The large size of the HER2-positive breast cancer market in Europe, driven by high incidence and long treatment duration with expensive agents, is of great commercial interest to drug developers. Premium-priced and highly effective agents including Roche’s Herceptin, Perjeta, and Kadcyla, have revolutionized the treatment algorithms for this indication, but costly agents are set to join them. With escalating drug costs and increasingly tight healthcare budgets, convincing EU5 payers of cost-effectiveness is crucial for reimbursement, while maximizing uptake thereafter is a huge tactical challenge. This research analyzes the treatment landscape and market access environment for HER2-positive breast cancer across the EU5.

Questions Answered in This Report:

  • What role do key brands like Herceptin, Perjeta, and Kadcyla play in HER2-positive breast cancer treatment in the EU5? What are their prescribing patterns in different treatment settings?
  • What clinical and cost-related factors most strongly influence and restrict prescribing across lines of treatment? How do these differ across the EU5?
  • How do physicians and payers view late-stage emerging agents for HER2-positive breast cancer, such as margetuximab (MacroGenics) and neratinib (Puma Biotechnology)? How might prescribing change following market entry of such agents, and what will be the impact of payer policy upon this?
  • How will the entry of biosimilar trastuzumab affect prescribing of Herceptin? How will national, regional, and local payers promote and monitor biosimilar prescribing?

Scope:

  • Markets covered: France, Germany, Italy, Spain, United Kingdom.
  • Methodology: Survey of 252 medical oncologists and 10 country-specific interviews with European payers.
  • Indication coverage: HER2-positive breast cancer.
  • Key drugs covered: Herceptin IV and SC, Perjeta, Kadcyla, Tyverb, neratinib, margetuximab.
  • Key companies mentioned: Roche, Novartis, Puma Biotechnology, MacroGenics.

Table of contents

  • Breast Cancer - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Key Updates
      • December 2017
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Optimizing Market Access Opportunity for HER2-Positive Breast Cancer Therapies in the EU5
      • Successes and Stumbles
        • Successes and Stumbles Among HER2-Positive Breast Cancer Therapies in the EU5
        • Overview of Successes and Stumbles Among Therapies for HER2-Positive Breast Cancer in the EU5
      • 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 HER2-positive Breast Cancer
            • Patient Shares for the Neoadjuvant and Adjuvant Treatment of HER2-Positive Breast Cancer
            • Patient Shares for the First-Line Treatment of HER2-Positive Breast Cancer
            • Patient Shares for the Second-Line Treatment of HER2-Positive Breast Cancer
            • Advantages of Herceptin SC over Herceptin IV
            • Current Versus Future Use of Herceptin SC and Herceptin IV
          • Impact of Payer Policy on Prescribing for HER2-positive Breast Cancer
            • Overall Impact of EU5 Payer Policy on Prescribing for HER2-Positive Breast Cancer
            • Clinical and Non-Clinical Barriers to Prescribing of Key Drugs for First-Line Breast Cancer, Prescriber Perspective
            • Clinical and Non-Clinical Barriers to Prescribing of Key Drugs in Second-Line HER2-Positive Breast Cancer
            • Impact of Country-Specific Payer Policy on Prescribing for HER2-positive Breast Cancer
            • France: ALD Status
            • Germany: Richtgrößen or State-Specific Physician Budget Constraints
            • Italy: Prescribing of AIFA Register Drugs
            • Spain: Informe de Posicionamiento Terapéutico
            • United Kingdom: Extent of Local Authority/CCG Guidelines Additional to NICE Guidance
          • Top Prescribing Drivers in HER2-positive Breast Cancer
            • Factors Influencing Prescribing of First-Line Therapies for HER2-Positive Breast Cancer
            • Factors Influencing Prescribing of Second-Line Therapies for HER2-Positive Breast Cancer
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapies for HER2-positive Breast Cancer
            • Expected Patient Share for Ibrance Plus Herceptin, Perjeta, and Endocrine Therapy in First-Line HR-positive/HER2-Positive Breast Cancer
            • Expected Patient Share for Margetuximab in Second- and Subsequent-Lines HER2-Positive Breast Cancer
            • Expected Patient Share for Neratinib in HER2-Positive Breast Cancer
            • Statements Regarding Future Margetuximab Use in HER2-Positive Breast Cancer
            • Statements Regarding Future Neratinib Use in HER2-Positive Breast Cancer
            • Third-Line HER2-Positive Breast Cancer Therapies Most Likely to Be Replaced by Margetuximab and Neratinib
            • Expected Patient Share for Perjeta/Herceptin and Neratinib/Herceptin in Adjuvant HER2-Positive Breast Cancer
            • Impact of Biosimilar Trastuzumab on Herceptin and Herceptin/Perjeta Prescribing
            • Herceptin Prescribing After Trastuzumab Biosimilars' Launch
          • Market Access Challenges for Emerging HER2-positive Breast Cancer Therapies
            • Factors Influencing Prescribing of New Therapies for HER2-Positive Breast Cancer
            • Factors Expected to Limit Prescribing of Key Emerging Therapies in HER2-Positive Breast Cancer
            • Expected Hurdles for Perjeta/Herceptin and Neratinib/Herceptin in the Adjuvant Setting
          • Payer Opinion on Emerging Therapies for HER2-positive Breast Cancer
            • Payer Opinion on Emerging Therapies for HER2-Positive Breast Cancer
        • Methodology
          • Abbreviations
          • Primary Research Design
          • Background of Payers and Payer-Advising KOLs
          • Physician Demographics and Practice Setting
            • Physician Specialty
            • Years in Practice Post-Residency
            • Number of Breast Cancer Patients Treated Per Month
            • Country of Practice
            • U.K. Practice Location
            • Practice Location Within Community
            • Agents Prescribed Outside of a Clinical Trial for HER2-positive Breast Cancer
        • 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 (CAEs)
            • Spain: Commissions for Pharmacy and Therapeutics
            • Spain: Commissions for Pharmacy and Therapeutics
            • United Kingdom: Key Background Details of the Healthcare System
            • United Kingdom: P&R Process
            • United Kingdom: P&R Process
            • United Kingdom: Reimbursement Details and Budget Control
          • Key Current and Emerging Therapies for HER2-positive Breast Cancer
            • Profiles of Key Agents for HER2-Positive Breast Cancer in the EU5
            • Emerging Therapies Profiles
            • MacroGenics’ Margetuximab
            • Puma Biotechnology's Neratinib
          • Physician Survey Data
            • Drug-Treatment Rates for Neoadjuvant Treatment of HER2-Positive Breast Cancer
            • Clinical and Non-Clinical Barriers to Prescribing of Herceptin IV for First-Line Breast Cancer
            • Clinical and Non-Clinical Barriers to Prescribing of Herceptin SC for First-Line Breast Cancer
            • Clinical and Non-Clinical Barriers to Prescribing of Perjeta Plus Herceptin IV for First-Line Breast Cancer
            • Clinical and Non-Clinical Barriers to Prescribing of Perjeta Plus Herceptin SC for First-Line Breast Cancer
            • Clinical and Non-Clinical Barriers to Prescribing of Tyverb for First-Line Breast Cancer
            • Factors Deterring Prescribers from Switching from Intravenous to Subcutaneous Herceptin
            • Factors Expected to Limit Prescribing of Ibrance plus Herceptin, Perjeta, and Endocrine Therapy in First-Line HR-Positive/HER2-Positive Breast Cancer
            • Factors Expected to Limit Prescribing of Margetuximab in HER2-Positive Breast Cancer
            • Factors Expected to Limit Prescribing of Neratinib in HER2-Positive Breast Cancer
            • Richtgrößen Impact on Avastin Prescribing for HER2-Positive Breast Cancer
            • Richtgrößen Impact on Herceptin IV Prescribing for HER2-Positive Breast Cancer
            • Richtgrößen Impact on Herceptin SC Prescribing for HER2-Positive Breast Cancer
            • Richtgrößen Impact on Kadcyla Prescribing for HER2-Positive Breast Cancer
            • Richtgrößen Impact on Perjeta Prescribing for HER2-Positive Breast Cancer
            • Richtgrößen Impact on Tyverb Prescribing for HER2-Positive Breast Cancer
            • Impact of Added Benefit Rating on Prescribing of Premium-Priced Oncology Agents in France and Germany
            • Impact of Therapeutic Benefit and Ultimate Innovation Rating on Prescribing of Premium-Priced Oncology Agents in Italy
            • Impact of Lobbying the CFT of Hospitals to Include a Premium-Priced Oncology Agent on Formulary in Spain
            • Success of CDF Reform
            • Funding for Herceptin SC Across the EU5
            • Funding for Kadcyla Across the EU5
            • Funding for Perjeta Across the EU5

      Author(s): Dana Gheorghe; Yulia Privolnev, MA

      Dana Gheorghe, Ph.D., is a senior business insights analyst on the Oncology team at Decision Resources Group, specializing in non-Hodgkin’s lymphoma and renal cell carcinoma, with expertise in multiple myeloma and metastatic colorectal cancer. Her previous experience includes postdoctoral positions at Imperial College London and the Marie Curie Research Institute. Dr. Gheorghe holds a Ph.D. in cellular biology and biochemistry from the University of Sheffield and a B.Sc./Honors in Molecular Biology from the University of Edinburgh.

      Yulia Privolnev is a manager on the Global Market Access Insights team at Decision Resources Group, primarily focusing on European market access. She is responsible for monitoring, analyzing, and reporting on global market access through the production of DRG’s Global Market Access Solution (GMAS) and Access & Reimbursement products. Yulia’s specific focus is on all aspects of market access in Western and Eastern Europe, as well as external reference pricing (ERP) and managed entry agreements (MEAs) on a global scale. Yulia holds a bachelor’s degree from the University of Toronto and a master’s degree from the London School of Economics.


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