Tackling the Market Access Challenges in Brazil, Mexico, and Argentina

Increases in seroprevalent cases of hepatitis C virus (HCV), disease awareness, and patient access to HCV treatment create significant market opportunity in Latin America. The recent or imminent launch of several direct-acting antiviral (DAA) agents, such as sofosbuvir (Gilead’s Sovaldi) and simeprevir (Janssen’s Olysio), in Brazil, Mexico, and Argentina is heralding the all-oral, interferon (IFN)-free era of HCV treatment in the region, which is expected to challenge the IFN-based standards of care. However, while all-oral, IFN-free regimens will likely dramatically improve treatment outcomes for HCV patients, they are also expected to carry price premiums over the current standards of care and will likely be met by ever-demanding payers and strict reimbursement environments. Drug manufacturers must overcome these and other challenges to market access if they aspire to significantly penetrate this highly lucrative disease space.

Questions Answered in This Report:

  • Market access landscape for current HCV therapies in Brazil, Argentina, and Mexico. Which protease inhibitors, IFNs, and DAAs are currently approved in Brazil, Mexico, and Argentina and included in the national and/or institutional drug formularies of government-sponsored and social security programs? How does coverage vary between countries?

  • Market access challenges and opportunities for novel DAAs. How do payers expect access to the increasing number of high-cost HCV treatments to evolve in the next year? And in the next three years? Are government or patient initiatives and/or HTA evaluations underway to expand access? Following approval, which emerging DAAs do clinicians and payers expect to be included in the national and institutional drug formularies? What type of cost/risk-sharing agreements and patient access schemes would encourage wider coverage and access to DAAs?

  • Current and future impact of payer policies on prescribing trends for HCV. What does an analysis of prescribing patterns for currently available HCV regimens reveal about the real-life impact of payer policies in each market? How will this impact shift over the next three years after the launches of DAAs that will offer all-oral, IFN-free regimen options? How do reimbursement/coverage constraints limit prescribing and rank against other market access hurdles? How do physicians expect to prescribe emerging DAAs and IFN-free combinations to their HCV patient populations (treatment-naïve versus treatment-experienced patients, cirrhotic versus non-cirrhotic)?

  • Perception, challenge, and differentiating factors for emerging HCV therapies. How do payers and prescribers perceive the emerging brands? What are the market access hurdles the emerging brands will need to overcome in these markets? To what extent do these brands address unmet clinical needs, and how do clinicians expect to prescribe them? What clinical and commercial factors will be important in differentiating emerging IFN-free combinations during health technology assessments? What weight will head-to-head and pharmacoeconomic outcomes have in the coverage of emerging agents versus current mainstays?

Scope:

For this Emerging Physician & Payer Forum report titled Positioning of Current and Emerging HCV Regimens in Latin America: Tackling the Market Access Challenges in Brazil, Mexico, and Argentina, we surveyed 151 gastroenterologists, hepatologists, and infectious disease specialists and interviewed 9 payers to explore how these stakeholders expect to balance the growing influx of HCV patients seeking treatment and the rising costs associated with emerging all-oral treatment regimens against increasingly cost-conscious payer policies in each country in the next two to three years.

Markets covered: Argentina, Brazil, and Mexico.

Primary research: 82 infectious diseases specialists, 48 gastroenterology specialists, and 21 hepatology specialists completed an online quantitative survey designed by therapeutic and country experts and nine payers/payer-advising thought leaders who have influence on patient access to HCV drugs at a regional or national level were interviewed and include:

Brazil:

- Technical Advisor of the Department of Technology Incorporation in the Ministry of Health (CONITEC): current President of the Ebserh’s (Empresa Brasileira de Serviços Hospitalares) Committee for Patient Safety, and member of the Committee for New MoH Regulations for the Treatment of Hepatitis C; Health Technical Director of the Department of Health of São Paulo State - CEAF; fully involved with the assistance program for patients with hepatitis C in São Paulo State’s Health Department; Director of the Division of Pharmacy in Hospital das Clinicas of São Paulo, linked to the University of São Paulo (USP); member of the Pharmacology Committee of São Paulo’s State Health Department, reference for CONITEC; member of Brazilian Society of Hospitals; Pharmacists.

Mexico:

- Head of the Department of Special Programs (including Hepatitis C) and Hospital Regulation of ISSSTE; Gastroenterologists and hepatologist KOLs, Chief of Gastroenterology Service at SSA reference hospital and the Hospital of High Specialty of the Yucatan Peninsula, members of the Mexican Association of Hepatology; professor and active international speaker.

Argentina:

- Hepatology KOLs; Chiefs of Hepatology and Gastroenterology Departments at Julio Mendez Sanatorium from Obra Social of Buenos Aires, and the Hospital Carlos G. Durand; advisor National Technology Assessment and Management Units from the Direction of Medical Technology of UCEETS; members of AAEEH and the Argentinean Society of Gastroenterology.

Author(s): Solsire Zevallos, Ph.D.
Nuno T. Antunes, Ph.D.