OBJECTIVES: This primary research aimed to obtain perspectives regarding the influence of federal price-setting policies and external value assessment on diverse US payer organizations.

METHODS: Experienced stakeholders from US payer organizations were recruited to participate in an online quantitative and qualitative primary research survey in May 2024, consisting of 12 key themes and 53 questions. Descriptive statistics and contextual analyses of the results were conducted.

RESULTS: The survey included 20 participants, including 4 medical directors, 11 pharmacy directors, 4 industry/trade relations, and 1 actuary representing national and regional MCOs, PBMs, and IDNs.

Participants had mixed views around the level of impact they believe the US IRA will have on biopharmaceutical innovation (low impact, 20%; moderate impact, 50%; high impact, 30%). When asked how CMS evaluation and negotiation will impact payer decision processes, 90% felt this would decrease the number of covered drugs within therapeutic classes, including those with a Maximum Fair Price (MFP) under the IRA.

The influence of ICER reports on the initial review of products/formulary decisions also continues to vary widely, with 45% stating moderate influence, 25% high influence, and 30% no influence at all. The reasons for low or moderate influence were mainly due to ICER assessment not being available for most/all drugs reviewed (77%), lack of agreement with ICER assessment methods (41%), and more valuable sources of information available (35%). Considering ICER’s ‘Shared Savings’ approach to cost-offsets in modeling, 65% of participants had a low level of knowledge, and 85% had a low level of utility of this controversial approach.

CONCLUSIONS: With a rapidly evolving healthcare policy and value assessment landscape in the US, it is critical to understand how these changing dynamics may impact payer access determinations to biopharmaceutical innovations.