Improvements in patient access to novel treatments for chronic obstructive pulmonary disease (COPD) in Brazil and Mexico are largely dependent on the expansion of drug coverage by local authorities. New premium-priced agents, such as the long-acting beta2 agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) and the recently approved once-daily LABA/inhaled corticosteroid (ICS) FDC Relvar/Relvare (GlaxoSmithKline/Theravance’s vilanterol/fluticasone furoate), will compete with established marketed therapies, especially the LABA/FDCs soon to be generically available. New brands will face not only the initial market access hurdle of the regulatory agencies in the countries under study but also the subsequent challenge of incorporation into publically funded formularies in these highly competitive markets dominated by aggressive cost-control mechanisms.

Questions Answered in This Report:

  • How does coverage of approved COPD agents vary between countries? How do national healthcare authorities regulate the prescribing of these drugs?

  • How do prescribing patterns for key COPD brands vary by country? How does coverage compare in the public and private settings, and how do resulting restrictions affect on-label and off-label prescribing of COPD agents?

  • What have been the main cost/clinical constraints to the uptake of LABA- and LAMA-containing products for COPD in Brazil and Mexico?

  • How do public patients in Brazil access treatment for COPD, given the extreme coverage constraints?

  • Which treatments for COPD are included in drug formularies of government-sponsored and/or in social security programs in Mexico? What procedures must patients and providing institutions follow to receive drugs listed, and not listed, in the drug formularies?

  • What are payers’ opinions of the first LABA/LAMA FDC?

  • How will pulmonologists embrace the recently launched LABA/ICS FDC Relvar/Relvare, and how do they intend to prescribe the LABA/LAMA FDCs Ultibro (Novartis’s indacaterol/glycopyrronium), Anoro (GlaxoSmithKline/Theravance’s vilanterol/umeclidinium), and olodaterol/tiotropium (Boehringer Ingelheim), assuming these agents are approved in Brazil and Mexico?

  • How will prescribing patterns evolve with the availability of generic LABA/ICS FDCs?

  • How do payers expect access to key COPD brands to evolve in the next three years? Are any government initiatives under way to expand patient access?

  • What types of clinical advantages could secure coverage for emerging agents?

  • What market access levers can drug developers use to optimize positioning of their new products for COPD in Brazil and Mexico?

  • What weight will head-to-head and pharmacoeconomic outcomes play in the coverage of emerging agents versus current mainstays?


Decision Resources Group’s Emerging Markets Physician & Payer Forum report “Positioning of Current and Emerging Agents for COPD: Physician and Payer Perspectives on the Prescribing and Patient Access Landscape in Brazil and Mexico” surveys 101 pulmonologists and interviews 6 payers in Brazil and Mexico to explore prescribing and coverage dynamics and assess the key market access levers and barriers that will influence treatment of COPD in Brazil and Mexico over the next two to three years. Interviewed payers include the following:

- Brazil: Head of the pharmaceutical division of a major public hospital in Brazil, São Paulo State, and member of the P&T committee from the institution; pulmonologist KOL, effective member of INCOR (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo) and a major HMO in Brazil, and member of the P&T committee of those two institutions and of the Department of Health of the São Paulo State; director of drug supply with service providers/budget controller of a major HMO in Brazil.

- Mexico: Internist specializing in pulmonary diseases in the emergency medical services of Hospital Tacuba from ISSSTE and a major HMO in Mexico; pulmonologist KOL, chief of emergency department at the INER (Instituto Nacional de Enfermedades Respiratorias) of the Ministry of Health, and member of the Mexican Society of Pulmonology and Thoracic Surgery; director of a family medical unit from IMSS.

Author(s): Susana Silva, M.S.
Andreia Ribeiro, Ph.D.