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EU ISPOR 2011 Feedback

EU ISPOR 2011 Feedback. All presentations of the plenary sessions available at http://www.ispor.org/congresses/spain1111/releasedpresentations.asp. Hans-George Eichler (1st plenary Session on Pros & Cons of a centralized eu pricing & reimbursement agency ):

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EU ISPOR 2011 Feedback

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  1. EU ISPOR 2011 Feedback • All presentations of the plenary sessions available at http://www.ispor.org/congresses/spain1111/releasedpresentations.asp

  2. Hans-George Eichler (1st plenary Session on Pros & Cons of a centralized eu pricing & reimbursementagency): http://www.ispor.org/congresses/Spain1111/presentations/Eichler-Hans-Georg-1st-Plenary.pdf

  3. EU ISPOR 2011 Feedback • „price“ and „value based pricing“ (mainly driven by UK) was everywhere; unclear if & how this will work (different threshold for every therapeutic area); worry about level of negotiation neededdue 2014 • multi-criteria decision analysis (MCDA) – using this to come to a discussion but also using the process itself as a help – way to formalize the decision and make it more transparent (“process of going through to a MCDA is more important that the value we get”) • SubgroupsPlenary Session on heterogeneity in cost-effectiveness IQWiG – only look at subgroups if they are included in the randomization (stratification) and/or incorporate them into the secondary criteriause subgroup identification during clinical planning • Systematic review / MA / ICMost payer bodies now require this; MTC are stronger when drug is longer in the market (done too early in the moment?) Look at mixed evidence and check if there are inconsistencies; if there are, then try to understand where the inconsistencies are coming from • A lot of presentations on diagnostics

  4. EU ISPOR 2011 Feedback Modeling • Building (economic) models right from the early stages of the trial planning and make it better throughout the phases • ISPOR guidelines of modeling to come out soonsimplistic vs complex models (depends on whom you talk to) – how influential will the guidelines be? Teams could go the wrong path if they don‘t get a good consultation on what is needed and asked for. • Modeling -> uncertainty, variabilitythere has to be stats involved as this is our core competency (how to deal with uncertainty) Decision • inform the decision -> frequentist approach might not be the best solution to address this (do we need p-values?)->Do we need a Bayesian way of thinking in this whole area? multi-dimensional (cost-effectiveness; ethics; …)

  5. EU ISPOR 2011 Feedback Real (local) world data • need of real world data; combine obs study data and RCT data in a meta-analysis; CER; registries vs retrospective database analysis vs prospective obs studies; pragmatic trials (how feasible are those in EU?) • do industry sponsored RCTs give the results that industry is wanting?belief from the outside is different than belief within the industry

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