Christopher Terrone | VP, Healthcare Insights
Cynthia Miller, MD, MPH, FACP | VP, Medical Director, Access Experience Team
Mitch DeKoven, MHSA | Vice President, Evidence Generation
Payer scrutiny of new therapies has intensified as the industry faces a surge in accelerated approvals, reliance on surrogate endpoints, and the introduction of products with limited, if any, long-term data. Payers often make coverage decisions in the midst of such uncertainty, leading to restrictive policies and access barriers. In this context, RWE has become indispensable for determining and demonstrating value, informing policy, and supporting market access strategies.
To better understand how payers are using RWE, Precision AQ conducted its second annual survey, Real-World Evidence in Payer Decision-Making. This initiative engaged 25 market access decision-makers, including pharmacy and medical directors from both national and regional health plans as well as pharmacy benefit managers. The survey was designed to capture a cross-section of viewpoints from those responsible for shaping coverage and formulary policy across the United States.
Key findings from this year’s research include:
- The first year after FDA approval is a critical period when payers expect real-world evidence (RWE), reflecting their growing demand for timely data to support decision making
- A key challenge to using RWE is that payers often do not find it actionable
- Payers report that manufacturers deliver RWE with mixed success, with some communications falling short of payer needs
“RWE in a vacuum is usually not helpful. It has to be comparative and actionable and fill a clear unmet need using the correct endpoints.”
In particular, these findings suggest several practical steps for manufacturers seeking to align with payer expectations and maximize the impact of RWE:
- Make RWE available early in the lifecycle when payers need it to secure maximum access.
- Evidence isn’t enough: Collaborate across market access and HEOR functions to ensure that your evidence generation plan will produce data that is not only scientifically valid, but also meaningful for payers making or revisiting coverage and access decisions.
- Strive for clarity, transparency, and non-promotional language to maximize effectiveness of RWE communications.
To review the full results, including detailed findings on the types of RWE studies payers value, the most meaningful endpoints, expectations for country of origin, and year-over-year trends, please contact our experts on the Access Experience or Evidence Generation teams. Our team is available to discuss the implications of these insights for your access strategy and to support your evidence planning efforts.