Category: Fellows Posters
Purpose: From 1983 to 2012, Food and Drug Administration (FDA) approvals of new antibiotics declined by over 90%. Increasing research and development costs and antibiotics’ short courses of therapy made new antibiotics less promising investments than chronic medications. In response, the Generating Antibiotic Incentives Now (GAIN) Act was passed in 2012 allowing products designated by the FDA as a Qualified Infectious Disease Product (QIDP) to receive fast track and priority review and extended exclusivity. Many new antibiotics are coming to market now but at high costs, requiring pharmacy decision-makers to implement efficient means of evaluating new antibiotics utilizing cost and efficacy.
Information on new antibiotics and their comparators was collected from package inserts, primary literature, and tertiary resources. Antibiotic names, manufacturers, on- and off-label indications, bacterial coverage, dosing regimens, wholesale acquisition cost (WAC), and efficacy data were identified.
A pharmacoeconomics calculator for new antibiotics was created using the data collected and the Slicer Tool in Microsoft Excel. A user can select an indication and then a bacterium to generate a table of applicable antibiotics. The table includes details on the antibiotics such as brand and generic names, FDA approval status for the indication, dosing regimen, infusion time, treatment duration range, average treatment duration (based on clinical trials), the calculated WAC price per day, the calculated WAC price per average treatment duration, and efficacy rating.
The pharmacoeconomics calculator for new antibiotics generates quick and customizable comparisons of antibiotics. While pairing this tool with local antibiograms, pharmacists can efficiently assess the medications’ key clinical, operational, and economic factors and identify the most cost-effective alternative. Furthermore, the addition of off-label indications through clinical trials and post-marketing data provides an additional level of information for more robust decision making. Potential uses range from patient specific decisions to administrative decisions. The tool could also be adapted to other medication classes.