May 2, 2016 – In order to make reasonable coverage decisions about new medicines, payers need access to information from drug companies about those medicines prior to their FDA approval, a practice that currently is restricted under FDA policy, according to a recent blog post in The Catalyst, a Pharmaceutical Research and Manufacturers of America (PhRMA) publication.
Andrew Powaleny writes in the April 29 PhRMA blog that outdated FDA regulations “may inhibit biopharmaceutical companies from communicating scientifically sound, truthful and non-misleading information about medicines with payers prior to FDA approval,” and that even after approval “current rules can stand as an obstacle to timely dissemination of important efficacy information about a medicine that is not included in the labeling.” He states that the FDA “has not provided a clear regulatory safe harbor to facilitate companies’ timely information sharing with payers.”
“As the prescription power passes from the doctor to the formulary, it’s time for the FDA to clearly state in its policies that biopharmaceutical companies can participate aggressively in formulary discussions,” commented Coalition for Healthcare Communication Executive Director John Kamp. “Payers are among the most educated and informed decisionmakers and need not be protected from the sponsor companies. Indeed, the sponsor companies often have the best information available on the safe and effective use of drugs and, as such, they should be empowered to share that information with payers.”
According to PhRMA, “modernizing FDA policy to allow biopharmaceutical companies to share accurate, science-based information with payers about approved and unapproved uses of medicines will benefit patient care,” particularly when the new medicine or indication “is a breakthrough in treating a life-threatening disease or where the new drug is safer or more effective than existing treatment.”
Specifically, the blog states, companies should be able to communicate the following with payers:
- Research and development pipeline information
- Status of FDA applications
- Anticipated use of products in the pipeline
- Relevant data from clinical trials
- Applicable treatment guidelines
- Pharmacoeconomic information
PhRMA applauds Congress for working to modernize the FDA approach toward payer communications as part of the 21st Century Cures Act, and states that at a recent forum featuring stakeholders from industry, insurers, patient groups and payers, these entities endorsed such modernization efforts.