharmaceuticals, Inc, SanDiego, CA, USA DB2: COST-EFFECTIVENESS ANALYSIS OF PREGABALIN FOR THE MANAGEMENT OF NEUROPATHIC PAINASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY IN MEXICO Arreola-Ornelas H1, Dorantes-Aguilar J1, García-Mollinedo MDL2, Rosado-Buzzo AA2, Mould-Quevedo J3, Davila-Loaiza G3, 1Fundación Mexicana para la Salud, Funsalud, Mexico City, Mexico, 2Links & Links S.A. de C. V, MexicoCity, Mexico, 3Pfizer Mexico, Mexico City, Mexico DB3: REAL-WORLD ANALYSIS OF PERCENT OF PATIENTS WITH TYPE 2 DIABETES ACHIEVING GLYCEMICGOAL WITH INSULIN GLARGINE Misurski D1, Schroeder B2, Wade R3, Quimbo R3, Nielsen L2, Fabunmi R2, Wintle M2, 1Eli Lilly and Company,Indianapolis, IN, USA, 2Amylin Pharmaceuticals, Inc, San Diego, CA, USA, 3HealthCore, Inc, Wilmington, DE, USA DB4: RETROSPECTIVE STUDY OF TYPE 2 DIABETES MELLITUS (T2DM) PATIENTS NOT OPTIMALLY CON-TROLLED BY METFORMIN MONOTHERAPY He J, Neslusan C, Johnson & Johnson Pharmaceutical Services L.L.C, Raritan, NJ, USA

Drug Use Research I DU1: DEMOGRAPHIC RISK FACTORS FOR STROKE RELATED AMBULATORY CARE UTILIZATION: ANALYSISOF UNITED STATES NATIONAL DATA 2000-2005 Karve S, Levine D, Balkrishnan R, The Ohio State University, Columbus, OH, USADU2: DOES COMMUNITY-BASED HEALTH INSURANCE IMPROVE ACCESS TO DRUGS AND HEALTH CAREFOR THE POOREST IN AFRICA? Souares A1, Savadogo G2, Gnawali DP1, Sauerborn R1, 1Heidelberg University, Heidelberg, BadenWürttemberg,Germany, 2Centre de Recherche en Santé de Nouna, Nouna, Kossi, Burkina FasoDU3: CALIFORNIA WILDFIRES AND THEIR IMPACT ON MEDICATION ACQUISITION Hutchins DS1, Liberman JN2, Tong W1, Berger JE3, 1CVS Caremark, Scottsdale, AZ, USA, 2CVS Caremark Corporation,Hunt Valley, MD, USA, 3CVS|Caremark Inc, Northbrook, IL, USA DU4: PRESCRIPTION DRUG UTILIZATION AMONG A NATIONALLY REPRESENTATIVE SAMPLE OF MEDICAREBENEFICIARIES WITH HEART FAILURE Bain KT1, Richardson D2, Liao D2, Diamond J3, Novielli KD2, Goldfarb NI3, 1excelleRx, Inc, Philadelphia, PA, USA,2Jefferson Medical College, Philadelphia, PA, USA, 3Thomas Jefferson University, Philadelphia, PA, USA

Research on Outcomes Research Methods OM1: VALIDATING A SURVEY INSTRUMENT USING NONPARAMETRIC ITEM RESPONSE THEORY – APPLICA-TION OF KERNEL REGRESSION Lin HW1, Pickard AS1, Karabatsos G2, Mahady GB1, Crawford SY1, Popovich NG1, 1College of Pharmacy, University ofIllinois at Chicago, Chicago, IL, USA, 2College of Education, University of Illinois at Chicago, Chicago, IL, USA OM2: USING VALUE OF INFORMATION METHODOLOGY TO DETERMINE THE SAMPLE SIZE FOR A RANDOMIZED CLINICAL TRIAL FROM AN INDUSTRY PERSPECTIVE Willan AR, SickKids Research Insitute, Toronto, ON, Canada OM3: WAS IT NICE FOR YOU? ESTIMATING SUBGROUP QUALITY OF LIFE TARIFFS FROM CONJOINTANALYSES: RESULTS FROM A BEST-WORST SCALING STUDY Flynn TN1, Louviere JJ2, Peters TJ1, Coast J3, 1University of Bristol, Bristol, UK, 2University of Technology, Sydney,NSW, Australia, 3University of Birmingham, Birmingham, UK OM4: LONG-TERM COST-EFFECTIVENESS OF A DIABETES RISK SCORE IN CLINICAL PRACTICE Sullivan SD1, Garrison LP1, Rinde H2, Kolberg J3, Moler E3, Urdea M4, 1University of Washington, Seattle, WA, USA,2BioBridge Strategies, Binningen, Switzerland, 3Tethys Bioscience Inc, Emeryville, CA, USA, 4Tethys Bioscience, Inc,Emeryville, CA, USA

5:15PM-6:15PM PODIUM PRESENTATIONS - SESSION IVResearch On Adherence and Compliance II AC5: ORAL ANTIDIABETIC MEDICATION ADHERENCE AND HEALTH CARE COSTS AND UTILIZATION AMONGMEDICAID-ENROLLED TYPE 2 DIABETES PATIENTS NEWLY STARTING MONOTHERAPY Shenolikar R1, Balkrishnan R2, 1Glaxo SmithKline, Columbus, OH, USA, 2The Ohio State University, Columbus, OH, USAAC6: ASSOCIATION OF NONCOMPLIANCE WITH DIABETES CARE GUIDELINES AND DISEASE BURDEN IN ACALIFORNIA MEDICAID TYPE 2 DIABETES MELLITUS POPULATION

Nichol MB1, Knight TK1, Wu J1, Priest JL2, Cantrell CR2, 1University of Southern California, Los Angeles, CA, USA,2GlaxoSmithKline, Research Triangle Park, NC, USA AC7: COMPARING ADHERENCE TO FIXED DOSE COMBINATION VERSUS MULTI-PILL COMBINATION THER-APIES AMONG PATIENTS WITH DYSLIPIDEMIA IN A MANAGED CARE POPULATION Balu S1, Simko RJ1, Burge RT1, Quimbo R2, Cziraky MJ2, 1Abbott Laboratories, Abbott Park, IL, USA, 2HealthCore, Inc,Wilmington, DE, USA AC8: ASSOCIATION OF MEASURES OF MEDICATION ADHERENCE AND SEVERE RELAPSES WITH MULTIPLESCLEROSIS DISEASE-MODIFYING THERAPY Dickson M1, Kozma C2, Okuda DT3, Fincher C4, Meletiche D4, 1University of South Carolina, College of Pharmacy,Columbia, SC, USA, 2University of South Carolina, West Columbia, SC, USA, 3University of California, San Francisco,San Francisco, CA, USA, 4EMD Serono, Inc, Rockland, MA, USA

Drug Use Research II DU5: IMPACT OF FORMULARY RESTRICTIONS ON ADHERENCE TO SECOND GENERATION ANTIPSYCHOTICS Zeng F1, Leslie RS1, Patel BV1, Chen CC2, Kim E2, Knoth R2, Tran QV3, 1MedImpact Healthcare Systems, Inc, San Diego,CA, USA, 2Bristol-Myers Squibb, Plainsboro, NJ, USA, 3Otsuka America Pharmaceutical Inc, Rockville, MD, USADU6: ASSESSMENT OF DRUG UTILIZATION PATTERNS AND COSTS FOR ERYTHROPOIETIC STIMULATINGAGENTS IN ELDERLY PATIENTS WITH CHRONIC KIDNEY DISEASE Lafeuille MH1, Lefebvre P1, Bookhart B2, Laliberte F1, Bailey R2, Corral M2, Piech CT2, 1Groupe d’analyse, Ltee,Montreal, QC, Canada, 2Ortho Biotech Clinical Affairs, LLC, Bridgewater, NJ, USA DU7: NATIONAL ESTIMATES AND DETERMINANTS OF DEPRESSION AND ANTIDEPRESSANT TREATMENT INCANCER PATIENTS IN THE UNITED STATES, 2004-2005 Sankaranarayanan J, Smith LM, Meza J, Burke WJ, University of Nebraska Medical Center, Omaha, NE, USA DU8: THE EFFECT OF THREE-TIER FORMULARY ADOPTION FOR ALPHA-BLOCKERS ON DRUG UTILIZATIONIN THE DEPARTMENT OF DEFENSE Devine JW, Conrad RC, Tiller KW, Department of Defense Pharmacoeconomic Center, Fort Sam Houston, TX, USA

Infectious Disease Outcomes Research IN1: C. ALBICANS AND C. GLABRATA BLOODSTREAM INFECTIONS IN ADULTS: OUTCOMES AND ASSOCIAT-ED COSTS Grussemeyer CA1, Friedman JY1, Spalding JR2, Benjamin DK3, Moran C3, Reed SD1, 1Duke Clinical Research Institute,Durham, NC, USA, 2Astellas Pharma US, Deerfield, IL, USA, 3Duke University Medical Center, Durham, NC, USA IN2: UPPER RESPIRATORY ILLNESS AND EMPLOYEE PRODUCTIVITY – RESULTS FROM THE CHILD ANDHOUSEHOLD INFLUENZA-ILLNESS AND EMPLOYEE FUNCTION (CHIEF) Palmer L1, Nichol KL2, Johnston S1, Mahadevia PJ3, Rousculp MD3, 1Thomson Healthcare, Inc, Washington, DC, USA,2Veterans Affairs Medical Center, Minneapolis, MN, USA, 3MedImmune, Inc, Gaithersburg, MD, USA IN3: A MICROSIMULATION OF THE COST-EFFECTIVENESS OF MARAVIROC FOR ANTIRETROVIRAL TREAT-MENT-EXPERIENCED HIV-INFECTED INDIVIDUALS Chancellor JV1, Kuehne FC2, Mollon P3, Louie M4, Powderly WG5, 1i3 Innovus, Uxbridge, Middlesex, UK,2PharmacoConsult, Wanzleben-Buch, Germany, 3Pfizer Limited, Sandwich, Kent, UK, 4Pfizer Inc, New York, NY, USA,5University College Dublin, Dublin, Ireland IN4: COST-EFFECTIVENESS OF DORIPENEM IN THE TREATMENT OF NOSOCOMIAL PNEUMONIA McGarry LJ1, Merchant S2, Pawar V1, Delong K1, Thompson D1, Akhras K2, Ingham M2, Weinstein MC3, 1InnovusResearch, Inc, Medford, MA, USA, 2Johnson & Johnson Pharmaceutical Services, L.L.C, Raritan, NJ, USA, 3HarvardUniversity, Boston, MA, USA

Patient-Reported Outcomes Research PR1: VARIABILITY OF HEALTH UTILITIES INDEX MARK 3 (HUI3) MEASUREMENTS DURING TREATMENT FORACUTE LYMPHOBLASTIC LEUKEMIA IN CHILDHOOD Rae CS1, Furlong W2, De Pauw S1, Barr RD1, Gelber RD3, Sallan S3, 1McMaster University, Hamilton, ON, Canada,2McMaster University and Health Utilities Inc, Hamilton, ON, Canada, 3Harvard University, Boston, MA, USA PR2: VALIDATION OF THE PATIENT HEALTH QUESTIONNAIRE IN BRFSS - APPLICATION OF CROSS-VALIDATION METHOD Yeh Y, Mapi Values, Boston, MA, USAPR3: IMPACT OF UNCONTROLLED PEDIATRIC ASTHMA ON HEALTH-RELATED QUALITY OF LIFE (HRQOL) Dean BB1, Calimlim B1, Aguilar D1, Sacco P2, Maykut R2, Tinkelman D3, 1Cerner LifeSciences, Beverly Hills, CA, USA,2Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 3National Jewish Medical and Research Center,Denver, CO, USA PR4: EVALUATION OF IMPACT OF ORAL TOPOTECAN ON HEALTH-RELATED QUALITY OF LIFE IN RELAPSEDSMALL CELL LUNG CANCER Duh MS1, Pickard AS2, Chen L1, Antras L1, Cella D3, Neary MP4, O’Brien ME5, 1Analysis Group, Inc, Boston, MA, USA,2College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA, 3Evanston Northwestern Healthcare,Evanston, IL, USA, 4GlaxoSmithKline, Collegeville, PA, USA, 5Royal Marsden Hospital, Sutton, UK

Women’s Health Outcomes Research WH1: EXPOSURE TO CONTRAINDICATED AND OTHER POTENTIALLY DANGEROUS MEDICATIONS DURINGPREGNANCY: A POPULATION BASED STUDY IN ITALY Gagne JJ, Maio V, Berghella V, Louis DZ, Gonnella JS, Jefferson Medical College, Philadelphia, PA, USA WH2: DISABILITY AND ASSOCIATED COSTS AMONG WOMEN WITH EMPLOYER-SPONSORED INSURANCEAND NEWLY DIAGNOSED BREAST CANCER Meadows E1, Johnston S2, Cao Z3, Foley K4, Pohl G1, Johnston JA1, Ramsey SD5, 1Eli Lilly and Company, Indianapolis,IN, USA, 2Thomson Healthcare, Inc, Washington, DC, USA, 3Thomson Healthcare, Cambridge, MA, USA, 4ThomsonMedstat, Philadelphia, PA, USA, 5Fred Hutchinson Cancer Research Center, Seattle, WA, USA WH3: CLINICAL AND ECONOMIC OUTCOMES AMONG WOMEN USING LEVONORGESTREL-RELEASINGINTRAUTERINE SYSTEM (LNG-IUS) Yu AP1, Wu E1, Perrson B1, Chang J2, Costales AC2, Gricar JA3, 1Analysis Group, Inc, Boston, MA, USA, 2BayerHealthCare Pharmaceuticals, Inc, Wayne, NJ, USA, 3Independent Health Care Consultant, New York, NY, USA WH4: PROBIOTICS IN PREGNANCY: A SYSTEMATIC REVIEW AND META-ANALYSIS OF THE SAFETY OFLACTOBACILLUS, BIFIDOBACTERIUM AND SACCHAROMYCES Dugoua JJ1, Zhu X1, Chen X1, Koren G2, Machado M1, Einarson TR1, 1University of Toronto, Toronto, ON, Canada,2Hospital for Sick Children, Toronto, ON, Canada

6:30PM-7:00PM ISPOR ANNUAL BUSINESS MEETING6:15PM-7:15PM AUTHOR PRESENTATION HOUR (POSTER PRESENTATIONS - SESSION I)

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6:15PM-8:00PM EXHIBITORS’ OPEN HOUSE RECEPTION & POSTER PRESENTA-TIONS VIEWING - SESSION I 6:30PM-8:00PM ISPOR Russia Chapter Forum Presented in RussianThe Economics of Rare Diseases, Rare Surgical Treatments, Diagnostic Technologies and theManagement of Hemophilia in Russia: ISPOR Russia Chapter ForumThis forum will present experiences from Russia’s medical system with the economics and access challenges ofrare disease and surgical treatments and diagnostic technologies. The patient’s viewpoint of the management ofhemophilia in Russia will also be presented.

TUESDAY, MAY 6, 20087:30AM-8:30AM ISPOR FORUMS (Open forum with buffet breakfast) Health Technology Assessment: Reimbursement Processes, Methods and Assessments Forum The following will be discussed: a) differences and similarities in global health care systems and reimbursementthrough the newly developed on-line ISPOR Global Roadmap of Health Care Systems; b) preliminary results of asurvey assessing current methods used globally in health technology assessment and health care reimbursement;and c) preliminary results of interviews with health technology assessment groups to determine how new tech-nologies are assessed to inform health care policy decisions.

ISPOR Fellowship Standards Task Force Breakfast ForumThis forum provides an opportunity to discuss the upcoming publication of the Task Force report “Joint ACCP andISPOR Guidelines for Pharmacoeconomic and Outcomes Research Fellowship Training Programs” and an opportu-nity for all participants, including fellows, preceptors of fellows, academics and other interested parties, to meetand share their thoughts and ideas about Pharmacoeconomic Fellowships.

8:30AM-8:45AM INCOMING PRESIDENTIAL ADDRESSChris L. Pashos PhD, Vice President and Executive Director of HERQuLES, Abt Associates, Lexington, MA, USA

8:45AM-10:00AM SECOND PLENARY SESSION: Drug Safety and Risk-BenefitDecision-Making Both delayed market entry of life-saving therapies and withdrawals of products from the market underscore theneed to determine risk-benefit of a new technology early and often in a product’s life cycle. Interest in developingsingle risk-benefit metrics is reappearing but will these advances lead to improved decision-making? This sessionwill explore how regulators and payers determine the risk-benefit tradeoffs and act upon that information.Moderator/Speaker: Adrian Levy PhD, Associate Professor, University of British Columbia, Vancouver, BC, CanadaSpeakers: Gerald J. Dal Pan MD, MHS, Director, Office of Surveillance and Epidemiology, FDA, Silver Spring, MD,USA; Robert Powell PharmD, Director, Pharmacometrics, Offices of Clinical Pharmacology and TranslationSciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA; F. Reed Johnson PhD, SeniorFellow and Principal Economist, RTI International, Research Triangle Park, NC, USA; Robyn Lim PhD, ScientificAdvisor, Progressive Licensing Project, Therapeutic Products Directorate, Health Products and Food Branch, HealthCanada, Ottawa, ON, Canada

10:00AM-10:15AM ISPOR SERVICE AWARDS PRESENTATION10:15AM-10:45AM BREAK, EXHIBITS, POSTER PRESENTATIONS VIEWING - SESSION II10:45AM-11:45AM ISPOR FORUMS: Assessment, Determinants & Economics of Medication Compliance & Persistence ForumResearch including the key considerations for researchers undertaking prospective assessment of medication com-pliance and persistence; the economic consequences of non-compliance; and the key ‘determinants’ of non-com-pliance will be presented by the ISPOR Medication Compliance & Persistence SIG.

ISPOR Good Research Practices for Retrospective Database Analysis ForumThe initial draft of Design and Analysis of Non-Randomized Studies of Treatment Effects using SecondaryDatabases will be presented. The report includes the major issues of design, analysis, and interpretation of find-ings from therapeutic effectiveness studies using secondary databases. Your comments and input are invited.

ISPOR Good Research Practices on Economic Data Transferability ForumThe draft final report and recommendations on best practices in transferability of economic data in health eco-nomic evaluations will be discussed. Several factors may limit the generalizability of economic (i.e. resource, costand utility) data, including differences in relative prices, practice patterns, availability of health care resourcesand community values of health states. This session will focus on issues identified by ISPOR members concerningthe draft Task Force Report now at the ISPOR website. These issues include defining key variable economic data,guidelines for acceptance of data from outside a country while considering existing national guidelines, anddirections for future research.

Quality Improvement in Cost-Effectiveness Research (QICER) ForumThis session will focus on facilitating the improvement of health care economic evaluation research and its use inmaking health care policy. Updates on the present and future of global guidelines, statistical problems in cost-effectiveness research and ideas for improving the science, the prevalence and scope of quality guidelines in jour-nals and publications, and barriers to use of cost-effectiveness data by decision-makers and patients will be pre-sented by the ISPOR QICER Task Force.

ISPOR Student Educational Forum: Decision Analysis - Overview and ApplicationThe ISPOR student educational forum will provide a basic overview of the key terminology in decision analysis.During this forum, students will bridge the gap between understanding pharmacoeconomics and the practice ofdecision analysis.

12:00PM-1:00PM ISSUE PANELS - SESSION II CLINICAL OUTCOMES RESEARCH ISSUESIP6: ARE GOOD PRACTICE PRINCIPLES FOR OBSERVATIONAL COMPARATIVE EFFECTIVENESS RESEARCHNEEDED?Moderator: Nancy A. Dreyer PhD, Chief of Scientific Affairs, Outcome, Cambridge, MA, USA. Panelist(s): Marc L. Berger MD, Vice President, Eli Lilly, Global Health Outcomes, West Point, PA, USA; Sean DSullivan PhD, RPh, Professor of Pharmacy and Public Health and Director, University of Washington,Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA; Jacques Lelorier PhD, Professor,Université de Montreal, Montreal, QC, Canada.IP7: NOW WHAT FOR GENOMICS? TURNING PROMISE INTO PRACTICEModerator: Clifford Goodman PhD, Senior Vice President, The Lewin Group, Falls Church, VA, USA.

Panelist(s): Deborah Marshall PhD, Vice President, i3 Innovus, Global Health Economics and Outcomes, Burlington,ON, Canada; Gurvaneet Randhawa MD, MPD, Medical Officer and Senior Advisor, Center for Outcomes andEvidence, Genomics & Personalized Medicine, Rockville, MD, USA; Emily S. Winn-Deen, PhD, Vice President,Cepheid, Sunnyvale, CA, USA.

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUESIP8: QUANTITATIVE APPROACHES TO REGULATORY RISK-BENEFIT ASSESSMENT FOR FDA DECISION-MAKING: WHAT WOULD WORK?Moderator: James T. Cross MS, Graduate Student, University of Washington, Pharmaceutical Outcomes Researchand Policy Program, Seattle, WA, USA.Panelist(s): F. Reed Johnson PhD, Senior Fellow and Principal Economist, RTI International, Research Triangle Park,NC, USA; Larry D. Lynd PhD, Assistant Professor, University of British Columbia, Faculty of PharmaceuticalSciences, Vancouver, BC, Canada; Louis P. Garrison PhD, Professor of Pharmacy, University of Washington,Department of Pharmacy, Seattle, WA, USA.IP9: PRACTICAL CONSIDERATIONS ON COVERAGE WITH EVIDENCE DEVELOPMENT: HOW WILL THE PIPERBE PAID? Moderator: Stuart MacLeod MD, PhD, FRCPC, Executive Director, Children’s & Women’s Health Centre of BritishColumbia, Vancouver, BC, Canada.Panelist(s): Mike F Drummond PhD, Professor of Health Economics, University of York, Centre for HealthEconomics, York, Heslington, UK; Sean Tunis MD, MSc, Executive Director, Center for Medical Technolgy Policy,Baltimore, MD, USA; Pierre Philippe Sagnier MD, Vice President Global Health Economics, Bayer Schering Pharma,Outcomes and Reimbursement, Wuppertal, Germany.

PATIENT-REPORTED OUTCOMES RESEARCH ISSUESIP10: QALYS GONE WILD?Moderator: Peter I. Juhn MD, MPH, Vice President, Evidence and Regulatory Policy, Johnson & Johnson, NewBrunswick, NJ, USA.Panelist(s): Adrian Griffin MsC, Vice President, Strategic Affairs, LifeScan, Inc, High Wycombe, Buckinghamshire,UK; Peter J. Neumann ScD, Professor, Tufts-New England Medical Center, Institute for Clinical Research andHealth Policy Studies, Boston, MA, USA; Michael Schlander, MD, MBA, Professor, Institute for Innovation &Valuation in Health Care (InnoVal-HC), University of Heidelberg, Eschborn, Germany.

1:00PM-2:30PM LUNCH, EXHIBITS, POSTER PRESENTATIONS VIEWING - SESSION II1:30PM-2:00PM GUIDED TOUR OF HEALTH CARE DECISIONS USING OUTCOMESRESEARCH INFORMATION POSTER SESSION1:30PM-2:30PM EDUCATIONAL SYMPOSIUM (Sponsored by RTI Health Solutions)Obtaining a Patient-Reported Outcomes Label Claim: What Evidence Do You Need?This symposium will review what is a label claim, what evidence is needed to support the claim, and how todesign a conceptual framework and endpoint model for a PRO Evidence Dossier.

2:30PM-3:30PM WORKSHOPS - SESSION I ECONOMIC OUTCOMES RESEARCHW1: PRESENTING UNCERTAINTY IN COST-EFFECTIVENESS RESEARCHDiscussion Leaders: Katia Noyes PhD, MPH, Associate Professor, University of Rochester School of Medicine,Community and Preventive Medicine, Rochester, NY, USA; Elisabeth Fenwick PhD, Lecturer, University of Glasgow,Public Health and Health Policy, Division of Community Based Medicine, Glasgow, UK

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCHW2: PAYING FOR PILLS BY RESULT: PERFORMANCE-BASED REWARDS FOR INNOVATIONDiscussion Leaders: Louis P. Garrison PhD, Professor of Pharmacy, University of Washington, Department ofPharmacy, Seattle, WA, USA; Sean D. Sullivan PhD, RPh, Professor of Pharmacy and Public Health and Director,University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA; Peter J.Neumann ScD, Professor, Tufts-New England Medical Center, Institute for Clinical Research and Health PolicyStudies, Boston, MA, USA; Adrian Towse MPhil, Director, Office of Health Economics, London, UK

PATIENT-REPORTED OUTCOMES RESEARCHW3: GOOD RESEARCH PRACTICES FOR THE APPLICATION OF CONJOINT ANALYSIS IN HEALTH – A CHECK-LIST FOR PUBLISHING IN OUTCOMES RESEARCHDiscussion Leaders: John FP Bridges PhD, Assistant Professor, Johns Hopkins University, Bloomberg School ofPublic Health, Health Policy and Management, Baltimore, MD, USA; F. Reed Johnson PhD, Senior Fellow andPrincipal Economist, RTI Health Solutions, Health Preference Assessment, Research Triangle Park, NC, USA; A. BrettHauber PhD, Senior Economist and Head, RTI Health Solutions, Health Preference Assessment, Research TrianglePark, NC, USAW4: DEVELOPMENT AND USE OF DECISION BOARDS FOR DETERMINATION OF THE GENERAL PUBLIC’SPREFERENCE IN WILINGNESS-TO-PAY ANALYSISDiscussion Leaders: Michael Iskedjian BPharm, MSc, President, PharmIdeas, Buffalo, NY, USA; Olivier DesjardinsBSc, Senior Research Analyst, PharmIdeas Research and Consulting Inc, Ottawa, ON, Canada; Thomas EinarsonPhD, V-P Scientific Affairs, PharmIdeas Research and Consulting Inc, Oakville, ON, Canada

USE OF REAL WORLD DATAW5: RECOMMENDATIONS FOR THE USE OF PATIENT REGISTRY DATA AS A COMPLEMENT FOR RANDOM-IZED CLINICAL TRIALS Discussion Leaders: Steven K Takemoto PhD, Associate Professor, Saint Louis University, Center for OutcomesResearch, Saint Louis, MO, USA; Nancy A. Dreyer PhD, Chief of Scientific Affairs, Outcome, Cambridge, MA, USA;Claudio Faria PharmD, MPH, Associate Director of Clinical Research, UMass Medical School, Charlestown, MA,USA; Fang Wang MD, PhD, Director, GlaxoSmithKline, Global Health Outcomes, King of Prussia, PA, USA

3:30PM-3:45PM BREAK, EXHIBITS & POSTER PRESENTATIONS VIEWING - SESSION II3:45PM-5:00PM THIRD PLENARY SESSION: Patient-Reported Outcomes:Implementing Good Research PracticesPatient-reported outcomes (PROs) are sometimes viewed as inherently subjective because they are derived frompatients. There are objective ways to gather and analyze PROs, which must be explored amidst the mounting evi-dence of international and cultural differences in health-related quality of life that reinforce the subjectivity ofresponses. This session will review the FDA Guidance on PROs and recommendations from the ISPOR Task Forceand explore improvements in methodology and application of PROs.

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Moderator/Speaker: Stephen Joel Coons PhD, Professor, Department of Pharmacy Practice and Science, Collegeof Pharmacy, University of Arizona, Tucson, AZ, USASpeakers: Nancy E. Mayo BSc, MSc, PhD, James McGill Professor, Department of Medicine, School of Physicaland Occupational Therapy, McGill University Division of Clinical Epidemiology, Division of Geriatrics, McGillUniversity Health Center, Montreal, QC, Canada; Margaret Rothman PhD, Senior Director, WW PRO Center ofExcellence, Johnson & Johnson Pharmaceutical Services, LLC, Washington, GA, USA; Ron Hays PhD, Professor ofMedicine, UCLA Department of Medicine, Division of General Internal Medicine & Health Services Research, LosAngeles, CA, USA

5:00PM-5:15PM ISPOR RESEARCH AWARDS5:15PM-6:15PM AUTHOR PRESENTATION HOUR (POSTER PRESENTATIONS – SESSION II)5:15PM-7:00PM EXHIBITORS’ WINE & CHEESE RECEPTION & POSTER PRESENTA-TIONS VIEWING - SESSION II7:30PM-11:00PM ISPOR SOCIAL EVENT!!! (Registration Required)Enjoy dinner and the ISPOR Band (the “Monte Carlos”) by Lake Ontario

WEDNESDAY, MAY 7, 20087:30AM-8:30AM BUFFET BREAKFAST (Open to all attendees)8:30AM-9:30AM WORKSHOPS - SESSION II CLINICAL OUTCOMES RESEARCHW6: SURVIVAL DATA MINING TO EXAMINE SEQUENTIAL TREATMENT OF CHRONIC DISEASEDiscussion Leaders: Patricia B Cerrito PhD, Professor, University of Louisville, Mathematics, Louisville, KY, USA;John C Cerrito PharmD, Pharmacist, Kroger Pharmacy, Louisville, KY, USA

ECONOMIC OUTCOMES RESEARCHW7: COUNTRY-TO-COUNTRY ADAPTATION OF PHARMACOECONOMIC RESEARCH: METHODOLOGIC CHAL-LENGES & POTENTIAL SOLUTIONSDiscussion Leaders: David Thompson PhD, Vice President, i3 Innovus, Medford, MA, USA; Amy K O’Sullivan PhD,Associate Director, i3 Innovus, Medford, MA, USA; Debbie L Becker MSc, Director, i3 Innovus, Burlington, ON,Canada

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCHW8: ARE WE BETTER OFF OR WORSE OFF WITH VALUE-BASED PURCHASING (VBP)?Discussion Leaders: Peter K. Wong PhD, MBA, MS, RVP, Quality, Clinical Effectiveness & Chief Pharmacy Officer,Southwest Ohio, Cincinnati, OH, USA; Dennis J Hanseman PhD, Senior Health Researcher, Southwest Ohio,Cincinnati, OH, USA; Alan H Mutnick PharmD, FASHP, Director, Clincial Effectiveness Mercy Health Partners,Southwest Ohio, Cincinnati, OH, USAW9: CONSIDERATION OF CLINICAL AND ECONOMIC VALUE IN U.S. HEALTH TECHNOLOGY ASSESSMENT:A MULTIPLE STAKEHOLDER VIEWDiscussion Leaders: Daniel A. Ollendorf MPH, Chief Review Officer, Institute for Clinical & Economic Review,Boston, MA, USA; Steven D. Pearson MD, MSc, Senior Fellow, America’s Health Insurance Plans, Washington, DC,USA; Amy Knudsen PhD, Senior Scientist, Massachusetts General Hospital, Institute for Technology Assessment,Boston, MA, USA

PATIENT-REPORTED OUTCOMES RESEARCHW10: SELECTING, EVALUATING AND DOCUMENTING SUPPORT FOR EXISTING INSTRUMENTS FOR MAKINGLABELING CLAIMS: CONTENT VALIDITYDiscussion Leaders: Pennifer Erickson PhD, Founder, OLGA, State College, PA, USA; Nancy Leidy PhD, Senior VicePresident Scientific Affairs, United BioSource Corporation, Bethesda, MD, USA; Charles D Petrie PhD, SeniorDirector/Group Leader, Neurosciences, Pfizer, Global Outcomes Research, Groton, CT, USA; Margaret RothmanPhD, Senior Director, WW Patient Reported Outcomes Center of Excellence, Johnson & Johnson PharmaceuticalServices, LLP, Washington, GA, USAW11: METHODS FOR MEDICATION COMPLIANCE STUDIES: AN OVERVIEW OF THE ISPOR MEDICATIONCOMPLIANCE SIG GUIDELINESDiscussion Leaders: Elizabeth Manias MPharm, PhD, Associate Professor, University of Melbourne, School ofNursing and Social Work, Faculty of Medicine, Dentistry and Health Sciences, Carlton, Victoria, Australia; FemidaGwadry-Sridhar BScPhm, MSc, PhD, Assistant Professor, University of Western Ontario, Depts. of Medicine andPhysiology & Pharmacology, London, ON, Canada; Joshua S. Benner PharmD, ScD, Principal, IMS Health, Inc,Health Economics and Outcomes Research, Falls Church, VA, USA; Andrew M. Peterson PharmD, Chair,Department of Pharmacy Practice and Pharmacy Administration, University of the Sciences in Philadelphia,Pharmacy Practice and Pharmacy Administration, Philadelphia, PA, USA

USE OF REAL WORLD DATAW12: ECONOMIC DATABASES FOR PHARMACOECONOMIC EVALUATIONS IN CANADA: OVERVIEW AND USEDiscussion Leaders: Carl V. Asche PhD, Research Associate Professor, University of Utah College of Pharmacy,Outcomes Research Center, Department of Pharmacotherapy, Salt Lake City, UT, USA; Philip Jacobs DPhil, Director,Institute of Health Economics, Edmonton, AB, Canada; Rita Yim MA, MHSA, Research Fellow, Institute of HealthEconomics, Edmonton, AB, Canada; Joanne Kingston PhD, Senior Economist, Institute of Health Economics,Edmonton, AB, CanadaW13: MISINTERPRETATIONS AND MISTAKES USING CODES IN RETROSPECTIVE CLAIMS DATA ANALYSIS—AND HOW TO AVOID THEMDiscussion Leaders: George A. Goldberg MD, Medical Director, i3 Innovus, Santa Monica, CA, USA; Matt MooreMHA, Director Health Economics, Ethicon Endo-Surgery, Inc, Health Economics, Cincinnati, OH, USA; MichaelDutro PharmD, Director, Pfizer Inc, Albuquerque, NM, USA

9:30AM-9:45AM BREAK9:45AM-10:45AM WORKSHOPS - SESSION III CLINICAL OUTCOMES RESEARCHW14: ADVANCES IN META ANALYSIS: TECHNIQUES FOR INCLUDING MULTIPLE STUDY DESIGNS, MULTI-PLE ENDPOINTS, AND MULTIPLE TREATMENTS Discussion Leaders: Jeroen P Jansen PhD, Associate Research Director, Mapi Values, Boston, MA, USA; MelvinOlson PhD, Senior Biostatician, Novartis Pharma AG, Basel, Switzerland; Chris Evans PhD, MPH, Director ofEconomics and Outcomes, Mapi Values, Boston, MA, USA

W15: AN UNBIASED OVERVIEW AND UNDERSTANDING OF THE USE OF PROPENSITY SCORING IN PHAR-MACOECONOMIC AND PHARMACOEPIDEMIOLOGY RESEARCHDiscussion Leaders: Matthew W. Reynolds PhD, Managing Director, Epidemiology and Database Services, UnitedBioSource Corporation, Medford, MA, USA; Christopher Hollenbeak PhD, Assistant Professor, Penn State College ofMedicine, Health Evaluation Sciences, Hershey, PA, USA; David J. Vanness PhD, Assistant Professor, University ofWisconsin-Madison, Department of Population Health Sciences School, Madison, WI, USA

ECONOMIC OUTCOMES RESEARCHW16: METHODOLOGIC DIFFERENCES BETWEEN BUDGETARY IMPACT & COST-EFFECTIVENESS ANALYSES:IMPLICATIONS FOR “ALL-IN-ONE” PHARMACOECONOMIC MODELINGDiscussion Leaders: David Thompson PhD, Vice President, i3 Innovus, Medford, MA, USA; Douglas CA Taylor, MBA,Director, Health Economics & Outcomes Research, i3 Innovus, Medford, MA, USA; Joanna Campbell PhD, SeniorManager, i3 Innovus, Medford, MA, USA

EDUCATION/COMMUNICATIONS IN OUTCOMES RESEARCHW17: HEALTH BEHAVIOR CHANGE: LEADING MODELS AND THEIR PRACTICAL APPLICATIONDiscussion Leaders: Vernon F Schabert PhD, Senior Director, IMS Consulting, Health Economics and OutcomesResearch, Santa Barbara, CA, USA; Alexandra Drane BA, President, Eliza Corporation, Beverly, MA, USA

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCHW18: EFFECTIVELY COMMUNICATING OUTCOMES RESEARCH TO ENHANCE PRODUCT SUCCESSDiscussion Leaders: Allen Lising HBA, Managing Director, Dymaxium Inc, Consulting Division, Toronto, ON,Canada; Deborah Marshall PhD, Vice President, i3 Innovus, Global Health Economics and Outcomes, Burlington,ON, Canada; Eric Nauenberg PhD, Senior Health Economist, Associate Professor, Ontario Ministry of Health andLong Term Care, University of Toronto, Department of Health Policy, Management and Evaluation, Toronto, ON,CanadaW19: TRANSPARENT AND QUANTIFIABLE APPROACHES TO HEALTH CARE DECISION MAKING: CHAL-LENGES AND OPPORTUNITIES FOR MULTI CRITERIA DECISION ANALYSIS (MCDA)Discussion Leaders: Mireille M Goetghebeur PhD, VP Operations, BioMedCom Consultants Inc, Montreal, QC,Canada; Louis Niessen MD, PhD, Senior Researcher, Erasmus Medical Center, Institute for Medical TechnologyAssessment, Rotterdam, The Netherlands; Lonny J Erickson PhD, Senior Associate, Health Technology Assessment,BioMedCom Consultants Inc, Montreal, QC, Canada; Hanane Khoury PhD, Senior Research Application Associate,BioMedCom Consultants Inc, Montreal, QC, Canada

PATIENT-REPORTED OUTCOMES RESEARCHW20: DEVELOPING AN IMPROVED MEASURE OF HEALTH OUTCOMES: EQ-5D IN TRANSITIONDiscussion Leaders: Frank De Charro PhD, Senior Scientific Advisor, Pharmerit Europe, Rotterdam, TheNetherlands; Paul Kind, Professor, University of York, Outcomes Research Group, York, UK; Ben A. Van Hout PhD,Professor, Pharmerit BV, Rotterdam, The Netherlands; Xavier Badia MD, PhD, PhD, IMS Health, Health Economicsand Outcomes, Barcelona, Spain

USE OF REAL WORLD DATAW21: APPLES, ORANGES, AND PEARS: SURVIVAL ANALYSIS OF MULTIPLE ENDPOINTSDiscussion Leaders: Nicole M. Engel-Nitz PhD, Senior Researcher, i3 Innovus, an Ingenix Company, Eden Prairie,MN, USA; Xin (Sam) Ye MS, PhD, Senior Researcher i3 Innovus, an Ingenix Company, Eden Prairie, MN, USA

10:45AM-11:00AM BREAK11:00AM-12:00PM WORKSHOPS - SESSION IV CLINICAL OUTCOMES RESEARCHW22: QUANTITATIVE APPROACHES TO BENEFIT-RISK ASSESSMENT OF PHARMACEUTICALS Discussion Leaders: Lisa McGarry MPH, Director, i3 Innovus, Health Economics & Outcomes Research, Medford,MA, USA; Anju Parthan PhD, Senior Project Manager, i3 Innovus, Health Economics and Outcomes Research, SanFrancisco, CA, USA

ECONOMIC OUTCOMES RESEARCHW23: WORKPLACE IMPACT MODEL OF A PHARMACEUTICAL TREATMENT FROM AN EMPLOYER PERSPECTIVEDiscussion Leaders: Peter Sun, MD, PhD, Chief Health Economist, Kailo Research Group, Indianapolis, IN, USA;Lizheng Shi, PhD, Assistant Professor, Tulane University, Health Systems Management, New Orleans, LA, USA;Howard Birnbaum PhD, Vice President, Analysis Group, Inc, Boston, MA, USAW24: ASSESSING PATIENT COSTS FOR CANCER IN THE U.S: HOW, WHO, WHEN, AND WHATDiscussion Leaders: Michael T. Halpern MD, PhD, Strategic Director, American Cancer Society, Health ServicesResearch, Atlanta, GA, USA; K. Robin Yabroff PhD, Epidemiologist, National Cancer Institute, Applied ResearchProgram, Bethesda, MD, USA; Ya-Chen Tina Shih PhD, Associate Professor, University of Texas M.D. AndersonCancer Center, Department of Biostatistics and Applied Mathematics, Houston, TX, USAW25: EXTRACTING PATIENT INFORMATION FROM NATIONAL DATABASES: INCLUDING NIS AND MEPSDiscussion Leaders: Patricia B Cerrito PhD, Professor, University of Louisville, Mathematics, Louisville, KY, USA;John C Cerrito PharmD, Pharmacist, Kroger Pharmacy, Louisville, KY, USA

EDUCATION/COMMUNICATIONS IN OUTCOMES RESEARCHW26: TRAINING CONSIDERATIONS FOR PATIENT-REPORTED OUTCOMESDiscussion Leaders: Adam John Butler SR, Assistant Vice-President, Training and Education, United BioSourceCorporation, Wayne, PA, USA; Anne M Rentz MSPH, Research Scientist, United BioSource Corporation, The Centerfor Health Outcomes Research, Bethesda, MD, USA

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCHW27: DIFFERENCES IN PHARMACOECONOMIC DATA SUBMISSION GUIDELINES FOR THE US, CANADA,AND MEXICO: IMPLICATIONS FOR MULTI-COUNTRY HEALTH-ECONOMICS PROGRAMSDiscussion Leaders: David Thompson PhD, Vice President, i3 Innovus, Medford, MA, USA; Shawn J Barry MA,Associate Director, Analytics, i3 Innovus, Burlington, ON, Canada; Jf Mould-Quevedo PhD, MSc, MBA,Pharmacoeconomics Manager, Pfizer Mexico, Pharmacoeconomics Department, Mexico City, MexicoW28: REAL-LIFE PATIENT-REPORTED OUTCOMES: A NOVEL USE OF THE FDA ADVERSE EVENT REPORT-ING SYSTEM (AERS) SAFETY DATABASEDiscussion Leaders: Matthew W. Reynolds PhD, Managing Director, Epidemiology and Database Services, UnitedBioSource Corporation, Medford, MA, USA; Donald Stull PhD, Research Scientist, United BioSource Corporation,Center for Health Outcomes Research, Bethesda, MD, USA; Robert Nordyke PhD, MS, Director, Amgen, Inc, GlobalHealth Economics, Thousand Oaks, CA, USAW29: CAPTURING THE IMPACT OF HETEROGENEITY IN PHARMACOECONOMIC EVALUATIONDiscussion Leaders: Denis Getsios BA, Research Scientist, United BioSource Corporation, Concord, MA, USA;Kristen Migliaccio-Walle BS, Research Scientist, United BioSource Corporation, Concord, MA, USA; DuyguBozkaya MSc, MBA, Researcher, United BioSource Corporation, Concord, MA, USA

PROGRAM continued



SATURDAY, MAY 3, 2008 (ALL DAY COURSES) 8:00 AM - 5:00 PMPharmacoeconomics for Decision-MakersFaculty: Lorne Basskin PhD, Healthsouth Sunrise Rehab HospitalCourse Description: This course is designed to teach clinicians and new researchers how toincorporate pharmacoeconomics into study design and data analysis. Participants will learn howto collect and calculate the costs of different alternatives, determine the economic impact ofclinical outcomes, and how to identify, track and assign costs to different types of health careresources used. The development of economic protocols and data collection sheets will be dis-cussed. Different pharmacoeconomic models and techniques will be demonstrated and practicedin lectures and case studies. These include cost-minimization, cost-of-illness, cost-effectiveness,cost-benefit, and cost-utility analysis. Decision analysis, sensitivity analysis, and discounting willall be demonstrated and practiced. Participants will also learn to compare and evaluate interven-tions such as drugs, devices and clinical services. This course is suitable for those with little or no expe-rience with pharmacoeconomics.

Bayesian Analysis: Overview & ApplicationsFaculty: Bryan Luce MBA, PhD, United BioSource Corporation; Christopher S. Hollenbeak PhD,Penn State College of Medicine; David Vanness PhD, University of Wisconsin Medical SchoolCourse Description: The first portion of this course is designed to provide an overview of theBayesian approach and its applications to health economics and outcomes research. The coursewill cover basic elements of Bayesian statistics, contrasting briefly with classical (frequentist) sta-tistics and will introduce available statistical packages. The second portion of this course willfocus on the Bayesian “informative prior.” Several example vignettes of how a Bayesian analysiscan be used within outcomes modeling problems will be presented. Participants will learn how aBayesian approach is different, why it is useful for their work and what tools are available tothem. Participants of this course should be prepared to use their own laptops as the exercisespresented use interactive software. This course is designed for those with a limited understanding ofBayesian statistical concepts.

SATURDAY, MAY 3, 2008 (MORNING COURSES) 8:00 AM - 12:00 PMPHARMACOECONOMIC / ECONOMIC METHODSFinding and Extracting Cost DataFaculty: L. Clark Paramore MSPH, United BioSource Corporation; Gregory de Lissovoy MPH,PhD, United BioSource CorporationCourse Description: This course will focus on practical aspects of cost development for pharma-coeconomic studies. The objective is to help the participant bridge the gap between understand-ing pharmacoeconomic theory and the practice of developing cost estimates. Factors to considerwhen costing pharmacoeconomic analyses, such as perspective, data sources, data classificationsystems, developing resource use profiles, obtaining unit costs, and making cost adjustments willbe presented. Examples of issues encountered when identifying and extracting cost data will bediscussed. This course is designed for those with some experience with pharmacoeconomic analysis.

Modeling: Design and Structure of a ModelFaculty: Marc Botteman MA, PharMerit North America LLC; Ben van Hout PhD, PharMeritCourse Description: This course will include a review of modeling techniques (Markov models,discrete event simulations, and Monte Carlo techniques) including a discussion of the ISPORPrinciples of Good Practice for Decision Analytic Modeling in Health Care Evaluations. Markovmodels and first and second order Monte Carlo simulations including data identification, datamodeling, and data incorporation will be demonstrated. Using a series of examples, the coursewill carefully review the practical steps involved in developing and using these kinds of models.Examples will be presented using Microsoft Excel, supplemented with add on simulation soft-ware. This course will cover the practical steps involved in the selection of models and options in modeling ofdata inputs. Participants should have a basic understanding of decision analysis.

Applications in Using Large DatabasesFaculty: Diana Brixner PhD, RPh, University of Utah; John Parkinson PhD, GPRD; MichaelEaddy PhD, PharmD, XcendaCourse Description: This course will provide a review of 3 health care databases – GPRD (UKdatabase), GE Centricity electronic medical record and Medicaid (USA databases). Each databasewill be discussed in-depth including directions on how to access the information and howresearchers utilize this information. Instructors will distinguish the important differences betweenthese databases including the limitations and strategies to maximize their value through the useof an interactive format with interactive examples. Discussion will include a reference to theISPOR Classification of Database Working Group / Retrospective Database Special Interest Groupand its digest of International Databases. Participants must have some knowledge of administrativehealth care database analysis.

SATURDAY, MAY 3, 2008 (AFTERNOON COURSES) 1:00 PM - 5:00 PMFinancial Impact / Cost of IllnessFaculty: Josephine Mauskopf PhD, RTI Health Solutions; C. Daniel Mullins PhD, University ofMaryland Course Description: This course will describe methods to determine the costs associated with ahealth condition and the budget impact of new technologies for that condition. The course willpresent incidence and prevalence-based costing strategies. Treatment algorithms and event-based approaches will be demonstrated for disease-specific costs from different decision-makerperspectives. Both static and dynamic methods for estimating the budget impact of adding a new

drug to a health plan formulary will be presented. Issues related to imputing missing data willalso be discussed. This course is designed for those with some experience with pharmacoeconomic analysis.

Cost-Effectiveness Analysis Alongside Clinical TrialsFaculty: Scott Ramsey MD, PhD, Fred Hutchinson Cancer Research Center; Richard Willke PhD,US Development Sites Pfizer, Inc.Course Description: The growing number of prospective clinical/economic trials reflects bothwidespread interest in economic information for new technologies and the regulatory and reim-bursement requirements of many countries that now consider evidence of economic value alongwith clinical efficacy. This course will present the design, conduct, and reporting of cost-effec-tiveness analyses alongside clinical trials based on, in part, the Good Research Practices for Cost-Effectiveness Analysis alongside Clinical Trials: The ISPOR RCT-CEA Task Force Report. Trial design,selecting data elements, database design and management, analysis, and reporting of results willbe presented. Trials designed to evaluate effectiveness (rather than efficacy), as well as clinicaloutcome measures will be discussed. How to obtain health resource use and health state utilitiesdirectly from study subjects and economic data collection fully integrated into the study will alsobe discussed. Analyses guided by an analysis plan and hypotheses, an incremental analysis usingan intention to treat approach, characterization of uncertainty and standards for reporting resultswill be presented. This is an introductory/intermediate level course. Familiarity with economic evaluationswill be helpful.

Advanced Quantitative Methods for Quality of Life / Patient-ReportedOutcomesFaculty: Kathleen Rosa MS, PhD, Mapi Values; Jeffrey McDonald MS, Mapi ValuesCourse Description: This course will provide an in-depth discussion of operating characteristics,validity testing, analysis and interpretation with examples of each. It will provide a range ofmethods that may help to solve common problems encountered with quality of life / patient-reported outcomes. These include an overview of psychometric validation methods including: abrief overview of Rasch analysis, pragmatic issues in validating a PRO from clinical trial data,ePRO validation, methods of estimation of minimally clinically important differences and alterna-tives to provide information on interpretation. Clinical trial analysis will include missing dataanalysis techniques and mixed modeling appropriate to PRO data and study design. There will bea focus on addressing these issues within the framework provided by the PRO guidance recentlyreleased by the SEALD group at the FDA. Specific examples will be used throughout the courseand participants will be asked to complete a short exercise. This course is designed for those withintermediate experience in health-related quality-of-life assessment.

Instrumental Variables in Addressing Selection Bias in Observational StudiesFaculty: Benjamin M. Craig PhD, University of Wisconsin; Antoine C. El Khoury, PhD, Merck &Co Inc.; Bradley Martin PhD, RPh, PharmD, University of Arkansas for Medical SciencesCourse Description: In any non-randomized study, selection bias is a potential threat to thevalidity of conclusions reached. Failure to account for sample selection bias can lead to conclu-sions about treatment effectiveness or treatment cost that are not really due to the treatment atall, but rather to the unobserved factors that are correlated with both treatment and outcomes.Sample selection models provide a test for the presence of selection bias. These models also pro-vide a correction for selection bias, enabling an investigator to obtain unbiased estimates oftreatment effects. This course will discuss the various models and their applications, and in par-ticular will address instrument variables (two-stage least squares, intuition, RCTs), including anoverview of examples from the current literature. Participants will benefit from interactive exer-cises using instrumental variables and sample selection techniques using STATA. For those whohave STATA loaded on their laptops, you are encouraged to bring your laptop. This course is suitablefor those with some knowledge of econometrics.

Elements of Pharmaceutical/Biotech Pricing I - IntroductionFaculty: Jack Mycka, MME LLC; Renato Dellamano PhD, ValueVector Course Description: This course will give participants a basic understanding of the key terminol-ogy and issues involved in pharmaceutical pricing decisions. It will cover the tools to build anddocument product value including issues, information and processes employed (including pricingresearch); the role of pharmacoeconomics and the differences in payment systems that help toshape pricing decisions. These tools will be further explored through a series of interactive exer-cises. This course is designed for those with limited experience in the area of pharmaceutical pricing and willcover topics within a global context.

SUNDAY, MAY 4, 2008 (ALL DAY COURSES) 8:00 AM - 5:00 PMRetrospective Database Analysis – Econometric MethodsFaculty: William H. Crown PhD, i3 Innovus; Henry Henk PhD, i3 InnovusCourse Description: Large administrative claims databases provide a unique opportunity toexamine retrospectively the effects of drug use on clinical and economic outcomes in "real world"settings. This course will cover a discussion of the ISPOR Checklist for Retrospective DatabaseStudies - Report of the ISPOR Task Force on Retrospective Databases and selected topics relatedto estimators and sampling distributions, properties of sampling distributions (unbiasedness, effi-ciency, mean square error), and ordinary least squares (OLS) regression. OLS model assumptionsand the implications of violations (e.g., heteroscedasticity, multicollinearity, autocorrelation) willalso be discussed. More complex topics beginning with the problem of endogeneity, identifica-tion, instrumental variables, sample selection models, propensity score models, maximum likeli-hood methods and the estimation of limited dependent variables models including logit, multino-mial logit, count models, and survival models will be discussed. This course will assume participantshave knowledge of statistical methods through OLS regression and experience in the analysis of administrativeclaims databases.

SHORT COURSE PROGRAM



SUNDAY, MAY 4, 2008 (MORNING COURSES) 8:00 AM - 12:00 PMPropensity Scores and Comorbidity Risk AdjustmentFaculty: Fadia Shaya MPH, PhD, University of Maryland Course Description: A large part of the evidence about the effectiveness of different treatmentsis based on retrospective studies. Issues of bias and confounding relate to the non-randomassignment of subjects and co-morbidity burden. This course will outline the concerns about biasand explain the methods for causal inference in observational studies, where researchers have nocontrol over the treatment assignment. A lack of balance in the covariates between the treat-ment and control groups can produce biased estimates of the treatment effects. We will explainhow propensity scores can be used to reduce bias, through stratification, matching or regression.Confounding and the pros and cons of standard adjustment, propensity scoring methodology (subclassification on one confounding variable, overlap in treatment groups, variable selection) will bediscussed. In the second part, we will elaborate on risk adjustment models, focusing on morbidityindices, e.g the Charlson Comorbidity Index, and Chronic Disease Scores. Examples using a step bystep approach will be presented. This is an introductory course, designed for those with little experiencewith this methodology but some knowledge of observational databases.

Bayesian Analysis: AdvancedFaculty: Bryan Luce MBA, PhD, United BioSource Corporation; Keith R. Abrams PhD, Universityof LeicesterCourse Description: This course introduces the use of Bayesian methods in evidence synthesis(including meta-analysis) and allows participants to gain hands on experience using such model-ing techniques within WinBUGS. Methodological issues considered in the course include; fixedand random effects models, choice of prior distributions, subgroups, meta-regression and adjust-ing for baseline risk, together with indirect and mixed treatment comparisons. Further meta-analysis topics for which a Bayesian approach can be of benefit will also be highlighted.Participants will be expected to be familiar with the use of WinBUGS and will be responsible forbringing a laptop with the latest, unrestricted version of WinBUGS pre-installed. This course is afollow-up to the short course: Bayesian Analysis-Overview and Applications. Basic knowledge of the Bayesianapproach and use of WinBUGS (equivalent to attendance at Bayesian Analysis-Overview and Applications)will be assumed.

Discrete Event Simulation for Economic AnalysesFaculty: J. Jaime Caro MDCM, FCRPC, FACP, United BioSource Corporation; Jörgen MöllerMSc Mech Eng, United BioSource CorporationCourse Description: This course will provide a basic understanding of the key concepts of dis-crete event simulation (DES). The focus will be on the use of these simulation models to addresspharmacoeconomic (and device-related) problems. The course will be structured around practicalexercises. Topics to be covered are: Why DES? Dynamic simulation as a tool; Components of aDES; How do you build a model? Modeling of processes and resource use; Modeling of variablesand decisions. If time permits, simple animation will be demonstrated. We will use ARENA tobuild simple models. Instructors will distribute training versions of Arena. This course is designed forthose with some experience with modeling.

Patient-Reported Outcomes - Item Response TheoryFaculty: Lori McLeod PhD, RTI Health Solutions; Cheryl Hill PhD, RTI- Health SolutionsCourse Description: There is a great need in health outcomes research to develop instrumentsthat accurately measure a person's health status with minimal response burden. This need forpsychometrically sound and clinically meaningful measures calls for better analytical toolsbeyond the methods available from traditional measurement theory. Applications of itemresponse theory (IRT) modeling have increased considerably because of its utility for instrumentdevelopment and evaluation, assessment of measurement equivalence, instrument linking, andcomputerized adaptive testing. IRT models the relationship, in probabilistic terms, between a per-son's response to a survey question and their standing on a health construct such as fatigue ordepression. This information allows instrument developers to develop reliable and efficient qualityof life measures tailored for an individual or group. This introductory workshop will discuss thebasics of IRT models and applications of these models to improve health outcomes measurement.Illustrations will be used throughout the presentation that focus on measuring key health-relatedquality of life domains in different disease populations. This introductory course is designed for thosewith none to little experience with IRT.

Case Studies in Pharmaceutical/Biotech Pricing II - AdvancedFaculty: Jack Mycka, MME LLC; Renato Dellamano PhD, ValueVector Course Description: Case studies will be employed to lead participants through the key steps ofnew product pricing, with focus on the need to thoroughly analyze the business environment andits constraints and opportunities and the need to closely integrate the pricing, reimbursementand pharmacoeconomic strategy for the new product with the clinical development and market-ing strategies. Practical exercises will allow participants to consolidate the concepts delivered inthe “Elements” introductory session and expanded here. Areas covered will include the post-launch issues of reimbursement and pricing maintenance as a part of life-cycle management in aglobal environment. This course is for individuals who have completed Elements of Pharmaceutical Pricing I– Introduction or are familiar with both the key determinants of pharmaceutical pricing and the main interna-tional health systems. Enrollment for this course is limited.

Statistical Considerations in Health Economic EvaluationsFaculty: Henry Glick PhD, University of Pennsylvania; Jalpa Doshi PhD, University ofPennsylvaniaCourse Description: The adoption and diffusion of new medical treatments depend increasinglyon robust analysis of costs and cost-effectiveness. During this course, the following statisticalconsiderations in economic evaluations will be discussed: affect of distributional assumptions,analyzing univariate and multivariable analysis data, analyzing censored data, sample size andpower calculations, sampling uncertainty, point estimates for variables, net monetary benefit, andconfidence intervals for cost-effectiveness ratios. During this course, study examples will be provided toillustrate concepts. Participants should have some knowledge of basic economic evaluations and statistics.

SUNDAY, MAY 4, 2008 (AFTERNOON COURSES) 1:00 PM - 5:00 PMApplications of Statistical Considerations in Health Economic EvaluationsFaculty: Henry Glick PhD, University of Pennsylvania; Jalpa Doshi PhD, University ofPennsylvaniaCourse Description: This course will provide applications of statistical considerations in econom-ic analysis. Specific exercises will be conducted to illustrate affect of distributional assumptions,univariate & multivariable analysis of costs, the effect of sample size & power calculations oneconomic evaluations and point estimates for cost-effectiveness ratios. Participants are encour-aged to have hands-on experience and bring their laptops. STATA trial software will be distributedif not already installed and used in this course. The publication “Economic Evaluation in ClinicalTrials” (Oxford: OUP, 2007) is suggested as recommended reading for this course. The course,Statistical Considerations in Economic Evaluations, is a strong prerequisite for this course.

Patient RegistriesFaculty: Chris Pashos PhD, Abt Associates – HERQuLESCourse Description: This course is designed to provide an overview of patient registries and theirapplications in identifying 'real world' clinical, safety, and patient-perspective issues. The pros andcons of registry data compared to other ‘real world’ and clinical trial data collection will be pre-sented. How registry information can be used to support other health economics /outcomesresearch initiatives and health care decision-making will be addressed. Registry strategy, design,operations and measures of program success will be discussed. In addition, regulatory trendsand requirements, including the Agency for Healthcare Research & Quality’s (AHRQ) May 2007publication: “Registries for Evaluating Patient Outcomes: A User's Guide”, will be examined. Thiscourse is designed for those with little experience with patient registries.

Utility MeasuresFaculty: F. Reed Johnson PhD, RTI Health Solutions; A. Brett Hauber PhD, RTI Health SolutionsCourse Description: Course participants will learn the conceptual and empirical features of vari-ous health-utility measures and their uses for informing health care decision-making. Cost-utilityanalysis (CUA), risk-benefit analysis (RBA), and cost-benefit analysis (CBA) are often used to eval-uate new health-care technologies. These methods are useful for informing decision-makersabout the relative benefits of an intervention to individual patients and to society as a whole.CUA employs health-state utilities based on cardinal utility theory to define quality-adjusted lifeyears (QALYs) for different health states. RBA employs utility measures to place both risks andbenefits in comparable units. CBA estimates take the form of ordinal utility values expressed asmoney-equivalent values (often called ‘willingness to pay’). This course will review the theory andapplication of utility estimation in health economics and risk-benefit analysis. This course is designed forthose with some experience with psychometric measures.

Outcomes Research for Medical Devices & DiagnosticsFaculty: Seema Sonnad PhD, University of Pennsylvania; Stacey Ackerman MSE, PhD, CovanceMarket Access ServicesCourse Description: This course will present outcomes research practices that are specificallytailored for the fast-paced medical device and diagnostics technology environment and addressissues related to these health technology assessment methodologies. Outcomes research includ-ing clinical outcomes, economic outcomes, and patient-reported outcomes will be discussed.Outcomes research for medical devices & diagnostics will be differentiated from other health careinterventions such as drugs. The evidence hierarchy for medical devices and diagnostic proceduresincluding ‘real world’ outcomes research information in coverage and reimbursement decisionswill be discussed. This course is designed for those with little experience with outcomes research for medicaldevices and diagnostic technologies.

Introduction to Risk/Benefit Management in Health CareFaculty: Dennis W. Raisch PhD, VA Cooperative Studies Program; Anthony Lockett MD, PhD,MBA, ICO; Suellen Curkendall PhD, Cerner Health Insights Course Description: This course will provide an overview of risk/benefit management for phar-maceuticals and devices. The risk/benefit assessment process will be described in regards to stageof product development, from pre-marketing through post-marketing. Risk mitigation includesthe various strategies employed by manufacturers, regulators, and health care providers, with anemphasis on international differences in risk mitigation and decision-making. Risk/benefit com-munication processes will be described, focusing on how decisions regarding risks and benefits ofpharmaceuticals and devices are communicated to health care providers and the public. Thisincludes direct mailing, direct-to-consumer marketing, and labeling. Real world exercises willallow participants to discuss key topics and propose implementation strategies for risk manage-ment. This course is designed for those with a basic understanding of pharmacoepidemiology principles.

Advanced Decision Modeling for Health Economic EvaluationsFaculty: Andrew Briggs PhD, University of Glasgow; Mark Sculpher PhD, MSc, University of YorkCourse Description: During this course, the key aspects and new developments of decision mod-eling for economic analysis will be considered. How models can be made probabilistic to captureparameter uncertainty (including rationale, choosing parameter distributions, & types of uncer-tainty) will be covered. How to analyze and present the results of probabilistic models will bepresented. How the results of probabilistic decision modeling should be interpreted and howdecisions should be made (including decisions with uncertainty, and expected value of perfectinformation [EVPI]), will be presented. Specific examples including Excel programming will beused to illustrate concepts. The publication “Decision Modeling for Health Economic Evaluation”(Oxford, 2006) is recommended reading for this course. This is an advanced course. Participants shouldhave a basic understanding of decision analysis. The course, Modeling: Design and Structure of a Model, is astrong prerequisite for this course.

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SPONSORIncrease your visibility!Give your company increased visibility and prominence.

Benefits to Sponsors:• Sponsorship recognition at plenary session• Event signage • Listing and 1/4 page advertisement in the Program and

Schedule of Events• Listing and 1/4 page advertisement on the ISPOR website• One complimentary registration per booth• Preferential exhibit booth location

ADVERTISEAdvertise in the Program and Schedule of Events!Advertising Deadline: MARCH 20, 2008

EMPLOYMENTTargeted employment assistance!ISPOR’s Professional Recruitment Assistance Program (PRAP)provides participants with a CONFIDENTIAL, EFFICIENT, andPROFESSIONAL service which matches individuals seeking posi-tions with employers who have available positions.

PRAP Includes:• List of available positions• List of qualified candidates• Interview Room• Confidential mailbox system for applicants and employers• 1/4 page employment advertisement in the Program and

Schedule of Events• List of 13th Annual International Meeting PRAP positions at

the ISPOR website

Advertising Deadline for the Program andSchedule of Events: MARCH 20, 2008

For Further Information: www.ispor.org

For additional information visit: www.ispor.org3100 Princeton Pike, Bldg 3, Suite E, Lawrenceville, NJ 08648, USA

Tel:+609-219-0773 Toll Free: +800-992-0643 Email: [email protected] www.ispor.org


Hotel Reservations Sheraton Centre Toronto, 123 Queen Street West,Toronto, ON M5H 2M9 CanadaPhone: (416) 361-1000 Discounted room rates available for ISPOR Meetingattendees from CND$179 plus applicable taxes

**The discounted room rates are available April 29 - May11 and will be charged in CND$****The deadline for hotel reservations at the discountedrate is April 12, 2008**(Please mention the ISPOR 13th Annual InternationalMeeting to receive the discounted rate)

Making Hotel Reservations:Online reservations can be made through the ISPORwebsite at www.ispor.org or by phone by calling theSheraton Centre Toronto at 1-866-716-8101.

International Society for Pharmacoeconomics and Outcomes Research

3100 Princeton Pike, Building 3, Suite E

Lawrenceville, NJ 08648 USA

ispor connections vol. 14 no 1

Documents