PNS85 MARKET ACCESS TRENDS ACROSS THE EU5 AND US: 2009 TO 2018- AN UPDATE

Abstract

Examine the time between regulatory approval and launch/pricing and reimbursement (P&R) approval in the EU5 and US; analyze potential changes in market access timelines in the EU5 countries and US between 2009 and 2018. Examined new molecular entities, formulations and combinations with EC centralized authorization, and their launches in the EU5 countries and US from 2009 to 2018. Compared timing from regulatory approval to price listing across countries and among all medicines versus orphan/oncology indications, including shifts over time. Data was gathered from official national HTA agencies and P&R bodies. Of all EC approved drugs between 2009 and 2018: 87% launched in Germany (vs. 57% in France); 91% of orphan drugs launched in Germany (vs. 36% in Spain); 91% of oncology drugs launched in Germany (vs. 62% in France). US launches occurred for 69% of all EC approved drugs and 79% of all orphan and oncology drugs. Overall, average time to market was 17 weeks in Germany, 25 in the UK, 68 in Spain, 76 in France and 77 in Italy (Class C-nn drugs were excluded). US average time to market for the same drugs was 6 weeks overall and shorter for oncology (2 weeks) and orphan (3 weeks) medications. Oncology drugs’ time to market was faster in all EU5 countries, except Spain. Spanish time to market for orphan drugs was significantly higher than all other countries. Analysis of market access trends across the EU5 suggests that France and Spain are showing a consistent increase in time to market. Time to market in Europe is substantially longer than in the US and seems to be rising in some EU countries (France, Spain). It is important to monitor timing disparities in launch which has major implications on the availability of new drugs to patients.