Promoting Antibacterial Drug Development: Select Policies and Challenges.
BACKGROUND
The development pipeline for antibacterial drugs has not met the demand of hospitals and healthcare providers struggling to cope with increasing problems of antibacterial resistance. Although the challenges associated with antibacterial drug development have been known for some time, previous efforts to address them have not been sufficient. There remains an urgent need for targeted incentives to foster antibacterial drug development while encouraging prudent use.


OBJECTIVE
We examine the effects of two types of incentives, a 5-year delay in competition from generics and a lump-sum US$50 million prize payment upon successful US Food and Drug Administration approval, on antibacterial drug company returns.


METHODS
We use the decision-tree framework developed in a study for the US Department of Health and Human Services, which models the drug company's decision process as a revenue maximizer under uncertainty.


RESULTS
Our results show that, to maximize societal benefit, such incentives need to take into consideration the indication(s) the new antibacterial drug is designed to treat as well as the drug development stage.


CONCLUSIONS
Optimal policies should maximize the difference between societal benefit, primarily measured as the reduction in public health burden from the development of a new antibacterial drug that treats an infectious disease while ensuring prudent use, and social cost. Here, we show that the two types of policies examined under-incentivize early-stage developers (i.e., do not achieve the desired outcome) and over-incentivize late-stage developers (i.e., achieve the desired outcome but at a cost that is higher than needed) ceteris paribus.
Eastern Research Group, Inc., 110 Hartwell Avenue, Lexington, MA, 02421, USA. aylin.sertkaya@erg.com.
Aylin
A
Sertkaya
US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Science and Data Policy, Washington, DC, USA.
Amber
A
Jessup
US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Science and Data Policy, Washington, DC, USA.
Hui-Hsing
HH
Wong
D000900:Anti-Bacterial Agents / Q000191:economics* / Q000627:therapeutic use; D003663:Decision Trees; D055808:Drug Discovery / Q000191:economics / Q000458:organization & administration*; D004345:Drug Industry / Q000191:economics / Q000458:organization & administration; D006291:Health Policy; D006801:Humans; D009042:Motivation; D014481:United States; D014483:United States Dept. of Health and Human Services / Q000458:organization & administration
D000900:Anti-Bacterial Agents