PHP139 - REGULATORY APPROVAL TO PATIENT ACCESS: AN EVALUATION OF EU5 AND US NATIONAL TIMING DIFFERENCES - AN UPDATE (2009–2015)

Abstract

Examine the time between regulatory approval and launch/pricing and reimbursement (P&R) approval in the US and EU5 countries. Examined new molecular entities, formulations and combinations with EMA approval between Jan 2009 and August 2015. Time comparison for general medicines vs. orphan/oncology indications was made including shifts over time. Data gathered from: USA: FDA approval date, wholesale; acquisition cost effective date UK/Germany: Product availability/introduction France: P&R decision (Agrément collectivités/date published in Journal Officiel) Italy: First Official Gazette P&R Decree publication Spain: Date of commercialization Overall, for launches between Jan 2009 and August 2015, the average time from FDA approval to US launch was 8 weeks (oncology 5 weeks; orphan drugs 4 weeks). Across the EU5, Germany was the fastest to market (16 weeks) with the most drugs launched (219) in the six year period. Italy appeared to be the slowest to market (67 weeks); however HTA assessments by NICE in the UK often mean significant delays, with access times for some drugs, especially oncology agents being several months/years. Lowest number of drugs were launched in France between 2009 and 2015 (117) with time to P&R completion over one year (55 weeks). Few orphan drugs launched in Spain; only 13 compared to 48 in Germany with average time to launch being 79 weeks. Substantial differences exist in number of products approved by the EMA that are eventually launched in the EU5 countries. Huge disparity in time to P&R completion underlines market realities and has access implications for all drugs, in particular specialty oncology and orphan therapies. Further analysis of shifts in the launch timing during this period is warranted.