The malignant melanoma market in Europe has become crowded. Small-molecule targeted therapies such as Novartis’s Tafinlar and Mekinist, monoclonal antibodies including Merck & Co.’s Keytruda and Bristol-Myers Squibb’s Opdivo, and Amgen’s therapeutic vaccine Imygic have all been approved in the last six years. The premium price of these agents has resulted in spiraling healthcare costs, which means payers must make increasingly economical reimbursement decisions. In turn, oncologists face mounting challenges as they strive to balance superior efficacy and clinical need with strict eligibility criteria and other prescribing restrictions set by healthcare agencies. This research examines the reimbursement environment for malignant melanoma in the EU5, and analyzes the evolving impact of payer policy on prescribing as additional costly therapies penetrate the market and healthcare budgets tighten.

Questions Answered

  • What role do key brands play in the treatment of malignant melanoma in the EU5? In what treatment settings are they mostly prescribed? How is their use restricted in each country under study?
  • Do EU5 payers believe that efficacy of the various therapy combinations justifies their cost, and which drug or drug combination do they think performs best on clinical and other attributes?
  • How do oncologists and payers view therapies in late-stage development for malignant melanoma? How will these agents perform in HTA, and what pricing and reimbursement terms can they expect to achieve?
  • How will prescribing evolve, and what factors will drive key changes?

Product Description

Access & Reimbursement: Provides in-depth insight regarding the impact of payer policy on physician prescribing behavior so you can build your market access strategy and optimize your brand positioning.

Table of contents

  • Malignant Melanoma - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Key Updates
      • December 2017
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Optimizing Market Access Opportunity for Malignant Melanoma Therapies in the EU5
      • Successes and Stumbles
        • Successes and Stumbles Among Malignant Melanoma Therapies in the EU5
        • Overview of Successes and Stumbles Among Key Malignant Melanoma 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 First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Patient Shares for the First-Line Treatment of Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Prescriber Preferences in the Absence of Reimbursement or Access Hurdles for the First-Line Treatment of Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Treatment Sequence for Rapidly Progressing Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Treatment Sequence for Slowly Progressing Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
          • Impact of Payer Policy on Prescribing for First-Line Unresectable or Metastatic Malignant Melanoma
            • Overall Impact of EU5 Payer Policy on Prescribing for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Clinical and Nonclinical Factors Restricting Prescribing of Combination Regimens for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Overall Impact of EU5 Payer Policy on Prescribing of Imlygic for Unresectable or Metastatic Malignant Melanoma
            • Clinical and Nonclinical Factors for Not Prescribing Imlygic for Unresectable or Metastatic Malignant Melanoma: Nonprescribers
            • Clinical and Nonclinical Factors for Restricting Prescribing of Imlygic for First-Line Unresectable or Metastatic Malignant Melanoma: Prescribers
            • Impact of Country-Specific Payer Policies on Prescribing for Malignant Melanoma
            • Impact of ALD Status on Malignant Melanoma Patients in France
            • Impact of Richtgrößen or Similar State Prescribing Budget on Patient Access to Malignant Melanoma Therapies in Germany
            • Impact of AIFA's Monitoring Registry on Prescribing of Malignant Melanoma Drugs in Italy
            • Impact of National-Level IPT on Prescribing of Malignant Melanoma Therapies in Spain
            • Impact of Prescribing Guidelines in Local Authority/CCG and Hospital/Clinics in the United Kingdom
          • Top Prescribing Drivers for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Factors Influencing Prescribing of BRAF/MEK Combination Therapies for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Top Prescribing Drivers for Single-Agent Immune Checkpoint Inhibitors for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapies for Malignant Melanoma
            • Likely Impact of Emerging Therapies for Unresectable or Metastatic Malignant Melanoma
            • Willingness to Prescribe BRAF/MEK and PD-1/PD-L1 Triplet Therapy for Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Physician Perspective on Potential Future Use of BRAF/MEK and PD-1/PD-L1 Triplet Therapy for Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Maximum Anticipated Patient Share for Epacadostat Plus Keytruda in First-Line Unresectable or Metastatic Malignant Melanoma
            • Maximum Anticipated Patient Share for Encorafenib Plus Binimetinib in First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Physician Perspective on Potential Future Use of Encorafenib Plus Binimetinib for Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Likely Impact of Future Label Expansions of Currently Marketed Malignant Melanoma Therapies
            • Physician Perspective on the Future Potential of Imlygic Plus Keytruda for Unresectable or Metastatic Malignant Melanoma
            • Willingness to Prescribe Immune Checkpoint and BRAF/MEK Inhibitors for High-Risk Stage III Malignant Melanoma
            • Physician Perspective on Potential Future Use of Immune Checkpoint and BRAF/MEK Inhibitors for High-Risk Stage III Malignant Melanoma
          • Market Access Challenges for Emerging Malignant Melanoma Therapies
            • Factors Influencing Prescribing of a New Therapy for Malignant Melanoma
            • Factors Expected to Limit Prescribing of Epacadostat plus Keytruda for First-Line Unresectable or Metastatic Malignant Melanoma: Prescribers
            • Factors Expected to Limit Prescribing of Encorafenib plus Binimetinib for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma: Prescribers
          • Payer Opinion on Emerging Therapies for Malignant Melanoma
            • Payer Opinion on Emerging Malignant Melanoma Therapies
        • Methodology
          • Abbreviations
          • Primary Research Design
          • Background of Payers and Payer-Advising KOLs
          • Physician Demographics and Practice Setting
            • Physician Specialty
            • Country of Practice
            • Average Number of Years in Practice Postresidency
            • Type of Clinical Practice
            • Average Number of Patients Treated per Month with Malignant Melanoma
            • Therapies Prescribed Outside of Clinical Trial for Malignant Melanoma
        • 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 Malignant Melanoma
            • Profiles of Key Drugs for Malignant Melanoma in the EU5
            • Emerging Therapies Profiles
            • Incyte's Epacadostat Profile
            • Pierre Fabre's Encorafenib plus Binimetinib Profile
          • Physician Survey Data
            • Biomarker Testing in Malignant Melanoma
            • Reasons for Not Testing a Malignant Melanoma Patient for BRAF Mutations
            • Reasons for Not Testing a Malignant Melanoma Patient for PD-L1 Expression
            • Factors Influencing First-Line Prescribing of Yervoy for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Factors Influencing First-Line Prescribing of Single-Agent PD-1 Inhibitor for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma
            • Physician Perspective on Retreating with Agents Prescribed as Adjuvant Therapy in the First-Line Unresectable or Metastatic Setting
            • Factors Expected to Limit Prescribing of Epacadostat plus Keytruda for First-Line Unresectable or Metastatic Malignant Melanoma: Prescribers Versus Nonprescribers
            • Factors Expected to Limit Prescribing of Encorafenib plus Binimetinib for First-Line Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma: Prescribers Versus Nonprescribers
            • Estimated Time Delay Between European Approval and Market Access for Novel Oncology Drugs in the EU5
            • Funding Channels for Malignant Melanoma Therapies in the EU5
            • 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 the Prescribing of Premium-Priced Agents in Italy
            • Impact of Lobbying the CFT of Hospitals to Include Premium-Priced Oncology Agents on Their Formulary in Spain
            • Anticipated Success of the Redesign of the CDF in the United Kingdom

      Author(s): Rachel Webster; Yulia Privolnev, MA

      Rachel Webster M.Sc., D.Phil., is a senior director in the oncology and biosimilars team at Decision Resources Group, where she manages a team of analysts in producing syndicated primary and secondary market research reports on a wide range of oncology indications. She also provides sales and client support for all oncology products.

      Previously, Dr. Webster was a senior analyst in the oncology group at Decision Resources. Dr. Webster has extensive experience in market forecasting with detailed expertise in cancer immunotherapies, prostate cancer, gastric cancer, and malignant melanoma. Dr Webster is also experienced in conducting primary research with physicians and payers in a wide range of oncology indications across the major pharmaceutical markets. Prior to joining Decision Resources Group, Dr. Webster was a research scientist at Immunocore in the target validation group, where her research focused on identifying target antigens expressed in cancers and autoimmune diseases using a proprietary T-cell receptor (TCR) technology platform, molecular biology and phage display techniques. Dr. Webster obtained her D.Phil., in biochemistry, M.Sc. and M.A (Hons) in biological sciences, from the University of Oxford.

      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.


      Related Reports

      Malignant Melanoma - Landscape & Forecast - Disease Landscape & Forecast

      The introduction of immune checkpoint inhibitors Keytruda (Merck & Co.), Opdivo ± Yervoy (Bristol Myers Squibb), and Tecentriq (Roche / Genentech; United States only), as well as BRAF/ME...

      View Details

      Malignant Melanoma | Disease Landscape and Forecast | G7 | 2020

      The introduction of immune checkpoint inhibitor therapies, Keytruda (Merck & Co.) and Opdivo ± Yervoy (Bristol Myers Squibb), as well as BRAF/MEK inhibitor combination regimens, such as Roche /...

      View Details

      Malignant Melanoma - Epidemiology - Extrapolated Worldwide Coverage

      DRG’s extended worldwide coverage is the first and only evidence-based data set of epidemiological forecasts for key endometrial cancer pati...

      View Details

      Malignant Melanoma - Epidemiology - Mature Markets

      DRG Epidemiology's coverage of malignant melanoma comprises epidemiological estimates of key patient populations across 45 countries worldwide. We report both the incidence and prevalence of ma...

      View Details