Pharmacoeconomic analysis in r&d decision making


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Pharmacoeconomic analysis in r&d decision making

  1. 1. Pharmacoeconomic Analysis in R&D Decision MakingPublished:October 2011No.Of Pages:86Price:US $ 3835IntroductionThis report gives in depth analysis of the ways in which the pharmaceutical industry canensure that it collects sufficient data to support health technology assessments for newproducts and how it can apply economic analyses to support decision making during theR&D process.Features and benefits* Understand the importance of health technology assessment in reimbursement decisionsand how to optimize data to get a positive outcome.* Compare different methods that use health economics early in product development andcan enable decisions to be made that will reduce R&D costs.* Understand how trials can be designed to provide good evidence to support positivereimbursement decisions.* Understand the impact of increasing interaction between the various stakeholders in thereimbursement decision making process.* Discover the views of experts in the field of pharmacoeconomics including the AssociateDirector of the Scientific Advice Programme at NICE.Highlights* Pharma companies should think earlier about potential HTA requirements for any newdrug. Understanding patient perspectives, existing practice, including treatmentheterogeneity, unmet needs, and the costs associated with a condition will help to framediscussions of cost-effectiveness lbefore a new product comes to market.* Phase III trials can be designed in such a way as to provide data that supports positivereimbursement decisions. Studies that provide evidence to support reimbursement willtypically include a comparator, be longer, include a broader patient population, and realisticoutcome measures.* In the light of healthcare reform in the US, discussion of the costs – and cost-effectiveness – of treatment will be raised more and more frequently. The FDA and Centersfor Medicaid and Medicare Services have announced their intention to work together toexplore a parallel review process.Browse All Pharmaceuticals Market Research Reports
  2. 2. Table Of ContentsAbout the authorsDisclaimerEXECUTIVE SUMMARYDefining pharmacoeconomicsPharmacoeconomic analysis to support decision making in drug developmentStudies to support pricing and reimbursementFuture directions for value-based drug developmentDefining pharmacoeconomicsSummaryDefining pharmacoeconomicsHealth Technology AssessmentNational authoritiesGlobal collaboration for HTAAssessing valuePharmacoeconomics in drug developmentPharmacoeconomic analysis to support decision making in drug developmentSummaryIntroductionThe MATCH projectThe Headroom ApproachThe Health Economic (HE) Evaluation ToolBayesian decision theory and the value of informationPortfolio optimizationConclusionsStudies to support pricing and reimbursementSummaryUnderstanding pharmacoeconomics in early drug developmentCost-of-illness studiesEpidemiological studiesPatient perspectivesMeasuring utilityIncluding health economics in Phase III study designsComparatorsStudy designEndpointsPost-approval studies and data analysesObservational studiesPragmatic clinical trialsData synthesis to support HTACosts of comparative effectiveness researchConclusionFuture directions for value-based drug developmentSummaryHarmonization of HTA requirements across jurisdictionsMulti-stakeholder dialogue in EuropeThe NICE Scientific Advice processMulti-stakeholder dialogue
  3. 3. Cost-effectiveness and the US healthcare systemPrivate sectorMinimizing the gap between efficacy and effectivenessProgressive approvalsPharmacogenomicsPrescribers and patientsGlobal development teamsFuture directionsAppendixResearch methodologyAcknowledgementsAbbreviationsGlossaryReferencesLIST OF TABLESTable: Influential HTA and reimbursement authorities in different regionsTable: Potential benefits from innovative medicinesTable: Trials described in approval packages in the US and EUTable: Possible Phase III study designs to support HTATable: Sample sizes for a 3-arm randomized controlled trial or an adaptive Phase III/IV trialTable: Post-approval study types that support HTALIST OF FIGURESFigure: Evidence required for regulatory approval and reimbursement decisionsFigure: Areas of potential benefit from innovative medicinesFigure: Definitions of the Quality-Adjusted Life-Year and the Incremental Cost-EffectivenessRatioFigure: Decision-making supported by early health economic analysisFigure: Applying the Headroom method for a regenerative medicine for surgical treatmentof bladder cancerFigure: An iterative, Bayesian approach to integrating health economic data into the drugdevelopment lifecycleFigure: Relationship between the size of Phase IIb and the probability of success in PhaseIIIFigure: Relationship between the size of Phase IIb and the product’s expected Net PresentValueFigure: Using health economic evaluation in drug development and post-approvalFigure: Designs of studies for efficacy and effectivenessFigure: Adaptive Phase III/IV trial designFigure: Variation acceptance of surrogate outcomes by disease and HTA bodyFigure: Costs of different study typesFigure: Evaluation factors influencing reimbursement decisions in Australia and EnglandFigure: Functions required in Global Development Teams from the early stages of drugdevelopment
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