ispor methods guidance a report of the ispor task force on budget impact modeling january 21, 2009...

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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  • ISPOR Methods Guidance A Report of the ISPOR Task Force on Budget Impact Modeling

    January 21, 2009

    Sean D. Sullivan, PhDPharmaceutical Outcomes Research and Policy ProgramSchool of PharmacyUniversity of WashingtonSeattle, WA

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    TopicsIntroduction to the Task ForceTask Force ReportOutline of ReportKey RecommendationsComments From ReviewersPublication

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    BackgroundEvidence requirements from payers now include mandates for budget impact analyses (models)No formal methods guidelines exist on conduct and reporting of budgetary impact analyses.Heterogeneity in type, quality and reporting of analyses conducted for/by payers.The ISPOR BIA Task Force has produced the first set of Methods Guidance on the conduct and reporting of budgetary impact analyses.

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Source: IMS Health Consulting Nov 2005 Pharmas Shift to Specialty Products

  • *Source: EC 2006, adapted

    Relative efficacyRelative effectiveness Cost effectivenessBudget impactAustriaxxxBelgiumxxxxCzech RepublicxxxDenmarkxxEstoniaxxxFinlandxxxFrancex x GermanyxxxGreecexxxHungaryxxIreland xxxxItalyxxxLatviaxxLithuaniaxxThe NetherlandsxxxxPolandxxPortugalxxSloveniaxxxSpainxxxUKxxx

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    History of ISPOR Guidance ISPOR Health Sciences Policy CouncilAdvise the ISPOR BOD on matters related to science policy.Determine areas of scientific consensus and translate into methods guidance documents for researchers and users.

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    History of ISPOR Guidance Current ISPOR Methods Guidance DocumentsResearch EthicsModeling StudiesRetrospective StudiesReal World Data/EvidenceBudgetary Impact AnalysesPatient-Reported Outcomes

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Task Force MissionDevelop a coherent set of methodological guidelines* for those developing or reviewing budget impact analyses Develop a template for presenting the results of budget impact analyses that is useful for decision makers* Not an instruction manual

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Task Force MembersJo Mauskopf, PhD and Sean D. Sullivan, PhD (Chair)Jerusha Harvey ISPOR StaffLieven Annemans, PhDJaime Caro, MD, CMDan Mullins, PhDMark Nuijten, MD, PhDEwa Orlewska, MD, PhDPaul Trueman, MAJohn Watkins, Pharm.D., MHA

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Report OutlineAbstractIntroductionDefinitions and Intended UseHistory of BIATask Force ProcessRecommendations for Analytic FrameworkRecommendations for Inputs and Data SourcesRecommendations for Reporting FormatRecommendations for Budget Impact Computer ModelFinal Discussion

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

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

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

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Purpose of BIAThere may be circumstances where the CEA indicates an efficient technology while the BIA results indicate that it may not be affordable to the budget holder. In such instances, there is, unfortunately, no current scientific guidance on how to resolve this dilemma.

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

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

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

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

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

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

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    BIA - Analytic FrameworkSpecific recommendations in this section relate to:Proper design of the analytic frameworkDisease model consistent with CEA disease modelReports all budgetary implications NOT JUST the technology under evaluationPerspective of the analysisThe budget holderBase case analysisMost likely funding scenario w/wo restrictionsPopulation includedAll persons likely to receive the new technology including induced demand

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    BIA - Analytic FrameworkSpecific recommendations in this section relate to:Time horizon of the analysisOne to three years with longer time horizons if of interest to budget holderCosting and discountingBudget holder transaction prices, stream of costs over time and no discountingUncertainty analysis and validationPrimarily alternative scenarios chosen by budget holderPSA not required

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    BIA - Inputs and Data SourcesSpecific recommendations in this section relate to:Size and characteristics of the populationEpidemiology, disease natural history, and database estimatesCurrent intervention mix (without the new intervention)Budget holder data or published or market research dataNew intervention mix (with the new intervention)Market forecast with transparent assumptions about how switch from or add-on to other treatments occursCost of the current and new intervention mixAcquisition cost plus administration, monitoring, and side effects, adjusted for adherence, product discounts, and co-payments from budget holder database or assumptionsUse and cost of condition- and treatment-related healthcare servicesBased on data from clinical trials or that used in disease model designed to estimate impact on population resource use and costs each year after product approval.

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    BIA - Reporting FormatThis section of the report contains a suggested format for reporting on the conduct and results of a BIA.Important in that it promotes a consistent and standard format for reporting model and resultsOutputBudgetary implications represented by monetary flow (raw or per capita) over the study time horizon.Components of budget impact to be displayed.In addition to a report that follows the main headings of the framework, inputs and data sources section, guidance is given on tabular and graphical display. These include:Figure of the model structureTable of model assumptionsTables of inputs and outputsSchematic representation of uncertainty/scenarios

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Recommendations for Computer ModelThis section of the report contains recommendations on the development and use of computer simulation models for reporting the results of BIASimple spreadsheet modelInclude default input parameter values and text description of each parameter and reference to data sourceUser ability to change all input parameter values and also to restore defaultsPresentation of results in tabular and graphical formatPresentation of results at different levels of detailUser ability to change the scope of the analysis including the duration of results and the cost components included

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    Peer Review ProcessComments from Researchers and Users RepresentingBelgium, Canada, Korea, Poland, Spain, The Netherlands, Sweden, UK, USISPOR Membership (> 40 respondents)

    Pharmaceutical Outcomes Research and Policy ProgramUniversity of Washington*

    ISPOR Web Sitewww.ispor.org

    **

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