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Research & Reports

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Axial Spondyloarthritis | Access & Reimbursement | Detailed, Expanded Analysis Axial Spondyloarthritis and Psoriatic Arthritis (Brazil & Mexico)

Axial Spondyloarthritis | Access & Reimbursement | Detailed, Expanded Analysis Axial Spondyloarthritis and Psoriatic Arthritis (Brazil & Mexico)

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Introduction:

The prevalence of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in Brazil and Mexico is estimated at 1.3 million and is expected to keep growing. The entry of biosimilars and the upcoming arrival of novel therapies for PsA and AS are shaping a new therapeutic landscape in Brazil and Mexico, which is currently dominated by the long established TNF-alfa inhibitors. In this Access & Reimbursement analysis, we discuss the current access landscape to PsA and AS treatments in Brazil and Mexico and the expected future uptake of biosimilars and key emerging therapies (e.g., Novartis’s Cosentyx, Janssen’s Stelara, Celgene’s Otezla)— and the levers and roadblocks to their uptake—based on primary research with rheumatologists and payers in these two countries.

Questions Answered in This Report:

  • Explore current and evolving drug coverage and prescribing trends. How does coverage of approved biologics vary between countries and public and private settings? What are the most prescribed and the preferred biologics for the treatment of PsA and AS, by line of treatment? What are the key drivers for the prescribing of a specific biologic over others? How do cost/reimbursement-related constraints outline prescribing patterns? How do payers perceive biosimilars? Will their presence drive a price cut on the branded products and impact the reimbursement status of biologics? How does the availability of etanercept and infliximab biosimilars impact prescribing and what are physicians’ off-label prescribing patterns in AS and PsA.
  • Explore the outlook for emerging agents for PsA and AS. What are payers’ attitudes toward emerging agents? How do payers expect access to premium-priced agents to evolve in the next three years?  What market access obstacles will these novel therapies face? Which clinical and coverage opportunities can drug developers benefit from to better position their products in these markets? What role will head-to-head and pharmacoeconomic outcomes play in the coverage of novel agents versus current standards of care? How will prescribing patterns evolve with the availability of novel agents? How do rheumatologists expect to prescribe biosimilars and emerging agents and their likely impact on current brands over the next three years?

Scope:

For this Access & Reimbursement module on PsA and AS, we surveyed 105 rheumatologists and interviewed 6 payers to explore the current and future dynamics in the use and coverage of premium-priced PsA and AS therapies in Brazil and Mexico. Interviewees have regional or national influence or inform regulations on AS and PsA.

Markets covered: Brazil, Mexico.

Primary research:

  • 105 rheumatologists.
  • 3 payers in Brazil: Member of the National Committee for Incorporation of Technologies in the Health System (CONITEC) for 3 years, current Ad-hoc consultant for MoH, nurse and specialist in pharmacoecomics; 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.
  • 3 payers in Mexico: Coordinator of the Nacional 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.

Table of contents

  • Detailed, Expanded Analysis Axial Spondyloarthritis and Psoriatic Arthritis (Brazil & Mexico)
    • Actionable Recommendations to Optimize Market Access
      • Actionable Recommendations to Optimize Market Access for New PsA and AS Therapies in Brazil and Mexico
    • Successes and Stumbles
      • Successes Among PsA and AS Therapies in Brazil and Mexico
      • Stumbles Among PsA and AS Therapies in Brazil and Mexico
    • Key Stakeholders in the Road to Market Access
      • Expert Opinion
      • Brazil: 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 PsA and AS Therapies in Brazil and Mexico
    • Reimbursement Dynamics
      • Brazil: Coverage Dynamics for AS and PsA
        • Brazil: HTA Details and Implications in Drug Coverage
        • Brazil: Drivers of Formulary Coverage
        • Brazil: Coverage Detail and Successes or Stumbles
        • Brazil: Lessons Learned and Key Takeaways
        • Brazil: Reimbursement Background
      • Mexico: Coverage Dynamics for AS and PsA
        • Mexico: HTA Details and Implications in Drug Coverage
        • Mexico: Drivers of Formulary Coverage
        • Mexico: Coverage Detail and Successes or Stumbles
        • Mexico: Lessons Learned and Key Takeaways
        • Mexico: Reimbursement Background
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Prescriber Preferences for PsA
      • Prescriber Preferences for AS
      • Impact of Payer Policy on Prescribing for PsA and AS
      • Top Prescribing Drivers for Current Agents
      • Top Drivers of Biosimilar Prescribing
      • Payer Policy Uptake Constraints
      • Key Levers and Constraints on Current Therapies
    • Market Access Landscape for Emerging Therapies
      • Likely Impact of Emerging Therapies for PsA
      • Likely Impact of Emerging Therapies for AS
      • Likely Impact of Emerging Therapies for PsA and AS (cont.)
        • Likely Impact of Emerging Therapies for PsA and AS
        • Preferred Agents in Second- and Third-Line Therapy for Public Patients with PsA and AS Refractory to Conventional DMARDs
      • Market Access Challenges for Emerging Therapies for PsA and AS: Mexico
      • Payer Opinion on Emerging Therapies for PsA and AS
        • Brazil: Payer Opinion of Emerging Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
        • Mexico: Payer Opinion of Emerging Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
    • Methodology
      • Primary Research Design
      • Physician Demographics and Practice Setting
      • Pricing for the First Year of Treatment
    • Appendix
      • Commercial Context
        • Estimated Prevalent Cases of PsA and AS
        • Key Therapies Used for Ankylosing Spondylitis and Psoriatic Arthritis
        • Advantages and Disadvantages of Key Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
        • Brazil: National Treatment Guidelines for the Treatment of PsA and AS
        • Mexico: Government Guidelines for the Treatment of PsA and AS
        • Price of Select Key PsA and AS Drugs for the First Year of Treatment
        • Approval of Key Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
        • Emerging Therapy Profile─Secukinumab (Cosentyx)
        • Emerging Therapy Profile─Ustekinumab (Stelara)
        • Emerging Therapy Profile─Apremilast (Otezla)
        • Emerging Therapy Profile─Tofacitinib (Xeljanz)
        • Emerging Therapies and Biosimilars for PsA and AS─Timeline of Launches
        • Parcerias de Desenvolvimento Produtivo (PDPs)
        • Parcerias de Desenvolvimento Produtivo (PDPs) - Flowchart
      • Survey Data
        • Formulary Inclusion and Current Treatment Practices
        • Biosimilars
        • Emerging Therapies

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  • Pub Date: April 2016
  • Author(s): Susana Ribeiro da Silva

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