Scott Gottlieb of the FDA (Food and Drug Administration) has recently made a pitch to change the current reimbursement model for antimicrobial drugs. This unique proposal by Gottlieb suggests a move to a licensing model, in a similar way to software packages are acquired.
“Developing new drugs is a costly endeavor. But the current reimbursement model, where drugs are reimbursed based on each episode of their use, presents incentives that run contrary to effective stewardship over new antibiotics that might be highly effective against very rare and dangerous pathogens,”
Scott Gottlieb, FDA (Food and Drug Administration)
Strains of bacteria resistant to most antibiotics are on the rise according to Gottlieb, coupled with an overall decline in antibiotic research. Providers have imposed "understandable" restrictions according to Gottlieb which means drugmakers may not invest the sums necessary for research into pathogens developing resistance.
It's with such a concern that Gottlieb accounced this proposal. The new licensing model would allow acute institutions to prescribe antibiotics the ability to a “fixed licensing fee for access to the drug, which would offer them the right to use a certain number of annual doses.”
"Natural market for drugs that meet certain public health criteria, by providing a predictable return on investment and revenue stream; and would put the care institutions in charge of the stewardship of the medications. 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. This reimbursement model would address some of the investment challenges associated with the market for potent antimicrobials that target multidrug-resistant organisms. These are drugs that we want to have available to us, but that we should keep in reserve and hope that we seldom have to use them. It is my belief that a licensing model might offer an effective ‘pull incentive’ that attempts to create a predictable market for antimicrobial drugs that would meet a narrow set of critical, public health criteria.”
2 million people will become infected with bacteria resistant to antibiotics according tot he U.S Centers for Disease Control and Prevention, of those, 23,000 die annually. The FDA though has issued a draft guidance to assist the development of drugs in the future. The pathway was established in the 21st Century Cures Act.