The US Food and Drug Administration (FDA) has published a statement from its commissioner Scott Gottlieb proposing a new reimbursement model for antibiotics and antimicrobials, which it believes will help achieve associated public health goals and overcome investment challenges.
The FDA’s idea is that instead of hospitals being reimbursed for antimicrobials on a per-use, which it claims is hindering research and development in the field, they will be reimbursed for licences for certain antimicrobials drugs that target multi-drug resistant infections.
In the statement Gottlieb said: “Under such an approach, instead of paying for drugs that meet a narrow set of critical, public health criteria on a per use basis — for each prescription that’s written, as is done now — one might move instead to a licensing model.
“This is similar to the way that software often gets reimbursed, where institutions pay a licensing fee for a fixed number of installations. We have been speaking with our counterparts at the Centre for Medicare and Mediaid Services (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.”
The FDA believes this model will help to achieve public health goals because it would ‘create a natural market for drugs that meet certain public health criteria, by providing a predictable return on investment and revenue stream through more foreseeable licensing fees’ and ‘it would put the institutions fully in charge of stewardship of these important medicines. Once they purchase the ability to access a drug, they would be stewards of its use up to a certain number of annual doses’.
It also said the proposal would address investment challenges faced by producers of antimicrobials that target multi-drug resistant organisms because it may offer a ‘pull incentive’ that can create a predictable market for antimicrobials with a narrow set of public health applications. In addition, it could disconnect return on investment on these drugs from the volume of the drug that is used.
The FDA’s suggestion addresses the need for the pharmaceutical industry to deal with antimicrobial resistance by ensuring better stewardship and appropriate use of these drugs. This has created more barriers to antimicrobial drug development, which is a major problem since this type of drug remains crucial for treating certain conditions.
The institution aims to announce more information regarding this proposal and its feasibility soon.