There are two primary objectives to this study: 1) the creation of an economic framework for antibacterial drug development decisions and 2) the assessment of the impact of various incentives on their development. As secondary objectives, this study creates a similar framework for the development of vaccines and rapid point of care diagnostics and examines the social returns to developing new antibacterial products.
For the antibacterial drug development framework, the study examines the private and social returns (i.e., expected present value, EPV) to developing a new antibacterial drug for oral or intravenous (IV) administration for each of the following six indications:
- Acute bacterial otitis media (ABOM);
- Acute bacterial skin and skin structure infections (ABSSSI);
- Community acquired bacterial pneumonia (CABP);
- Complicated intra-abdominal infections (CIAI);
- Complicated urinary tract infections (CUTI); and
- Hospital acquired/ventilator associated bacterial pneumonia (HABP/VABP).
These six indications represent major areas of antibacterial use. In our EPV model, they are differentiable by forecasted developer revenues and costs, as well as by associated social costs and benefits that would accrue as a result of having a new drug available to treat them.
We also examine vaccines and rapid diagnostics. Vaccine markets vary with the specific disease under consideration. Thus, for the purposes of this study, we model a new vaccine designed to offer protection against acute bacterial otitis media (ABOM) infections commonly caused by nontypeable Haemophilus influenzae and by Moraxella catarrhalis.
Rapid diagnostics tools influence the rate and effectiveness of antibacterial use and thus affect their use in healthcare settings. In this study, we focus on a new rapid diagnostic tool designed to identify methicillin-resistant Staphylococcus aureus (MRSA) that can cause serious infections, such as skin or wound infections, pneumonia, or infections of the blood. While a newer type of MRSA is community-acquired, here we focus primarily on healthcare-associated MRSA infections, which occur in hospitals and nursing homes.
The study also considers a number of possible incentives within the private and social EPV framework developed. We examine the following four categories of incentives that encompass the majority of strategies that have been proposed in the policy literature:
- Intellectual property (IP) extensions;
- Tax incentives;
- Modifications to the clinical trial process and approval standards; and
- Grants, awards, and prizes for antibacterial drug research and development.
The above incentive categories are described in more detail in Section 2.