Comparative analysis of trends in HTA for new INNs in Bulgaria and France

Abstract

Abstract Background Decisions on pricing and reimbursement of medicines are made at national in the context of the country's health system. Although there has been significant progress towards partial harmonization in health technology assessment (HTA) approach in EU member-states, currently HTA process is still country-specific. This fact does not prevent countries to exercise significant efforts for regular improvement/upgrade of their HTA systems, based on health policy's goals, budget, existing good practices in other countries etc. The aim of the current publications is to perform a comparative analysis of the reimbursement systems for medicines in Bulgaria and France. Methods The methodology includes comparative analysis based on the assessment of the health technologies in both countries for the period from April.2019 until Sep.2020; sociological Methods documentary method and statistical Methods graphical analysis. Results The number of the HTA reports reviewed in both countries is similar as well as the ratio of approved/non-approved therapies. In both countries the largest share of new medicinal products approved for reimbursement were cancer products and the number of orphan medicines was significant. The main difference is that in Bulgaria there is only one evaluation needed for inclusion in the reimbursement system, while in France two evaluations form the reimbursement level. Some differences regarding reimbursement of hospital use medicines were also found. Conclusions The efficacy of systems in both countries is similar as far as the number of approved therapies is concerned. Slight difference in the methods applied was observed. Key messages The Haute Autorité de Sante (HAS) is amongst the few HTA decisions recognized and reviewed in Bulgaria which obviously impacted the Bulgarian system and resulted in the observed similarities. Sharing best practices and assessment reports amongst countries facilitate future harmonization of HTA on EU level.