HPR30 Reimbursement Pathway for Advanced Therapy Medicinal Products in Bulgaria

The aim of this study is to examine the reimbursement pathway and current status payer coverage ATMPs in Bulgaria. Data was collected from regulatory database Bulgarian National Health Insurance Fund (NHIF) which sole responsible for contracting paying healthcare providers all services including medicines country. Drug Agency searched included Positive List list determining maximum price drugs that are not covered by national insurance system. Bulgaria follow same as other medicines. process regulated Law human medicine local health technology assessment (HTA) requirements. Currently, there two being assessed reimbursement. Kymriah has been drug 336,000 Euros. Inclusion does guarantee NHIF, however, therapy can be reimbursed third party payers or patients themselves. Zolgensma submitted a decision expected shortly. There no data available whether NHIF plans enter into managed entry agreements based on financial performance considerations with manufacturers. HTA bodies have currently limited experience assessing reimbursing compared USA Europe. Only could potentially used treatment lack pose challenge patient’s access. will consider developing pathways dedicated outcome-based alleviate burden payer.