With an increased focus on patient centricity and the 21st Century Cures Act, the US Food and Drug Administration (FDA) has been advocating for patient-focused drug development through a series of guidance documents to “ensure that patient’s experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation.” Thus, sponsors are increasingly collecting patient reported outcomes (PROs) data as endpoints in pivotal trials and using them to support label claims. This trend thus begs the question: will US payers give more consideration to PRO data when making their coverage and formulary decisions?
To find out, ICON surveyed 10 US payers via in-depth phone interviews in June 2020. The participants represented a mix of medical and pharmacy directors at Managed Care Organizations (MCOs), Integrated Delivery Networks, (IDNs), and Pharmacy Benefit Managers (PBMs) at regional and national levels.
This whitepaper will cover their insights on:
- The use of PROs in clinical development
- Payers’ perspective when making formulatry decisions
- Influencing factors and the challenges in using PROs
- Payers use of quality adjusted life years (QALYs)
- The impact of Institute for Clinical and Economic Review (ICER)
- Future outlook of PROs in coverage decisions