Recent Food and Drug Administration guidance offers some “much-needed clarity” on communications involved with developing value-based contracts between payers and biopharmaceutical companies, according to a PhRMA report.
The alternative payment schemes, PhRMA reports, can “help deliver savings for patients, private payers and the government in addition to the potential for better clinical outcomes.”
PhRMA describes three barriers preventing more broad implementation of value-based contracts:
- The Anti-Kickback Statute, which could be hampering innovative contracts;
- Dated Medicaid price-reporting regulations which fail to “accurately capture the innovative value-based contracting methods”; and
- Unclear FDA regulations involving biopharma-to-payer communications.
The FDA’s recent guidance documents address the latter.