Introduction

Rheumatoid arthritis (RA) is a chronic disease that affects more than 1 million Brazilians and often requires the use of premium-priced therapies. The coverage of these drugs is extensive, and rheumatologists have several therapeutic options available for the treatment of RA patients. However, the long period on the market and the extensive experience rheumatologists have with biologic agents, particularly TNF-α-inhibitors, represents a challenge to the use of new molecules, forcing them to compete for use in TNF-α-inhibitor-refractory patients. More recently, two biosimilars became available, and it is anticipated that more biosimilars will be launched in the short to mid term, representing an additional challenge to current therapies. In addition, Brazil is a sizeable and heterogeneous country that is currently experiencing an economic crisis that may exacerbate current access barriers. New agents to market will encounter an increasingly competitive market and a country that will be trying to meet clinical needs while keeping the budget balanced. This Access & Reimbursement analysis provides important insights for navigating the RA market in Brazil and adjusting to payers’ and physicians’ needs and expectations.

Scope:

For this Access & Reimbursement module on RA, we surveyed 52 rheumatologists and 3 payers to explore the current and future dynamics in the use and coverage of premium-priced RA therapies in Brazil.

Markets covered: Brazil.

Primary research:

  • 52 rheumatologists.
  • 3 payers/payer-advising thought leaders who have influence on patient access to premium-priced RA therapies at a regional or national level were interviewed:
    • Member of the National Committee for Incorporation of Technologies in the Health System (CONITEC); current ad-hoc consultant for Ministry of Health and specialist in pharmacoeconomics.
    • Rheumatologist KOL; member of the Rheumatology Departments of São Paulo’s State Health Department and one of the most important private hospitals in Brazil; active member of the drug standardization (P&T) committee of these institutions.
    • Medical audit department manager of important Brazilian HMO with nationwide operations.

Questions Answered in This Report:

· Market access landscape for current RA therapies in Brazil. Which biologic and synthetic agents are available for the treatment of RA in Brazil? Which of them are covered in the public and private sectors? Which barriers to diagnosis and treatment do RA patients encounter, and how do they vary across the country? What are the current drivers of physician prescribing of RA therapies?

· Current and future impact of payer policies on prescribing trends for RA.What does an analysis of prescribing patterns for currently available RA therapies reveal about the real-life impact of payer policies in Brazil? How do reimbursement/coverage constraints limit prescribing and rank against other market access hurdles? How do health authorities’ policies impact the prescription of biosimilars?

· Perception, challenge, and differentiating factors for emerging RA therapies. How will payers and prescribers perceive the emerging therapies? What challenges will those therapies need to overcome? How do new therapies meet physicians’ needs, and how do physicians expect to prescribe them? What differentiating characteristics will new therapies need for success with coverage requests? What will be the importance of head-to-head and pharmacoeconomic outcomes against current therapies for coverage decisions?

Table of contents

  • Rheumatoid Arthritis - Access & Reimbursement - Detailed, Expanded Analysis (Brazil)
    • Actionable Recommendations to Optimize Market Access
      • Actionable Recommendations to Optimize Market Access for New RA Therapies in Brazil
    • Successes and Stumbles
      • Successes Among RA Therapies in Brazil
      • Stumbles Among RA Therapies in Brazil
    • Key Stakeholders in the Road to Market Access
      • Brazil: Stakeholder Dynamics in the Road to Market Access
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for Emerging RA Therapies in Brazil
    • Reimbursement Dynamics
      • Brazil: HTA Details and Implications in Drug Coverage
        • Brazil: Drivers of Formulary Coverage
          • Brazil: Drivers of Formulary Coverage for Premium-Priced RA Therapies
        • Brazil: Coverage Detail and Successes or Stumbles
          • Brazil: Lessons Learned and Key Takeaways
            • Reimbursement Background Brazil
              • Key Background Details of the Healthcare System
              • Organization of the RENAME
              • Organization of the CEAF Drugs
              • Brazilian Payer Insight on Biosimilars for RA
          • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
            • Prescriber Preferences for Branded RA Therapies
              • Prescriber Preferences for Biosimilar RA Therapies
                • Current Use of Infliximab Biosimilars
              • Impact of Payer Policy on Prescribing
                • Patient Access to RA Therapies
              • Top Prescribing Drivers for Branded Biologics
                • Main drivers for the choice of one TNF-α inhibitor over the others for first line of therapy (n = 52)
                • Main drivers for the choice of biologic agent for second line of therapy (n = 52)
                • Main drivers for the prescription of Xeljanz (n = 19)
              • Top Prescribing Drivers for Biosimilars
                • Remsima (n = 46)
                • Bio-Manguinhos Infliximabe (n = 48)
              • Payer Policy Uptake Constraints
                • Impact of Government Coverage
                  • Key Levers and Constraints on Current Therapies
                  • Market Access Landscape for Emerging Therapies
                    • Likely Impact of Baricitinib and Sarilumab
                      • Sarilumab
                      • Preferred RA Therapies in the Second and Third Lines of Treatment for Patients Refractory to Conventional DMARDs, Assuming 100% Coverage in the Future
                    • Baricitinib: Market Access Challenges
                      • Suggested Price Relative to Humira
                      • Main Reasons for Not Prescribing (% of rheumatologists (n = 14)
                    • Sarilumab: Market Access Challenges
                      • Suggested Price Relative to Humira
                      • Main Reasons for Not Prescribing (% of rheumatologists (n = 15)
                    • Payer Opinion on Emerging Therapies for RA
                      • Brazilian Payer Insight on Emerging Therapies for RA
                  • Methodology
                    • Abbreviations
                    • Methodology: Primary Research Design
                    • Methodology: Background of Payers and Payer-Advising KOLs
                    • Methodology: Clinician Demographics – Location and Experience of Surveyed Rheumatologists
                      • In what country is your practice located?
                      • What is your specialty?
                      • How would you best describe the setting(s) in which you practice?
                      • In what city is your practice located?
                      • How many years have you practiced post-residency?
                    • Methodology: Clinician Demographics –Patient Populations and Medical Practice Characteristics
                      • What is your hospital type?
                    • Methodology: Clinician Demographics – Patient Population’s Characteristics
                      • Methodology: Pricing for the First Year of Treatment
                      • Appendix
                        • Commercial Context
                          • Prevalent and Diagnosed RA Populations
                          • Reference Hospitals Highlighted by Interviewed Payers
                          • Yearly Cost of Select RA Drugs
                          • Timeline of Approval of Select RA Drugs
                        • Survey Data
                          • Patient Shares for RA Biologics
                          • Most Used Biologics by Line of Therapy─Public Patients
                          • Most Used Biologics by Line of Therapy─Private Patients
                          • Most Used Biologics by Line of Therapy in a Scenario of 100% Coverage
                          • Administration of SC Biologics
                          • Preferred Delivery Method (SC vs. IV) for Orencia and Actemra by Patient Type
                          • Reasons for Choosing an IV vs. an SC Version
                          • Expected Changes in the Use of SC Biologics by 2019
                          • Drivers for Selection of Biologic Therapy
                          • One TNF inhibitor over the Others in the First Line for RA
                          • Choice of Second-Line Agent for RA
                          • Choice of Second-Line Agent for RA
                          • Patient Eligibility and Current Treatment Rates for Biologics and Tofacitinib
                          • RA Patients Not Treated with Biologics or Tofacitinib for Budgetary/Reimbursement Reasons
                          • Coverage of RA Therapies
                          • Cost and Reimbursement Issues Limiting Prescribing of Biologics and Tofacitinib for RA
                          • Common Access Routes to Biologics or Xeljanz When Unavailable or Uncovered
                          • Healthcare Authorities’ Preferred Therapy for First-Line Treatment of RA Patients Refractory to Conventional DMARD/NSAID Therapy
                          • Health Authority Bodies Considered Barriers to Reimbursement of Premium-Priced Therapies for RA
                          • Physicians’ Expectations of CONITEC’s Evaluation of Tocilizumab as First-Line Biologic Therapy
                          • Reason to Expect a Positive/Negative Outcome from CONITEC’s Evaluation of Tocilizumab as First-Line Biologic Therapy
                          • Drivers of Use/No Use of Xeljanz
                          • Anticipated Changes in Prescription Patterns of Xeljanz in Three Years
                          • Reasons for Not Prescribing Xeljanz in Three Years
                          • Rheumatologists’ Recommendations for Coverage of Tofacitinib─Lines of Treatment
                          • Rheumatologists’ Recommendations for Coverage of Tofacitinib─Current Agents Likely to Replace
                          • Current Patient Share for RA Biosimilars
                          • Current Patient Share of Brand vs. Biosimilar Infliximab
                          • Willingness to Use and Clinical Scenarios for the Prescribing of RA Biosimilars
                          • Drivers of Biosimilar Use
                          • Factors Preventing Biosimilar Use
                          • Pharmacy-Level Substitution of Biologics
                          • Health Authority Encouragement of Biosimilars’ Use
                          • Rheumatologists’ Opinion on Indication Extrapolation
                          • Acceptable Launch Prices for Biosimilars
                          • Delays in the Prescribing of Biosimilars to RA Patients
                          • Expected Patient Shares for Biosimilars in RA Patients Two Years After the Biosimilar’s Launch
                          • Rheumatologists’ Reasons for Not Prescribing Biosimilars Within Two Years of Launch
                          • Anticipated Prescribing Patterns for Baricitinib and Sarilumab
                          • Drivers of Use of Baricitinib and Sarilumab over Current Therapies
                          • Rheumatologists’ Reasons for Not Prescribing Baricitinib or Sarilumab
                          • Rheumatologist Choices of Treatments for RA Patients Without Access Barriers Three Years from Now
                          • Rheumatologist Choices of Emerging Therapy to be Granted Coverage/Reimbursement
                          • Acceptable Launch Prices for Baricitinib and Sarilumab

                    Author(s): Nuno Tiago Giao Antunes, PhD

                    Nuno T. Antunes, Ph.D., is senior business insights analyst on the Infectious, Niche, and Rare Diseases team at Decision Resources Group, specializing in antibacterial agents. Previously, he was a Latin America Market Access senior analyst in the Global Market Access Insights Team, where he developed expertise in market access, pricing and reimbursement, health technology assessment, and health policy.

                    Nuno holds a Ph.D. in animal health from the Universidad de las Palmas de Gran Canaria, Spain, and a D.V.M. degree from the Universidade de Trás-os-Montes e Alto Douro, Portugal. Prior to joining DRG, he conducted research in antimicrobial resistance and antimicrobial development, and worked in the medical devices industry as a scientist.


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