Gram-negative infections (GNIs) represent a high-value segment of the antibiotic market and are often treated in the hospital setting. Infections due to Gram-negative pathogens (GNPs) are frequently severe and difficult to treat - particularly those due to multi-drug-resistant (MDR) GNPs, the prevalence of which continues to increase. Despite the availability of broad-spectrum antibiotics from multiple drug classes (e.g., carbapenems, quinolones, cephalosporins, beta-lactam/beta-lactamase inhibitors) to treat hospitalized patients with GNIs, the rising rates of antibiotic resistance and scarce new drug launches have resulted in highly-limited treatment options for an increasing number of GNI patients. However, several late-stage products targeting drug-resistant GNPs are expected to launch near-term, notably expanding the physicians’ armamentarium for these infections. These include two promising cephalosporin/beta-lactamase inhibitor combinations, Cubist’s ceftolozane/tazobactam (formerly CXA-201) and Actavis/AstraZeneca’s ceftazidime/avibactam (CAZ-AVI), as well as Tetraphase’s novel tetracycline derivative, eravacycline. Multi-pronged efforts are currently underway to promote and incentivize the development of novel antibiotics, including those targeting MDR GNPs. The Infectious Disease Society of America’s proposed Limited Population Antibacterial Drug (LPAD) approval mechanism is one such initiative that could expedite clinical development timelines and decrease associated costs for novel antibiotics targeting MDR pathogens.

Questions Answered in This Report:

  • Understand current treatment practices and evolving trends in hospital treatment of GNIs. How are ID specialists and internist currently managing specific infections (e.g., nosocomial pneumonia, complicated intra-abdominal infections and urinary tract infections) due to common drug-resistant GN pathogens?

  • Identify key factors influencing hospital formulary decision making and access to new drugs within the hospital market. Which marketed antibiotic brands used for GNIs have the most favorable positioning within the hospital formulary and what are the key drivers, beyond efficacy, for hospital formulary inclusion of antibiotics? Who are the key stakeholders in hospital formulary decision making? What is the impact of payment bundling on prescribing? What is the anticipated inclusion of emerging therapies on hospital formularies and what restrictions are payers likely to impose on novel premium-priced antibiotics with activity against multi-drug resistant GN pathogens?

  • Explore physicians’ and payers’ perceptions of unmet needs and emerging therapies. What are the gram-negative pathogens (GNPs) of most concern among physicians and payers? What drugs do physicians anticipate increasing or decreasing their usage of over the next years and why? What GNPs represent the highest level of need for new antibiotics? How familiar are physicians with emerging therapies? What drug attributes of emerging antibiotics will be most convincing and influential in the decision-making of hospital pharmacy and therapeutic (P&T) committee members? What current therapies do physicians see as the greatest competitors to key emerging antibiotics? Based on available clinical data, how do physicians anticipate emerging antibiotics will be incorporated into their treatment of specific infections? How do P&T committee members expect to include emerging therapies on hospital formularies based on various pricing scenarios?

  • Examine physicians and payers perceptions of the Limited Population Antibacterial Drug Development (LPAD) approval pathway. How familiar are physicians and payers with the LPAD approval pathway? What are the pricing implications on uptake and access to LPAD-approved agents by physicians? What improvements over comparator drugs are physicians and payers most interested in with regard to LPAD-approved agents and how will these factors impact formulary inclusion of these agents?

Scope:

Through a survey of 71 infectious disease (ID) specialists, 70 internal medicine specialists, and 30 hospital pharmacy directors (PDs), this U.S. Physician & Payer Forum explores how clinical and cost-related attributes drive or constrain physicians’ antibiotic prescribing in treatment of patients with GNIs in the hospital setting. We investigate the hospital formulary status of currently available therapies, as well as the receptivity of both physicians and payers towards late-stage emerging antibiotics for GNIs and evaluate their likelihood of being prescribed and included in formulary. Additionally, we probe physician and payer awareness of, and receptivity to, novel, premium-priced therapies if approved via the proposed LPAD approval mechanism across key types of infections due to MDR GNPs and efficacy measures.

Markets covered: United States.

Primary research: Online survey of 71 ID specialists, 70 internists, and 30 hospital PDs.

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