The launch of novel oral anticoagulants (NOACs), such as Bayer/Janssen’s Xarelto, Bristol-Myers Squibb/Pfizer’s Eliquis/Elicuis, and Boehringer Ingelheim’s Pradaxa/Pradaxar, in Brazil and Mexico for the treatment and prophylaxis of venous thromboembolism (VTE) and stroke prevention in atrial fibrillation (AF) has expanded the market landscape and given physicians alternatives to the more traditional anticoagulation strategies. Further, anticipated use of NOACs in the prevention of thrombotic episodes in acute coronary syndrome (ACS) will possibly enlarge the list of approved indications for some of these agents. However, successful uptake of NOACs depends highly on securing formulary coverage across healthcare programs in Brazil and Mexico, and the NOACs’ premium-price tag poses a major challenge to these cost-contained healthcare systems.

Questions Answered in This Report:

  • How does access to therapies for VTE, AF, and ACS occur in public and private settings, especially access to NOACs?

  • How are Brazilian public patients accessing the NOACs, given that none are listed in the RENAME? Is there any recommendation to include the NOACs in the SUS coverage or discussion about including them?

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

  • How do coverage/reimbursement status and resulting restrictions affect on-label and off-label prescribing of NOACs?

  • What role do NOACs play in the treatment of VTE, AF, and ACS in Brazil and Mexico, and how do prescribing patterns vary by country?

  • Under what circumstances are cardiologists prescribing the NOACs? What are the key drivers for the prescribing of NOACs instead of other drug classes and over one another?

  • What have been the main cost/clinical constraints to the uptake of the NOACs? Does access vary between inpatient and outpatient settings?

  • How do payers expect access to costly NOACs to evolve in the next three years? Are government initiatives under way to expand access?

  • How likely is approval of Daiichi Sankyo’s Lixiana/Savaysa (edoxaban) in Brazil and Mexico? What clinical and commercial advantages could secure coverage for Lixiana/Savaysa, according to payers?

  • How will cardiologists change their prescribing patterns in the next three years, assuming expansion of indications for currently marketed brands and the approval of Lixiana/Savaysa?

  • What role will head-to-head and pharmacoeconomic outcomes play in differentiating the NOACs and the coverage of novel treatments versus current mainstays?

  • 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?

Scope:

Decision Resources Group’s Emerging Markets Physician & Payer Forum report “Novel Oral Anticoagulants in LATAM (Brazil and Mexico): Physician and Payer Perspectives on the Evolving Treatment of Venous Thromboembolism, Atrial Fibrillation, and Acute Coronary Syndrome” surveys 100 cardiologists and interviews 6 payers in Brazil and Mexico to explore how both parties shape the prescribing and access environment for currently approved brands for VTE, AF, and ACS. In addition, it assesses how the anticoagulation market will evolve in the next three years as the anticoagulation armamentarium expands in these two countries. Interviewed payers include the following:

- Brazil: Head of the pharmaceutical division of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) (reference for the MoH and CONITEC for development of protocols); director of pharmaceutical assistance and representative of HC pharmacy in the therapeutic committee of the Department of Health of the São Paulo State; cardiologist KOLs; members of the P&T committees at Incor (Instituto do Coração), ICESP (Instituto do Câncer do Estado de São Paulo), and private hospitals with broad experience in the standardization of drugs and development of protocols in the public and private sector.

- Mexico: Subdirector of healthcare agreements, OPD (Organismo Provincial de Desarrollo) Northern Region, MoH (accountable for administration of all healthcare agreements and healthcare resources provided by the federal government at the state level, including for Seguro Popular); national coordinator of special programs, including cardiology, at the Sub-Direction of Hospital Regulation of the Medical Department of ISSSTE; cardiologist KOL at the National Institute of Cardiology and member of the Mexican Society Of Cardiology; editor of the Mexican Archives of Cardiology.

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

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