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

  • Axial Spondyloarthritis - Access & Reimbursement - 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
        • HTA Details and Implications in Drug Coverage
        • Brazil: Drivers of Formulary Coverage for Premium-Priced Therapies for AS and PsA
        • Brazil: Drivers of Formulary Coverage of Key Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
        • Key Background Details of the Healthcare System
        • Organization of the RENAME
        • Acquisition, Planning, Distribution, and Dispensation of CEAF Drugs
        • Access to Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
      • Mexico: Coverage Dynamics for AS and PsA
        • HTA Details and Implications in Drug Coverage
        • Mexico: Drivers of Formulary Coverage for Premium-Priced Therapies for AS and PsA
        • Mexico: Drivers of Formulary Coverage of Key Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
        • Key Background Details of the Healthcare System
        • Access to Therapies for Ankylosing Spondylitis and Psoriatic Arthritis
        • Treatment Guidelines for Ankylosing Spondylitis and Psoriatic Arthritis in Mexico
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Prescriber Preferences for PsA
        • Mean Patient Share Among Public PsA Patients
        • Rheumatologists’ Choice for First-Line Biologic
      • Prescriber Preferences for AS
        • Mean Patient Share Among Public AS Patients
        • Rheumatologists’ Choice for First-Line Biologic
      • Impact of Payer Policy on Prescribing for PsA and AS
        • Public patients’ access to select biologics
        • Percentage of clinically eligible public patients actually treated with a biologic for PsA or AS
      • Top Prescribing Drivers for Current Agents
        • Key Factors Driving Prescribing of One TNF Inhibitor over Others in the First Line for PsA and AS, After Failure of DMARD Treatment
      • Top Drivers of Biosimilar Prescribing
        • Reasons for Not Prescribing a Biosimilar: Brazil
        • Reasons for Not Prescribing a Biosimilar: Mexico
      • Payer Policy Uptake Constraints
        • Impact of Government Coverage on Biologics' Prescibing for PsA and AS
      • Key Levers and Constraints on Current Therapies
      • Market Access Landscape for Emerging Therapies
        • Likely Impact of Emerging Therapies for PsA
          • Preferred Lines of Therapy for Emerging Agents for PsA Refractory to Conventional DMARDs, Assuming 100% Coverage in the Future
        • Likely Impact of Emerging Therapies for AS
          • Preferred Lines of Therapy for Emerging Agents for AS Refractory to Conventional DMARDs, Assuming 100% Coverage in the Future
        • Likely Impact of Emerging Therapies for PsA and AS (cont.)
          • Likely Impact of Emerging Therapies for PsA and AS
          • Second Line PsA
          • Second Line AS
          • Third Line PsA
          • Third Line AS
        • Market Access Challenges for Emerging Therapies for PsA and AS: Mexico
          • Product Selected for Coverage (% of rheumatologists)
          • Suggested Prices for Emerging Therapies Relative to Humira
        • Payer Opinion on Emerging Therapies for PsA and AS
          • Brazilian Payer Insight on Emerging Therapies for AS and PsA
          • Mexican Payer Insight on Emerging Therapies for AS and PsA
      • 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
              • PsA Total Prevalent Cases
              • AS Total Prevalent Cases
              • Populations Eligible to Receive Therapy with Public Funding in Brazil
              • Populations Eligible to Receive Biologic Therapy with Public Funding in Mexico
              • Yearly cost of selected PsA and AS drugs
              • Novartis’s Secukinumab (Cosentyx)
              • Novartis’s Secukinumab (Cosentyx)
              • Celgene’s Apremilast (Otezla)
              • Pfizer’s Tofacitinib (Xeljanz)
              • Commercial Context: Parcerias de Desenvolvimento Produtivo (PDPs) – Flowchart
            • Survey Data
              • PsA and AS Patient Eligibility for Biologics
              • Brazil: Public Formulary Inclusion of Biologics for PsA and AS
              • Mexico: Public Formulary Inclusion of Biologics for PsA and AS
              • Patient Shares for PsA and AS Therapies After Conventional DMARD Treatment Fails
              • Most Used Biologics for PsA by Line of Therapy─Public Patients
              • Most Used Biologics for PsA by Line of Therapy─Private Patients
              • Most Used Biologics for AS by Line of Therapy─Public Patients
              • Most Used Biologics for AS by Line of Therapy─Private Patients
              • Location of Administration for SC Biologics
              • Anticipated Future Use of SC Versions
              • Off-Label Use of Select Therapies for PsA and AS
              • Off-Formulary Use of Rituximab for PsA and AS
              • Reasons for Prescribing Select Biologics for PsA and AS
              • Reasons for Prescribing Select Biologics for PsA and AS
              • Budgetary Issues Limiting the Prescribing of Select Therapies for Eligible PsA and AS Patients
              • Patients Not Treated with Biologics for Budgetary Reasons
              • Mexico: Patients Not Treated with Biologics for Budgetary Reasons
              • Most-Preferred Biologic for PsA and AS
              • Healthcare Authorities’ Preferred Therapy for First-Line Treatment of Conventional-DMARD/NSAID-Refractory PsA and AS Patients
              • Health Authority Bodies That Are Considered Barriers to Reimbursement of Premium-Priced Therapies for PsA and AS
              • Therapeutic Failure Prior to the Use of a Biologic
              • Expectations for the Prescribing of SC Therapies for PsA and AS─Private Patients
              • Physician Recommendation for the Public Coverage of Simponi for PsA and AS
              • Anticipated Public Coverage of Simponi for PsA and AS
              • Reasons for the Anticipated Public Coverage of Simponi for PsA and AS
              • Brazil: Current Patient Share for PsA and AS Biosimilars
              • Mexico: Current Patient Share for PsA and AS Biosimilars
              • Current Patient Share of Brand versus Biosimilar Infliximab
              • Mexico: Current Patient Share of Brand vs. Biosimilar Etanercept
              • Brazil: Willingness to Use and Clinical Scenarios for the Prescribing of PsA and AS Biosimilars
              • Mexico: Willingness to Use and Clinical Scenarios for the Prescribing of PsA and AS Biosimilars
              • Brazil: Drivers of Biosimilar Use
              • Mexico: Drivers of Biosimilar Use
              • Brazil: Factors Preventing Biosimilar Use
              • Mexico: Factors Preventing Biosimilar Use
              • Brazil: Ability to Choose Between the Branded Biologic and the Biosimilar Version for Public Patients
              • Mexico: Ability to Choose Between the Branded Biologic and the Biosimilar Version for Public Patients
              • Health Authority Encouragement of Biosimilar Use
              • Rheumatologists’ Opinion of Indication Extrapolation
              • Price Expectations for Biosimilars at Launch
              • Delays in the Prescribing of Biosimilars to PsA and AS Patients
              • Brazil: Expected Patient Shares of Biosimilars for PsA and AS Patients Two Years After the Biosimilar’s Launch
              • Mexico: Expected Patient Shares of Biosimilars for PsA and AS Patients Two Years After the Biosimilar’s Launch
              • Rheumatologists’ Reasons for Not Prescribing Biosimilars Within Two Years of Launch
              • Anticipated Use of Cosentyx, Stelara, Otezla, and Xeljanz for PsA and AS by 2019
              • Brazil: Reasons for Using Novel Therapies for PsA and AS Instead of the Currently Approved Biologics by 2019
              • Mexico: Reasons for Using Novel Therapies for PsA and AS Instead of the Currently Approved Biologics by 2019
              • Brazil: Reasons for Expecting Not to Prescribe Cosentyx, Stelara, Otezla, and Xeljanz by 2019
              • Mexico: Reasons for Expecting Not to Prescribe Cosentyx, Stelara, Otezla, and Xeljanz by 2019
              • Anticipation of the Most-Prescribed Agent by Line of Therapy for DMARD-Refractory Patients by 2019
              • Anticipation of the Most-Prescribed Agent by Line of Therapy for DMARD-Refractory Patients by 2019 in a Hypothetical Full-Coverage Scenario
              • Most-Preferred Emerging Therapy to Be Granted Coverage for PsA and AS
              • Price Expectations for Emerging Therapies

        Author(s): Susana Ribeiro da Silva

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