OBJECTIVES: Multi-Criteria Decision Analysis (MCDA) is used in HTA to make decisions, based on more than one criterion. Being incorporated in December 2015 in Bulgaria, MCDA delivers complex HTA decisions where while cost-effectiveness remains the dominant consideration. The decision making process is based on a list of criteria, including but not limiting to the cost per a QALY gained, to be measured, scored and weighted.

METHODS: Legislative review and analysis of the new methological Score List (SL) for inclusion of the new INN in the Positive Drug List (PDL) in Bulgaria.

Retrospective, descriptive study, examining all new approved INN by the pricing and reimbursement competent authority and by the HTA Commision in Bulgaria.

RESULTS: Adopting a solution with a reimbursement recommendation in the SL with points was introduced in 2016. For inclusion of the medicinal product in the PDL after HTA assessment is at more than 75% of the maximum number of MDCA points (965). Between MDCA 50% (643) and 75% (965) the decision for admission is under certain conditions, and below 50% (643) the MDCA is negative.

Based on that SL in 2016 n=30 INN received a positive HTA assessment MCDA points between 50-75%. Out of them 40% INN were included in the reimbursement system of the country and n=18 INN with more than 60% MCDA (positive HTA assessment) were not listed for reimbursement.

CONCLUSIONS: The MCDA is a reliable method and the approach is well formulated, consistent and replicable, but nevertheless all INN with a positive HTA assessment were not included for reimbursement in 2016, which is an indication that the MCDA need a further validated approach.