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Research & Reports

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Rheumatoid Arthritis | Access & Reimbursement | Detailed, Expanded Analysis (Argentina/Mexico)

Rheumatoid Arthritis | Access & Reimbursement | Detailed, Expanded Analysis (Argentina/Mexico)

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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

  • 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: HTA Details and Implications for Drug Coverage
        • Argentina: Drivers of Formulary Coverage
        • Argentina: Coverage Detail and Successes or Stumbles of Premium Therapies for RA
        • Argentina: Lessons Learned and Key Takeaways
        • Reimbursement Background
      • Mexico: Coverage Dynamics for Rheumatoid Arthritis
        • Mexico: HTA Details and Implications for Drug Coverage
        • Mexico: Drivers of Formulary Coverage
        • Mexico: Coverage Detail and Successes or Stumbles of Premium Therapies for RA
        • Mexico: Lessons Learned and Key Takeaways
        • Reimbursement Background
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Prescriber Preferences per Line of Treatment
      • Impact of Payer Policy on Prescribing
      • Top Prescribing Drivers - Current Branded Therapies
      • Top Prescribing Drivers - Biosimilars
      • Payer Policy Uptake Constraints
      • Key Levers and Constraints on Current Therapies
    • Market Access Landscape for Emerging Therapies
      • Likely Impact of Baricitinib and Sarilumab
      • Mexico: Market Access Challenges
      • Argentina: Market Access Challenges
      • Argentina: Payer Opinion on Emerging Therapies for RA
      • Mexico: Payer Opinion on Emerging Therapies for RA
    • Methodology
      • Primary Research Design
      • Physician Demographics and Practice Setting
        • Methodology: Clinician Demographics - Location of Surveyed Rheumatologists
        • Clinician Demographics - Experience, Patient Populations, and Medical Practice Characteristics
        • Clinician Demographics - Patient Populations and Medical Practice Characteristics
      • Pricing for the First Year of Treatment
    • Appendix
      • Commercial Context
        • Epidemiology
        • Timeline of Approval and Other Key Market Events of Select RA Drugs
        • Advantages/Disadvantages of Subcutaneous TNF-α Inhibitors for RA
        • Advantages/Disadvantages of the IV TNF-α Inhibitor Infliximab for RA
        • Advantages/Disadvantages of Non-TNF-α Inhibitors for RA
        • Government Restrictions on the Reimbursement of Biologics for RA
        • Price of Select Key RA Drugs for the First Year of Treatment
        • Emerging Therapies for RA─Clinical Profiles and Timeline of Launches
      • Physician Survey Data

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  • Pub Date: April 2016
  • Author(s): Andreia Ribeiro, PhD; Nuno Tiago Giao Antunes, PhD
  • Andreia Ribeiro, 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 in chemical and biochemical engineering from the University of Maryland Baltimore County focused on translational biomaterials research. She holds a 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.

  • Nuno T. Antunes, ,  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 in animal health from the Universidad de las Palmas de Gran Canaria, Spain, and a 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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