FDA and CMS Pursue New Antibiotic Payment Models

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced that FDA is working with the Centers for Medicare and Medicaid Services (CMS) to develop new payment models for urgently needed new antibiotics that would help stimulate research and development as well as promote judicious use. IDSA has long championed new federal incentives for antibiotic research and development as well as policies to advance stewardship. Commissioner Gottlieb said one model under consideration is similar to a software licensing approach, in which hospitals most likely to need a new antibiotic would pay a fee to receive a set amount of the antibiotic. In theory, the fee would be sufficiently substantial to incentivize R&D, and the small set amount of the antibiotic made available should encourage judicious use. IDSA is further communicating with FDA and CMS to raise several key points:

• New policies are necessary to stimulate antibiotic R&D and to promote stewardship.
• Under such a licensing policy, who would provide the funding for the fee?
• In the event that a patient at a hospital that was not part of the licensing agreement needed the antibiotic, how would access be arranged? Similarly, what would be done if a hospital required more than its allotment of the antibiotic?
• Such a licensing arrangement would work best in hospitals with robust, ID physician-led stewardship programs that are aligned with the CDC Core Elements, and CMS should establish policy to advance the implementation of stewardship programs.
• Under such a licensing agreement, it will be particularly important to monitor the use of antibiotics, such as through the CDC National Healthcare Safety Network.

We will continue to report on the progress of this proposal and insight we gain on the issues we are raising.