Introduction

Colorectal cancer (CRC) affects several thousands of people in Brazil and Mexico. Once it metastasizes, the only available therapeutic options are premium-priced targeted agents and chemotherapy. In Mexico, coverage varies across the different healthcare programs, and in Brazil, the uniqueness of public funding for oncology drugs limits public coverage of treatments. The future will bring an influx of new drugs and biosimilars, and while both countries are eager to adopt new technologies, they have limited budgets. In this increasingly competitive market, only drugs that meet the clinical and economic expectations of both countries will achieve success.This A&R analysis provides key insights for navigating the CRC therapy market in Brazil and Mexico and adapting a branded therapy’s value message to payers and physician needs and expectations in each country.

Scope:

Decision Resources Group’s Access and Reimbursement module for colorectal cancer in Brazil and Mexico explores the prescribing patterns for current CRC therapies; the potential impact of the anticipated arrival of novel therapies; and key national, regional, and institutional market access factors that will shape the use of CRC therapies over the next two to three years. This report draws on insights from 104 surveyed physicians and from interviews with 6 payers in Brazil and Mexico, all of whom have influence at the institutional, regional, or national level.

Markets covered: Brazil and Mexico.

Primary research:

  • 104 oncologists/medical oncologists
  • 6 payers:
    • Brazil:
      • Senior Member of the Department of Logistics, Purchasing, and Dispensing of Drugs in a reference institution for cancer treatment.
      • Pharmacology Commission member in national reference institution in São Paulo.
      • Head of medical audit department of a major HMO.
    • Mexico
      • National coordinator of Special Programs at ISSSTE.
      • Head of the Department of Oncology at an IMSS hospital.
      • Head of the Department of Medical Oncology at INCAN.

Questions Answered in This Report:

  • What is the public and private healthcare coverage for premium-priced CRC therapies in Brazil and Mexico? How do payers’ policies and infrastructure influence access to specialized healthcare and treatments?
  • What are the current drivers of and barriers to the prescribing of premium-priced CRC therapies? What are the main cost-related/clinical constraints to uptake?
  • What is surveyed physicians’ and payers’ expected pricing of emerging therapies for CRC?
  • How do payers expect access to premium-priced therapies and biosimilars for CRC to evolve in the next three years, and which emerging therapies do payers expect will be covered?
  • How do physicians expect to prescribe emerging agents and biosimilars for CRC? What are these therapies’ likely impact on current brands over the next three years?
  • What clinical benefits do physicians and payers in Brazil and Mexico seek from emerging CRC therapies? What types of savings on direct and indirect costs are payers looking for?
  • What roles will head-to-head and pharmacoeconomic outcomes play in differentiating the reimbursement of high-priced targeted therapies versus currently available targeted therapies?

Table of contents

  • Colorectal Cancer - Access & Reimbursement - Detailed, Expanded Analysis (Brazil/Mexico)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New Metastatic Colorectal Cancer Therapies in Brazil and Mexico
    • Successes and Stumbles
      • Successes Among Targeted Therapies for Metastatic CRC in Brazil and Mexico
      • Stumbles Among Targeted Therapies for Metastatic CRC in Brazil and Mexico
      • Brazil: Coverage Successes & Stumbles
        • Mexico: Coverage Successes & Stumbles
        • Key Stakeholders in the Road to Market Access
          • Brazil
          • Mexico
        • Key Market Access Roadblocks
          • Key Market Access Roadblocks for Metastatic CRC Therapies in Brazil and Mexico
          • Brazil: Key Market Access Roadblocks
          • Mexico: Key Market Access Roadblocks
        • Reimbursement Dynamics
          • Brazil: Coverage Dynamics for Metastatic Colorectal Cancer
            • Brazil: HTA Process
            • Brazil: Drivers of Formulary Coverage for Metastatic Colorectal Cancer Drugs
            • Brazil: Coverage & HTA Details for Key Drugs for Metastatic Colorectal Cancer
            • Brazil: Key Background Details of the Healthcare System
          • Mexico: Coverage Dynamics for Metastatic Colorectal Cancer
            • Mexico: HTA Process
            • Mexico: Drivers of Formulary Coverage for Metastatic Colorectal Cancer Drugs
            • Mexico: Coverage Details for Key Drugs for Metastatic Colorectal Cancer
            • Mexico: Key Background Details of the Healthcare System
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences for Therapies for Wild-Type RAS Patients
            • Patient Shares for First-Line Therapy
            • Patient Shares for First-Line Therapy Among Patients Receiving a Targeted Therapy
            • Most-Prescribed Drugs for Second- and Third-Line Therapy in Wild-Type RAS Patients in the Public Sector
            • Most-Prescribed Drugs for Second- and Third-Line Therapy in Wild-Type RAS Patients in the Private Sector
          • Prescriber Preferences for Therapies for Mutated RAS Patients
            • Most-Prescribed Drugs for Mutated RAS Patients in the Public Sector
            • Most-Prescribed Drugs for Mutated RAS Patients in the Private Sector
          • Prescriber Preferences for Biosimilars
            • Speed of Biosimilar Uptake by Surveyed Oncologists
            • Oncologists’ Reasons for Not Prescribing Biosimilars Within Two Years of Launch
          • Impact of Payer Policy on Prescribing for Metastatic Colorectal Cancer
            • Percentage of Patients Receiving Treatment
            • Percentage of Patients Eligible for Treatment with Targeted Therapies But Not Receiving Them Because of Cost, Budgetary, or Reimbursement Reasons
            • Percentage of Metastatic CRC Patients Eligible for Targeted Therapy But Not Receiving It Because of Budgetary/Reimbursement Restrictions
            • Top Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Eligible Metastatic CRC Patients
            • Most Prescribed First-Line Therapies for Wild-Type RAS Patients in Three Years
            • Treatment of Choice for Wild-Type RAS Patients in the Absence of Access Barriers
            • Treatment of Choice for Mutated RAS/RAS Status Unknown in the Absence of Access Barriers
          • Top Prescribing Drivers: Metastatic Colorectal Cancer
            • Top Prescribing Drivers: First-Line Therapy for Wild-Type RAS Patients
          • Key Levers and Constraints on Current Therapies
          • Market Access Landscape for Emerging Therapies
            • Likely Impact of Emerging Therapies on the Treatment of Metastatic Colorectal Cancer
              • Oncologists' Choice of Second- and Third-Line Treatment of Wild-Type RAS Patients in the Absence of Access Barriers
              • Oncologists' Choice of Second- and Third-Line Treatment for Wild-Type RAS Patients in the Presence of Access Barriers
              • Oncologists' Choice of Second- and Third-Line Treatment for Mutated RAS Patients in the Absence of Access Barriers
              • Oncologists' Choice of Second- and Third-Line Treatment for Mutated RAS Patients in the Presence of Access Barriers
            • Market Access Challenges for Emerging Therapies for Metastatic Colorectal Cancer
              • Acceptable Launch Prices for Emerging Therapies
              • Oncologists' Preference for Stivarga, Lonsurf, or Vargatef
              • Oncologists' Preference for Avastin, Bevacizumab Biosimilar, Cyramza, or Zaltrap
            • Payers' Opinion of Emerging Therapies for Metastatic Colorectal Cancer
              • Brazil: Payers' Opinion of Emerging Therapies for Metastatic Colorectal Cancer
              • Mexico: Payers' Opinion of Emerging Therapies for Metastatic Colorectal Cancer
          • Methodology
            • Abbreviations
            • Primary Research Design
            • Background of Payers and Payer-Advising KOLs
            • Physician Demographics and Practice Setting
              • In What Country Is Your Practice Located?
              • What Is Your Specialty?
              • How Many Years Have You Practiced Postresidency?
              • How Would You Best Describe the Setting(s) in Which You Practice?
              • How Many Adult Patients (≥ 18 Years) Do You Treat per Month per Setting?
              • Brazil: In What City Is Your Practice Located?
              • Mexico: In What City Is Your Practice Located?
              • At What Kind of Hospital(s) Do You Practice?
              • Mexico: What Is Your Public Hospital Affiliation?
              • Which of the Following Treatments Have You Prescribed to Your Adult mCRC Patients Outside of Clinical Trials?
            • Pricing Methodology
          • Appendix
            • Commercial Context
              • Epidemiology: Diagnosed Prevalence of Colorectal Cancer in Brazil and Mexico
              • Treatment Guidelines for Colorectal Cancer in Brazil
              • Guidelines for Colorectal Cancer
              • Treatment Guidelines for Colorectal Cancer in Mexico
              • Sources of Treatment Guidelines for Colorectal Cancer
              • Profiles of Key Drugs for Metastatic Colorectal Cancer in Brazil and Mexico
              • Advantages and Disadvantages of Key Drugs for Metastatic Colorectal Cancer
              • Price per 28 Days of Treatment with Select Metastatic Colorectal Cancer Drugs
              • Brazil: APAC Values for Metastatic Colorectal Cancer Treatments
              • Timeline of Approvals of Key Current and Emerging Therapies for Metastatic Colorectal Cancer
              • Emerging Therapy (Mexico Only): Zaltrap (Aflibercept)
              • Regeneron/Sanofi’s Aflibercept (Zaltrap)
              • Emerging Therapy: Lonsurf (TAS-102)
              • Taiho Pharmaceutical’s TAS-102 (Lonsurf)
              • Emerging Therapy: Cyramza (Ramucirumab)
              • Eli Lilly’s Ramucirumab (Cyramza)
              • Emerging Therapy (Brazil Only): Stivarga (Regorafenib)
              • Bayer’s Regorafenib (Stivarga)
              • Emerging Therapy: Vargatef (Nintedanib)
              • Boehringer Ingelheim’s Nintedanib (Vargatef)
              • Brazil: Productive Development Partnerships for Bevacizumab and Cetuximab
              • Brazil: Phases of the Productive Development Partnerships
            • Physician Survey Data
              • Brazil: Percentage of Metastatic Colorectal Cancer Patients Receiving Treatment
              • Mexico: Percentage of Metastatic Colorectal Cancer Patients Receiving Treatment
              • Brazil: Formulary Inclusion of Targeted Therapies for Metastatic Colorectal Cancer
              • Mexico: Formulary Inclusion of Targeted Therapies for Metastatic Colorectal Cancer
              • Brazil: mCRC Patients Not Receiving Targeted Therapies Because of Budgetary/Reimbursement Reasons
              • Mexico: mCRC Patients Not Receiving Targeted Therapies Because of Budgetary/Reimbursement Reasons
              • Brazil: Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Treatment-Eligible mCRC Patients
              • Mexico: Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Treatment-Eligible mCRC Patients
              • Mexico: Detailed Analysis of Subset of Coverage/Reimbursement and Cost Restrictions Limiting Prescribing to Treatment-Eligible mCRC Patients
              • Brazil: Common Access Routes to Targeted Therapies When Unavailable or Uncovered
              • Mexico: Common Access Routes to Targeted Therapies When Unavailable or Uncovered
              • Brazil: Oncologists' Opinions of CONITEC's Decision Not to Cover Cetuximab (Erbitux) plus Chemotherapy as First-Line Therapy for Wild-Type RAS mCRC
              • Brazil: Reasons to Agree/Disagree with CONITEC's Decision
              • Mexico: Physicians' Opinions of the Lack of Coverage for Targeted Therapies by Seguro Popular and IMSS
              • Mexico: Physicians' Expectations for Coverage of Targeted Therapies by Seguro Popular and IMSS
              • Brazil: Healthcare Authorities' Preferred Targeted Therapy for Metastatic Colorectal Cancer
              • Mexico: Healthcare Authorities' Preferred Targeted Therapy for Metastatic Colorectal Cancer
              • Brazil: Reimbursement Under the APAC
              • RAS (KRAS/NRAS) Testing
              • RAS (KRAS/NRAS) Testing: Conclusive Results
              • Average Time to Receive Results of RAS (KRAS/NRAS) Testing
              • Oncologists' Opinion of the Impact of Time to Receive RAS (NRAS/KRAS) Testing Results
              • Restrictions on RAS Mutation Testing
              • Origin of Funding for RAS Mutation Testing
              • Patient Shares for First-Line Treatment of Metastatic Colorectal Cancer Wild-Type RAS
              • Brazil: Most Prescribed Second- and Third-Line Treatment Regimens for Wild-Type RAS Patients
              • Mexico: Most Prescribed Second- and Third-Line Treatment Regimens for Wild-Type RAS Patients
              • Brazil: Most Prescribed Treatment Regimens for Mutated RAS Patients
              • Mexico: Most Prescribed Treatment Regimens for Mutated RAS Patients
              • Brazil: Off-Label Prescribing
              • Mexico: Off-Label Prescribing
              • Access Routes to Prescribing Treatments Off-Label
              • Mexico: Impact of the "Torre de Control" and ISSSTE's Administrative Process on Patients' Access to Targeted Therapies
              • Mexico: Impact of "Torre de Control" and ISSSTE's Administrative Process on the Time It Takes to Access Treatments
              • Brazil: Prescribing Drivers of Current Therapies
              • Brazil: Prescribing Drivers of Specific Therapies for Public Patients with Wild-Type RAS
              • Brazil: Prescribing Drivers of Specific Therapies for Public Patients with Mutated RAS
              • Brazil: Prescribing Drivers of Specific Therapies for Private Patients with Wild-Type RAS
              • Brazil: Prescribing Drivers of Specific Therapies for Private Patients with Mutated RAS
              • Mexico: Prescribing Drivers of Current Therapies
              • Mexico: Prescribing Drivers of Specific Therapies for Public Patients with Wild-Type RAS
              • Mexico: Prescribing Drivers of Specific Therapies for Public Patients with Mutated RAS
              • Mexico: Prescribing Drivers of Specific Therapies for Private Patients with Wild-Type RAS
              • Mexico: Prescribing Drivers of Specific Therapies for Private Patients with Mutated RAS
              • Mexico: Prescribing Drivers of Stivarga
              • Brazil: Prescribing Drivers of Zaltrap
              • Brazil: Percentage of Patients Receiving Zaltrap
              • Mexico: Percentage of Patients Receiving Stivarga
              • Mexico: Hurdles to Prescribing Stivarga
              • Brazil: Hurdles to Prescribing Zaltrap
              • Brazil: Oncologists' Choice of Treatments in the Absence of Access Barriers
              • Mexico: Oncologists' Choice of Treatments in the Absence of Access Barriers
              • Delays in the Prescribing of Biosimilars for Metastatic Colorectal Cancer
              • Expected Patient Shares of Biosimilars for Metastatic Colorectal Cancer Two Years After Their Launch
              • Oncologists’ Reasons for Not Prescribing Biosimilars Within Two Years of Launch
              • Brazil: Impact of the Availability of PDP-Developed Biosimilars on Patient Access to Treatments
              • Brazil: Oncologists' Willingness to Prescribe Emerging Therapies
              • Mexico: Oncologists' Willingness to Prescribe Emerging Therapies
              • Brazil: Drivers to Prescribing Emerging Therapies
              • Mexico: Drivers to Prescribing Emerging Therapies
              • Brazil: Obstacles to Prescribing Emerging Therapies
              • Mexico: Obstacles to Prescribing Emerging Therapies
              • Oncologists' Preference for Stivarga, Lonsurf, or Vargatef
              • Oncologists' Preference for Avastin, Bevacizumab Biosimilar, Cyramza, or Zaltrap
              • Acceptable Launch Prices for Emerging Therapies
              • Brazil: Oncologists' Recommendation for Coverage of Emerging Therapies for Wild-Type RAS Patients
              • Mexico: Oncologists' Recommendation for Coverage of Emerging Therapies for Wild-Type RAS Patients
              • Brazil: Oncologists' Recommendation for Coverage of Therapies for Mutated RAS Patients
              • Mexico: Oncologists' Recommendation for Coverage of Therapies for Mutated RAS Patients
              • Expected Choices of Treatments for Wild-Type RAS Patients
              • Brazil: Expected Choices of Treatments for Wild-Type RAS Patients
              • Mexico: Expected Choices of Treatments for Wild-Type RAS Patients
              • Expected Choices of Treatments for Mutated RAS Patients
              • Brazil: Expected Choices of Treatments for Mutated RAS Patients
              • Mexico: Expected Choices of Treatments for Mutated RAS Patients
              • Oncologists' Choice of Treatment for Wild-Type RAS Patients in the Absence of Access Barriers
              • Oncologists' Choice of Treatment for Mutated RAS Patients in the Absence of Access Barriers

        Author(s): Nuno Tiago Giao Antunes, 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.


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