Comment gérer les suites d'ATU après l'obtention de l'AMM, à l'hôpital ? Quand évaluer ? Rôle de la Commission du médicament et des dispositifs médicaux stériles (COMEDIMS) à l'Assistance publique des hôpitaux de Paris (AP-HP)

Before marketing authorization, several new medicines benefit from an authorization for temporary use (ATU), a usually named-patient authorization delivered by the French Drug Agency (Afssaps); thus, they can be used in our group of forty university hospitals, AP-HP, before any assessment from our Pharmacy and Therapeutic Committee (PTC). At the end of the ATU period, and until the medicine is completely assessed by our PTC, patients enrolled are maintained, but what should be done for enrolling new patients? Method: Between January 2006 and July 2007, a decision tree was implemented by the PTC bureau. Results: Fourteen decisions were made: seven in favour of enrolling new patients (for severe, disabling states, without alternative treatment), three in favour if written explanations from the prescriber (available alternatives; non-urgent treatments; labelled uses larger from ATU) and four unfavourable (undefined hospital positioning), with possible re-assessment. All pharmacies and local PTC's were informed of these decisions by e-mail, along with a mention to the new rule given by the General Health Authority (DGS 2007-04-11). Conclusion: This assessment by PTC was found necessary to determine the added value of these new medicines and their role in the therapeutic pathways.