The critical need for new medicines to combat infectious diseases that fail to respond to current medical treatment is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies and reimbursement strategies to support innovation in this area. A main problem is that current payment and coverage policies for new drugs encourage widespread use of the product to generate a sufficient return on investment to companies sponsoring research on new treatments. But to remain effective against lethal pathogens, new antimicrobials need to be used very sparingly, cutting revenues in the process.
These financial obstacles have curbed industry investment in developing new antimicrobials. The Pew Charitable Trusts reports that as of June 2018 only 42 new antibiotics were in clinical development to treat serious bacterial infections. Just one in 5, moreover, are likely to succeed, and only a handful have potential to address serious resistance problems, such as gram-negative bacteria, which cause particularly hard-to-treat infections.
To address this crisis, FDA issued a plan that includes policies and programs to encourage development of new drugs, diagnostic tests and vaccines; to promote responsible stewardship of antimicrobials in animals and humans; to improve surveillance of antimicrobial use and resistance; and to advance research for developing new tools, standards and policies in this area.
Key to spurring innovation in this field is to devise new reimbursement strategies to support the development of products that would be prescribed and used on a highly limited basis. The FDA is working on pilot programs or demonstrations of reimbursement strategies with the Centers for Medicare and Medicaid Services (CMS) and other health and research agencies, such as the Gates Foundation, the Center for Medicare and Medicaid Innovation, and the Biomedical Advanced Research and Development Authority (BARDA), along with insurers and payers. These might include add-on payments for new technology, including antibacterial drugs that meet public health needs.
Addressing these issues will be key in the continued manufacturing of much needed critical improvements in antimicrobial coverage, while reimbursing manufacturers at a fair rate, and making these drugs available to the general population.