OBJECTIVES: In Bulgaria health technology assessment (HTA) was introduced in late 2015. Ministerial Order N9 was issued and legally framed the process – all new drugs must go under HTA procedure if applied for Positive drug list (PDL) inclusion, which grants reimbursement by the National Health Insurance Fund (NHIF). In April 2019 the legislation was amended and HTA regulation have become part of Medicinal Products In Human Medicine Act. The aim of this study is to provide a better understanding of the timeliness of HTA processes in Bulgaria.

METHODS: Outcomes of HTA appraisals and supplementary documents issued and uploaded on website of the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) between 1 January, 2016 and 31 December, 2021 were reviewed. The HTA appraisals for oncology drugs were identified and the EMA marketing authorization information was reviewed and included.

RESULTS: From 152 HTA appraisals 52 (34%) were selected as treatments in oncology – 42 drugs and 2 diagnostic kits; 48 indications; 3 negative decisions for PDL inclusion. The therapeutic area with the highest proportion was leukemia (18%, n=9), followed by carcinoma, non-small-cell lung (18%, n=9) and breast cancer (14%, n=7). The median time from EMA authorization to HTA application was 634.5 days (min=50 days; max=4864 days). The median length of the HTA procedure was 185.5 days (180 days by regulation) (min=82 days; max=651 days). The median time taken from HTA application to PDL inclusion was 225.5 days (min=44 days; max=955 days). The overall median duration from EMA authorization to PDL inclusion was estimated to be – 1040 days (min=383 days; max=3397 days).

CONCLUSIONS: Positive HTA recommendations facilitate market access of innovative drugs. In Bulgaria, part of the observed delay in patient access is induced by legislative barriers – finalized HTA process and positive recommendations in UK, France, Germany, and Sweden.