PIN143 Analysis of the Time to Market Access in Bulgaria of New Daa Medicines for Chronic HCV Infection Authorized UNDER the EMA Specific Procedures for EARLY Access

Abstract

European medicines agency (EMA) supports early patient access to innovative therapies, especially in areas with unmet medical needs or high social burden (oncology, rare diseases, chronic diseases, etc) with the introduction of several specific procedures - conditional approval, accelerated assessment, approval under exceptional circumstances and compassionate use. The objective of the study is to evaluate time to market access since marketing authorization of new direct acting antivirals (DAA) for HCV. First, we analysed the EMA database for type of specific procedure and the Bulgarian Positive drug list (PDL) for time of inclusion of the new DAAs. Time to market access is evaluated as the elapsed time from EMA's marketing authorization to inclusion in Bulgaria's Positive Drug List as well as to the actual time of reimbursement by the National Health Insurance Fund Second (NHIF). EMA introduced the specific procedures for early access in 2002 and since then has issued 29 conditional approvals, 34 exceptional circumstances and 39 accelerated assessments. 7 out 8 authorized DAAs for chronic HCV infection are authorized with accelerated assessment. All of the medicines are included in PDL as time inclusion in PDL in Bulgaria since marketing authorization in the EU is 1-1.5 years on average in 2014-2016 and 2 years in 2017-2019. Time to reimbursement varies from 6 months to 1 to year since inclusion in PDL. The difference in time to market access between the two observed periods may be attributed to the dynamic pharmaceutical legislation in 2016-2019 which experienced a lot of changes in the health technology assessment domain. Nevertheless there are mechanisms in place to foster patient access of innovative medicines for unmet medical needs and diseases with high social burden, there are still some barriers to earlier market access attributed to nationally specific pricing and reimbursement practices.