The autorisations temporaires d’utilisation nominatives (temporary authorisation for use for nominated patient, ATUn) process will be updated in September 2018, altering how this early access model works for patients in France. ATUn is used by physicians to gain patient access to medicines without marketing authorisation, but which are likely to provide benefit. Almost 20,000 patients make use of the ATUn scheme each year, so changes will represent a significant challenge for those used to the current system.
The Agence National de Sécurité du Médicament et des Produits de Santé (ANSM) says:
“As part of its modernization and transparency program, the ANSM is transforming its application processing system for Temporary Use Authorizations (ATUn) in September, in order to simplify it and reinforce rapid and equitable access to therapeutic innovation for patients.”
Expected changes to the system will be:
- “As of September 2018, a one-stop shop will be made available to health professionals in order to simplify the procedures for requests and exchanges as close as possible to the patients requiring these treatments in ATUn
- The ANSM will publish on its website a repository of the specialties delivered within the framework of the ATUn with, for the great majority of the specialties, the criteria allowing the fast granting of these ATUNs. These criteria come from clinical situations commonly encountered by practitioners
- During requests (initiation or renewal of treatment), health professionals may, if necessary, commit to comply with the criteria for awarding a grant based on the patient’s clinical situation. Applications with this commitment can be processed more quickly. To this end, a new application form allowing this commitment will be made available to health professionals
- At the end of the year, an e-Saturn web application will be made available to health professionals to allow teletransmission of ATUn requests (replacing the system by fax) and thus further simplify exchanges”