in seroprevalence cases of hepatitis B virus (HBV), disease awareness, and
patient access to HBV treatment create significant market opportunity in Latin
America. Our report covers the prescribing and reimbursement environment in Brazil,
Mexico, and Argentina for nucleoside/nucleotide analogues, including Baraclude
(Bristol-Myers Squibb) and Viread (Gilead Sciences), and currently available interferon
(IFN)-based therapies. In addition, we examine the likely impact of biosimilar
versions of PEG-IFN-α brands and of the emerging interferon therapy
PEG-IFN-lambda-1a (ZymoGenetics/Bristol-Myers Squibb).
- Brazil: How are current nucleoside/nucleotide analogues and interferon-based agents covered under the national programs for pharmaceutical assistance? Are any covered by the Farmácia Popular? How do the real limitations of national budgets impact supply and access? What do payers say about regional differences in adherence to RENAME formularies and whether this impacts access to HBV drugs? What is the role of judicial actions in Brazil as a lever for accessing premium-priced agents for hepatitis B? How do payers expect access to high-cost brands to evolve in the next three years? How do patient assistance programs influence access? What impact will CONITEC have on drug assessment/approval in Brazil, and what information will be key to successful health technology assessment (HTA)? Following approval by ANVISA, which emerging drugs do clinicians and payers expect to be included in national programs?
- Mexico: Which interferons and nucleoside/nucleotide analogues are included in the institutional drug formularies of government-sponsored programs, such as Seguro Popular, and social security programs, such as the IMSS and ISSSTE, for Hepatitis B? What is the impact of MNC-led patient assistance programs on access? How will the availability of generics impact coverage and prescribing of key brands? How do healthcare budget restrictions impact treatment for Hepatitis B? Following approval by COFEPRIS, which emerging drugs do clinicians and payers expect to be included in the national and institutional drug formularies? How does HTA factor into this decision at both a national and institutional level? What are payers’ and prescribers’ expectations for inclusion of current and emerging brands in the government-sponsored and social security programs?
- Argentina: How are nucleoside/nucleotide analogues and immunomodulators reimbursed in Argentina? Which brands are listed on the Programa Médico. Obligatorio (PMO) and the Sistema Unico de Reintegros (formerly Administración de Programes Especiales [APE]), and what restrictions apply? What are payers’ and prescribers’ expectations for inclusion of various agents in SUR updates? How does inclusion in Argentinean treatment guidelines impact reimbursement? What is the impact of healthcare budget restrictions at the national and provincial levels on HBV drugs?
- In Brazil, Mexico, and Argentina: What does an analysis of prescribing patterns for nucleoside/nucleotide analogues and immunomodulators (including biosimilar versions in Mexico) reveal about the real-life impact of payer policies in each market? How will this impact shift over the next three years? Are there difficulties in obtaining reimbursement for HBV treatment in specific patient populations? How does access vary between drug classes? What procedures must patients and providing institutions follow in order to receive drugs listed, and not listed, in the drug formularies? How do differences in prescriber perceptions of Western-branded agents versus generic equivalents impact prescribing? What is the anticipated impact of availability of key generic entries (e.g., generic entecavir) on prescribing? In several discount scenarios, how much power would price discounts have to shift prescribing? How will access to biologics evolve by the end of 2017?
- In Brazil, Mexico, and Argentina: What are the market access hurdles that ZymoGenetics’ emerging brand, peg-IFN-lambda-1a, will need to overcome in these markets? How are biosimilar versions of peg-IFN alpha likely to be reimbursed and prescribed, and how will their approval impact access to current brands? How do payers and prescribers perceive the new interferon? How do clinicians expect to prescribe it? What clinical and commercial factors would most likely convince payers to grant emerging brands coverage or advantaged positioning?
This Emerging Markets Physician and Payer Forum report explores the market access hurdles and levers that affect HBV market dynamics in Brazil, Mexico, and Argentina. The report is based on a survey of 146 prescribers (infectious disease specialists, gastroenterologists/hepatologists, and internal medicine specialists) and interviews with 10 payers. Interviewed payers have an influence at a national or regional level and include the following:
- Brazil: Head of the pharmacy department at a hospital from SUS; general coordinator of strategic programs management at ANVISA (National Health Surveillance Agency); manager of pharmaceutical assistance at a state health secretariat.
- Mexico: Chief of the department of preventable diseases by vaccination at a ISSSTE; medical coordinator of the IMSS’s compulsory program; director at Seguro Popular, Health Services Management at the National Commission of Social Protection in Health.
- Argentina: Special programs director at a private HMO; head of special programs at a union Obra Social; purchase manager for the high cost programs at PAMI (social health insurance fund for retired workers); government advisor, Division of Scientific and Technological Activities, Department of Economic Development.