ispor, pharmacoeconomic

Download ispor, pharmacoeconomic

Post on 26-Mar-2015

139 views

Category:

Documents

2 download

Embed Size (px)

TRANSCRIPT

International Society for Pharmacoeconomics and Outcomes Research

PHARMACOECONOMICS: IDENTIFYING THE ISSUESADVISORY PANEL REPORTS

(1998 International Society for Pharmacoeconomics and Outcomes Research All rights reserved

Conference Chaired by:

Jean Paul Gagnon PhDDirector, Health Economics Policy Hoechst Marion Roussel, Inc

Written by:

Advisory Panel Chairsand

Donna Rindress PhDPresident BioMedCom Consultants, Inc.

Edited by:

Marilyn Dix Smith PhDExecutive Director International Society for Pharmacoeconomics and Outcomes Research

This conference and report was supported by a grant from the United States Department of Health and Human Services, Agency for Health Care Policy and Research and the Health Outcomes Work Group of the Pharmaceutical Research and Manufacturers of America. This project was supported by grant number R13 HS09806 from the Agency for Health Care Policy and Research.

1998 International Society for Pharmacoeconomics and Outcomes Research All rights reserved under International and Pan-American Copyright Conventions Published in the United States of America by: International Society for Pharmacoeconomics and Outcomes Research 20 Nassau Street Suite 307 Princeton, NJ 08542 USA

Warning: No part of this publication may be used or reproduced in any manner whatsoever or by any means - graphics, 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. The only exception is as follows: Permission is granted for this report to be entered into the National Technical Information Services (NTIS) and reproduced as necessary on a demand basis.

Inquiries should be addressed to: International Society for Pharmacoeconomics and Outcomes Research 20 Nassau Street, Suite 307 Princeton, NJ 08542 USA Email: info@ispor.org Website: http://www.ispor.org

TABLE OF CONTENTSEXECUTIVE SUMMARY .............................................................................................................................. OVERVIEW ................................................................................................................................................... ISSUE I ......................................................................................................................................................... METHODOLOGICAL ISSUES IN CONDUCTING PHARMACOECONOMIC EVALUATION - CLINICAL STUDIESGoal .................................................................................................................................................................. Specific Objectives ........................................................................................................................................... Panel Co-chairs ............................................................................................................................................... Panelists ........................................................................................................................................................... Background and Context ................................................................................................................................. Problem Statement .......................................................................................................................................... Issues ............................................................................................................................................................... 1. When should randomized clinical studies be the primary approach to assessing questions of value? 2. What modifications to randomized clinical studies would improve their usefulness as tools for health economic decision-making? ......................................................................................................................................... 3. When should observational studies be used to assess questions of value? ....................................... 4. What modifications to observational studies would improve their usefulness as tools for health economic decisionmaking? ........................................................................................................................................................ Recommendations ........................................................................................................................................... Summary ..........................................................................................................................................................

ISSUE II ........................................................................................................................................................ METHODOLOGICAL ISSUES IN CONDUCTING PHARMACOECONOMIC EVALUATION - MODELING STUDIESGoal .................................................................................................................................................................. Specific Objectives ........................................................................................................................................... Co-chairs .......................................................................................................................................................... Background and Context ................................................................................................................................. Problem Statement .......................................................................................................................................... Issues ............................................................................................................................................................... 1. Standardization .................................................................................................................................... 2. Making Choices ................................................................................................................................... 3. Methodological Development ............................................................................................................... 4. Extending Clinical studies and Data Issues ......................................................................................... 5. Effectiveness Measures ....................................................................................................................... 6. Model Validation ................................................................................................................................... 7. Peer review of models ......................................................................................................................... Recommendations ........................................................................................................................................... Summary ..........................................................................................................................................................

ISSUE III ....................................................................................................................................................... METHODOLOGICAL ISSUES IN CONDUCTING PHARMACOECONOMIC EVALUATIONS - RETROSPECTIVE AND CLAIMS DATA STUDIES ..............................................................................................................Goal .................................................................................................................................................................. Specific Objectives ........................................................................................................................................... Co-chairs .......................................................................................................................................................... Panelists ........................................................................................................................................................... Background and Context ................................................................................................................................. Problem Statement .......................................................................................................................................... Issues ............................................................................................................................................................... 1. What research questions can be answered by retrospective database analyses? ............................. 2. What data sources are available to answer the question? .................................................................. 3. How is cost-effectiveness measured using automated databases? .................................................... 4. How can data quality within a database be evaluated? ....................................................................... 5. What types of statistical methods can be utilized to control for treatment effects? .............................. 6. What potential types of bias exist in retrospective database analyses? .............................................. 7. What alternative methods for assessing selection bias are available? ................................................

8. How can transparency be ensured in retrospective database analyses? ............................................ Recommendations and Next Steps ...............................................................................................

Recommended

View more >