The hospital-treated gram-negative infection (GNI) market is dominated by highly effective, generically available antibiotics. However, the rising prevalence of multidrug-resistant (MDR) pathogens makes GNIs increasingly challenging to treat. Agents once considered the most potent antibiotics (e.g., carbapenems) are losing efficacy, thereby driving use of severely toxic last-line agents. Merck’s Zerbaxa (ceftolozane/tazobactam) and Pfizer’s Zavicefta (ceftazidime/avibactam), both of which are active against MDR gram-negative pathogens, are newly approved in Europe. Nonetheless, the opportunity for value-based pricing has rekindled interest from pharmaceutical firms, and the late-stage pipeline for new agents that can address the threat of MDR bacteria has swelled accordingly. As EU5 payers, hospitals, and prescribers balance clinical need with budget constraints, the value proposition for new drugs must be tailored to secure optimal market share in what is fast becoming a crowded segment of the GNI market.

  • QUESTIONS ANSWERED
    • What attributes must an emerging GNI therapy offer to secure a favorable HTA at national and regional levels in each EU5 country?
    • What do payers consider the primary drivers and considerations for coverage of key emerging GNI antibiotics?
    • What are the most prescribed and most preferred antibiotics for GNI treatment, including therapies for drug-resistance pathogens? How do payer policies influence physician prescribing practices?
    • What impact will newly approved antibiotics like Zerbaxa and Zavicefta have on the GNI market? How will payers receive value-based pricing of new drugs that address the high unmet need for treatment of MDR infections?
  • PRODUCT DESCRIPTION: Access & Reimbursement: Provides in-depth insight regarding the impact of payer policy on physician prescribing behavior so that you can build your market access strategy and optimize your brand positioning.

Table of contents

  • Hospital-Treated Gram-Negative Infections - Access & Reimbursement - Detailed, Expanded Analysis (EU)
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Optimizing Market Access Opportunity for GNI Therapies in the EU5
      • Successes and Stumbles
        • Successes and Stumbles Among GNI Therapies in the EU5
        • Overview of Successes and Stumbles Among Key GNI Therapies in the EU5, by Country
      • Key Stakeholders in the Road to Market Access
        • France
        • Germany
        • Italy
        • Spain
        • United Kingdom
      • Key Market Access Roadblocks
        • Reimbursement Dynamics
          • France
            • France: Crucial HTA Criteria
            • France: P&R Drivers and Key HTA Considerations
            • France: HTA Review Details
            • France: Reimbursement Regulations and Prescribing Parameters
            • France: Key Takeaways
          • Germany
            • Germany: Crucial HTA Criteria
            • Germany: P&R Drivers and Key HTA Considerations
            • Germany: HTA Review Details
            • Germany: Reimbursement Regulations and Prescribing Parameters
            • Germany: Key Takeaways
          • Italy
            • Italy: Crucial HTA Criteria
            • Italy: P&R Drivers and Key HTA Considerations
            • Italy: HTA Review Details
            • Italy: Reimbursement Regulations and Prescribing Parameters
            • Italy: Key Takeaways
          • Spain
            • Spain: Crucial HTA Criteria
            • Spain: P&R Drivers and Key HTA Considerations
            • Spain: P&R Drivers and Key HTA Considerations
            • Spain: HTA Review Details
            • Spain: Reimbursement Regulations and Prescribing Parameters
            • Spain: Key Takeaways
          • United Kingdom
            • United Kingdom: Crucial HTA Criteria
            • United Kingdom: P&R Drivers and Key HTA Considerations
            • United Kingdom: HTA Review Details
            • United Kingdom: Reimbursement Regulations and Prescribing Parameters
            • United Kingdom: Key Takeaways
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences for Multidrug-Resistant Pathogens
            • Most Prescribed First- and Second-Line Therapy for NP due to ESBL-Producing Enterobacteriaceae
            • Most Preferred First- and Second-Line Therapy for NP due to ESBL-Producing Enterobacteriaceae
            • Prescriber Preferences for Carbapenem-Resistant Enterobacteriaceae, Carbapenem-Resistant Acinetobacter, and MDR Pseudomonas
            • Most Prescribed First- and Second-Line Therapy for NP due to Carbapenem-Resistant Enterobacteriaceae
            • Most Preferred First- and Second-Line Therapy for NP due to Carbapenem-Resistant Enterobacteriaceae
            • Reasons Why Ceftolozane/Tazobactam or Ceftazidime/Avibactam Is the Most-Preferred but Not the Most-Prescribed Therapy
          • Impact of Payer Policy on Prescribing for Multi-Drug Resistant Pathogens
            • Overall Impact of EU5 Payer Policy on Prescribing for Multi-Drug Resistant Pathogens
            • Formulary Status of Key Current Therapies
            • Formulary Restrictions of Key Branded Antibiotics
            • Top Three Factors Influencing Antibiotic Selection for ESBL-Producing Enterobacteriaceae
            • Impact of Country-Specific Payer Policy on Prescribing for Multidrug-Resistant Pathogens
            • Estimated Time from EMA Approval to Availability for Prescribing
            • The Prevalence of Antimicrobial Stewardship Programs
            • Impact of Regional Formulary on Patient Access to Novel Antibiotics
          • Top Prescribing Drivers in Multidrug-Resistant Pathogens
            • Top Three Factors Influencing Antibiotic Selection for Carbapenem-Resistant Enterobacteriaceae
            • Top Three Drivers for Prescribing Ceftolozane/Tazobactam
            • Top Three Drivers for Prescribing Ceftazidime/Avibactam
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapies for Multidrug-Resistant Pathogens
            • Anticipated Prescribing for Meropenem/Vaborbactam
            • Reasons for Not Prescribing Meropenem/Vaborbactam
            • Top Three Prescribing Scenarios for Meropenem/Vaborbactam
          • Market Access Challenges for Emerging Therapies for Multidrug-Resistant Pathogens
            • Expected Patient Share of Emerging Therapies, Formulary-Included or -Excluded
            • Reasons for Not Prescribing Plazomicin
          • Payer Opinion of Emerging Therapies for Multidrug-Resistant Pathogens
          • Appendix
            • Country-Specific Reimbursement Background Details
              • France: Key Background Details of the Healthcare System
              • France: P&R Process
              • France: P&R Process
              • Germany: Key Background Details of the Healthcare System
              • Germany: P&R Process
              • Germany: P&R Process
              • Italy: Key Background Details of the Healthcare System
              • Italy: P&R Process
              • Italy: P&R Process
              • Italy: Additional Funding Mechanisms for Off-Label Use
              • Spain: Key Background Details of the Healthcare System
              • Spain: P&R Process
              • Spain: P&R Process
              • Spain: HTA Bodies
              • Spain: Autonomic Evaluation Committees
              • Spain: Autonomic Evaluation Committees
              • Spain: Pharmacy & Therapeutics Committee
              • Spain: Pharmacy & Therapeutics Committee
              • United Kingdom: Key Background Details of the Healthcare System
              • United Kingdom: P&R Process
              • United Kingdom: P&R Process
            • Key Current and Emerging Therapies for Gram-Negative Infections
              • Profiles of Key Drugs for Gram-Negative Infections in the EU5
              • Pfizer's Zavicefta (Ceftazidime/Avibactam)
              • Merck & Co.'s Zerbaxa (Ceftolozane/Tazobactam)
              • Achaogen's Plazomicin
              • The Medicines Company's Carbavance (Meropenem/Vaborbactam)
              • Merck & Co.'s Imipenem/Cilastatin/Relebactam
              • Shionogi's Cefiderocol
              • Tetraphase's Eravacycline
            • Physician Survey Data
              • Most Prescribed First- and Second-Line Therapy for BSIs due to ESBL-Producing Enterobacteriaceae
              • Most Preferred First- and Second-Line Therapy for BSIs due to ESBL-Producing Enterobacteriaceae
              • Most Prescribed First- and Second-Line Therapy for cUTIs due to ESBL-Producing Enterobacteriaceae
              • Most Preferred First- and Second-Line Therapy for cUTIs due to ESBL-Producing Enterobacteriaceae
              • Most Prescribed First- and Second-Line Therapy for cIAIs due to ESBL-Producing Enterobacteriaceae
              • Most Preferred First- and Second-Line Therapy for cIAIs due to ESBL-Producing Enterobacteriaceae
              • Most Prescribed First- and Second-Line Therapy for BSIs due to Carbapenem-Resistant Enterobacteriaceae
              • Most Preferred First- and Second-Line Therapy for BSIs due to Carbapenem-Resistant Enterobacteriaceae
              • Most Prescribed First- and Second-Line Therapy for cUTIs due to Carbapenem-Resistant Enterobacteriaceae
              • Most Preferred First- and Second-Line Therapy for cUTIs due to Carbapenem-Resistant Enterobacteriaceae
              • Most Prescribed First- and Second-Line Therapy for cIAIs due to Carbapenem-Resistant Enterobacteriaceae
              • Most Preferred First- and Second-Line Therapy for cIAIs due to Carbapenem-Resistant Enterobacteriaceae
              • Most Prescribed First- and Second-Line Therapy for BSIs due to MDR Pseudomonas
              • Most Preferred First- and Second-Line Therapy for BSIs due to MDR Pseudomonas
              • Most Prescribed First- and Second-Line Therapy for NP due to MDR Pseudomonas
              • Most Preferred First- and Second-Line Therapy for NP due to MDR Pseudomonas
              • Most Prescribed First- and Second-Line Therapy for cUTIs due to MDR Pseudomonas
              • Most Preferred First- and Second-Line Therapy for cUTIs due to MDR Pseudomonas
              • Most Prescribed First- and Second-Line Therapy for cIAIs due to MDR Pseudomonas
              • Most Preferred First- and Second-Line Therapy for cIAIs due to MDR Pseudomonas
              • Most Prescribed First- and Second-Line Therapy for BSIs due to Carbapenem-Resistant Acinetobacter
              • Most Preferred First- and Second-Line Therapy for BSIs due to Carbapenem-Resistant Acinetobacter
              • Most Prescribed First- and Second-Line Therapy for NP due to Carbapenem-Resistant Acinetobacter
              • Most Preferred First- and Second-Line Therapy for NP due to Carbapenem-Resistant Acinetobacter
              • Most Prescribed First- and Second-Line Therapy for cUTIs due to Carbapenem-Resistant Acinetobacter
              • Most Preferred First- and Second-Line Therapy for cUTIs due to Carbapenem-Resistant Acinetobacter
              • Most Prescribed First- and Second-Line Therapy for cIAIs due to Carbapenem-Resistant Acinetobacter
              • Most Preferred First- and Second-Line Therapy for cIAIs due to Carbapenem-Resistant Acinetobacter
              • Top Three Factors Influencing Antibiotic Selection for MDR Pseudomonas
              • Top Three Factors Influencing Antibiotic Selection for Carbapenem-Resistant Acinetobacter
              • Top Three Prescribing Drivers for Tygacil
              • Top Three Prescribing Drivers for Polymyxins
              • Top Three Prescribing Drivers for Carbapenems
              • Measures Implemented by Antimicrobial Stewardship Programs
              • Strategies Used in the Absence of Antimicrobial Stewardship Programs, by Country
              • Strategies Used in the Absence of Antimicrobial Stewardship Programs
              • Anticipated Prescribing for Ceftazidime/Avibactam
              • Reasons for Not Prescribing Ceftazidime/Avibactam, by Country
              • Reasons for Not Prescribing Ceftazidime/Avibactam
              • Anticipated Prescribing for Ceftolozane/Tazobactam
              • Reasons for Not Prescribing Ceftolozane/Tazobactam, by Country
              • Reasons for Not Prescribing Ceftolozane/Tazobactam
              • Anticipated Prescribing for Plazomicin
              • Reasons for Not Prescribing Plazomicin, by Country
              • Reasons for Not Prescribing Meropenem/Vaborbactam, by Country
              • Anticipated Prescribing for Imipenem/Cilastatin/Relebactam
              • Reasons for Not Prescribing Imipenem/Cilastatin/Relebactam, by Country
              • Reasons for Not Prescribing Imipenem/Cilastatin/Relebactam
              • Anticipated Prescribing for Cefiderocol
              • Reasons for Not Prescribing Cefiderocol, by Country
              • Reasons for Not Prescribing Cefiderocol
              • Anticipated Prescribing for Eravacycline
              • Reasons for Not Prescribing Eravacycline, by Country
              • Reasons for Not Prescribing Eravacycline
              • Top Three Prescribing Scenarios for Ceftazidime/Avibactam
              • Top Three Prescribing Scenarios for Ceftolozane/Tazobactam
              • Top Three Prescribing Scenarios for Plazomicin
              • Top Three Prescribing Scenarios for Imipenem/Cilastatin/Relebactam
              • Top Three Prescribing Scenarios for Cefiderocol
              • Top Three Prescribing Scenarios for Eravacycline
              • Expected Patient Share of Key Antibiotics and Emerging Therapies, Whether Included or Excluded from the Formulary
              • Unmet Needs in the Treatment of Gram-Negative Pathogens

        Author(s): Jiamin Zhuo, Ph.D.; Yulia Privolnev, M.A.

        Jiamin Zhuo, Ph.D., is a business insights analyst on the Infectious, Niche, and Rare Diseases team at DRG, part of Clarivate. He provides expert insight into the commercial aspects of drug development and market dynamics in bacterial infections, including gram-negative infections and Methicillin-resistant Staphylococcus aureus. He earned his Ph.D. at the Mayo Graduate School of the Mayo Clinic in Minnesota and his B.Sc. in physiology from Peking University in China. Prior to joining DRG, Dr. Zhuo was a postdoctoral fellow at Boston University and MIT, where he gained extensive experience in quantitative research methods.

        Yulia Privolnev, M.A., is a manager on the Global Market Access Insights team at DRG, part of Clarivate. She focuses on European market access. She holds a bachelor’s degree from the University of Toronto and a master’s degree from the London School of Economics.