PharmaVOICE Blog Post

The Role of Integrated Scientific Advice for the Early Determination of RWE Requirements in HTA and Payer Assessments

Posted By: Dan Limbach
October 21, 2019

The aim of this article is to discuss the current use of real-world data and evidence in health technology assessment (HTA) and payer appraisals, its potential role in lifecycle management, and how the early dialogue provided by Integrated Scientific Advice (ISA) engagement can be used as a key tool in real-world evidence (RWE) generation planning.

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 Key points in the paper:

  • Integrated Scientific Advice is a multi-stakeholder advice process that brings together regulatory advice (either with country-level agencies or the European Medicines Agency [EMA]) and HTA advice (either with individual country-level agencies or multi-country collaborations).
    • Early engagement with ISA is a valuable strategy to refine and evaluate evidence generation plans and align them with regulators’ and HTA bodies’ needs.
  • As it is evident that RWE is increasingly finding its place and use in HTA appraisals and in market access in general, and healthcare systems will likely see an increasing need for data on pharmacotherapies throughout the product lifecycle, it will be key for manufacturers to establish ways to plan an RWE strategy as early and as efficiently as possible.
  • The global pricing, reimbursement, and market access (PRMA) landscape is seemingly shifting towards demands for iterative demonstration of value in real-world populations in order for therapies to earn and maintain their place in clinical pathways. In such an environment, ISA represents an opportunity to gain early external and internal cross-functional alignment on RWE strategy and goals for new therapies at launch and beyond.

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About the Blog Poster: Dan Limbach

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