Introduction:

The lucrative EU5 rheumatoid arthritis market is dominated by biologics, including five tumor necrosis factor (TNF)-α inhibitors and four biologics with alternative mechanisms of action. The TNF-α inhibitors are the most widely prescribed biologics in RA patients refractory to conventional DMARDs, and the non-TNF-α biologics largely compete for use in TNF-refractory patients. However, the premium-priced branded TNF-α inhibitors face a competitive threat from the recent launch of biosimilars, including biosimilar infliximab and biosimilar etanercept, which provide cost-effective alternatives. In addition, Jak inhibitors Xeljanz (Pfizer’s tofacitinib) and Olumiant (Eli Lily/Incyte’s baricitinib) received EC marketing authorization for use in RA in the first quarter of 2017. With the impending entry of additional IL-6 inhibitors and Jak inhibitors, and biosimilars of several other TNF and non-TNF biologics, marketers are faced with fierce competition as EU5 payers and prescribers balance clinical need with budgetary constraints.

Questions Answered:

  •  What clinical and cost-related factors most strongly influence and restrict prescribing of key RA therapies? How do these differ across the EU5?
  • What factors will determine the success of recently approved and emerging Jak and IL-6 inhibitors, including Sanofi/Regeneron’s sarilumab and Janssen’s sirukumab? How do payers intend to reimburse emerging agents? To what extent will payer policy impact prescribing of them?
  • What can manufacturers do to achieve favorable pricing and reimbursement terms, maximize uptake and, therefore, optimize market access?

Scope:

  • Markets covered: France, Germany, Italy, Spain, United Kingdom.
  • Methodology: Surveys of 252 dermatologists and 10 country-specific interviews with European payers.
  • Indication coverage: Rheumatoid arthritis.
  • Key drugs covered: Enbrel, Humira, Remicade, Simponi, Cimzia, Orencia, RoActemra, MabThera, Xeljanz, Olumiant, Inflectra, Remsima, Flixabi, Benepali, Truxima, Amgevita, sarilumab, sirukumab, ABT-494.
  • Key companies mentioned: Pfizer, Merck, AbbVie, UCB, Roche, Bristol-Myers Squibb, Janssen, Eli Lilly, Sanofi, Regeneron, Hospira, Celltrion, Biogen.

Table of contents

  • Rheumatoid Arthritis - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Key Updates
      • December 2017
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Optimizing Market Access Opportunity for Rheumatoid Arthritis Therapies in the EU5
      • Successes and Stumbles
        • Successes Among Rheumatoid Arthritis Therapies in the EU5
        • Stumbles Among Rheumatoid Arthritis Therapies in the EU5
        • Overview of Successes and Stumbles for Rheumatoid Arthritis
      • 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: Lessons Learned and 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: Lessons Learned and 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: Lessons Learned and 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: Lessons Learned and 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: Lessons Learned and Key Takeaways
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences for Rheumatoid Arthritis
            • Current Patient Share of RA Therapies
            • Current Patient Share of TNF-Alpha Inhibitors in RA
            • Current Lines of Therapy with RA Biologics
          • Impact of Payer Policy on Prescribing for Rheumatoid Arthritis
            • Overall Impact of EU5 Payer Policy on Prescribing for Rheumatoid Arthritis
            • Reasons Eligible RA Patients Are Not Receiving Biologics
            • Nonclinical Factors Limiting Prescription of RA Biologics
            • Reasons for Prescribing Biosimilars for RA
            • Impact of Country-Specific Payer Policy on Prescribing for Rheumatoid Arthritis
            • Impact of ALD Status on Patient Access to RA Biologics: France
            • Impact of Richtgrößen on Patient Access to RA Biologics: Germany
            • Impact of Regional Guidelines/Directives on Patient Access to RA Biologics: Italy
            • Impact of Regional Guidelines/Directives or Out-of-Pocket Costs/Copays on Patient Access to RA Biologics: Spain
            • Impact of CCG or Local Formulary on Patient Access to RA Biologics: United Kingdom
          • Top Prescribing Drivers in Rheumatoid Arthritis
            • Most Influential Factors in Choice of RA Biologic
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapies for Rheumatoid Arthritis
            • Anticipated Patient Share of RA Therapies in 2020
            • Anticipated Patient Share of TNF-Alpha Inhibitors in 2020
            • Anticipated Lines of Therapy with RA Biologics and Jak Inhibitors in 2020
            • Likely Impact of Emerging Jak and IL-6 Inhibitors for Rheumatoid Arthritis
            • Most Likely Patient Groups Expected to Be Treated with Xeljanz
            • Most Likely Patient Groups Expected to Be Treated with Olumiant
            • Most Likely Patient Groups Expected to Be Treated with Sarilumab
            • Most Likely Patient Groups Expected to Be Treated with Sirukumab
            • Likely Impact of Emerging Biosimilars for Rheumatoid Arthritis
            • Physician Expectations of Timeframe for Prescribing Biosimilars for RA
            • Patient Groups Expected to Be Treated with New RA Biosimilars
          • Market Access Challenges for Emerging Rheumatoid Arthritis Therapies
            • Key Drivers for Prescribing New RA Therapy as First-Line Agent in Conventional DMARD-Refractory Patients
            • Physician Expectations of Reimbursement of Jak Inhibitors at Varying Prices
            • Reasons for Not Expecting to Prescribe Jak Inhibitors
            • Physician Expectations of Reimbursement of IL-6 Inhibitors at Varying Prices
          • Payer Opinion on Emerging Therapies for Rheumatoid Arthritis
            • Payer Opinion on Emerging Rheumatoid Arthritis Therapies
        • Methodology
          • Abbreviations
          • Primary Research Design
          • Background of Payers and Payer-Advising KOLs
          • Physician Demographics and Practice Setting
            • Distribution of Medical Practice by Country
            • Average Number of Years Practiced Postresidency
            • Average Number of Adult RA Patients Under Management per Month
            • Percentage of RA Biologics Prescribers
            • Physician Practice Setting
        • 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
          • Key Current Therapies for Rheumatoid Arthritis
            • Profiles of Key Drugs for Rheumatoid Arthritis in the EU5
            • Emerging Therapies Profiles
            • Eli Lilly's Olumiant (Baricitinib)
            • Pfizer's Xeljanz (Tofacitinib)
            • Sanofi/Regeneron's Sarilumab
            • Janssen's Sirukumab
            • AbbVie's ABT-494
          • Physician Survey Data
            • Percentage of RA Patients by Severity
            • Percentage of RA Patients Currently Eligible and Currently Receiving Biologics
            • Percentage of RA Patients Discontinuing Therapy
            • Top Reasons for Discontinuing RA Therapy
            • Treatment Satisfaction with Key RA Drugs
            • Rates of Combination Therapy with Biologics and Conventional DMARDs
            • Best-Performing RA Biologics in Terms of Clinical Factors
            • Best-Performing RA Biologics in Terms of Market Access Factors
            • Payer-Preferred Therapy for First-Line Biologic in RA
            • Treatment History of RA Patients Receiving Biosimilar Infliximab or Biosimilar Etanercept
            • Availability of Biosimilar Rituximab
            • Reasons for Not Prescribing Biosimilars for RA
            • Measures Taken by Payers to Promote Prescription of Biosimilars
            • Expected Prescribing Drivers for New RA Biosimilars
            • Reasons for Not Expecting to Prescribe New RA Biosimilars
            • Physician Expectations of Payer Measures Promoting Biosimilar Prescribing
            • Approach to Automatic Pharmacy-Level Substitution of Branded Biologics for Biosimilars
            • Familiarity with Emerging RA Therapies
            • Reasons Physicians Expect to Prescribe Jak Inhibitors in Later Treatment Lines
            • Physicians' Likelihood to Prescribe Xeljanz or Olumiant for RA
            • Reasons for Prescribing Olumiant Ahead of Xeljanz
            • Reasons for Prescribing Xeljanz Ahead of Olumiant
            • Anticipated Usage of Sarilumab, Sirukumab, and ABT-494
            • Factors Driving Choice of Agent Within Jak Inhibitors and IL-6 Inhibitors Drug Class
            • Physician Perception of Risk-Benefit Profiles of RA Agents
            • Preference for Formulary Inclusion Among Emerging RA Therapies
            • Delay from Marketing Approval to Availability for Prescribing RA Agents
            • Means of Funding/Reimbursement of RA Agents
            • Impact of Added Benefit or ASMR Rating on Prescribing of RA Agents
            • Impact of Therapeutic Benefit and Ultimate Innovation on Prescribing of RA Agents
            • Impact of Lobbying the Comisión de Farmacia y Terapéutica on Formulary Inclusion of RA Agent
          • About Decision Resources Group
            • Author#1 Biography
            • Author#1 Picture
            • Author#2 biography
            • Author#2 Picture

      Author(s): Anna Reyes, MSc; Ronnie Yoo, PhD

      Anna Reyes is an analyst 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. Anna’s specific focus is on all aspects of market access in the EU5, as well as in select LatAm countries. Anna holds a bachelor’s degree from the University Rovira i Virgili and a master’s degree in bioengineering from IQS Barcelona.

      Ronnie Yoo is an analyst on the Immune and Inflammatory Disorders team at Decision Resources Group, primarily focusing on rheumatoid arthritis. She has authored research reports on the RA disease landscape and commercial outlook of drugs, current treatment algorithms, and market access and reimbursement for RA biologics.

      Prior to joining DRG, Dr. Yoo was a business development intern at the Technology and Innovation Development Office at Boston Children’s Hospital, where she conducted market research for pre-patent filing technology assessments. She received her Ph.D. in biological and biomedical sciences from Harvard Medical School and a B.S. in biological sciences from Smith College.


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