Are Managed Entry Agreements a Feasible Approach to Improve Patient Access to Innovative Therapies in Latin America?

OBJECTIVES: To assess whether Managed Entry Agreements (MEAs) are a feasible solution in Latin America to improve patient access, reduce clinical and/or financial uncertainty for payers, providers and manufacturers and ensure health systems sustainability. We aim to present a summary of the status of MEAs in the public sector with case studies, discussions with key stakeholders on main barriers for implementation and provide recommendations.

METHODS: Ten policies (access/competition, INN prescribing, generic substitution, reference pricing, tax-exemptions, mark-up regulation, health technology assessment, centralized negotiations, public purchasing and MEAs) were studied in 11 countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Panama, Peru, and Uruguay). Country workshops with support from the local pharmaceutical chamber and key stakeholders were held to present the study results and discuss the main priorities to advance in the policy agenda.

RESULTS: The level of development, implementation and evaluation of these policies varies between countries and their success depend on health system capacity/capabilities and regulations. MEAs was consistently seen as an area of opportunity where stakeholders had alignment and willingness to implement. Uruguay has been successful in implementing MEAs in the public sector as a sustainable policy. Despite the existence of a legal framework, Chile, Colombia, and Peru still face operational barriers for MEAs implementation. Other countries had announced MEAs (Argentina, Brazil, Costa Rica, and Mexico), however policy gaps or decision maker changes had turned mixed results. Two countries, Colombia and Peru are planning pilots to test MEAs feasibility and address policy gaps.

CONCLUSIONS: MEAs are perceived by stakeholders as a solution to reconcile access to innovative therapies with the health system sustainability. Despite legal frameworks promoting their use, MEAs require stakeholder alignment. Technical assistance by Multilateral Organizations and/or Think-tanks involving all interested parties is critical to ensure the success of MEAs as a policy solution.