Introduction

Chronic Hepatitis C (HCV) affects several thousand people in Brazil and Colombia. New therapies allow cure in a short period of time with minimal side effects, in contrast to older options. Brazil updated the HCV clinical guidelines in 2015, and Colombia has recently started prioritizing this disease. Both countries are eager to adopt new technologies, but are also undergoing economic hardships. Likewise, Colombia’s plan of benefits will soon experience significant changes, and ongoing discussions may freeze the healthcare budget in Brazil. Hence, only drugs meeting payers’ and physicians’ clinical and economic expectations will succeed in this highly profitable, yet competitive, market. This Access and Reimbursement analysis provides key insights for navigating the chronic HCV therapy market in Brazil and Colombia, and for 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 the hepatitis C virus in Brazil and Colombia explores the prescribing patterns for current chronic HCV 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 chronic HCV therapies over the next two to three years. This report draws on insights from 103 surveyed physicians and from interviews with six payers in Brazil and Colombia, all of whom have influence at the regional or national level.

Markets covered: Brazil and Colombia

Primary research:

  • 103 specialists:
    • 36 specialists in infectious diseases
    • 30 specialists in gastroenterology
    • 19 specialists in hepatology
    • 18 physicians from other specialties such as internal medicine
  • 6 payers:
    • Brazil:
      • Former member of CONITEC, responsible for receiving, analyzing, and assembling dossiers to support the plenary decision.
      • Health technical director in the Group of Pharmaceutical Support of the Coordinating Body of Science, Technology and Strategic Products of São Paulo’s State Health Secretary.
      • Technical analyst of social policies in the Health Ministry. Formerly at the Health Ministry’s Department of Pharmaceutical Care.
    • Colombia:
      • University professor in health economics and health management. Former president of the Board of Medical Devices Assessment of INVIMA (Colombia) and member of the board of ISPOR-Colombia.
      • Director of medical audit at SALUDVIDA EPS (Contributive and Subsidized Schemes).
      • Representative of Aliansalud EPS (Contributive Scheme and Pre-paid Medicine).

Questions Answered in This Report:

  • What is the public and private healthcare coverage for chronic HCV therapies in Brazil and Colombia? 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 chronic HCV therapies? What are the main cost-related/clinical constraints to uptake?
  • What is surveyed physicians’ and payers’ expected pricing of emerging therapies for chronic HCV?
  • How do payers expect access to premium-priced therapies for chronic HCV 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 for chronic HCV? What are these therapies’ likely impact on current brands over the next three years?
  • What clinical benefits do physicians and payers in Brazil and Colombia seek from emerging chronic HCV 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 emerging chronic HCV therapies versus those currently available?

Table of contents

  • Hepatitis C Virus - Access & Reimbursement - Detailed, Expanded Analysis (Brazil & Colombia)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New Hepatitis C Therapies in Brazil and Colombia
    • Successes and Stumbles
      • Successes Among Hepatitis C Therapies in Brazil and Colombia
      • Stumbles Among Hepatitis C Therapies in Brazil and Colombia
      • Brazil: Coverage Successes and Stumbles of DAAs
        • Colombia: Coverage Successes and Stumbles of DAAs
        • Key Stakeholders in the Road to Market Access
          • Brazil
          • Colombia
        • Key Market Access Roadblocks
          • Key Market Access Roadblocks for Hepatitis C Therapies in Brazil and Colombia
          • Brazil: Key Market Access Roadblocks
          • Colombia: Key Market Access Roadblocks
        • Reimbursement Dynamics
          • Brazil: Coverage Dynamics for Hepatitis C
            • Brazil: HTA Process
            • Brazil: Drivers of Formulary Coverage for Hepatitic C Drugs
            • Brazil: Coverage and HTA Details for HCV Drugs
            • Brazil: Key Background Details of the Healthcare System
            • Brazil: RENAME Components
            • Brazil: CEAF Drugs
          • Colombia: Coverage Dynamics for Hepatitis C
            • Colombia: HTA Process
            • Colombia: Drivers of Formulary Coverage for Hepatitis C Drugs
            • Colombia: Coverage Details for HCV Drugs
            • Colombia: Key Background Details of the Healthcare System
            • Colombia: UPC Values
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences for Genotype-1-Infected Patients
            • Brazil: Patient Shares for Genotype 1
            • Colombia: Patient Shares for Genotype 1
          • Prescriber Preferences for Genotype-2-Infected and Genotype-3-Infected Patients
            • Brazil: Patient Shares for Genotypes 2 and 3
            • Colombia: Patient Shares for Genotypes 2 and 3
            • Most Prescribed Therapeutic Regimens for Genotype-2 Public Patients
            • Most Prescribed Therapeutic Regimens for Genotype-3 Public Patients
          • Impact of Payer Policy on Prescribing for Chronic Hepatitis C
            • Impact of Payer Policy on Prescribing for Chronic Hepatitis C: Dynamics of Access
            • Percentage of Patients Eligible for Treatment but Not Receiving Treatment Because of Budgetary/Reimbursement Reasons
            • Top Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Eligible Chronic Hepatitis C Patients
            • Impact of Payer Policy on Prescribing for Chronic Hepatitis C—Changes in Prescribing Without Access Barriers
            • Preferred Treatment for Genotype-1 Patients in the Absence of Barriers
            • Brazil: Preferred Treatment for Genotype-2 Patients in the Absence of Barriers
            • Brazil: Preferred Treatment for Genotype-3 Patients in the Absence of Barriers
          • Top Prescribing Drivers: Chronic Hepatitis C
            • Brazil: Top Prescribing Drivers for Treatment-Naive Noncirrhotic Patients
            • Colombia: Top Prescribing Drivers for Treatment-Naive Noncirrhotic Patients
          • Key Levers and Constraints on Current Therapies
          • Market Access Landscape for Emerging Therapies
            • Likely Impact of Emerging Therapies for Chronic Hepatitis C
              • Brazil: Physicians' Choices of Treatments for Genotype-1 Patients Without Access Barriers
              • Brazil: Physicians' Choices of Treatments for Genotype-1 Patients with Access Barriers
              • Colombia: Physicians' Choices of Treatments for Genotype-1 Patients Without Access Barriers
              • Colombia: Physicians' Choices of Treatments for Genotype-1 Patients with Access Barriers
              • Physicians' Choices of Treatments for Genotype-2 Patients Without Access Barriers
              • Brazil: Physicians' Choices of Treatments for Genotype-2 Patients with Access Barriers
              • Colombia: Physicians' Choices of Treatments for Genotype-2 Patients with Access Barriers
              • Physicians' Choices of Treatments for Genotype-3 Patients Without Access Barriers
              • Brazil: Physicians' Choices of Treatments for Genotype 3-Patients with Access Barriers
              • Colombia: Physicians' Choices of Treatments for Genotype-3 Patients with Access Barriers
            • Market Access Challenges for Emerging Therapies for Chronic Hepatitis C
              • Main Reasons for Not Prescribing Emerging Therapies in Brazil
              • Main Reasons for Not Prescribing Emerging Therapies in Colombia
              • Acceptable Launch Prices for Emerging Therapies
            • Payer Opinion on Emerging Therapies for Chronic Hepatitis C
              • Brazil: Payer Opinion on Emerging Therapies for Chronic Hepatitis C
              • Colombia: Payer Opinion on Emerging Therapies for Chronic Hepatitis C
          • Methodology
            • Abbreviations
            • Primary Research Design
            • Background of Payers and Payer-Advising KOLs
            • Physician Demographics and Practice Setting
              • Country Practice Location
              • Physician Specialties
              • Years in Practice Postresidency
              • Chronic HCV Patients Treated/Monitored in the Last Six Months
              • Awareness of Current and Emerging Therapies for Chronic HCV
              • Percentage of Chronic HCV Patients with Different Genotypes Currently Treated/Treated in the Past Six Months with Pharmacotherapy
              • Practice Setting
              • Percentage of Public and Private Patients Receiving Treatment
              • Brazil: Location of Practice
              • Colombia: Location of Practice
              • Type of Hospital Where Respondents Practice
              • Colombia: Affiliation of Public Patients Receiving Treatment
              • Prescribing of Chronic HCV Therapies Within the Past Six Months
            • Pricing Methodology
          • Appendix
            • Commercial Context
              • Epidemiology: Total Prevalence of Hepatitis C in Brazil and Colombia
              • Brazil: Treatment Guidelines for Chronic Hepatitis C
              • Colombia: Treatment Guidelines for Chronic Hepatitis C
              • Colombia: Treatment Guidelines for Chronic Hepatitis C
              • Profiles of Key Drugs for Chronic Hepatitis C
              • Advantages and Disadvantages of Key Drugs for Chronic Hepatitis C
              • Price per Day of Treatment with Drugs for Chronic Hepatitis C (Second-Generation DAAs)
              • Timeline of Approvals of Key Drugs for Chronic Hepatitis C
              • Emerging Therapy (Colombia Only): Sovaldi (Sofosbuvir)
              • Gilead's Sovaldi (Sofosbuvir)
              • Emerging Therapy: Epclusa (Sofosbuvir/Velpatasvir)
              • Gilead's Epclusa (Sofosbuvir/Velpatasvir)
              • Emerging Therapy: Harvoni (Sofosbuvir/Ledipasvir)
              • Gilead's Harvoni (Sofosbuvir/Ledipasvir)
              • Emerging Therapy: Zepatier (Grazoprevir/Elbasvir)
              • Merck's Zepatier (Grazoprevir/Elbasvir)
            • Physician Survey Data
              • Brazil: Formulary Inclusion of Drugs for Chronic HCV
              • Colombia: Formulary Inclusion of Drugs for Chronic HCV
              • Brazil: Chronic Hepatitis C Patients Not Receiving Treatment Because of Budgetary/Reimbursement Reasons
              • Colombia: Chronic Hepatitis C Patients Not Receiving Treatment Because of Budgetary/Reimbursement Reasons
              • Brazil: Treatment Barriers and Priorities of Different Chronic Hepatitis C Patient Populations
              • Colombia: Treatment Barriers and Priorities of Different Chronic Hepatitis C Patient Populations
              • Brazil: Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Treatment-Eligible Chronic Hepatitis C Patients
              • Colombia: Coverage/Reimbursement and Cost Restrictions Limiting Prescribing for Treatment-Eligible Chronic Hepatitis C Patients
              • Brazil: Common Access Routes to Hepatitis C Therapies When Unavailable or Uncovered
              • Colombia: Common Access Routes to Hepatitis C Therapies When Unavailable or Uncovered
              • Colombia: Common Access Routes to Hepatitis C Therapies When Unavailable or Uncovered (continued)
              • Brazil: Origin of Funding of Hepatitis C Treatment for Private Patients
              • Brazil: Agreement with CONITEC's Decison to Not Cover Viekira Pak
              • Brazil: Expected Prescribing Changes If Viekira Pak Becomes Covered by SUS
              • Colombia: Factors Deterring Inclusion of Drugs for the Treatment of Chronic Hepatitis C in the POS
              • Colombia: Factors Deterring Inclusion of Drugs for the Treatment of Chronic Hepatitis C in the POS (continued)
              • Brazil: Healthcare Authorities' Preferred Therapy for Chronic Hepatitis C
              • Colombia: Healthcare Authorities' Preferred Therapy for Chronic Hepatitis C
              • Allowed Prescribers of Hepatitis C Drugs
              • Colombia: Source of Clinical Guidelines Consulted for Hepatitis C Treatment
              • Colombia: Impact of Consulted Guidelines on Prescribing of Hepatitis C Treatments
              • Brazil: Impact of New PCDTs on Physicians' Prescribing
              • Specific Conditions for Which Prescribing Was Modified
              • Brazil: Impact of Loss of Coverage of Boceprevir/Telaprevir in Prescribing
              • Diagnostic Laboratory Tests and Liver Health Assessment Tests Prescribed to Hepatitis C Patients
              • Brazil: Time to Receive Laboratory Test Results
              • Colombia: Time to Receive Laboratory Test Results
              • Brazil: Impact of Coverage of Noninvasive Liver Stiffness Measurement in the Use of Liver Biopsy
              • Brazil: Impact of New PCDTs on Warehoused Patients
              • Colombia: Percentage of Public Chronic Hepatitis C Patients Who Are Warehoused
              • Colombia: Percentage of Private Chronic Hepatitis C Patients Who Are Warehoused
              • Brazil: Stage of Liver Disease Among Genotype-1, -2, and -3 Public Patients
              • Colombia: Stage of Liver Disease Among Genotype-1, -2, and -3 Public Patients
              • Brazil: Stage of Liver Disease Among Genotype-1, -2, and -3 Private Patients
              • Colombia: Stage of Liver Disease Among Genotype-1, -2, and -3 Private Patients
              • Patient Shares for Treatment-Naive Noncirrhotic Chronic Hepatitis C Patients
              • Brazil: Patient Shares for Treatment-Naive Noncirrhotic Chronic Hepatitis C Patients
              • Colombia: Patient Shares for Treatment-Naive Noncirrhotic Chronic Hepatitis C Patients
              • Patient Shares for Treatment-Naive Cirrhotic Chronic Hepatitis C Patients
              • Brazil: Patient Shares for Treatment-Naive Cirrhotic Chronic Hepatitis C Patients
              • Colombia: Patient Shares for Treatment-Naive Cirrhotic Chronic Hepatitis C Patients
              • Patient Shares for Treatment-Experienced Noncirrhotic Chronic Hepatitis C Patients
              • Brazil: Patient Shares for Treatment-Experienced Noncirrhotic Chronic Hepatitis C Patients
              • Colombia: Patient Shares for Treatment-Experienced Noncirrhotic Chronic Hepatitis C Patients
              • Patient Shares for Treatment-Experienced Cirrhotic Chronic Hepatitis C Patients
              • Brazil: Patient Shares for Treatment-Experienced Cirrhotic Chronic Hepatitis C Patients
              • Colombia: Patient Shares for Treatment-Experienced Cirrhotic Chronic Hepatitis C Patients
              • Colombia: Common Routes of Access to Sovaldi
              • Brazil: Most Prescribed Therapeutic Regimens for Genotype-2 Patients
              • Colombia: Most Prescribed Therapeutic Regimens for Genotype-2 Patients
              • Brazil: Most Prescribed Therapeutic Regimens for Genotype-3 Patients
              • Colombia: Most Prescribed Therapeutic Regimens for Genotype-3 Patients
              • Brazil: Prescribing Drivers for Current Therapies in Genotype-1 Patients
              • Colombia: Prescribing Drivers for Current Therapies in Genotype-1 Patients
              • Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Naive Noncirrhotic Public Patients
              • Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Naive Cirrhotic Public Patients
              • Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Experienced Noncirrhotic Public Patients
              • Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Experienced Cirrhotic Public Patients
              • Brazil: Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Naive Noncirrhotic Private Patients
              • Colombia: Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Naive Noncirrhotic Private Patients
              • Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Naive Cirrhotic Private Patients
              • Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Experienced Noncirrhotic Private Patients
              • Prescribing Drivers for Specific Current Therapies in Genotype-1 Treatment-Experienced Cirrhotic Private Patients
              • Colombia: Prescribing Drivers for Current Therapies in Genotype-2 Patients
              • Colombia: Prescribing Drivers for Specific Current Therapies in Genotype-2 Treatment-Naive Noncirrhotic Patients
              • Colombia: Prescribing Drivers for Specific Current Therapies in Genotype-2 Treatment-Naive Cirrhotic Patients
              • Colombia: Prescribing Drivers for Specific Current Therapies in Genotype-2 Treatment-Experienced Noncirrhotic Patients
              • Colombia: Prescribing Drivers for Specific Current Therapies in Genotype-2 Treatment-Experienced Cirrhotic Patients
              • Brazil: Prescribing Drivers for Current Therapies in Genotype-3 Patients
              • Brazil: Prescribing Drivers for Specific Current Therapies in Genotype-3 Treatment-Naive Noncirrhotic Patients
              • Brazil: Prescribing Drivers for Specific Current Therapies in Genotype-3 Treatment-Naive Cirrhotic Patients
              • Brazil: Prescribing Drivers for Specific Current Therapies in Genotype-3 Treatment-Experienced Noncirrhotic Patients
              • Brazil: Prescribing Drivers for Specific Current Therapies in Genotype-3 Treatment-Experienced Cirrhotic Patients
              • Most Frequently Prescribed Treatment Regimen for Specific Genotype-1 Subpopulations
              • Brazil: Most Frequently Prescribed Treatment Regimen for Specific Genotype-1 Subpopulations
              • Colombia: Most Frequently Prescribed Treatment Regimen for Specific Genotype-1 Subpopulations
              • Colombia: Most Frequently Prescribed Treatment Regimen for Specific Genotype-2 Subpopulations
              • Brazil: Most Frequently Prescribed Treatment Regimen for Specific Genotype-3 Subpopulations
              • Physicians' Choice of Treatments for Genotype 1 in the Absence of Access Barriers
              • Brazil: Physicians' Choice of Treatments for Genotype 1 in the Absence of Access Barriers
              • Colombia: Physicians' Choice of Treatments for Genotype 1 in the Absence of Access Barriers
              • Brazil: Physicians' Choice of Treatments for Genotype 2 in the Absence of Access Barriers
              • Brazil: Physicians' Choice of Treatments for Genotype 3 in the Absence of Access Barriers
              • Brazil: Interruption of Treatments Following the New PCDTs
              • Brazil: Reasons for Interruption of Treatments
              • Colombia: Reasons for Lack/Interruption of Treatment
              • Brazil: Bodies/Entities Considered a Barrier to Coverage/Reimbursement for Drug Therapy for Chronic Hepatitis C
              • Colombia: Bodies/Entities Considered a Barrier to Coverage/Reimbursement for Drug Therapy for Chronic Hepatitis C
              • Colombia: Expected Impact of the New Treatment Guidelines in the Treatment of Genotype-1 Public Patients
              • Colombia: Expected Impact of the New Treatment Guidelines in the Treatment of Genotype-2 Public Patients
              • Colombia: Expected Impact of the New Treatment Guidelines in the Treatment of Genotype-3 Public Patients
              • Unmet Needs in the Treatment of Chronic Hepatitis C
              • Brazil: Expected Prescribing of Emerging Therapies
              • Colombia: Expected Prescribing of Emerging Therapies
              • Brazil: Prescribing Drivers of Emerging Therapies
              • Colombia: Prescribing Drivers of Emerging Therapies
              • Brazil: Reasons for Not Prescribing Emerging Therapies
              • Colombia: Reasons for Not Prescribing Emerging Therapies
              • Acceptable Launch Prices for Emerging Therapies
              • Acceptable Launch Price for Emerging Therapies with Specific Properties
              • Physicians' Recommendation for Coverage of Emerging Therapies for Chronic Hepatitis C
              • Physicians' Recommendation for Coverage of Emerging Therapies for Chronic Hepatitis C (Genotypes)
              • Brazil: Impact of the Availability of Emerging Therapies on Current Prescribing for Genotype-1 Treatment-Naive Patients
              • Brazil: Impact of the Availability of Emerging Therapies on Current Prescribing for Genotype-1 Treatment-Experienced Patients
              • Expected Choices of Treatments for Genotype-1 Public Patients
              • Brazil: Expected Choices of Treatments for Genotype-1 Public Patients
              • Colombia: Expected Choices of Treatments for Genotype-1 Public Patients
              • Expected Choices of Treatments for Genotype-1 Private Patients
              • Brazil: Expected Choices of Treatments for Genotype-1 Private Patients
              • Colombia: Expected Choices of Treatments for Genotype-1 Private Patients
              • Expected Choices of Treatments for Genotype-2 Public Patients
              • Expected Choices of Treatments for Genotype-2 Private Patients
              • Expected Choices of Treatments for Genotype-3 Public Patients
              • Expected Choices of Treatments for Genotype-3 Private Patients
              • Physicians' Choices of Treatments for Genotype-1 Patients Without Access Barriers
              • Brazil: Physicians' Choices of Treatments for Genotype-1 Patients Without Access Barriers
              • Colombia: Physicians' Choices of Treatments for Genotype-1 Patients Without Access Barriers
              • Physicians' Choices of Treatments for Genotype-2 Patients Without Access Barriers
              • Physicians' Choices of Treatments for Genotype-3 Patients Without Access Barriers
              • Preferred Treatment Regimen for Specific Subpopulations of Genotype-1 Patients
              • Brazil: Preferred Treatment Regimen for Specific Subpopulations of Genotype-3 Patients

        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.