Precision-Led Working Group Provides Suggestions to Close Gaps When Creating Value Frameworks for New Medical Therapies

Randomized controlled trials don’t capture real-world evidence regarding how patients will actually interact with, adhere to, or find value in a costly new medical therapy, yet current value frameworks and assessments don’t include this “real world” element. A new working group led by PHE’s Anupam Jena, Jacki Chou, and Darius Lakdawalla aim to improve this dynamic by offering guidance on closing the gap between real-world and clinical trial data when formulating value frameworks.

In a commentary appearing in the November issue of The American Journal of Managed Care (AJMC), the authors make recommendations to improve how healthcare system decision makers assess the value of new, potentially costly medical technologies, in light of growing concerns from payers, employers, patients, and other stakeholders.

To help guide these decisions, a working group was formed in 2017. The Value FORWARD (Frameworks, Outcomes, and Real-World Adherence in Chronic Disease) Committee aimed to improve upon existing frameworks, and their recommendations are contained in the AJMC commentary. The authors suggest that value frameworks and assessments:

  • Integrate real-world effectiveness to complement the efficacy found in randomized controlled trials
  • Incorporate the way real-world behavior—or patient adherence—mediates outcomes
  • Discuss how therapies affect real-world equity and disparities in care

Additional resources are needed to understand how human behavior impacts real-world outcomes, causing different results from those seen in clinical trials, the researchers wrote.

For more information,  the AJMC commentary can be found here.

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