Download - ISPOR Methods Guidance A Report of the ISPOR Task Force on Budget Impact Modeling January 21, 2009 Sean D. Sullivan, PhD Pharmaceutical Outcomes Research

ISPOR Methods Guidance

A Report of the ISPOR Task Force on Budget Impact Modeling

January 21, 2009January 21, 2009

Sean D. Sullivan, PhDSean D. Sullivan, PhDPharmaceutical Outcomes Research and Policy ProgramPharmaceutical Outcomes Research and Policy Program

School of PharmacySchool of PharmacyUniversity of WashingtonUniversity of Washington

Seattle, WASeattle, WA

Pharmaceutical Outcomes Research and Policy Program

University of Washington

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TopicsTopics

Introduction to the Task ForceIntroduction to the Task Force Task Force ReportTask Force Report

– Outline of ReportOutline of Report

– Key RecommendationsKey Recommendations Comments From ReviewersComments From Reviewers PublicationPublication



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BackgroundBackground

Evidence requirements from payers now Evidence requirements from payers now include mandates for budget impact analyses include mandates for budget impact analyses (models)(models)

No formal methods guidelines exist on conduct No formal methods guidelines exist on conduct and reporting of budgetary impact analyses.and reporting of budgetary impact analyses.– Heterogeneity in type, quality and reporting of Heterogeneity in type, quality and reporting of

analyses conducted for/by payers.analyses conducted for/by payers.

The ISPOR BIA Task Force has produced the The ISPOR BIA Task Force has produced the first set of Methods Guidance on the conduct first set of Methods Guidance on the conduct and reporting of budgetary impact analyses.and reporting of budgetary impact analyses.



4Source: IMS Health Consulting Nov 2005

Pharma’s Shift to Specialty ProductsPharma’s Shift to Specialty Products

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Relative efficacy

Relative effectiveness

Cost effectivenessBudget impact

Austria x x x

Belgium x x x x

Czech Republic x x x

Denmark x x

Estonia x x x

Finland x x x

France x x

Germany x x x

Greece x x x

Hungary x x

Ireland x x x x

Italy x x x

Latvia x x

Lithuania x x

The Netherlands x x x x

Poland x x

Portugal x x

Slovenia x x x

Spain x x x

UK x x x

Source: EC 2006, adapted



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History of ISPOR GuidanceHistory of ISPOR Guidance

ISPOR Health Sciences Policy CouncilISPOR Health Sciences Policy Council

– Advise the ISPOR BOD on matters related to Advise the ISPOR BOD on matters related to science policy.science policy.

– Determine areas of scientific consensus and Determine areas of scientific consensus and translate into methods guidance documents translate into methods guidance documents for researchers and users.for researchers and users.



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History of ISPOR GuidanceHistory of ISPOR Guidance

Current ISPOR Methods Guidance DocumentsCurrent ISPOR Methods Guidance Documents

– Research EthicsResearch Ethics

– Modeling StudiesModeling Studies

– Retrospective StudiesRetrospective Studies

– Real World Data/EvidenceReal World Data/Evidence

– Budgetary Impact AnalysesBudgetary Impact Analyses

– Patient-Reported OutcomesPatient-Reported Outcomes



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Task Force MissionTask Force Mission

Develop a coherent set of methodological Develop a coherent set of methodological guidelines* for those developing or reviewing guidelines* for those developing or reviewing budget impact analysesbudget impact analyses

Develop a template for presenting the results of Develop a template for presenting the results of budget impact analyses that is useful for budget impact analyses that is useful for decision makersdecision makers

* Not an instruction manual



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Task Force MembersTask Force Members

Jo Mauskopf, PhD and Sean D. Sullivan, PhD (Chair)Jo Mauskopf, PhD and Sean D. Sullivan, PhD (Chair)

Jerusha Harvey – ISPOR StaffJerusha Harvey – ISPOR Staff

Lieven Annemans, PhDLieven Annemans, PhD

Jaime Caro, MD, CMJaime Caro, MD, CM

Dan Mullins, PhDDan Mullins, PhD

Mark Nuijten, MD, PhDMark Nuijten, MD, PhD

Ewa Orlewska, MD, PhDEwa Orlewska, MD, PhD

Paul Trueman, MAPaul Trueman, MA

John Watkins, Pharm.D., MHAJohn Watkins, Pharm.D., MHA



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Report OutlineReport Outline

AbstractAbstract IntroductionIntroduction

– Definitions and Intended UseDefinitions and Intended Use

– History of BIAHistory of BIA

– Task Force ProcessTask Force Process Recommendations for Analytic FrameworkRecommendations for Analytic Framework Recommendations for Inputs and Data SourcesRecommendations for Inputs and Data Sources Recommendations for Reporting FormatRecommendations for Reporting Format Recommendations for Budget Impact Computer ModelRecommendations for Budget Impact Computer Model Final DiscussionFinal Discussion



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Purpose of BIAPurpose of BIA

Budget Impact Analysis (BIA) is an essential part of a Budget Impact Analysis (BIA) is an essential part of a comprehensive economic assessment of a health care technology comprehensive economic assessment of a health care technology and is increasingly required, along with cost-effectiveness analysis and is increasingly required, along with cost-effectiveness analysis (CEA), prior to formulary approval or reimbursement. (CEA), prior to formulary approval or reimbursement.

The purpose of a BIA is to estimate the financial consequences of The purpose of a BIA is to estimate the financial consequences of adoption and diffusion of a new health care intervention within a adoption and diffusion of a new health care intervention within a specific health care setting or system context given inevitable specific health care setting or system context given inevitable resource constraints. resource constraints.



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Purpose of BIAPurpose of BIA

There may be circumstances where the CEA There may be circumstances where the CEA indicates an efficient technology while the BIA indicates an efficient technology while the BIA results indicate that it may not be affordable to results indicate that it may not be affordable to the budget holder. the budget holder.

In such instances, there is, unfortunately, no In such instances, there is, unfortunately, no current scientific guidance on how to resolve current scientific guidance on how to resolve this dilemma.this dilemma.



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Intended AudienceIntended Audience

The intended audience is health care decision The intended audience is health care decision makers who are responsible for local, regional makers who are responsible for local, regional or national budgets as well as research or national budgets as well as research analysts who perform these studies for health analysts who perform these studies for health care decision makers.care decision makers.

Others who may find this guidance useful Others who may find this guidance useful include patient advocacy groups, health care include patient advocacy groups, health care professionals, drug and other technology professionals, drug and other technology manufacturers and those developing guidelines manufacturers and those developing guidelines for their settings.for their settings.



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BIA - Analytic FrameworkBIA - Analytic Framework

The purpose of a budget impact analysis is The purpose of a budget impact analysis is not to produce exact not to produce exact estimatesestimates of the budget consequences of an intervention but to of the budget consequences of an intervention but to provide a provide a valid computing frameworkvalid computing framework that allows users to that allows users to understand the relation between the unique characteristics of the understand the relation between the unique characteristics of the budget holder and the possible budgetary implications of budget holder and the possible budgetary implications of introduction of a new health technology.introduction of a new health technology.

The modeled outcomes should reflect the impact on the The modeled outcomes should reflect the impact on the budget of budget of interest to the decision makerinterest to the decision maker and should be and should be based on relevant based on relevant scenariosscenarios that consist of a set of specific assumptions about the that consist of a set of specific assumptions about the likely impact of the new technology in the health plan and other likely impact of the new technology in the health plan and other health plan characteristics rather than a scientifically chosen “base health plan characteristics rather than a scientifically chosen “base case” or “reference case” based on nationally valid assumptions case” or “reference case” based on nationally valid assumptions and inputs.and inputs.



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Specific recommendations in this section relate to:Specific recommendations in this section relate to:– Proper design of the analytic frameworkProper design of the analytic framework

Disease model consistent with CEA disease modelDisease model consistent with CEA disease model Reports all budgetary implications NOT JUST the Reports all budgetary implications NOT JUST the

technology under evaluationtechnology under evaluation

– Perspective of the analysisPerspective of the analysis The budget holderThe budget holder

– Base case analysisBase case analysis Most likely funding scenario w/wo restrictionsMost likely funding scenario w/wo restrictions

– Population includedPopulation included All persons likely to receive the new technology including All persons likely to receive the new technology including

induced demandinduced demand



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Specific recommendations in this section relate to:Specific recommendations in this section relate to:– Time horizon of the analysisTime horizon of the analysis

One to three years with longer time horizons if of interest to One to three years with longer time horizons if of interest to budget holderbudget holder

– Costing and discountingCosting and discounting Budget holder transaction prices, stream of costs over time Budget holder transaction prices, stream of costs over time

and and no discountingno discounting

– Uncertainty analysis and validationUncertainty analysis and validation Primarily alternative scenarios chosen by budget holderPrimarily alternative scenarios chosen by budget holder PSA not requiredPSA not required



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BIA - Inputs and Data SourcesBIA - Inputs and Data Sources

Specific recommendations in this section relate to:Specific recommendations in this section relate to:

– Size and characteristics of the populationSize and characteristics of the population Epidemiology, disease natural history, and database estimatesEpidemiology, disease natural history, and database estimates

– Current intervention mix (without the new intervention)Current intervention mix (without the new intervention) Budget holder data or published or market research dataBudget holder data or published or market research data

– New intervention mix (with the new intervention)New intervention mix (with the new intervention) Market forecast with transparent assumptions about how switch from or Market forecast with transparent assumptions about how switch from or

add-on to other treatments occursadd-on to other treatments occurs

– Cost of the current and new intervention mixCost of the current and new intervention mix Acquisition cost plus administration, monitoring, and side effects, Acquisition cost plus administration, monitoring, and side effects, adjusted adjusted

for adherencefor adherence, product discounts, and co-payments from budget holder , product discounts, and co-payments from budget holder database or assumptionsdatabase or assumptions

– Use and cost of condition- and treatment-related healthcare servicesUse and cost of condition- and treatment-related healthcare services Based on data from clinical trials or that used in disease model designed to Based on data from clinical trials or that used in disease model designed to

estimate impact on population resource use and costs each year after estimate impact on population resource use and costs each year after product approval.product approval.



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BIA - Reporting FormatBIA - Reporting Format

This section of the report contains a suggested format for reporting on the This section of the report contains a suggested format for reporting on the conduct and results of a BIA.conduct and results of a BIA.

– Important in that it promotes a consistent and standard format for Important in that it promotes a consistent and standard format for reporting model and resultsreporting model and results

OutputOutput

– Budgetary implications represented by monetary flow (raw or per Budgetary implications represented by monetary flow (raw or per capita) over the study time horizon.capita) over the study time horizon.

– Components of budget impact to be displayed.Components of budget impact to be displayed.

In addition to a report that follows the main headings of the framework, In addition to a report that follows the main headings of the framework, inputs and data sources section, guidance is given on tabular and inputs and data sources section, guidance is given on tabular and graphical display. These include:graphical display. These include:

– Figure of the model structureFigure of the model structure

– Table of model assumptionsTable of model assumptions

– Tables of inputs and outputsTables of inputs and outputs

– Schematic representation of uncertainty/scenariosSchematic representation of uncertainty/scenarios



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Recommendations for Recommendations for Computer ModelComputer Model

This section of the report contains recommendations on the This section of the report contains recommendations on the development and use of computer simulation models for reporting development and use of computer simulation models for reporting the results of BIAthe results of BIA

– Simple spreadsheet modelSimple spreadsheet model

– Include default input parameter values and text description of Include default input parameter values and text description of each parameter and reference to data sourceeach parameter and reference to data source

– User ability to change all input parameter values and also to User ability to change all input parameter values and also to restore defaultsrestore defaults

– Presentation of results in tabular and graphical formatPresentation of results in tabular and graphical format

– Presentation of results at different levels of detailPresentation of results at different levels of detail

– User ability to change the scope of the analysis including the User ability to change the scope of the analysis including the duration of results and the cost components includedduration of results and the cost components included



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Peer Review ProcessPeer Review Process

Comments from Researchers and Users Comments from Researchers and Users RepresentingRepresenting

– Belgium, Canada, Korea, Poland, Spain, The Belgium, Canada, Korea, Poland, Spain, The Netherlands, Sweden, UK, USNetherlands, Sweden, UK, US

– ISPOR Membership (> 40 respondents)ISPOR Membership (> 40 respondents)



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ISPOR Web SiteISPOR Web Site

www.ispor.orgwww.ispor.org

Download - ISPOR Methods Guidance A Report of the ISPOR Task Force on Budget Impact Modeling January 21, 2009 Sean D. Sullivan, PhD Pharmaceutical Outcomes Research

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