The success of an anticancer therapy is not only dependent on the outcome of its pivotal trial, but also on that trial’s design, which is examined by the regulatory bodies, payers, and prescribers. In our analysis, we assess the influence of trial design on treatment and reimbursement decisions regarding current and emerging therapies for malignant melanoma, renal cell carcinoma (RCC), and gastrointestinal stromal tumors (GIST). In addition, we explore payers’ and prescribers’ cost-sensitivity and preference for trial design features, such as primary end points and comparators.

Table of contents

  • Clinical Trial Design - Access & Reimbursement - Detailed, Expanded Analysis On Importance Of Clinical Trial Design In Malignant Melanoma, Renal Cell Carcinoma And Gastrointestinal Carcinoma (EU5)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for Malignant Melanoma, RCC, and GIST Therapies in the EU5
    • Successes and Stumbles
      • Successes Among Malignant Melanoma, RCC, and GIST Therapies in the EU5
      • Stumbles Among Malignant Melanoma, RCC, and GIST Therapies in the EU5
      • France: Reimbursement Successes and Stumbles
        • Germany: Reimbursement Successes and Stumbles
          • Italy: Reimbursement Successes and Stumbles
            • Spain: Reimbursement Successes and Stumbles
              • United Kingdom: Reimbursement Successes and Stumbles
              • Key Stakeholders in the Road to Market Access
                • France
                • Germany
                • Italy
                • Spain
                • United Kingdom
              • Key Market Access Roadblocks
                • France: Key Market Access Roadblocks
                • Germany: Key Market Access Roadblocks
                • Italy: Key Market Access Roadblocks
                • Spain: Key Market Access Roadblocks
                • United Kingdom: Key Market Access Roadblocks
              • Reimbursement Dynamics
                • France
                  • France: Crucial HTA Criteria
                  • France: P&R Drivers and Key HTA Considerations
                  • France: P&R Drivers and Key HTA Considerations
                  • France: HTA Review Details for Therapies for Malignant Melanoma, RCC, and GIST
                  • France: Lessons Learned and Key Takeaways
                  • France: Key Background Details of the Healthcare System
                  • France: P&R Process
                  • France: P&R Process
                  • France: Prescribing Restrictions, Dispensation, and Monitoring
                • Germany
                  • Germany: Crucial HTA Criteria
                  • Germany: P&R Drivers and Key HTA Considerations
                  • Germany: P&R Drivers and Key HTA Considerations
                  • Germany: HTA Review Details for Therapies for Malignant Melanoma, RCC, and GIST
                  • Germany: Lessons Learned and Key Takeaways
                  • Germany: Key Background Details of the Healthcare System
                  • Germany: P&R Process
                  • Germany: P&R Process
                  • Germany: Reimbursement Details and Mechanisms
                  • Germany: Prescribing Controls and Monitoring
                • Italy
                  • Italy: Crucial HTA Criteria
                  • Italy: P&R Drivers and Key HTA Considerations
                  • Italy: P&R Drivers and Key HTA Considerations
                  • Italy: HTA Review Details for Therapies for Malignant Melanoma, RCC, and GIST
                  • Italy: Lessons Learned and Key Takeaways
                  • Italy: Key Background Details of the Healthcare System
                  • Italy: P&R Process
                  • Italy: P&R Process
                  • Italy: Country-Specific Sections
                  • Italy: Additional Funding Mechanisms for Off-Label Use
                • 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 for Therapies Malignant Melanoma, RCC and GIST
                  • Spain: Lessons Learned and Key Takeaways
                  • 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
                  • United Kingdom: Crucial HTA Criteria
                  • United Kingdom: P&R Drivers and Key HTA Considerations
                  • United Kingdom: P&R Drivers and Key HTA Considerations
                  • United Kingdom: HTA Review Details for Therapies for Malignant Melanoma, RCC, and GIST
                  • United Kingdom: Lessons Learned and Key Takeaways
                  • 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
                  • United Kingdom: Reimbursement Details and Budget Control
                  • United Kingdom: Prescribing Control and Monitoring
              • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                • Impact of Clinical Trial Design on Prescribing Decisions
                  • Clinical Trial Design: Importance To Prescribers
                  • Value Placed on Secondary End Point Data Not Powered for Statistical Significance by Prescribers
                  • Impact of Head-to-Head vs. Single-Arm Trial Design in Different Drug-Pricing Scenarios
                • Prescriber Preferences for Malignant Melanoma
                  • Prescriber Preferences for First-Line BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma
                  • Prescriber-Preferred First-Line Treatment for BRAF-Mutation-Positive Unresectable or Metastatic Melanoma
                  • Prescriber Preferences for First-Line Treatment of BRAF-Wild-Type Unresectable or Metastatic Malignant Melanoma
                  • Prescriber-Preferred First-Line Treatment for BRAF-Wild-Type Unresectable or Metastatic Melanoma
                  • Key Reasons Why Keytruda and/or Opdivo Are Not Prescriber-Preferred First-Line Treatment Options for Unresectable/Metastatic BRAF-Wild-Type Melanoma
                • Prescriber Preferences for RCC
                  • Prescriber Preferences for Metastatic RCC by Line of Therapy
                  • Prescriber-Preferred Treatment for Metastatic RCC by Line of Therapy
                  • Key Reasons Why Nexavar Is Not the Prescriber-Preferred Treatment Option for Second-Line Metastatic RCC
                • Prescriber Preferences for GIST
                  • Patient Share of Treatments for Metastatic GIST by Line of Therapy
                • Impact of Payer Policy on Prescribing
                  • Impact of Regional/Local Guidelines or Directives on Patient Access to Drugs for Melanoma, RCC, and GIST: Italy and Spain
                  • Impact of NICE Recommendations and CDF Inclusion on Patient Access to Drugs for Melanoma, RCC, and GIST: United Kingdom
                  • Impact of Trial Design-Associated Payer Policy
                  • Impact of Head-to-Head vs. Single-Arm Trial Design in Different Drug-Pricing Scenarios
                • Top Prescribing Drivers: Clinical Trial Design-Related Factors
                  • Influential Factors of Pivotal Trial Design in Unresectable/Metastatic Melanoma: Key Prescribing Drivers
                  • Influential Factors of Pivotal Trial Design in RCC: Key Prescribing Drivers
              • Market Access Landscape for Emerging Therapies
                • Impact of Clinical Trial Design on Emerging Therapy Potential Prescribing
                  • Level of Satisfaction with Imlygic Phase III Clinical Trial Design and Results
                  • Expected Patient Share for Imlygic in Unresectable Stage IIIB-IVM1a Melanoma Without Evidence of Visceral Disease
                  • Impact of Clinical Trial Design Potential Prescribing of Yervoy in Resected Stage III Malignant Melanoma
                  • Expected Patient Share for Yervoy in Resected Stage III Melanoma Based on Current Data and if OS and QOL Benefit Were Observed
                  • Level of Satisfaction with Yervoy Phase III Clinical Trial Design and Results in the Adjuvant Setting
                • Clinical Trial Design Challenges for Emerging Therapies for Malignant Melanoma, RCC, and GIST
                  • Minimal Acceptable Clinical Trial Design Requirements for Approval and Market Access of Malignant Melanoma Therapies
                  • EU5 Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Primary End-point
                  • EU5 Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Comparator
                  • Minimal Acceptable Clincal Trial Design Requirements for Approval and Market Access of RCC Therapies
                  • EU5 Minimal Acceptable Clinical Trial Requirements for RCC: Primary End-point
                  • EU5 Minimal Acceptable Clinical Trial Requirements for RCC: Comparator
                  • Minimal Acceptable Clincal Trial Design Requirements for Approval and Market Access of GIST Therapies
                  • EU5 Minimal Acceptable Clinical Trial Requirements for GIST: Primary End-point
                  • EU5 Minimal Acceptable Clinical Trial Requirements for GIST: Comparator
                • Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • France: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • France: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • Germany: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • Germany: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • Italy: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • Italy: Payer Opinion on Emerging Therapies for Malignant Melanoma, NSCLC, and Ovarian Cancer
                  • Spain: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • Spain: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • United Kingdom: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
                  • United Kingdom: Payer Opinion on Emerging Therapies for GIST, Malignant Melanoma, and RCC
              • Methodology
                • Abbreviations
                • Primary Research Design
                • Background of Payers and Payer-Advising KOLs
                • Physician Demographics and Practice Setting
                  • Years in Practice Post-Residency
                  • Average Number of Patients Treated for GIST, Malignant Melanoma, and RCC
                  • Agents Prescribed Outside of Clinical Trials for GIST
                  • Agents Prescribed Outside of Clinical Trials for Malignant Melanoma
                  • Agents Prescribed Outside of Clinical Trials for RCC
                  • Practice Type
                  • Time Spent in Clinical Practice
                  • Country Practice Location
              • Appendix
                • Key Current Therapies for Malignant Melanoma, RCC and GIST
                  • Profiles of Key Therapies for Malignant Melanoma in the EU5
                  • Profiles of Key Therapies for RCC in the EU5
                  • Profiles of Key Therapies for GIST in the EU5
                • Physician Survey Data
                  • Percentage of Patients Currently Enrolled in Clinical Trials for Melanoma, RCC, and GIST by Patient Population
                  • Key Factors Restricting Patient Enrollment in Clinical Trials for Melanoma, RCC, and GIST
                  • Main Funding Source for Features of Care Within Melanoma, RCC, and GIST Clinical Trials: France
                  • Main Funding Source for Features of Care Within Melanoma, RCC, and GIST Clinical Trials: Germany
                  • Main Funding Source for Features of Care Within Melanoma, RCC, and GIST Clinical Trials: Italy
                  • Main Funding Source for Features of Care Within Melanoma, RCC, and GIST Clinical Trials: Spain
                  • Main Funding Source for Features of Care Within Melanoma, RCC, and GIST Clinical Trials: United Kingdom
                  • Extent to Which Prescribers Examine Clinical Trial Design Details Prior to Prescribing
                  • Impact of Clinical Trial Design on Prescribing
                  • Prescriber Concern About Drug Approval Based on Surrogate Survival End Points in Biomarker-Defined Patient Population Trials
                  • Prescriber Concern About Drug Approval Based on Surrogate Survival End Points in Non-Biomarker-Defined Patient Population Trials
                  • Value Placed on Secondary End Point Data Not Powered for Statistical Significance by National/Regional Healthcare Authority
                  • Value Placed on Secondary End Point Data Not Powered for Statistical Significance by Prescribers
                  • Level of Risk or Benefit to Patients of the Accelerated Assessment Procedure
                  • Level of Risk or Benefit to Patients of Conditional Marketing Approval
                  • Importance of Appropriate Clinical Design for Prescribers and Payers: Prescriber Perspective
                  • Estimated Price Premium Relative to Efficacy Achievement in Pivotal Study: Prescriber Perception
                  • Likelihood of Required Price Discount Relative to Efficacy Achievement in Pivotal Study: Prescriber Perception
                  • Impact of Head-to-Head vs. Single-Arm Trial Design in Different Drug-Pricing Scenarios
                  • Prescriber-Preferred First-Line Treatment for BRAF-Mutation-Positive Unresectable or Metastatic Melanoma
                  • Prescriber-Preferred Treatment for BRAF-Wild-Type Unresectable or Metastatic First-Line Melanoma
                  • KEYNOTE-006 Trial: Likely Impact of Positive Mature Overall Survival Data on Keytruda Prescribing
                  • CheckMate 066 Trial: Most Appropriate Comparator for Opdivo
                  • CheckMate 066 Trial: Impact of Choice of Comparator on Opdivo Prescribing
                  • CheckMate 066 Trial: Impact of Lack of Mature Overall Survival Data on Opdivo Prescribing
                  • CheckMate 066 Trial: Impact of Lack of First-Line, Unresectable/Metastatic BRAF-Mutation-Positive Patient Data on Opdivo Prescribing
                  • CheckMate 067 Trial: Likely Impact of Positive First-Line, Unresectable/Metastatic BRAF-Mutation-Positive Patient Data on Opdivo Prescribing
                  • Key Reasons Why Keytruda and/or Opdivo Are Not Prescriber-Preferred First-Line Treatment Options for Unresectable/Metastatic, BRAF-Wild-Type Melanoma
                  • Importance for Reimbursement of an Active Comparator in Pivotal Phase III Trials for Newly Diagnosed Melanoma: Prescriber Perception
                  • Importance for Reimbursement of an Active Comparator in Pivotal Phase III Trials for First-Line Melanoma: Prescriber Perception
                  • Importance for Reimbursement of an Active Comparator in Pivotal Phase III Trials for Second-Line Melanoma: Prescriber Perception
                  • Importance for EC Approval of Quality of Life Assessment in Pivotal Clinical Trials for Melanoma: Prescriber Perception
                  • Importance for Reimbursement of Quality of Life Assessment in Pivotal Clinical Trials for Melanoma: Prescriber Perception
                  • Importance to Prescribers of Quality of Life Assessment in Pivotal Clinical Trials for Melanoma
                  • Influential Factors of Pivotal Trial Design in Unresectable/Metastatic Melanoma: Key Prescribing Drivers
                  • EU5 Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Phase
                  • EU5 Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Primary End Point
                  • EU5 Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Single Arm or Randomized Trial Design
                  • EU5 Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Comparator
                  • Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: France
                  • Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Germany
                  • Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Italy
                  • Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: Italy
                  • Minimal Acceptable Clinical Trial Requirements for Malignant Melanoma: United Kingdom
                  • EU5 Minimal Acceptable Efficacy Requirements for Metastatic Malignant Melanoma
                  • Minimal Acceptable Efficacy Requirements for Newly-diagnosed, Resected, High-risk Malignant Melanoma
                  • Minimum Efficacy Benefit Required for Approval and Reimbursement for Melanoma by Subpopulation and End Point: Prescriber Perception
                  • Minimal Acceptable Response Rate Requirements for Malignant Melanoma
                  • Minimum Objective Response Rate Improvement for Approval and Reimbursement for Melanoma by BRAF-status and Line of Therapy: Prescriber Perception
                  • Level of Satisfaction with Imlygic Phase III Clinical Trial Design and Results
                  • Expected Patient Share for Imlygic in Unresectable Stage IIIB-IVM1a Melanoma Without Evidence of Visceral Disease
                  • Level of Satisfaction with Yervoy Phase III Clinical Trial Design and Results in the Adjuvant Setting
                  • Expected Patient Share for Yervoy in Resected Stage III Melanoma Based on Current Data and if OS and QOL Benefit Were Observed
                  • Prescriber-Preferred Treatment for Metastatic RCC by Line of Therapy
                  • Minimal Acceptable Clinical Trial Requirements for RCC: Italy
                  • Key Reasons Why Nexavar Is Not the Prescriber-Preferred Treatment Option for Second-Line Metastatic RCC
                  • Impact of COMPARZ Data on Market Acess for Votrient and Sutent
                  • Acceptance of PFS as Primary End Point in Phase III RCC Trials for Regulatory Approval: Prescriber Perception
                  • Acceptance of PFS as Primary End Point in Phase III RCC Trials for Reimbursement: Prescriber Perception
                  • Prescriber Acceptance of PFS as Primary End Point in Phase III RCC Trials
                  • Impact of Insubstantial Overall Survival Data on Willingness to Prescribe RCC Therapies
                  • Impact of Insubstantial Overall Survival Data on Ability to Prescribe RCC Therapies
                  • Impact of Insubstantial Efficacy Data in Non-Clear RCC Histologies on Ability to Prescribe RCC Therapies
                  • Impact of Insubstantial Efficacy Data in Non-Clear RCC Histologies on Willingness to Prescribe RCC Therapies
                  • Importance for Reimbursement of an Active Comparator in Pivotal Phase III Trials for RCC: Prescriber Perception
                  • Importance for EC Approval of Quality of Life Assessment in Pivotal Clinical Trials for RCC: Prescriber Perception
                  • Importance for Reimbursement of Quality of Life Assessment in Pivotal Clinical Trials for RCC: Prescriber Perception
                  • Importance to Prescribers of Quality of Life Assessment in Pivotal Clinical Trials for RCC
                  • Influential Factors of Pivotal Trial Design in RCC: Key Prescribing Drivers
                  • EU5 Minimal Acceptable Clinical Trial Requirements for RCC: Phase
                  • EU5 Minimal Acceptable Clinical Trial Requirements for RCC: Primary End Point
                  • EU5 Minimal Acceptable Clinical Trial Requirements for RCC: Single Arm or Randomized Trial Design
                  • EU5 Minimal Acceptable Clinical Trial Requirements for RCC: Clinical Comparator
                  • Minimal Acceptable Clinical Trial Requirements for RCC: France
                  • Minimal Acceptable Clinical Trial Requirements for RCC: Germany
                  • Minimal Acceptable Clinical Trial Requirements for RCC: Spain
                  • Minimal Acceptable Clinical Trial Requirements for RCC: United Kingdom
                  • EU5 Minimal Acceptable Efficacy Requirements for Resected RCC
                  • EU5 Minimal Acceptable Efficacy Requirements for Metastatic RCC
                  • Minimum Efficacy Benefit Required for Approval and Reimbursement for RCC by Line of Therapy and End Point: Prescriber Perception
                  • EU5 Minimally Acceptable Response Rate Requirements for RCC
                  • Minimum Objective Response Rate Improvement for Approval and Reimbursement for RCC by Line of Therapy and End Point: Prescriber Perception
                  • Level of Satisfaction with Opdivo Phase III Clinical Trial Design and Results
                  • Patient Share of Treatments for Metastatic GIST by Line of Therapy
                  • Past Importance for Reimbursement of an Active Comparator in Pivotal Phase III Trials for GIST: Prescriber Perception
                  • Current Importance for Reimbursement of an Active Comparator in Pivotal Phase III Trials for GIST: Prescriber Perception
                  • Acceptance of Surrogate Efficacy Primary End Points in Pivotal Trials for Regulatory Approval: Prescriber Perception
                  • Acceptance of Surrogate Efficacy Primary End Points in Pivotal Trials for Reimbursement: Prescriber Perception
                  • Prescriber Acceptance of Surrogate Efficacy Primary End Points in Pivotal Trials
                  • Importance for EC Approval of Quality of Life Assessment in Pivotal Clinical Trials for GIST: Prescriber Perception
                  • Importance for Reimbursement of Quality of Life Assessment in Pivotal Clinical Trials for GIST: Prescriber Perception
                  • Importance to Prescribers of Quality of Life Assessment in Pivotal Clinical Trials for GIST
                  • EU5 Minimal Acceptable Clinical Trial Requirements for GIST: Phase
                  • EU5 Minimal Acceptable Clinical Trial Requirements for GIST: Primary End Point
                  • EU5 Minimal Acceptable Clinical Trial Requirements for GIST: Single Arm or Randomized Trial Design
                  • EU5 Minimal Acceptable Clinical Trial Requirements for GIST: Comparator
                  • Minimal Acceptable Clinical Trial Requirements for GIST: Germany
                  • Minimal Acceptable Clinical Trial Requirements for GIST: Italy
                  • Minimal Acceptable Clinical Trial Requirements for GIST: Spain
                  • Minimal Acceptable Clinical Trial Requirements for GIST: United Kingdom
                  • Minimum Efficacy Benefit Required for Approval and Reimbursement of Therapies for Completely Resected GIST Patients by Subpopulation and End Point: Prescriber Perception
                  • EU5 Minimal Acceptable Efficasy Requirements for Metastatic GIST
                  • Minimum Efficacy Benefit Required for Approval and Reimbursement for GIST by Subpopulation and End Point: Prescriber Perception
                  • EU5 Minimal Acceptable Responce Rate Requirements for GIST
                  • Minimum Objective Response Rate Improvement for Approval and Reimbursement for GIST by Subpopulation: Prescriber Perception
                  • Drivers of Prescriptions for a Novel EC-Approved and Nationally/Regionally Reimbursed GIST Therapy
                  • Impact of ASMR Rating on Patient Access to Drugs for Melanoma, RCC, and GIST: France
                  • Extent to Which Prescribers Are Subject to Richtgrößen for Drugs for Melanoma, RCC, and GIST: Germany
                  • Impact of Richtgrößen on Patient Access to Drugs for Melanoma, RCC, and GIST: Germany
                  • Impact of AIFA's Oncology Drugs Register on Patient Access to Drugs for Melanoma, RCC, and GIST: Italy
                  • Impact of Regional/Local Guidelines or Directives on Patient Access to Drugs for Melanoma, RCC, and GIST: Italy and Spain
                  • Impact of NICE Recommendations and CDF Inclusion on Patient Access to Drugs for Melanoma, RCC, and GIST: United Kingdom
                  • Prescriber Access to EC-Approved Therapies for Melanoma, RCC, and GIST That Are Not Reimbursed by Healthcare Authority: Italy
                  • Prescriber Access to EC-Approved Therapies for Melanoma, RCC, and GIST That Are Not Reimbursed by Healthcare Authority: Spain
                  • Prescribing of EC-Approved Therapies for Melanoma, RCC, and GIST That Are Not Reimbursed by Healthcare Authority: Italy
                  • Prescribing of EC-Approved Therapies for Melanoma, RCC, and GIST That Are Not Reimbursed by Healthcare Authority: Spain

            Author(s): Niamh Buckley

            Niamh Buckley Ph.D. is a senior director in the oncology team at Decision Resources Group where she manages a team of analysts in producing syndicated and custom primary and secondary market research on a wide range of oncology indications. She also provides sales and client support for all oncology products.

            Dr. Buckley has extensive experience in market access and forecasting across oncology and hematology-oncology drug markets She also has considerable experience in conducting primary research with physicians and payers throughout the major pharmaceutical markets. Prior to joining Decision Resources, Dr. Buckley worked as a postdoctoral scientist focusing on translational breast cancer research. She has a B.Sc. in biotechnology and obtained her Ph.D. in molecular oncology from Trinity College in Ireland.


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