RESUMEN
Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower income countries rely mainly on financial based agreements to manage uncertainties associated with new therapies. We performed a survey, an exploratory literature review and an iterative brainstorming in parallel about potential barriers and solutions to outcome-based agreements in Central and Eastern Europe (CEE) and in the Middle East (ME). A draft list of recommendations deriving from these steps was validated in a follow-up workshop with payer experts from these regions. 20 different barriers were identified in five groups, including transaction costs and administrative burden, measurement issues, information technology and data infrastructure, governance, and perverse policy outcomes. Though implementing outcome-based reimbursement models is challenging, especially in lower income countries, those challenges can be mitigated by conducting pilot agreements and preparing for predictable barriers. Our guidance paper provides an initial step in this process. The generalizability of our recommendations can be improved by monitoring experiences from pilot reimbursement models in CEE and ME countries and continuing the multistakeholder dialogue at national levels.
RESUMEN
Objectives: Utilization of multisource biological (off-patent originator and its biosimilar) medicines can improve the efficiency of resource allocation by 1) generating savings while maintaining health outcomes or 2) increasing the number of patients treated with more affordable treatments. This study evaluates the efficiency of the Hungarian biosimilar drug policy on the case of biosimilar infliximab. Methods: We analyzed the utilization of biologicals in all reimbursed indications of infliximab including initial therapy of new patients and switching patterns retrospectively based on patient-level payer's data between September 2012 and December 2016. Results: Despite the economic rationale, patent expiry did not manifest in increased utilization of multisource infliximab in an access-restricted environment: 1) Patients previously treated with original biologicals were switched mainly to other original biologicals instead of more affordable biosimilar alternatives. 2) Although some treatment-naive patients started on more affordable multisource infliximab with price competition, the majority of new patients started on other original biologicals with monopolistic price. Conclusion: Policy tools and measures should be developed to facilitate first-line use of multisource biologicals for treatment-naive patients and promoting the use of more affordable multisource biologicals in case of switching.
