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.

Questions Answered in This Report:

  • There are multiple classes of antibiotics available for the treatment of GNIs in the inpatient setting. What are the most prescribed and the preferred antibiotics for the treatment of key GNIs (e.g., nosocomial pneumonia, intra-abdominal infections, urinary tract infections, bloodstream infections), including those due to drug-resistant GNPs?

  • The prevalence of drug resistant GNIs continues to rise across the U.S. What are the key drivers and constraints for prescribing antibiotics targeting GNPs in the inpatient setting, and how is prescribing evolving as a result of emergence of drug resistance?

  • Hospital formulary is critical for driving uptake of new antibiotics. Which marketed antibiotic brands for GNIs have the most favorable positioning within hospital formularies? What are the key drivers, beyond efficacy, for formulary inclusion of antibiotics by P&T committees?

Scope:

This U.S. Physician & Payer Forum report contains insights from a survey of 72 hospital-based infectious disease and 70 internal medicine specialists as well as 30 hospital pharmacy directors, to capture their views on anticipated prescribing and reimbursement barriers in relation to current and emerging agents for GNIs.

Markets covered: United States.

Primary research: Survey of 72 infectious disease and 70 internal medicine specialists as well as 30 pharmacy directors.

Author(s): Brenda Perez-Cheeks, Ph.D.
Mladen Tomich, Ph.D.