OBJECTIVES

A designated Health Technology Assessment (HTA) body was introduced in Bulgaria in December 2015, as part of the National Centre for Public Health and Analyses (NCPHA). The assessment process involves a weighted point-based scoring system covering 11 key criteria, including efficacy, safety, QoL, cost-effectiveness, and budget impact. A therapy scoring 75% of the maximum 965 points can be recommended for addition to the Positive Drug List (PDL), while a score between 50% and 75% allows PDL access with specific restrictions (e.g. specific populations only). This research evaluates the impact of the Bulgarian HTA committee.

METHODS

All publicly-available HTA assessments issued by the Bulgarian HTA committee (01/01/2015-31/12/2018) were screened and key information extracted.

RESULTS

75 HTA reports were published on the NCPHA website. 68/75 (91%) of the assessments received a positive recommendation for PDL addition, including 47/75 (63%) receiving unconditional positive recommendations (scoring ≥75% in the scoring criteria). Only 7/75 (9%) received a negative opinion. 24/75 (32%) of the assessments were in oncology, 21/24 (88%) of which received a positive recommendation (46% unconditionally). Many reports state that an incremental cost-effectiveness threshold of 37,000BGN ($21,700USD) per QALY applies in the assessment process.

CONCLUSIONS

The Bulgarian healthcare system is taking major strides in the direction of maximising the opportunity to offer cost-effective healthcare in a systematic approach. Further, from 2018, only cost-effective medicines with a positive recommendation and offered at a confidential discount to Bulgaria’s National Health Insurance Fund (NZOK) will be reimbursed, eliminating the prior costly practice of covering a basic threshold for a multitude of drugs, with patient co-pay. With almost two thirds of assessed therapies receiving unconditional recommendations to date, this HTA process holds promise to both relieve pharmaceutical expenditure, which has put immense pressure on NZOK in recent years, whilst maintaining access to innovative therapies.