OBJECTIVES: To gather payer and policymaker insights to help shape evidence gaps and prioritization for products that meet the requirements for CMS negotiation, as per the Inflation Reduction Act (IRA). To understand how risk will be divested and what the pricing and patient access implications will be given the new legislation.

METHODS: Conduct a mixed-methods approach (e.g., qualitative and quantitative questions) to evaluate access, value, and pricing implications because of IRA from two groups: US payer and policymakers and European payer advisors (n=25+). The research focused on 1) Evidence requirements from manufacturers on key data elements as part of negotiation process 2) Payer considerations on cost and patient access implications. Payers rated the key data elements required from manufacturers on a priority scale from (1-low to 7-high) for elements that could be considered for negotiation.

RESULTS: Findings showed CER focused on existing therapeutic alternatives and in specific (e.g., CMS-Medicare) populations were given the highest priority ranking; unmet needs also ranked as a high priority. R&D and unit costs of production and distribution are newer components that payers indicated will be critical to determining maximum fair price. Additional findings included the importance of the quality of real-world evidence (e.g.- demonstration of magnitude of effect, robust research methods, etc.) and implications for drugs with multiple indications and more restrictive formularies given the lower caps on out of pocket and co-insurance. Learnings from global HTAs should be considered. Effective communication of evidence will be critical given the amount of evidence and the word limits across all sections of the evidence package submissions.

CONCLUSIONS: Our research findings identified key evidence areas for manufacturers to immediately restructure data requirements to include highest priority data elements and to be able to synthesize and communicate these evidence packages to maximize successful submissions as part of IRA negotiations for eligible drugs identified.