Several newly approved agents for asthma together with others seeking approval are expanding the range of therapeutic options for this disease in Brazil and Mexico. Drugs such as the inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) fixed-dose combination (FDC) Relvar/Relvare (GlaxoSmithKline/Theravance’s vilanterol/fluticasone furoate) and the anticipated label extension of the long-acting muscarinic antagonist (LAMA) Spiriva (Boehringer Ingelheim/Pfizer’s tiotropium) for asthma are likely to drive market growth. Furthermore, Cinquil (Cephalon/Teva’s reslizumab) and Bosatria (GlaxoSmithKline’s mepolizumab), interleukin-5 (IL-5)-targeting biologics in late-stage development, will add a competitive dynamic to the severe, disease-refractory market segment, which represents a patient population characterized by high morbidity and frequent hospitalizations for whom Xolair (Genentech/Novartis’s omalizumab) is currently the only therapeutic option. Severe, refractory asthma is undoubtedly a burden to the healthcare systems in the countries under study, but it equally represents remaining therapeutic need and therefore ample opportunity for developers. However, the rising cost of the asthma treatment armamentarium will be balanced by increasing coverage restrictions; drug makers must carefully navigate the road to reimbursement in order to optimize uptake.

Questions Answered in This Report:

  • How does coverage of approved asthma therapies vary between countries? How do national healthcare authorities regulate prescribing?

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

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

  • What have been the main cost/clinical constraints to the uptake of Xolair for asthma in Brazil and Mexico?

  • How likely is it that Spiriva will obtain a label extension for asthma in these countries? What impact might such a label extension have on future prescribing trends?

  • What blocked public coverage of Xolair in Brazil? How are public patients in this country accessing key asthma agents given coverage constraints generally?

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

  • To what degree will prescribing constraints present a hurdle for novel biologics for asthma in Brazil and Mexico?

  • What are payer and physician reactions to the recent market entrance of the first once-daily LABA/ICS fixed-dose combination?

  • How will prescribing patterns evolve with the launch of new agents and the availability of generic twice-daily LABA/ICS FDCs?

  • What types of clinical advantages could secure coverage for emerging agents, according to payers?

  • What market access levers can drug developers take advantage of to optimize positioning of their new brands for asthma?

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

Scope:

Decision Resources Group’s Emerging Markets Physician & Payer Forum report “Positioning of Current and Emerging Agents for Asthma: 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 analyze the market access challenges facing current and emerging agents for asthma in Brazil and Mexico. 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, B.S./M.S.
Andreia Ribeiro, Ph.D.

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