Communicating Healthcare Economic and Pre-approval Information With Healthcare Decision-Makers: Opportunities Following the 21st Century Cures Act and FDA Guidance.

With rising US healthcare costs, population health decision-makers have expressed interest in receiving pre-approval information to help with the budgeting and forecasting needed to accommodate pharmaceutical and medical device launches. Additionally, there has been a strong emphasis placed on the economics and quality of new products. Manufacturers have historically been reluctant to share pre-approval or healthcare economic information (HCEI) due to unclear regulatory guidance for these types of communications. The 21st Century Cures Act, as well as the June 2018 FDA guidance on payor communications have more clearly defined guardrails to communicate this information. This paper provides insights on how to optimize this new guidance and facilitate robust and compliant conversations with decision-makers.