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Article History

Accepted: 26 March 2026

First Online: 13 April 2026

Declarations

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: Louis Marie Dourthe declares potential conflicts of interest with AstraZeneca, Bayer, Merck Sereno, Ipsen, Pfizer, and Johnson & Johnson. Aline Guillot declares lectures for Ipsen. Cécile Vassal and Christine Rebischung have no conflicts of interest that are directly relevant to the content of this article. Eyad Kazan declares potential conflicts of interest with Pfizer, AstraZeneca, Janssen, Bristol Myers Squibb, Merck Sharp and Dohme Corp, and Roche. David Coeffic declares potential conflicts of interest with Novartis, Astellas, Bristol Myers Squibb, Merck Sharp and Dohme Corp, Roche, AstraZeneca, Janssen, and Pfizer. Amélie Falabrègues is employed by AstraZeneca and has no conflict of interest, nor any stocks or shares to declare. Delphine Suau, Amir Lahouegue, Sofia Aboulabbes, and Hassiba Ould Lahsen are employed by AstraZeneca and may hold shares.

: Early access authorizations are granted by the HtA body since 1 July, 2021 for innovative medicines following an opinion from the ANSM as to their presumed efficacy and safety ratio. Ten months after this reform came into force through the 2021 French social security financing law, the HtA body and the ANSM issued a positive initial report on this procedure, which fast tracks and facilitates patient access to innovative medicines. This study followed the ethical principles set out in the Declaration of Helsinki. The process is formalized through the therapeutic use and data collection protocol (PUT-RD), which is a legal dossier required for each early access request and describes the methods of collecting patient data. All patient data collected are pseudonymized to respect the Declaration of Helsinki.

: The patients did receive a patient information leaflet from their physician. Patient consent was collected by the physician prior to administration of the medicine. This was mandatory and applied to all patients included in this study.

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: The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

: Not applicable.

: The fEA is not a clinical trial. Therefore, there is no study conception, design, or material preparation. LMD, AG, CV, EK, DC, and CR are the most important contributors among prescribing physicians during the EA. HOL, DS, and AL designed the study and submitted the study project to prescribing physicians. LMD, AG, CV, EK, DC, CR, HOL, DS, and AL contributed to the data collection and report writing. SA, AF, HOL, AL, and DS analyzed the data. SA, AF, and HOL wrote the paper with input from all authors. All authors read and approved the final version.