New restrictions for Prolia
Insider Insights

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


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

As of 29th 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’exceptionie 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.


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

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