PNS155 ACCESS OF BULGARIAN PATIENTS TO BIOSIMILAR MEDICINES

Abstract

To analyze the Bulgarian patients’ access to biosimilar medicines authorized in the European Union (EU). Information about the authorized biosimilar medicines in the EU was obtained for a 6-month period (November 2018 – April 2019) from the European Medicines Agency website. The availability of biosimilars in Bulgaria was analyzed by crossing the medicines identified in the European list with those in the Bulgarian Positive Drug List (PDL) Annex 1 and 2. Information on the biosimilars availability was systematized by International Nonproprietary Names, trade names, indications, year of approval and inclusion in the PDL. 71 biosimilars had received marketing authorization by April 2019, whereas in November 2018 they accounted 53. The reimbursed biosimilars for hospitalized patients in Bulgaria were 14 (26.42%) in 2018 and 29 (40.85%) in 2019. The ambulatory patients’ access to biosimilars was relatively low – 15 out of 71 (21.13%) in 2019. The dynamics in the number of reimbursed biosimilars within the 6-month period showed remarkable increase – almost 2 times. The average time to inclusion in the PDL is approximately 3 years after marketing authorization through centralized procedure. The longest time passed for inclusion of Somatropin (9 years) and the shortest - for infliximab, trastuzumab and insulin glargine. To the best of our knowledge, this is the first study analyzing the biosimilar medicines access for Bulgarian patients revealed significant increase in their number as more medicines are included in the PDL annex 2 probably because of the ‘restricted’ medical prescription of some biologic medicines, reserved for use only in certain specialized areas.