OBJECTIVES: Beginning in late 2015, health technology assessment (HTA) has taken the lead as the essential tool for governing how new pharmaceuticals are introduced and used in Bulgaria. Since 2017, the National Health Insurance Fund (NHIF) has reimbursed for all oncology medications included on the positive drug list (PDL) following a positive HTA recommendation. The purpose of this study is to describe the evolution of total annual cancer treatments expenditures from 2017 to 2021 following the introduction of HTA as a tool for healthcare decision-making.

METHODS: First, we identified HTA appraisals for oncology indications and medications that were uploaded to the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) website during the 5-year period of analysis; second, we checked the PDL inclusion date of these with positive HTA recommendation; and finally, we matched the medications' reimbursed expenses across all quarterly NHIF reports per year.

RESULTS: From 152 HTA appraisals 52 (34%) were identified as treatments in oncology – 42 drugs and 2 diagnostic kits; 48 indications; 3 negative decisions for PDL inclusion. In 2017 six new therapies were included in the PDL and the reimbursement expenses were calculated on 24,223,975.3 EUR – 5.9% of the overall NHIF budget for drug therapies. The NHIF budget for pharmaceuticals increased by 41.1% throughout the studied period, from 408,303,176 EUR in 2017 to 693,823,083 EUR in 2021. As the number of PLD-included oncology medications increased (42 therapies), reimbursement costs rose to 233,821,787.1 EUR, representing 33.7% of the 2021 NHIF budget for therapeutics. Oncology medications' NHIF budget overrun for 2021 was estimated to be 40,237,556.4 EUR, or almost 14% overspend.

CONCLUSIONS: Oncology therapies expenditures are increasing on an annual basis, accounting for one-third of total medication reimbursement expenses, despite the Bulgarian declining population on the one hand, and increased NHIF drug reimbursement capacity on the other.