FDA

Antimicrobial resistance: FDA discusses reimbursement reforms

Reimbursement reforms for antimicrobial treatments could include “a mix of milestone payments and subscription fees for developers of FDA-approved products with high economic and clinical value, targeted at multi-drug resistant organisms and linked to proven clinical outcomes,” FDA Commissioner Scott Gottlieb said in a speech at Pew Charitable Trusts on Friday.

He also offered the idea of using a “subscription-based model” that could see hospitals paying a flat rate for access to a certain number of doses of a new antimicrobial.

Currently, the Centers for Disease Control and Prevention (CDC) estimates that the direct cost of antimicrobial resistance on the US economy is $20 billion annually.

“These subscription fees could be priced at a level to create a sufficient return on the investment to develop drugs with a certain profile,” Gottlieb said. “This should have the effect of creating a natural market for drugs that meet certain important specifications.”

The FDA is also discussing payment pilots with other federal agencies, including the Centers for Medicare and Medicaid Services (CMS), noting interest in doing such pilots in concert with the private sector as well.

New approaches to reimbursement that could be explored might “also include new technology add-on payments for certain new antibacterial drugs that meet critical patient and public health needs,” he said.

Meanwhile, earlier this week, the FDA released a new request for information (RFI) to obtain external input into developing an annual list of regulatory science initiatives specifically for antimicrobial products. Part of such a list will be a focus on the “delay in availability of information regarding the identification and antibacterial susceptibility of the causal pathogen, when isolated.”

Responses to the RFI will be accepted until 31 October 2018.


Image: Scott Gottlieb. SHUTTERSTOCK

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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