The renal cell carcinoma drug market in Europe is increasingly competitive. Angiogenesis inhibitors (such as Pfizer’s Sutent and Novartis’s Votrient) and mTOR inhibitors (Pfizer’s Torisel and Novartis’s Afinitor) have long dominated the treatment algorithm, and in 2016, two novel antiangiogenic therapies (Eisai’s Kisplyx and Ipsen’s Cabometyx) and one immune checkpoint inhibitor (Bristol-Myers Squibb’s Opdivo) also gained marketing authorization. The approval of Kisplyx, specifically in combination with Afinitor, marked the first targeted therapy combination to enter the renal cell carcinoma market. With escalating drug costs amid tight healthcare budgets, robust demonstration of cost-effectiveness is crucial for reimbursement, while optimizing uptake thereafter is a tactical challenge. Drawing on prescriber and payer insight, this research analyzes the evolving treatment and market access landscape for renal cell carcinoma in the EU5.

Questions Answered

  • What clinical and cost/payer-related drivers and barriers shape oncologists’ prescribing decisions for renal cell carcinoma? How do these factors vary at national, regional, and local levels in each country under study?
  • How are payers reacting to the entry of novel premium-priced renal cell carcinoma agents? What cost-containment strategies do they employ and how will these evolve?
  • What role will evolving healthcare reforms play in differentiating the reimbursement of high-cost therapies versus currently available agents?
  • What clinical benefits are sought by oncologists and payers for emerging therapies in renal cell carcinoma? How are these ranked against pharmacoeconomic advantages?

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

  • Renal Cell Carcinoma - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Key Updates
      • December 2017
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Optimizing Market Access Opportunity for Renal Cell Carcinoma Therapies in the EU5
      • Successes and Stumbles
        • Successes and Stumbles Among Metastatic Renal Cell Carcinoma Therapies in the EU5
        • Overview of Successes and Stumbles Among Key Renal Cell Carcinoma 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 Metastatic Renal Cell Carcinoma
            • Prescriber Preferences for First-Line Metastatic Renal Cell Carcinoma
            • Patient Shares for First-Line Treatment of Metastatic Renal Cell Carcinoma
            • Prescriber Preferences in the Absence of Reimbursement/Access Issues for First-Line Metastatic Renal Cell Carcinoma
            • Prescriber Preferences for Second- and Third-Line Metastatic Renal Cell Carcinoma
            • Patient Shares for Second- and Third-Line Treatment of Metastatic Renal Cell Carcinoma
            • Prescriber Preferences in the Absence of Reimbursement/Access Issues for Second- and Third-Line Metastatic Renal Cell Carcinoma
          • Impact of Payer Policy on Prescribing for Metastatic Renal Cell Carcinoma
            • Overall Impact of EU5 Payer Policy on Prescribing for Metastatic Renal Cell Carcinoma
            • Clinical and Nonclinical Factors Restricting Prescribing of Key Agents for First-Line Metastatic Renal Cell Carcinoma
            • Clinical and Nonclinical Factors Restricting Prescribing of Key Agents for Previously Treated Metastatic Renal Cell Carcinoma
            • Factors Preventing the Prescription of Key Agents for Previously Treated Metastatic Renal Cell Carcinoma
            • Impact of Country-Specific Payer Policy on Prescribing for Metastatic Renal Cell Carcinoma
            • France: ALD Status
            • Germany: Richtgrößen or Similar State-Specific Physician Budget Constraints
            • Italy: Prescribing of AIFA Register Drugs
            • Spain: Prescribing Terms of the Informe de Posicionamiento Terapéutico
            • United Kingdom: Extent of Prescribing Guidelines in Local Authority/CCG and Hospital/Clinics
          • Top Prescribing Drivers in Metastatic Renal Cell Carcinoma
            • Top Prescribing Drivers of First-Line Treatment for Metastatic Renal Cell Carcinoma
            • Top Prescribing Drivers of Treatment for Previously Treated Metastatic Renal Cell Carcinoma
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapies for Metastatic Renal Cell Carcinoma
            • Likely Impact of Emerging Combination Therapies in First-Line Metastatic Renal Cell Carcinoma
            • Willingness to Prescribe Combination Regimens
            • Likely Impact of Tivozanib in Third- and Fourth-Line Metastatic Renal Cell Carcinoma
            • Expected Patient Share for Tivozanib in Third- and Fourth-Line Metastatic Renal Cell Carcinoma
          • Market Access Challenges for Emerging Metastatic Renal Cell Carcinoma Therapies
            • Clinical and Non-Clinical Factors Influencing the Prescription of a New Therapy for Metastatic Renal Cell Carcinoma
            • Factors Expected to Limit Prescribing of Tivozanib for Third- or Fourth-Line Metastatic Renal Cell Carcinoma (Without Split)
            • Physician Perspective on Tivozanib in the Third- or Fourth-Line Treatment of Metastatic Renal Cell Carcinoma
          • Payer Opinion on Emerging Therapies for Metastatic Renal Cell Carcinoma
            • Payer Opinion on Emerging Therapies for Renal Cell Carcinoma
        • Methodology
          • Abbreviations
          • Primary Research Design
          • Background of Payers and Payer-Advising KOLs
          • Physician Demographics and Practice Setting
            • Years in Practice Post-Residency
            • Years in Practice Post-Residency (EU5 Total)
            • Number of Renal Cell Carcinoma Patients Treated Per Month
            • Number of Renal Cell Carcinoma Patients Treated Per Month (EU5 Total)
            • Agents Prescribed Outside of a Clinical Trial for Renal Cell Carcinoma (EU5 Total)
            • Agents Prescribed Outside of a Clinical Trial for Renal Cell Carcinoma (Country Specific)
            • Country of Practice
            • U.K. Practice Location
            • Practice Location Within Community
            • Practice Location Within Community (EU5 Total)
        • 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 Metastatic Renal Cell Carcinoma
            • Profiles of Key Drugs for Renal Cell Carcinoma in the EU5
            • Emerging Therapies Profiles
            • AVEO Oncology's Tivozanib Profile
          • Physician Survey Data
            • Patient Shares for First-Line Treatment of Metastatic Renal Cell Carcinoma (EU5 Total)
            • Prescriber Preferences in the Absence of Reimbursement/Access Issues for First-Line Metastatic Renal Cell Carcinoma (EU5 Total)
            • Patient Shares for Second- and Third-Line Treatment of Metastatic Renal Cell Carcinoma (EU5 Total)
            • Prescriber Preferences in the Absence of Reimbursement/Access Issues for Second- and Third-Line Metastatic Renal Cell Carcinoma (EU5 Total)
            • Clinical and Non-Clinical Factors Restricting Prescribing of Key Agents for First-Line Metastatic Renal Cell Carcinoma (EU5 Total)
            • Clinical and Non-Clinical Factors Restricting Prescribing of Key Agents for Previously Treated Metastatic Renal Cell Carcinoma (EU5 Total)
            • Factors Preventing the Prescription of Key Agents for Previously Treated Metastatic Renal Cell Carcinoma (EU5 Total)
            • Funding of Key Agents in Light of Possible Reimbursement Hurdles
            • Funding of Key Agents in Light of Possible Reimbursement Hurdles (EU5 Total)
            • Impact of Added Benefit Rating on the Prescribing of Premium-Priced Oncology Drugs 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
            • Top Prescribing Drivers of First-Line Treatment for Metastatic Renal Cell Carcinoma (EU5 Total)
            • Top Prescribing Drivers of Treatment for Previously Treated Metastatic Renal Cell Carcinoma (EU5 Total)
            • Reported Performance of Key Agents on Clinical and Non-Clinical Factors in Previously Treated Metastatic Renal Cell Carcinoma
            • Reported Performance of Key Agents on Clinical and Non-Clinical Factors in Previously Treated Metastatic Renal Cell Carcinoma (EU5 Total)
            • Willingness to Prescribe Combination Regimens (EU5 Total)
            • Expected Patient Share for Tivozanib in Third- and Fourth-Line Metastatic Renal Cell Carcinoma (EU5 Total)
            • Clinical and Non-Clinical Factors Influencing the Prescription of a New Therapy for Metastatic Renal Cell Carcinoma (EU5 Total)
            • Factors Expected to Limit Prescribing of Tivozanib for Third- or Fourth-Line Metastatic Renal Cell Carcinoma (EU5 Total, Prescribers vs Non-Prescribers)
            • Factors Expected to Limit Prescribing of Tivozanib for Third- or Fourth-Line Metastatic Renal Cell Carcinoma (EU5 Total Without Split)
            • Physician Perspective on Tivozanib in the Third- or Fourth-Line Treatment of Metastatic Renal Cell Carcinoma (EU5 Total)
            • Estimate of Time Delay From European Marketing Approval to Availability for Prescribing New Therapies
            • Estimate of Time Delay From European Marketing Approval to Availability for Prescribing New Therapies (EU5 Total)
          • About Decision Resources Group
            • Joshua Dawkins
            • Yulia Privolnev

      Author(s): Joshua Dawkins, M.Pharmacol., PhD; Yulia Privolnev, MA

      Joshua Dawkins, M.Pharmacol., Ph.D., is a Business Insights Analyst in the oncology team at Decision Resources Group. Prior to joining DRG, Dr. Dawkins obtained his doctorate in molecular biology at the Barts Cancer Institute, Queen Mary University of London, where he investigated the roles of epigenetic histone modifiers in pancreatic ductal adenocarcinoma. Dr. Dawkins also holds a Master of Pharmacology degree awarded by the University of Bath, and completed a one-year professional placement within the oncology team at MedImmune.

      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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