Improved patient access to specialized medical care and increased use of target therapies in oncology are expanding the multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL) markets in Brazil and Mexico. Moreover, recent approvals and upcoming marketing authorizations will strengthen the treatment armamentarium for these diseases and provide further therapy options. However, premium-priced agents for MM and NHL (such as Janssen’s Velcade) face differing degrees of coverage and use restrictions within and across each country. In addition, in the past two years, Brazil’s National Agency of Health Regulation (Agência Nacional de Vigilância Sanitária, ANVISA) has denied approval of some agents for MM and NHL in Brazil, while in Mexico, others have received a conditional opinion from COFEPRIS’s New Molecules Committee. These market access hurdles showcase the increasingly rigorous regulatory and reimbursement environments in these countries.

Questions Answered in This Report:

  • What role do key brands play in the treatment of MM and NHL in Brazil and Mexico, and how do prescribing patterns vary by country?

  • Which key agents for MM and NHL are included in drug formularies of government-sponsored and/or social security programs in each country?

  • How does coverage/reimbursement status and its resulting restrictions impact prescribing of key brands under study in Brazil and Mexico?

  • How does the impact of payer policy vary between drugs, and between private and public patients?

  • How will access to currently marketed drugs for MM and NHL evolve over the next 2-3 years?

  • What role do high-cost brands play in the MM and NHL treatment algorithms in Brazil and Mexico?

  • What are the main constraints influencing decision makers with regard to inclusion of key therapies in national and institutional drug formularies in each country?

  • How much of an access lever for high-cost brands are judicial actions in Brazil?

  • How do payers expect access to high-cost brands to evolve in the next three years?

  • How can patient assistance programs and cost-sharing agreements influence access?

  • What market access hurdles must emerging brands and biosimilars overcome in these markets?

  • How do payers perceive the emerging brands, and are they prepared to accept price increases to reflect efficacy gains?

  • What impact will availability of rituximab biosimilars have on the uptake of new treatments for NHL?

  • What clinical and commercial factors would most likely convince payers to grant emerging agents coverage or advantaged positioning?

  • What is the ongoing impact of health technology assessments and pricing negotiations on coverage and access to new market entrants in each country?

  • What role will head-to-head and pharmacoeconomic outcomes play in reimbursement of novel, high-cost agents versus current mainstays?

  • How will emerging therapies for MM and NHL be embraced by oncologists and hematologists? What are clinician attitudes toward the pricing of emerging brands?


Decision Resources Group’s Emerging Markets Physician & Payer Forum report “The Impact of LATAM (Brazil and Mexico) Payer Policy on Prescribing in Non-Hodgkin’s Lymphoma and Multiple Myeloma” surveys 100 oncologists and hematologists and interviews 7 payers in Brazil and Mexico to explore how payer policy influences prescribing of approved key therapies for MM and NHL, determine the factors that will promote or restrict uptake of new entrants, and assess how access to treatment will evolve in the next 2-3 years for these indications. Interviewed payers include the following:

- Brazil: Head of pharmaceutical division of Hospital das Clinicas (HC) and director of the pharmacy and therapeutics (P&T) committee; representative of HC pharmacy in the therapeutic committee of the Department of Health of the São Paulo state; head of central service of drug distribution and logistics at INCA (Instituto Nacional do Cancer); director of drug supply and relationship with service providers/budget controller of Unimed; pharmacist and supply manager of specialty drugs from SUS programs in HCFMUSP.

- Mexico: National coordinator of special programs in the division of hospital regulation from the medical department of ISSSTE; coordinator of the Nacional Guías de Práctica Clínica; CENETEC-Salud and internist M.D. from the IMSS at a second level healthcare hospital; oncologist KOL from the Instituto Mexicano de Investigación del Cancer and Instituto Nacional de Cancerologia (INCan) specialized in onco-hematology;  former employee of COFEPRIS with regulatory affairs experience.

Author(s): Solsire Zevallos, Ph.D.

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