Immune checkpoint inhibitors (ICIs), including Bristol-Myers Squibb’s Opdivo and Yervoy and Merck & Co.’s Keytruda, are revolutionizing the therapeutic strategies for several cancers, notably malignant melanoma, non-small-cell lung cancer (NSCLC), and renal cell carcinoma (RCC). In Europe, Opdivo plus Yervoy is the first ICI regimen approved for malignant melanoma, and, in 2017, the European Commission granted a label expansion to Keytruda for the first-line treatment of PD-L1-positive metastatic NSCLC. As these premium-priced therapies launch for novel indications and patient populations, payer-imposed reimbursement restrictions and cost-containment strategies will play an increasingly pivotal role in oncologists’ choice of treatment and, in turn, the commercial success of ICIs.

Questions Answered in This Report:

  • What are the key driving forces and constraints that influence EU5 payers’ reimbursement decisions for ICIs in malignant melanoma, NSCLC, and renal cell carcinoma?
  • How do market access and reimbursement policies at the national, regional, and local level shape prescribing preferences for ICIs? How do payers prioritize diminishing budgets and monitor prescribing of ICIs accordingly?
  • How do oncologists view emerging ICIs and how do they expect to prescribe them? To what extent will EU5 payer policy affect the uptake of these new entrants?

Scope:

  • Markets covered: France, Germany, Italy, Spain, United Kingdom.
  • Methodology: Survey of 251 medical oncologists and 10 country-specific interviews with European payers.
  • Indication coverage: Malignant melanoma, NSCLC, renal cell carcinoma.
  • Key drugs covered: Yervoy, Opdivo, Keytruda.
  • Key companies mentioned: Bristol-Myers Squibb, Merck & Co., Roche.

Table of contents

  • Immune Checkpoint Inhibitors - Access & Reimbursement - Detailed, Expanded Analysis (EU)
    • Key Updates
      • December 2017
    • Market Access Overview
      • Overview of Market Access for Immune Checkpoint Inhibitors in Oncology
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for Immune Checkpoint Inhibitors in the EU5
    • Successes and Stumbles
      • Successes and Stumbles Among Immune Checkpoint Inhibitors in the EU5
      • Overview of Successes and Stumbles Among Immune Checkpoint Inhibitors 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 Immune Checkpoint Inhibitors in Malignant Melanoma, NSCLC, and RCC
          • Prescriber Preferences for First-Line Unresectable or Metastatic Malignant Melanoma
          • Patient Share of Drug Therapies for First-Line Unresectable or Metastatic Malignant Melanoma
          • Choice of Drug Therapy for First-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in Absence of Market Access Hurdles
          • Choice of Drug Therapy for First-Line BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in Absence of Reimbursement/Market Access Hurdles
          • Prescriber Preferences for First-Line and Previously Treated NSCLC
          • Patient Shares of Opdivo and Keytruda for Previously Treated Squamous and Nonsquamous Metastatic NSCLC
          • Patient Share of Keytruda for First-Line Metastatic NSCLC
          • Ease of Reimbursement for Keytruda in First-Line, PD-L1-Positive Metastatic NSCLC
          • Prescriber Preferences for Previously Treated Metastatic Renal Cell Carcinoma
          • Patient Shares of Opdivo for Previously Treated Metastatic Renal Cell Carcinoma
          • Reasons for Not Prescribing Opdivo for Renal Cell Carcinoma, EU5 Total
        • Impact of Payer Policy on Prescribing of Immune Checkpoint Inhibitors
          • Overall Impact of EU5 Payer Policy on Prescribing of Immune Checkpoint Inhibitors
          • Factors Restricting Prescription of Immune Checkpoint Inhibitors for First-Line Unresectable or Metastatic Malignant Melanoma
          • Factors Restricting Prescription of Opdivo and Keytruda for Previously Treated Metastatic NSCLC
          • Factors Restricting Prescription of Opdivo in Previously Treated Metastatic Renal Cell Carcinoma
          • Impact of Country-Specific Payer Policies on Prescribing of Immune Checkpoint Inhibitors
          • Impact of ALD Status on Malignant Melanoma, NSCLC, and Renal Cell Carcinoma Patients in France
          • Effect of Richtgrößen or Similar State Prescribing Budget on Use of Immune Checkpoint Inhibitors in Germany
          • Effect on AIFA's Oncology Drug Register on Prescribing of Immune Checkpoint Inhibitors in Italy
          • Impact of National-Level IPT Terms on Prescribing Immune Checkpoint Inhibitors in Spain
          • Impact of CCG or Local Formulary on Patient Access to Immune Checkpoint Inhibitors in the United Kingdom
        • Top Prescribing Drivers for Immune Checkpoint Inhibitors
          • Key Drivers of Drug Choice for First-Line Unresectable or Metastatic Malignant Melanoma
          • Key Drivers of Drug Choice for Previously Treated NSCLC
          • Key Drivers of Drug Choice for Previously Treated Metastatic Renal Cell Carcinoma
      • Market Access Landscape for Emerging Therapies
        • Likely Impact of Emerging Therapies for Malignant Melanoma, NSCLC, and Renal Cell Carcinoma
          • Likely Impact of Emerging Therapies for Malignant Melanoma
          • Maximum Anticipated Patient Share for Tecentriq plus Zelboraf and Cotellic in First-Line BRAF-Mutation-Positive Malignant Melanoma
          • Willingness to Prescribe Immune Checkpoint Inhibitors as Adjuvant Therapies for High-Risk Stage III Resectable Malignant Melanoma
          • Likely Impact of Emerging Therapies for NSCLC
          • Maximum Anticipated Patient Share of Select Immune Checkpoint Inhibitors in Second-Line Metastatic NSCLC Assuming Approval of Tecentriq
          • Statement Agreement on Opdivo-Based Combinations for First-Line Metastatic NSCLC
          • Perception of Combinatorial Approaches Involving Immune Checkpoint Inhibitors for First-Line Metastatic NSCLC
          • Likely Impact of Emerging Therapies for Renal Cell Carcinoma
          • Perception of Combinatorial Approaches Involving Immune Checkpoint Inhibitors for First-Line Metastatic Renal Cell Carcinoma
          • Statement Agreement on Future Prescribing of Immune Checkpoint Inhibitors for Metastatic Renal Cell Carcinoma
        • Market Access Challenges for Emerging Therapies in Malignant Melanoma, NSCLC, and RCC
          • Anticipated Barriers to Future Prescribers of Tecentriq plus Zelboraf and Cotellic in First-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma
          • Opinion on Immune Checkpoint Inhibitors for High-Risk Stage III Resectable Malignant Melanoma
        • Payer Opinion on Emerging Therapies for Malignant Melanoma, NSCLC, and Renal Cell Carcinoma
          • Payer Opinion on Emerging Immune Checkpoint Inhibitors
      • Methodology
        • Abbreviations
        • Primary Research Design
        • Background of Payers and Payer-Advising KOLs
        • Physician Demographics and Practice Setting
          • Surveyed Oncologists’ Average Number of Years Practiced Postresidency
          • Average Number of Patients Under Management per Year for Malignant Melanoma, NSCLC, and Renal Cell Carcinoma
          • Agents Prescribed for Malignant Melanoma Outside of Clinical Trials
          • Agents Prescribed for NSCLC Outside of Clinical Trials
          • Agents Prescribed for Renal Cell Carcinoma Outside of Clinical Trials
          • Distribution of Surveyed U.K. Respondents
          • Surveyed Oncologists’ Primary Practice Settings
      • 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 Therapies for Malignant Melanoma, NSCLC, and Renal Cell Carcinoma
          • European Approvals of Current Immune Checkpoint Inhibitors for Malignant Melanoma, NSCLC, and Renal Cell Carcinoma
          • Roche's Tecentriq Profile in Malignant Melanoma
          • Roche's Tecentriq Profile in NSCLC
          • Bristol-Myers Squibb's Opdivo Profile in NSCLC
          • Bristol-Myers Squibb's Opdivo Profile in NSCLC
        • Physician Survey Data
          • Estimated Time Delay Between European Approval and Market Access for Novel Oncology Drugs, by Country
          • Funding Channels for Current Immune Checkpoint Inhibitors in Select Indications in the EU5
          • Effect of Richtgrößen or Similar State Prescribing Budget on Use of Immune Checkpoint Inhibitors Among Nonprescribers in Germany
          • Effect of Richtgrößen or Similar State Prescribing Budget on Use of Immune Checkpoint Inhibitors Among Prescribers in Germany
          • Impact of HTA Benefit Rating on Oncologists' Preferred Prescribing of Premium-Priced Oncology Agents: France, Germany, and Italy
          • Impact of Lobbying the CFT on Formulary Inclusion of Premium-Priced Oncology Drugs in Spain
          • Surveyed Oncologists’ Perception of Impact of Recent CDF Reforms on Select Market Access Metrics in the United Kingdom
          • Patient Share of Drug Therapies for First-Line Unresectable or Metastatic Malignant Melanoma, EU5 Total
          • Choice of Drug Therapy for First-Line Unresectable or Metastatic Malignant Melanoma in Absence of Market Access Hurdles, EU5 Total
          • Key Drivers of Drug Choice for First-Line Unresectable or Metastatic Malignant Melanoma, EU5 Total
          • Performance of Current Immune Checkpoint Inhibitors in First-Line Unresectable or Metastatic Malignant Melanoma on Select Clinical and Nonclinical Attributes
          • Factors Restricting Prescription of Immune Checkpoint Inhibitors for First-Line Unresectable or Metastatic Malignant Melanoma, EU5 Total
          • Reasons for Not Prescribing Opdivo plus Yervoy for Malignant Melanoma
          • Reasons for Not Prescribing Opdivo plus Yervoy for Malignant Melanoma, EU5 Total
          • Treatment Sequence for Previously Treated BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma
          • Treatment Sequence for Previously Treated BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in Absence of Market Access Hurdles
          • Key Prescribing Drivers for a New Immune Checkpoint Inhibitor in Unresectable or Metastatic Malignant Melanoma
          • Key Prescribing Drivers for a New Immune Checkpoint Inhibitor in Unresectable or Metastatic Malignant Melanoma, EU5 Total
          • Anticipated Reasons for Not Prescribing Tecentriq plus Zelboraf and Cotellic as First-Line Therapy for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma
          • Anticipated Reasons for Not Prescribing Tecentriq plus Zelboraf and Cotellic as First-Line Therapy for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma
          • Anticipated Reasons for Not Prescribing Tecentriq plus Zelboraf and Cotellic as a First-Line Therapy for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma, EU5 Total
          • Anticipated Barriers to Future Prescribers of Tecentriq plus Zelboraf and Cotellic in First-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma, EU5 Total
          • Willingness to Prescribe Immune Checkpoint Inhibitors as Adjuvant Therapies for High-Risk Stage III Resectable Malignant Melanoma, EU5 Total
          • Oncologists' Opinion on Immune Checkpoint Inhibitors for High-Risk Stage III Resectable Malignant Melanoma, EU5 Total
          • Patient Shares of Opdivo and Keytruda for Previously Treated Squamous and Nonsquamous Metastatic NSCLC, EU5 Total
          • Key Drivers of Drug Choice for Previously Treated Metastatic NSCLC, EU5 Total
          • Factors Restricting Prescription of Opdivo and Keytruda for Previously Treated Metastatic NSCLC, EU5 Total
          • Statement Agreement on Prescribing of Opdivo and Keytruda for Previously Treated Metastatic NSCLC
          • Statement Agreement on Prescribing of Opdivo and Keytruda for Previously Treated Metastatic NSCLC, EU5 Total
          • Reasons for Not Prescribing Opdivo or Keytruda for NSCLC
          • Reasons for Not Prescribing Opdivo or Keytruda for NSCLC, EU5 Total
          • Patient Share of Keytruda for First-Line Metastatic NSCLC, EU5 Total
          • Ease of Reimbursement for Keytruda for First-Line, PD-L1-Positive Metastatic NSCLC, EU5 Total
          • Maximum Anticipated Patient Share of Select Immune Checkpoint Inhibitors in Second-Line Metastatic NSCLC Assuming Approval of Tecentriq, EU5 Total
          • Statement Agreement on Opdivo-Based Combinations for First-Line Metastatic NSCLC, EU5 Total
          • Perception of Combinatorial Approaches Involving Immune Checkpoint Inhibitors for First-Line Metastatic NSCLC, EU5 Total
          • Patient Shares of Opdivo for Previously Treated Metastatic Renal Cell Carcinoma, EU5 Total
          • Key Drivers of Drug Choice for Previously Treated Metastatic Renal Cell Carcinoma, EU5 Total
          • Factors Restricting Prescription of Opdivo in Previously Treated Metastatic Renal Cell Carcinoma, EU5 Total
          • Reasons for Not Prescribing Opdivo for Renal Cell Carcinoma
          • Perception of Combinatorial Approaches Involving Immune Checkpoint Inhibitors for First-Line Metastatic Renal Cell Carcinoma, EU5 Total
          • Statement Agreement on Future Prescribing of Immune Checkpoint Inhibitors for Metastatic Renal Cell Carcinoma, EU5 Total

    Author(s): Aarushi Kashyap, M.Tech.; Yulia Privolnev, MA

    Aarushi Kashyap is a Senior Insights Analyst in Oncology team at Decision Resources Group, based out of Gurgaon office in India.

    She comes with a work experience of 4 years as Business Analyst with practice across multiple oncology indications in various functions in Competitive Intelligence and Secondary Research, including pipeline analysis, competitive product reporting, clinical trials assessment and benchmarking, clinical and competitor landscaping, therapy area deep dive reporting, ad-hoc news tracking etc. She has attended various big and small oncology medical congresses across US and Europe in parallel to creating pre- and post-conference data summaries with implications and schedule trackers for abstracts of interest delivering to directly to clients. She has earned her Master's and Bachelor's in Technology in Biotechnology from Jaypee Institute of Information Technology University.

    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.