Drug Policy in Bulgaria.

Bulgaria has a mixed public-private health care financing system. Health care is financed mainly from compulsory health insurance contributions and out-of-pocket payments. Out-of-pocket payments constitute a large share of the total health care expenditure (44.14% in 2014). The share of drugs expenditure for outpatient treatment was 42.3% of the total health care expenditure in 2014, covered mainly by private payments (78.6% of the total pharmaceutical expenditure). The drug policy is run by the Ministry of Health (MoH), the National Council on Prices and Reimbursement of Medicinal Products, and the Health Technology Assessment Commission. The MoH defines diseases for which the National Health Insurance Fund (NHIF) pays for medicines. The National Council on Prices and Reimbursement of Medicinal Products maintains a positive drug list (PDL) and sets drug prices. Health technology assessment was introduced in 2015 for medicinal products belonging to a new international nonproprietary name group. The PDL defines prescription medicines that are paid for by the NHIF, the MoH, and the health care establishments; exact patient co-payments and reimbursement levels; as well as the ceiling prices for drugs not covered by the NHIF, including over-the-counter medicines. The reimbursement level can be 100%, 75%, or up to 50%. The PDL is revised monthly in all cases except for price increase. Physicians are not assigned with pharmaceutical budgets, there is a brand prescribing practice, and the substitution of prescribed medicines by pharmacists is prohibited. Policies toward cost containment and effectiveness increase include introduction of a reference pricing system, obligation to the NHIF to conduct mandatory centralized bargaining of discounts for medicinal products included in the PDL, public tendering for medicines for hospital treatment, reduction of markup margins of wholesalers and retailers, patient co-payment, and the introduction of health technology assessment. Although most of the policies have been introduced since 2011, there is still weak evidence for improvement regarding cost containment and effectiveness.