Abstract
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.
Highlights
As US healthcare costs continue to rise, decision-makers involved in population health management have put a greater focus on the economics and quality of pharmaceuticals and medical devices
The final guidance further expands the audience that can receive healthcare economic information (HCEI) to include drug information centers, technology assessment panels, pharmacy benefit managers, and other multidisciplinary entities, and it clarifies that individuals who serve multiple roles involving direct patient care and population health management, may receive HCEI when they are carrying out their responsibilities involving formulary management
The following are suggestions for optimizing application of the FDA guidance within a pharmaceutical or medical device company: 1 Engage medical, regulatory, legal, health economics and outcomes research (HEOR), and marketing teams to review the guidance and develop internal rules for what HCEI can be included in promotional materials
Summary
As US healthcare costs continue to rise, decision-makers involved in population health management have put a greater focus on the economics and quality of pharmaceuticals and medical devices. While pharmaceutical manufacturers have made strides in responding to value assessment considerations, the industry has historically been reluctant to share healthcare economic information (HCEI) with formulary decision-makers due to unclear regulatory guidance for these types of communications.
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