U.S. Physician and Payer Forum

September 2013

Novel Antibiotics Targeting Gram-Negative Infections: U.S. Payer and Prescriber Perspectives on Opportunities for Growth and Barriers to Success

Report Authors
Hannah E. Cummings, Ph.D.

Introduction:

Antibiotics from several different drug classes (e.g., carbapenems, quinolones, cephalosporins, beta-lactam/beta-lactamase inhibitors) are currently available to treat hospitalized patients with gram-negative infections (GNIs). However, the increasing prevalence and severity of infections caused by multi-drug-resistant (MDR) gram-negative pathogens (GNPs) and the meager pipeline of novel emerging antibiotic therapies currently in development to treat GNIs have resulted in limited treatment options for an increasing number of patients. Despite these challenges, the late-stage clinical pipeline for antibiotics against MDR GNPs includes two promising cephalosporin/beta-lactamase inhibitor combinations, Cubist’s CXA-201 (ceftolozane/tazobactam) and Forest/AstraZeneca’s CAZ-AVI (ceftazidime/avibactam), as well as Tetraphase’s IV and oral tetracycline, eravacycline, and a next generation aminoglycoside, Achaogen’s plazomicin. In addition, efforts are currently underway to promote and incentivize the development of novel antibiotics that can effectively combat MDR GNPs, including the Infectious Disease Society of America’s proposed Limited Population Antibacterial Drug (LPAD) approval mechanism and the Generating Antibiotics Incentives Now (GAIN) Act passed by Congress as part of the reauthorization of the Prescription Drug User Fee Act (PDUFA).

For this U.S. Physician and Payer Forum we surveyed 70 infectious disease (ID) specialists, 37 internal medicine specialists, 36 critical care/intensive care unit (ICU) specialists, and 30 hospital pharmacy directors (PDs) to gain a better understanding of how formulary and reimbursement constraints influence physicians’ treatment decisions for patients hospitalized with GNIs and to understand the factors that influence hospital formulary coverage. We also examine the perceptions of both physicians and payers on several emerging therapies and determine how pricing and formulary positioning will impact market access and uptake. Additionally, we probe physician and payer awareness and receptivity to novel therapies approved via the LPAD approval mechanism across several types of MDR GNPs, indications, and efficacy outcome measures.

Questions Answered in This Report:

  *   Understand current prescribing practices and future treatments trends for treatment of GNIs. How are different physician types currently managing specific infections (e.g., nosocomial pneumonia, intra-abdominal infections, urinary tract infections) due to common drug-resistant GN pathogens? How do they expect their prescribing to change in the future, and what factors will spur these changes? What drug attributes drive or limit physician prescribing of key antibiotic brands by indication? What factors influence off-label use of antibiotics?

  *   Identify key factors influencing formulary decision making and access to new drugs within the hospital setting. 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? What individuals have the greatest influence on antibiotic formulary decision-making? What is the impact of payment bundling on prescribing? What restrictions, if any, are payers likely to place on novel premium-priced antibiotics with activity against multi-drug resistant GN pathogens?

  *   Explore physicians’ and payers’ perceptions of unmet needs and emerging therapies (ETs). What are the gram-negative pathogens (GNPs) of most concern among physicians? What drugs do physicians anticipate increasing 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 (e.g., use by infection type for empiric versus confirmed infections, monotherapy versus combination use, use by line of therapy, use by pathogen)? How do P&T committee members expect to include emerging therapies CXA-201, CAZ-AVI, eravacycline, and plazomicin 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?

Scope:

This U.S. Physician & Payer Forum report contains insights from a survey of 147 physicians and 30 hospital pharmacy directors regarding the effect(s) formulary and reimbursement constraints have on physicians’ treatment decisions and the factors that influence hospital formulary coverage. We also examine the perceptions of both physicians and payers on several emerging therapies and potential LPAD-approved agents and determine how pricing and formulary positioning will impact market access and uptake.

- Markets covered: United States.

- Primary research: online survey of 70 ID specialists, 37 internal medicine specialists, 36 critical care/ICU specialists, and 30 hospital PDs.


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