EU Physician and Payer Forum

June 2013

Drug-Resistant Gram-Negative Infections: How Will the Threat of Multidrug-Resistant Gram-Negative Pathogens Impact Market Access for Current and Emerging Antibiotics in the EU5?

Report Authors
Maria Ascano, Ph.D.

Introduction:

Gram-negative infections represent a high-value segment of the antibiotics market given their severity and associated requirement for hospitalization. Because these infections tend to be acquired in healthcare facilities (i.e., hospitals or long-term-care facilities), the inciting pathogens have a high incidence of drug resistance to even the most powerful antibiotics (e.g., third-generation cephalosporins, fluoroquinolones, aminoglycosides, and carbapenems).  Within the next few years, however, the late-stage antibiotic pipeline will offer promising therapies, such as Cubist’s CXA-201 and Forest/AstraZeneca’s CAZ-AVI, for treatment of increasingly prevalent drug-resistant pathogens. As the EU5 continues to tighten its healthcare belt, physicians and payers are challenged with incorporating these essential but high-priced new agents into medical practice.Questions Answered in This Report:  *   Analyze the impact of emerging drug resistance among gram-negative pathogens on physician prescribing of current therapies: What are the most prescribed and preferred antibiotics for the treatment of gram-negative infections? What are the key drivers and constrainers that influence physician prescribing practices? What are the preferred antibiotics for treatment of drug-resistant gram-negative pathogens such as: extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae, Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae, and MDR-Acinetobacter?

  *   Assess the importance of favorable formulary placement and antimicrobial stewardship programs in prescribing and reimbursement practices: What restrictions do payers place on current antibacterial brands in each of the EU5? What does an analysis of prescribing patterns reveal about the impact of payer policies on reimbursement and uptake of these brands? How will these policies evolve as drug resistance becomes increasingly prevalent? What policies/penalties have been implemented in the hospital to encourage judicious antibiotic use, and how successful have these policies/penalties been?

  *   Determine the market access challenges facing drug developers seeking share in the gram-negative infection market: How do hospital funding mechanisms impact access to antibiotics? What budgetary constraints do prescribers and payers face, and how might these constraints evolve in the next few years? How have country-specific changes in hospital reimbursement policies in the cost-constrained climate affected clinical management of gram-negative infections? What attributes must an emerging therapy offer to secure a favorable HTA review, optimal pricing and reimbursement, and maximal formulary inclusion?

Scope:

Decision Resources’ European Physician & Payer Forum report “Drug-Resistant Gram-Negative Infections: How Will the Threat of Multidrug-Resistant Gram-Negative Pathogens Impact Market Access for Current and Emerging Antibiotics in the EU5?” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of antibacterial agents targeting gram-negative pathogens. It draws insights from 250 surveyed infectious disease specialists or internal medicine physicians in the EU5 and from interviews with 15 European payers, to explore how emergent pathogen drug resistance will affect sales of premium-priced branded agents for hospital-based treatment of gram-negative infections and to examine levers and barriers that will promote or restrict market access for key emerging therapies. Interviewed payers, all of whom have influence at a national or regional level, include the following:

- France: A past member of the Transparency Commission (CT) who advises the High Authority for Health (HAS) on market access, pricing, and reimbursement. Hospital Pharmacy Directors.

- Germany: Key opinion leader with expertise in quality assurance, quality management, drug budget guidance, managed care, and disease management. Provides medical guidance to the Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds (GBA) as a trained physician. A Pharmacy Director of a large university hospital.

- Italy: A regional hospital formulary (PTOR) member with responsibility for assessing new drugs for formulary inclusion, and a hospital formulary (PTO) co-chair with responsibility in the drug evaluation and tendering process. Regional payers and Chief Pharmacists.

- Spain: Consultant for the Ministry of Health, and hospital pharmacy committee member.  Hospital Pharmacy Director. Regional Formulary Committee member.

- United Kingdom: Hospital Program Director who sits on the local NHS commissioning board and on National Institute for Health and Care Excellence (NICE) technology appraisal committees. Head Pharmacist and formulary committee member. PCT Head of Medicines Management with responsibility for commissioning for drugs in primary and secondary care.


Search Reports

Mentioned in this report:

  • - AstraZeneca
  • - Basilea
  • - Cubist
  • - Forest
  • - Janssen
  • - Merck
  • - Pfizer
  • - Sanofi
Decision Resources Group brands include: