Introduction. The aim of this study is to examine the reimbursement pathway and the current status of payer coverage of ATMPs in Bulgaria.

Methods. Data was collected from the regulatory database of the Bulgarian National Health Insurance Fund (NHIF) which is the sole payer responsible for contracting and paying healthcare providers for all services including medicines in the country. The database of the Bulgarian Drug Agency was searched for ATMPs included in the Positive Drug List and the list determining the maximum price of drugs that are not covered by the national insurance system.

Results. ATMPs in Bulgaria follow the same reimbursement pathway as all other medicines. The reimbursement process is regulated by the Law for drugs in human medicine and the local health technology assessment (HTA) regulatory requirements. Currently, there are two ATMPs that are being assessed for reimbursement. Kymriah has been included in the drug list determining the maximum price which is 336,000 Euros. Inclusion in this list does not guarantee reimbursement from the NHIF, however, the therapy can be reimbursed by third party payers or by patients themselves. Zolgensma was submitted for assessment and a decision for reimbursement is expected shortly. There is no data available whether the NHIF plans to enter into managed entry agreements based on financial or performance considerations with the manufacturers. Bulgarian HTA bodies have currently a limited experience with assessing and reimbursing ATMPs as compared to payers in the USA and Europe.

Conclusion. Only two ATMPs could potentially be used for treatment of patients in Bulgaria. The lack of reimbursement coverage and the limited experience with assessment and managed entry agreements for ATMPs pose a challenge for patient’s access. NHIF will have to consider developing pathways dedicated to reimbursing ATMPs with outcome-based agreements that could alleviate the financial burden for the payer.