AJMC® Researchers Have 3 Suggestions to Close the Gaps When Creating Value Frameworks for New Medical Therapies

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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, and current value frameworks and assessments don’t include this “real world” element. In the current issue of The American Journal of Managed Care®, authors offer guidance on closing the gap between real-world and clinical trial data when formulating value frameworks.

In a commentary in the November issue of The American Journal of Managed Care®(AJMC®), health policy and health economics researchers make three 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.

Value frameworks developed by different organizations may come to separate conclusions about the same drug or treatment, depending on the perspectives and attributes of value that they use. Particularly for chronic diseases, value frameworks need to close the gap between evidence from clinical trials and real-world patient behavior when evaluating new therapies.

To help guide these decisions, the authors formed a working group in 2017, in partnership with Precision Health Economics and Intarcia Therapeutics. 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.

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