Introduction

Rheumatoid arthritis (RA) affects a significant percentage of Argentinian and Mexican populations and often requires the use of premium-priced biologics. Rheumatologists have several options available for the treatment of RA patients in these markets, yet drug coverage is fragmented across the different healthcare programs, and access to costly RA therapies is often limited in the public sector. New agents, along with a series of biosimilars, have recently entered or are about to enter the crowded RA space in these markets presenting an additional challenge to current RA therapies. However, the long postmarketing experience rheumatologists have with current biologic agents represents a barrier to the use of new molecules, particularly in earlier lines of therapy, forcing them to compete among TNF-α-inhibitor-refractory patients. New agents will meet an increasingly competitive market and two countries trying to meet clinical needs while keeping the budget balanced. This Access & Reimbursement analysis provides key insights for navigating the RA market in Argentina and Mexico while adjusting your brand’s value message to payers’ and physicians’ needs and expectations in each country.

Scope:

For this Access & Reimbursement module on RA, we surveyed 103 rheumatologists and 6 payers to explore the current and future dynamics in the use and coverage of premium-priced RA therapies in Argentina and Mexico. Interviewees have regional or national influence or inform regulations on RA.

Markets covered: Argentina and Mexico.

Primary research:

  • 103 rheumatologists.
  • 6 payers/payer-advising thought leaders who have influence on patient access to premium-priced RA therapies at the institutional, regional, or national level were interviewed:
  • Argentina:
    • Rheumatologist KOL at a large academic, reference hospital in Buenos Aires; PAMI provider. Member of PANLAR. Chief of practical work of the rheumatology medical specialists career path at the UBA.
    • Superintendent of health services responsible for drafting regulatory framework for reimbursement with high-cost medicines at Obras Sociales. Consultant for UCEETS (Unidad Coordinadora de Evaluación de Tecnologías Salud) Regulatory.
    • Medical Audit Department Manager of important Argentinian HMO with nationwide operations.
  • Mexico:
    • Coordinator of the National Guías de Práctica Clínica from CENETEC-Salud; internist at an IMSS hospital.\
    • Head of the Pharmacy and Therapeutics Committee at ISSSTE.
    • President of the Colegio Mexicano de Reumatología; rheumatologist at a private hospital.

Questions Answered in This Report:

Market access landscape for current RA therapies in Mexico and Argentina. Which biologic and synthetic agents are available for the treatment of RA in Mexico and Argentina? Which of them are covered at a national and institutional level? Which barriers to diagnosis and treatment do RA patients encounter, and how do they vary across the two countries? 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 Mexico and Argentina? 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 (Argentina/Mexico)
    • Actionable Recommendations to Optimize Market Access
      • Actionable Recommendations to Optimize Market Access for New RA Therapies in Mexico and Argentina
    • Successes and Stumbles
      • Successes Among RA Therapies in Mexico and Argentina
      • Stumbles Among RA Therapies in Mexico and Argentina
    • Key Stakeholders in the Road to Market Access
      • Key Stakeholders in the Path to Formulary Access
        • Argentina: Stakeholder Dynamics on the Road to Market Access
          • Mexico: Stakeholder Dynamics on the Road to Market Access
          • Key Market Access Roadblocks
            • Key Market Access Roadblocks for RA Therapies in Mexico and Argentina
          • Reimbursement Dynamics
            • Argentina: Reimbursement/Coverage Dynamics for Rheumatoid Arthritis
              • Argentina: Drivers of Formulary Coverage for Premium-Priced RA Therapies
              • Argentina: Key Background Details of the Healthcare System
              • Argentina: Details of Coverage and Reimbursement for Premium RA Therapies
              • Argentina: Treatment Guidelines for RA
            • Mexico: Coverage Dynamics for Rheumatoid Arthritis
              • Mexico: Drivers of Formulary Coverage for Premium-Priced RA Therapies
              • Mexico: Key Background Details of the Healthcare System
              • Mexico: Treatment Guidelines for RA in Mexico
          • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
            • Prescriber Preferences per Line of Treatment
              • Impact of Payer Policy on Prescribing
                • Patients’ Access to Biologics and Xeljanz
              • Top Prescribing Drivers – Current Branded Therapies
                • Top Prescribing Drivers – Biosimilars
                  • Payer Policy Uptake Constraints
                    • Impact of cost and coverage limitations on prescribing of RA Biologics
                  • Key Levers and Constraints on Current Therapies
                  • Market Access Landscape for Emerging Therapies
                    • Likely Impact of Baricitinib and Sarilumab
                      • Baricitinib
                      • Sarilumab
                      • Preferred RA therapies in the second and third lines of treatment for patients refractory to conventional DMARDs, assuming 100% coverage in the future
                    • Mexico: Market Access Challenges
                      • Suggested prices for emerging therapies relative to Humira
                    • Argentina: Market Access Challenges
                      • Suggested prices for emerging therapies relative to Humira
                    • Argentina: Payer Opinion on Emerging Therapies for RA
                      • Argentinian Payer Insight on Emerging Therapies for RA
                    • Mexico: Payer Opinion on Emerging Therapies for RA
                      • Mexican Payer Insight on Emerging Therapies for RA
                  • Methodology
                    • Abbreviations
                    • Primary Research Design
                    • Background of Payers and Payer-Advising KOLs
                    • Physician Demographics and Practice Setting
                      • Pricing for the First Year of Treatment
                      • Appendix
                        • Commercial Context
                          • Prevalent RA Populations
                          • Yearly cost of selected RA drugs
                        • Physician 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
                          • Location of Administration for SC Biologics
                          • Preferred Delivery Method (SC vs. IV) for Orencia and Actemra/RoActemra by Patient Type
                          • Reasons for Choosing an IV vs. an SC Version
                          • Expected Changes in the Use of SC Biologics by 2019
                          • Choices Contributing to Rheumatologists’ Decision to Preferentially Prescribe One TNF Inhibitor to DMARD-Refractory Patients
                          • Choices Contributing to Rheumatologists’ Decision to Preferentially Prescribe Etanercept, Adalimumab, and Infliximab to DMARD-Refractory Patients―Mexico
                          • Choices Contributing to Rheumatologists’ Decision to Preferentially Prescribe Etanercept, Adalimumab, and Certolizumab Pegol to DMARD-Refractory Patients―Argentina
                          • Choices Contributing to Rheumatologists' Decisions to Prescribe Their Choice of Second-Line Agent for DMARD-Refractory Patients
                          • Choice of 2nd-line Agent for RA
                          • Choices Contributing to Mexican Rheumatologists' Decisions to Prescribe Their Choice of Second-Line Agent for DMARD-Refractory Patients: Rituximab, Abatacept, and Tocilizumab
                          • Argentinian Rheumatologists' Choice of 2nd Agent for RA
                          • Argentinian Rheumatologists' Choice of 2nd Agent for RA
                          • Patient Eligibility and Current Treatment Rates for Biologics and Xeljanz
                          • RA Patients Not Treated with Biologics or Xeljanz for Budgetary/Reimbursement Reasons
                          • Coverage of RA Therapies in Mexico
                          • Coverage of RA Therapies in Argentina
                          • Cost and Reimbursement Issues Limiting Prescribing of Biologics and Tofacitinib for RA─Mexico
                          • Cost and Reimbursement Issues Limiting Prescribing of Biologics and Tofacitinib for RA─Argentina
                          • Prescribing of Rituximab with Coverage for RA─Mexico
                          • Common Access Routes to Biologics or Xeljanz When Unavailable or Uncovered─Mexico
                          • Common Access Routes to Biologics or Xeljanz When Unavailable or Uncovered─Argentina
                          • Healthcare Authorities’ Preferred Therapy for First-Line Treatment of Conventional-DMARD/NSAID-Refractory RA Patients
                          • Health Authority Bodies Considered Barriers to Reimbursement of Premium-Priced Therapies for RA
                          • Drivers of Use/Non-Use of Xeljanz─Mexico
                          • Drivers of Use/Non-Use of Xeljanz─Argentina
                          • Anticipated Changes in Prescription Patterns of Xeljanz in Three Years
                          • Reasons for Not Prescribing Xeljanz in Three Years
                          • Mexican Rheumatologists' Recommendations for Coverage of Xeljanz─Lines of Treatment
                          • Mexican Rheumatologists' Recommendations for Coverage of Xeljanz─Current Agents Likely to Replace
                          • Current Patient Share for RA Biosimilars
                          • Current Patient Share of Brand vs. Biosimilar Infliximab─Mexico
                          • Current Patient Share of Brand vs. Biosimilar Etanercept─Mexico
                          • Willingness to Use Biosimilars and Clinical Scenarios for the Prescribing of RA Biosimilars
                          • Drivers of Biosimilar Use─Mexico
                          • Factors Preventing Biosimilar Use─Mexico
                          • Factors Preventing Biosimilar Use─Argentina
                          • 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; Andreia S. Ribeiro, 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.

                    Andreia Ribeiro, Ph.D., is a Director in DRG’s Market Access Insights team. In this role, she manages the Emerging and European Markets Access & Reimbursement portfolios, the industry’s only primary market research solution that includes insights from both physicians and payers to get a true sense of how both parties determine access to key pharmaceutical markets. She joined DRG over 4 years ago as a Latin American analyst where she has pioneered extensive primary and secondary research in the Brazil, Mexico, and Argentina payer systems exploring how the different reimbursement contexts impact prescribing.

                    Dr. Ribeiro has a Ph.D. in chemical and biochemical engineering from the University of Maryland Baltimore County focused on translational biomaterials research. She holds a B.S./M.S. degree from the University of Porto and two professional certifications in biochemical regulatory engineering and biotechnology management. A native of Portugal, Dr. Ribeiro is fluent in Portuguese and Spanish.


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