When France’s ATU reform was implemented, some viewed it as restrictive. In this article published in European Pharmaceutical Review (EPR), Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
In July 2021, the French temporary authorisation for use (Autorisation Temporaire d’Utilisation, ATU) programme was the subject of a major reform, initially published within the 2021 healthcare plan on the 14th December 2020 (Article 78 – La Loi de financement de la sécurité sociale, FSSL). Among key changes, the reform introduced the need to meet three criteria: a presumption of innovation compared with the most clinically relevant comparator, an appropriate development plan, and an absence of significant safety or tolerability unknowns.
In the first seven months since this reform, July 2021 to February 2022, 17 new product applications were submitted for an autorisation d’accès précoce (AAP, which includes the previous cohort ATU). Of these, six concerned COVID-19 medications and were submitted in exceptional circumstances. To ensure applicability for the future, these applications were excluded from our analysis. Of the remaining 11, most products submitted for early access were oncology drugs and two products, Adtralza and Rinvoq, for atopic dermatitis.
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