The treatment armamentarium for chronic myelogenous leukemia (CML) in Brazil and Mexico includes all three currently marketed tyrosine kinase inhibitors (TKIs): Glivec (imatinib,Novartis) for newly diagnosed patients, and Sprycel (dasatinib, Bristol-Myers Squibb) and Tasigna (nilotinib, Novartis) for patients resistant to first-line TKI therapy. However, patient access to these agents can be challenging, especially in later lines of CML therapy where coverage of the TKIs is far from universal in both countries. Second-generation TKIs, such as Pfizer’s Bosulif (bosutinib)and Ariad Pharmaceuticals’ Iclusig (ponatinib), will soon compete in Latin America with branded and generic versions of currently available TKIs, therefore challenging payers and physicians to make tough reimbursement and prescribing decisions.

Questions Answered in This Report:

  • What role do TKIs play in the treatment of CML in Brazil and Mexico, and how do prescribing patterns vary by country?

  • How do coverage/reimbursement status and resulting restrictions impact prescribing of TKIs for CML in Brazil and Mexico?

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

  • How will access to currently marketed TKIs evolve within the next two to three years?

  • What are payers’ reactions to approval of high-cost TKIs?

  • What are the main constraints influencing decision makers on inclusion of premium-priced treatments for CML in the government-sponsored and/or social security programs in each country?

  • How do payers expect access to high-cost brands to evolve in the next three years? Are government initiatives under way to expand access?

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

  • What are the market access hurdles emerging brands will need to overcome in these markets?

  • How do payers perceive the emerging brands?

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

  • How will emerging therapies such as Bosulif and Iclusig be embraced by oncologists and hematologists? What are clinician attitudes to the pricing of emerging brands?

Scope:

Decision Resources Group’s Emerging Markets Physician & Payer Forum report “Patient Access to High-Cost Therapies for CML in LATAM (Brazil and Mexico): How Do Payers and Physicians Shape This Crowded and Changing Market?” explores reimbursement and additional payer policies that influence prescribing trends for approved targeted agents in CML in Brazil and Mexico. The report examines the current uptake of premium-priced therapies for CML in Brazil and Mexico, the obstacles they face, as well as strategies to overcome those obstacles. The report also explores physician attitudes and behaviors concerning emerging therapies and their expectations of these novel agents.

It draws on the insights of 100 oncologists and hematologists and interviews with 7 payers in Brazil and Mexico to explore how payer policies influence prescribing of approved targeted therapies for CML, to determine the factors that will promote or restrict uptake of emerging agents, and to determine how the CML market access space will evolve in the next two to three years. Interviewed payers include the following:

- Brazil: Head of Pharmaceutical Division of Hospital das Clinicas (HC), São Paulo; Director of the Pharmacy and Therapeutics (P&T) Committee of HCFMUSP and 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), Rio de Janeiro; Pharmacist and Supply Manager of Specialty Drugs from SUS Programs in HCFMUSP.

- Mexico: National Coordinator of Special Programs (including oncology), in the Division of Hospital Regulation from the Medical Department of ISSSTE; Coordinator of the Nacional Guías de Práctica Clínica from the Division of Guías de Práctica Clínica, CENETEC-Salud; Internist M.D. from the IMSS at a 2nd Level Health Care 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): Chiara Stella Cochetti, M.Sc.
Andreia Ribeiro, Ph.D.