Regulatory Approval To Patient Access, An Evaluation of Eu5 And Us National Timing Differences: An Update.

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 May 2014. Additional analysis of products launched between April 2013 and May 2014. 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; and Spain: Date of commercialization. Overall, for launches between Jan 2009 and May 2014, the average time from FDA approval to US launch was 6 weeks (oncology 4 weeks; orphan drugs 2 weeks). Across the EU5, Germany remains the fastest despite post-AMNOG increase to 18 weeks (vs. 11). Analysis of new products launched between April 2013 and May 2014 shows time to access in Spain has increased vs. the previous 5 years (75 vs. 54 weeks). Limited numbers of orphan drugs have completed full Spanish P&R process with 106 weeks to launch far exceeding all drugs (75 weeks). Italian average time to complete P&R is 69 weeks, while average time to be listed in class C-nn, without national reimbursement, is only 18 weeks. UK average time to oncology launch appears short (16 vs. 20 weeks), however HTA assessments often mean significant access delays. French orphan drugs assessment is faster vs. all drugs (46 vs. 50 weeks). The time to P&R post-regulatory approval increased ~3 weeks in Italy and ~21 weeks in Spain for products launched in the latest year vs. all drugs with EMA approvals between Jan 2009 and Dec 2013.