How Will the Rise in Antibiotic Resistance Shape the U.S. Prescribing and Reimbursement Environment for Novel Antibiotics?
Although antibiotics from several drug classes are available to treat patients with gram-negative infections (GNIs), bacterial resistance to these therapies is rapidly increasing. Multidrug resistance, in particular, represents a tremendous unmet need in the hospital antibiotic market, owing to the severely limited treatment options available and the increasing prevalence of GNIs due to highly drug-resistant pathogens. As a result, commercial opportunities in the hospital market exist for novel branded agents; however, these products must compete against, and demonstrate significant benefits over, entrenched generic therapies in a highly cost-sensitive healthcare climate. This report explores stakeholder perspectives that affect uptake and sales of key branded antibiotics for hospital-treated infections (HTIs) due to drug-resistant gram-negative pathogens (GNPs) as well as dynamics that will promote or restrict market access and uptake of emerging therapies to treat these infections. We evaluate current prescribing patterns, how emerging therapies fit into the treatment paradigm for key GNIs, formulary status of current and emerging therapies, and areas of unmet need. In addition, we examine the potential for new antibiotic development through the Limited Population Antibacterial Drug (LPAD) pathway aimed at streamlining development of antibacterials that address high medical need.