Value-based agreements, in which payment for the treatment is based on how well it helps patients meet specific health outcomes or other quality measures, are gaining interest as a means of driving value-based care. However, regulatory and communication barriers have impeded the development of these contracts. For example, until recently, there was a lack of clarity on whether detailed information about a treatment’s use and impact on population health and total cost of care, the basis for these contracts, could be shared with payers. To pave the way for value-based care, the Food and Drug Administration (FDA) issued new guidance that provided clarity on when and how health care economic information (HCEI) that is consistent with but not contained in the FDA label can be shared between payers and manufacturers.
The National Pharmaceutical Council (NPC) has long been involved in the issue of HCEI, playing a leadership role in the national conversation about HCEI since 2010, with research that raised awareness of the policy and legal ambiguities, conferences, comments to the FDA, and more. In this month’s issue of Specialty Pharmacy Times, NPC President and Chief Executive Officer Dan Leonard continues that conversation and explains how expanding HCEI for sophisticated audiences like payers and population health decision-makers benefits all stakeholders, and underscores the need to resolve remaining reimbursement and regulatory barriers that hinder the development of value-based contracts. Read the commentary in Specialty Pharmacy Times to learn more.