Study of the terms for performing procedures under the HTA of a medicinal product in Bulgaria for the period 04.2016-12.2018

Introduction: The Health technology assessment (HTA) is a multidisciplinary activity that systematically assesses the effects of technology on health, on the availability and allocation of resources and their effectiveness for the health system. It is a dynamic, rapidly evolving process that helps make informed decisions about the benefits, risks and costs of introducing new technologies. The administrative terms for the HTA vary in different European countries and depend on the type of evaluation that is performed - single, multiple, rapid assessments and more. For Bulgaria, the statutory deadline for carrying out the procedure under the HTA according to Ordinance № 9 of 01.12.2015 is 90 days from the date of submission of the application by the Marketing Authorization Holder (MAH). Objective: To monitor and analyze the average duration of HTA procedures and the factors that affect it in order to assess whether the normatively determined term of 90 days is sufficient. Methodology: Monitoring, analysis and synthesis are applied for data extraction and interpretation of information about the submitted applications for HTA in National Center of Public Health and Analyses (NCPHA), as well as the overall organization of the process. Criteria for completeness and duration of the procedure are analyzed. Results: In the general case of conducting HTA, the practice shows that the normatively determined term is extremely insufficient. The leading reason for going beyond the time frame is the interval for convening and holding regular meetings of the Heath Technology Assessment Committee (HTAC). Other factors are the incomplete information in the submitted documents or the need to revise the reports. The analysis of the deadlines shows that the share of procedures completed on time is very small and decreases over the years. The longest terms are for procedures in the field of oncology, urology and hematology, and the shortest - in the field of dermatology, rheumatology and endocrinology. Conclusion: The normatively set term is insufficient and regardless of the efforts made, it was not observed in 90% of the implemented procedures. The average duration of a HTA procedure in Bulgaria in the analyzed period is about 156 days. The established practice shows that in the country the duration of HTA is close to the group of EU countries with an established term of 90-220 days.