OBJECTIVES

: Autorisation Temporaire d’Utilisation de Cohorte (ATUc) is a French early access scheme dedicated to presumed innovative treatments before marketing authorization, and limited to patients with the highest need. These treatments are funded by the National Health Insurance at a price freely set by pharmaceutical companies. This research aims to compare ATUc prices versus launch prices in France, Germany, Italy, Spain and the United Kingdom, and to observe market access delays.

METHODS

: Between January 1st, 2017 and December 31, 2019, 42 ATUc drugs were assessed by the Haute Autorité de Santé (HAS). The ATUc prices were available for 39 of these drugs in the French Ministry of Health database, and launch prices and dates were taken from PricentricOne by Eversana (cut-off date on June 1, 2021). Appropriate statistical analysis was used.

RESULTS

: ATUc price in France is usually one of the first available. The first country publishing prices after ATUc France was Germany mainly due to its free pricing policy, followed by the UK and Italy. Subsequently, Germany published its negotiated prices after a year which was followed by Spain. And France was the last country to negotiate a public reimbursed price.

Compared to ATUc prices, observations show that prices in Germany are significantly higher (+11,9%, P=0.02) when they were freely set. And in Italy and Spain, there was no statistical difference in listed prices (P=0.08 and P=0.36) while in the United Kingdom (-7.5%, P=0.03) and France (-16%, P<0.01), the prices are significantly lower. Prices negotiated in Germany, one year after the launch were also significantly lower than ATUc (-11,1%, P=0.03).

CONCLUSIONS

: In France, where ATUc provides early access to a small part of the target population, high price expectations from companies may lead to longer delays in access, for the rest of the target population versus its reference countries.