Trends and Utilization of Real-World Evidence-Based Information to Support Market Access in the United States

Abstract

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. ConClusions: 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.