OBJECTIVES: Based on observations within the European market, patients in some countries have to wait much longer for access to new medicines compared to other countries. The primary objective of this analysis was to devise and perform a fast, adaptive, and reproducible analysis of delays in the availability of new medicines in the EU. The second objective was to separately analyze the availability of new biosimilar medicines.

METHODS: Time-to-price (TTP) was defined as an indicator of the availability of medicine. It measures the days that elapsed between the European Medicines Agency (EMA) marketing authorization date and the first date when the medicine’s price was available in the national reference source (i.e., a proxy for market availability). The dataset included 124 centrally registered EMA products with marketing authorization dates between 2017 and 2018. The date of price availability in 29 European countries was obtained from Cogvio's medicine price database, which contains prices published by the respective authorities.

RESULTS: The median TTP for innovative products was the lowest in Germany (67 days) and the highest for Latvia (556 days). The median TTP for biosimilar products was the lowest in the Netherlands (65 days) and the highest in Portugal (376 days). High TTP variance was observed for the same type of products within individual countries. For example, in the Czech Republic, the shortest TTP for a biosimilar product was 68 days compared to the longest of 559 days.

CONCLUSIONS: The results of the analysis confirm that patients in some EU countries gain access to newly registered medicines up to 500 days after the same medicine became available on the market of one or more other European countries. This delay leads to unnecessary life years lost for European patients. Information regarding TTP in an individual country might also be an important tool for planning optimal launch sequences.