HTA69 Delay of Innovative Oncology Treatments - Case from Bulgaria

In Bulgaria health technology assessment (HTA) was introduced in late 2015. Ministerial Order N9 was issued and legally framed the process – all new drugs must go under HTA procedure if applied for Positive drug list (PDL) inclusion, which grants reimbursement by the National Health Insurance Fund (NHIF). In April 2019 the legislation was amended and HTA regulation have become part of Medicinal Products In Human Medicine Act. The aim of this study is to provide a better understanding of the timeliness of HTA processes in Bulgaria.