Oncology indications increasingly use predictive biomarkers to guide prescribing of costly therapies. However, uptake of targeted therapies in Mexico and Argentina is highly dependent on their incorporation into publically funded formularies, a situation that varies widely between countries in terms of the drugs and indications covered. As multiple marketed and late-stage emerging agents seek to optimize the market access opportunities offered by using biomarkers to target those patients most likely to benefit from drug therapy, this report assesses how the rising cost of personalized medicine is balanced with clinical need in breast cancer, non-small-cell lung cancer (NSCLC), colorectal cancer (CRC), and malignant melanoma.

Questions Answered in This Report:

  • How are patients selected for biomarker testing? To what extent has biomarker-driven prescribing penetrated the indications under study, and how do prescribing patterns vary by country?



  • What are the current drivers and barriers to biomarker-driven prescribing in oncology, and what are the main cost-related/clinical constraints to the uptake of agents with biomarkers?



  • How do surveyed oncologists in Mexico and Argentina anticipate biomarker-driven prescribing will evolve by year-end 2017?



  • How does coverage/reimbursement of approved targeted therapies with companion diagnostics vary between countries? How do national and/or institutional healthcare authorities regulate the prescribing of these agents?



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



  • What are payers’ reactions to recently approved therapies with biomarkers? What factors influence reimbursement of companion biomarker tests?



  • How much of a market access lever is personalized medicine as health technology assessment evolves in the wake of tightening healthcare budgets in each country?



  • What role will head-to-head and pharmacoeconomic outcome studies play in differentiating the reimbursement of emerging high-priced targeted therapies versus currently available targeted therapies?



  • What market access levers can drug developers exploit to better position new targeted therapies with biomarkers in Mexico and Argentina?



  • How do payers expect access to key targeted therapies and their companion diagnostics brands to evolve in the next three years? Are government initiatives under way to expand patient access?



  • How will prescribing patterns change with the launch of new targeted therapies?



  • What do emerging agents with biomarkers need to demonstrate to encourage prescribing over existing nontargeted treatments?

     

Scope:

Decision Resources Group’s Emerging Markets Physician & Payer Forum report “Biomarker-Driven Prescribing in Oncology: Stakeholder Dynamics in Mexico and Argentina for Breast, Non-Small-Cell Lung, and Colorectal Cancers and Malignant Melanoma” surveys 99 medical oncologists and interviews six payers in Argentina and Mexico to explore the evolving reimbursement and market access landscape for biomarker-driven prescribing, the dynamics affecting prescribing of key targeted drugs in the cost-controlled climate, and the primary challenges facing emerging therapies aspiring to significantly penetrate this market segment. Interviewed payers include the following:

- Argentina: Director of pharmaceutical assistance programs (including oncology) from a major Obra Social, specializing in public health; government adviser to several public programs of pharmaceutical assistance; director of oncology service; coordinator and researcher of a support program for oncology at a major public hospital; oncologist KOL at two major public hospitals, specializing in oncology and molecular biology; medical auditor for a major Obra Social; members of the Argentinean Association of Clinical Oncology.

- Mexico: National coordinator of special programs (including oncology) in the Division of Hospital Regulation from the medical department of ISSSTE; head of a Medical Oncology Department of an IMSS’s Third Level Health Care Hospital; oncologist KOL from Instituto Nacional de Cancerologia (INCan) and a major private HMO; member of the Mexican Council of Oncology.

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

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