Ulcerative Colitis – Access & Reimbursement – Detailed, Expanded Analysis (Brazil/Mexico)

Treatment of ulcerative colitis (UC) and Crohn’s disease (CD) within Brazil and Mexico includes many of the predominant treatments in other parts of the world such as the TNF-α inhibitors. Notably, however, treatment is driven by the reimbursement status within given markets that curtail reimbursement of some therapies (with variations between public and private settings). The potential arrival of several more agents offering novel MOAs and/or formulations (e.g., Pfizer’s tofacitinib, Gilead/Galapagos’ filgotinib, Roche/Genentech’s etrolizumab), as well as increasing physician experience with prescribing biosimilars, will fuel competition and pricing pressure in these markets. Emerging therapies seeking to maximize patient shares must address the pressure points that drive reimbursement decisions within the Brazilian and Mexican markets.

Questions Answered in This Report:​​​​​​

  • What is the public and private healthcare coverage for targeted therapies in CD and UC, and how do payers’ policies and infrastructure influence access to specialized healthcare and treatments?
  • What are the current drivers and barriers for prescribing established premium-priced agents such as Humira and Remicade, or newer agents such as Entyvio?
  • What will be the impact of biosimilars on reimbursement and treatment decisions and how will this affect premium-priced agents?
  • What clinical benefits are physicians and payers looking for in emerging therapies such as etrolizumab, Xeljanz, and ozanimod? How will prescribing be impacted by expected barriers to access that result from these drugs’ prices?

Scope:

Decision Resources Group’s Access and Reimbursement module for Crohn’s disease and ulcerative colitis in Brazil and Mexico explores the prescribing patterns for current targeted therapies, the potential impact of the anticipated arrival of novel therapies, and key national and regional market access factors that will shape the use of targeted therapies over the next two to three years. This content draws on insights from 101 surveyed physicians and from interviews with 6 payers in Brazil and Mexico, all of whom have influence at the regional, institutional, or national level.

Markets covered: Brazil and Mexico

Primary research:

  • 101 gastroenterologists
  • 6 payers:
    • Brazil:
      • Pharmacist, specializing in public health. Member of the Department of Health of the State of São Paulo. Senior member of CCTIES (Coordinator of Science, Technology and Strategic Health Supplies) of the State of São Paulo. Close collaborator to MoH and CONITEC.
      • Official in the Department of Health of the São Paulo State, coordinating scientific dissemination for the introduction of new technologies in the State.
      • Medical Coordinator of the Gastroenterology Diagnostics Center within a São Paulo hospital center. Participates in committees for the elaboration of protocols of the public and private hospitals.
    • Mexico:
      • Gastroenterologist and hepatologist, members of the Mexican Council of Gastroenterology, have participated in the clinical practice guidelines and recommendations of the Mexican Gastroenterology Council.
      • Department head within ISSSTE, which evaluates medicines and other medical supplies for purchase, programming, and distribution at the national level including immunomodulatory medicines.
      • Official involved with clinical guidelines at the National Center for Technological Excellence in Health (CENETEC), developing and updating clinical practice guidelines in conjunction with experts from all the institutions of the health sector.​​​​​​ ​​​​​

Table of contents

  • Ulcerative Colitis - Access & Reimbursement - Detailed, Expanded Analysis (Brazil/Mexico)
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Optimizing Market Access Opportunity for New UC and CD Therapies in Brazil and Mexico
      • Successes and Stumbles
        • Successes Among UC and CD Therapies in Brazil and Mexico
        • Stumbles Among UC and CD Therapies in Brazil and Mexico
        • Brazil: Coverage Successes & Stumbles
          • Brazil: Coverage Successes and Stumbles
        • Mexico: Coverage Successes & Stumbles
        • Key Stakeholders in the Road to Market Access
          • Brazil
          • Mexico
        • Key Market Access Roadblocks
          • Key Market Access Roadblocks for UC and CD Therapies in Brazil and Mexico
          • Brazil: Key Market Access Roadblocks
          • Mexico: Key Market Access Roadblocks
        • Reimbursement Dynamics
          • Brazil: Coverage Dynamics for UC and CD
            • Brazil: HTA Process
            • Brazil: Drivers of Formulary Coverage for UC and CD Drugs
            • Brazil: Key Background Details of the Healthcare System
            • Brazil: RENAME Components
            • Brazil: CEAF Drugs
          • Mexico: Coverage Dynamics for UC and CD
            • Mexico: HTA Process
            • Mexico: Drivers of Formulary Coverage for UC and CD Drugs
            • Mexico: Key Background Details of the Healthcare System
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences for UC
            • Most Prescribed Biologics for UC Public Patients by Line of Therapy and Disease Stage
            • Most Preferred Biologics for UC in a Scenario of 100% Coverage
          • Prescriber Preferences for CD
            • Most Prescribed Biologics for CD Public Patients by Line of Therapy and Disease Stage
            • Most Preferred Biologics for CD in a Scenario of 100% Coverage
          • Impact of Payer Policy on Prescribing for UC and CD
            • Percentage of Public Patients Eligible for Treatment with Specific Biologics but Not Receiving Treatment Because of Budgetary/Reimbursement Reasons
            • Most Common Access Routes to Vedolizumab
          • Top Prescribing Drivers: UC
            • Top Prescribing Drivers: CD
              • Key Levers and Constraints on Current Therapies
                • Key Levers and Constraints on Current Therapies
            • Market Access Landscape for Emerging Therapies
              • Likely Impact of Emerging Therapies on UC and CD
                • Physicians' Choice of Treatment for UC Without Access Barriers
                • Physicians' Choice of Treatment for CD Without Access Barriers
              • Market Access Challenges for Emerging Therapies for UC and CD
                • Anticipated Most Prescribed Agent for UC with Access Barriers
                • Anticipated Most Prescribed Agent for CD with Access Barriers
                • Main Reasons for Not Prescribing Emerging Therapies
              • Payer Opinion on Emerging Therapies for UC and CD
                • Brazil: Payer Opinion on Emerging Therapies for UC and CD
                • Mexico: Payer Opinion on Emerging Therapies for UC and CD
            • Appendix
              • Commercial Context
                • Estimated Diagnosed Prevalence of Ulcerative Colitis in Brazil and Mexico
                • Estimated Diagnosed Prevalence of Crohn's Disease in Brazil and Mexico
                • Brazil: Treatment Guidelines for UC
                • Brazil: Treatment Guidelines for CD
                • Mexico: Treatment Guidelines for CD
                • Profiles of Key Therapies for Ulcerative Colitis and Crohn's Disease
                • Advantages and Disadvantages of Key Therapies for Ulcerative Colitis and Crohn's Disease
                • Yearly Cost of Select Biologics
                • Timeline of Launch of Key Current and Emerging Therapies
                • Emerging Therapy: Etrolizumab
                • Genentechu2019s Etrolizumab
                • Emerging Therapy: Xeljanz
                • Pfizer's Xeljanz: Tofacitinib
                • Celgene's Ozanimod
                • Emerging Therapy: Filgotinib
                • Galapagos' Filgotinib
                • Emerging Therapy: Cx-601
                • TiGenixu2019s Cx-601
              • Physician Survey Data
                • Biologics-Eligible CD Patients Who Are Actually Receiving Treatment
                • Biologics-Eligible UC Patients Who Are Actually Receiving Treatment
                • Brazil: Formulary Inclusion of Biologics for CD
                • Brazil: Formulary Inclusion of Biologics for UC
                • Mexico: Formulary Inclusion of Biologics for CD
                • Mexico: Formulary Inclusion of Biologics for UC
                • Coverage/Reimbursement and Cost Restrictions Limiting Prescribing of Biologics for Eligible CD Patients
                • Coverage/Reimbursement and Cost Restrictions Limiting Prescribing of Biologics for Eligible UC Patients
                • CD Patients Not Receiving Treatment with Select Biologics Because of Budgetary/Reimbursement Issues
                • UC Patients Not Receiving Treatment with Select Biologics Because of Budgetary/Reimbursement Issues
                • Common Access Routes to Vedolizumab
                • Common Access Routes to Treatment for CD and UC for Seguro Popular-Affiliated Patients
                • Physicians' Choice of Biological Treatments for CD in the Absence of Access Barriers
                • Most Commonly Prescribed Biologic Among CD Public Patients by Line of Therapy and Disease Stage
                • TNF-u03b1 Inhibitors Share of CD Patients
                • Percentages of Patients by CD Severity
                • Patient Shares for CD Drug Classes
                • Most Prescribed First-Line Treatments for CD Public Patients
                • Most Prescribed First-Line Treatments for CD Private Patients
                • Time Before Moving to a Second-Line Treatment for CD
                • Line of Biological Therapy Among CD Private Patients
                • Line of Biological Therapy Among CD Public Patients
                • Most Commonly Prescribed Biologic Among CD Private Patients by Line of Therapy and Disease Stage
                • Prescribing Drivers for the Preferred Biologic in CD Patients
                • Percentages of Patients by UC Severity
                • Patient Shares for UC Drug Classes
                • TNF-u03b1 Inhibitors Share of UC Patients
                • Physicians' Choice of Biological Treatments for UC in the Absence of Access Barriers
                • Most Commonly Prescribed Biologic Among UC Public Patients by Line of Therapy and Disease Stage
                • Most Commonly Prescribed Biologic Among UC Private Patients by Line of Therapy and Disease Stage
                • Most Prescribed First-Line Treatments for UC Public Patients
                • Most Prescribed First-Line Treatments for UC Private Patients
                • Time Before Moving to a Second-Line Treatment for UC
                • Physicians' Recommendation for Coverage of Emerging Therapies for CD
                • Line of Biological Therapy Among UC Private Patients
                • Line of Biological Therapy Among UC Public Patients
                • Prescribing Drivers for the Preferred Biologic in UC Patients
                • Anticipated Launch of Biosimilars
                • Use of Biosimilars in CD Patients
                • Use of Biosimilars in UC Patients
                • Brazil: Percentages of CD Patients Receiving Remsima vs. Bio-Manguinhos Infliximabe
                • Brazil: Percentages of UC Patients Receiving Remsima vs. Bio-Manguinhos Infliximabe
                • Prescribing Drivers of Biosimilar Infliximab for CD Patients
                • Prescribing Drivers of Biosimilar Infliximab for UC Patients
                • Reasons for Not Prescribing Biosimilar Infliximab for CD Patients
                • Reasons for Not Prescribing Biosimilar Infliximab for UC Patients
                • Physicians' Most Anticipated Therapy to Prescribe for CD
                • Anticipated Use of Emerging Agents for CD
                • Physicians' Anticipated Choice of Treatment for UC Patients Without Access Barriers
                • Prescribing Drivers of Emerging Therapies for CD
                • Reasons for Not Expecting to Prescribe Emerging Therapies for CD
                • Anticipated Use of Emerging Agents for UC
                • Physicians' Most Anticipated Therapy to Prescribe for UC
                • Physicians' Anticipated Choice of Treatment for CD Patients Without Access Barriers
                • Prescribing Drivers of Emerging Therapies for UC
                • Reasons for Not Expecting to Prescribe Emerging Therapies for UC
                • Country Practice Location
                • Years in Practice Postresidency
                • Practice Setting
                • CD Patients Treated/Monitored per Month
                • UC Patients Treated/Monitored per Month
                • Public CD Patients Treated with Biologics
                • Public UC Patients Treated with Biologics
                • Private CD Patients Treated with Biologics
                • Private UC Patients Treated with Biologics
                • Brazil: Location of Practice
                • Mexico: Location of Practice
                • Type of Hospital Where Respondents Practice
                • Mexico: Affiliation of Public Patients Receiving Treatment
              • About Decision Resources Group
                • Susana Silva