7:34 AM
Jun 12, 2018
 |  BC Extra  |  Politics & Policy

FDA proposes new reimbursement model for antimicrobials

FDA Commissioner Scott Gottlieb said Tuesday that FDA, CMS and other agencies are discussing changing the model for how new antimicrobials are reimbursed in order to counter the obstacles inherent in commercializing these drugs.

Gottlieb said the agency is considering a licensing model for reimbursement of antimicrobial products against multidrug resistant infections under which the acute care institutions most likely to prescribe them would pay a fixed licensing fee to access a certain number of annual doses of a drug. He said the model might offer an effective “pull incentive” to develop new drugs by providing a predictable return on investment and revenue stream.

“We have been speaking with our counterparts at CMS as to whether such an approach is feasible, whether it can be formulated as a demonstration, and as a demonstration, whether it would have the intended public health benefits,” Gottlieb said.

Since antimicrobials, especially those intended to treat drug resistant infections, are prescribed sparingly, the current market for new antimicrobials is limited and has led to a dwindling R&D pipeline due to a low ROI. The standard reimbursement model, which links ROI to the volume of drug sold, does not provide adequate incentive to develop new antibiotics.

Gottlieb said implementing a licensing model would create “a natural market” for such drugs by offering “a predictable return on investment and revenue stream through more foreseeable licensing fees.” He also said it would put the acute care institutions “fully in charge of stewardship” of these drugs.

“Once they purchase the ability to access a drug, they would be stewards of its use up to a certain number of annual doses, which could be tied to the number of beds an institution has or its likelihood of encountering certain organisms,” he said.

Gottlieb’s remarks came as FDA issued draft guidance to help manufacturers navigate the limited population pathway for antibacterial and antifungal drugs (LPAD).

Created under the 21st Century Cures Act, the LPAD pathway allows manufacturers to seek approval of products to treat serious or life-threatening infections for targeted populations based on smaller data sets than normally required.

The draft guidance describes criteria, processes and considerations for candidate approval and may allow for "smaller, shorter or fewer" trials. FDA will evaluate the severity, rarity and prevalence of infection as well as availability of alternative therapies in determining which products qualify for LPAD. The guidance will also help sponsors develop labels describing the candidate's benefit and risks in the limited population.

Last month, FDA’s Antimicrobial Drugs Advisory Committee recommended approval of plazomicin from Achaogen Inc. (NASDAQ:AKAO) to treat complicated urinary tract infections (cUTIs); however, the committee rebuffed the product for a second indication, to treat bloodstream infections, for which it is under review through the LPAD pathway. Plazomicin's PDUFA date for both indications is June 25 (see BioCentury Extra, May 2).

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

Purchase this article for limited one-time distribution and website posting

$750 USD