OBJECTIVES:

To examine trends in the time between regulatory approval and launch/pricing and reimbursement approval in the EU4, UK and US

METHODS:

Examined new molecular entities, formulations and combinations approved by the European Commission (EC) between January 2016 and December 2021, and their launches in the EU4, UK and US. Time comparisons were made for all products in scope, including analysis of orphan and oncology drug subgroups. Further analysis was conducted on 3 year cohorts (2016-2018 and 2019-2021) to look for changes in trends. Data was gathered from official national HTA agencies and P&R bodies.

RESULTS:

Overall time to launch post approval is fastest in the US (8 weeks) with no significant change over the years. Across Europe, average time to market for all drugs is consistently shortest in Germany and the UK (24 and 28 weeks) and longest in Spain (83 weeks). While time to market tends to be faster for oncology therapies in all countries, it is longer for orphan drugs in France and Spain.

However, the launch timing should be viewed within the context of the percentage of products that actually make it to market which varies widely; 90% in Germany to 52% in France. This has recently had another dimension added by the UK's regulator (MHRA) having approvals preceding the EC in some cases.

Cohort analysis shows a lower percentage of approved drugs were launched in all European countries in the more recent cohort (2019 to 2021), while US access remains stable.

CONCLUSIONS:

US continues to have considerably shorter time to market while Germany has the broadest and fastest access among the European countries. France, Italy and Spain have procedures that require a local filing and negotiation before entering the market resulting in longer lag between regulatory and pricing approval.