France: New restrictions for Prolia in response to post-marketing study

Legislation published in the Journal Officiel on 25^th January 2022 modifies the reimbursement conditions for Prolia (denosumab) 60mg injection for the treatment of post-menopausal osteoporosis.

As of 29^th January 2022:

• The initial prescription for Prolia must be issued by a specialist in osteoporosis. There are no restrictions over prescription renewals.
• Prolia is reimbursed as an ‘exception drug’ (médicament d’exception) ie the drug must be prescribed on a special script and the prescriber must confirm that the prescription is issued in accordance with the drug’s therapeutic information sheet (fiche d’information thérapeutique, FIT).

The restrictions follow a recommendation to this effect by the High Authority for Health (Haute Autorité de Santé, HAS) in response to a post-marketing study looking at the use of Prolia in clinical practice.  The study showed that 20-25% of all prescriptions for the drug were not in line with the drug’s authorised reimbursed usage.

Sources:

1. www.lequotidiendupharmacien.fr, “Prolia devient médicament d’exception”, 28^th January 2022
2. www.vidal.fr, “PROLIA : désormais médicament d’exception, assorti d’une restriction des prescripteurs”, 27^th January 2022