Italian Medicines Agency Agenzia Italiana del Farmaco

Early access and off-label use

Early access and off-label use

In some cases, free access to pharmaceutical treatment is allowed in Italy before AIFA authorises its marketing or, for medicines already authorised, for indications other than those for which the medicinal product has been authorised in Italy (off-label use).

The routes for early access to a medicinal product are:

  • Law 648/1996
  • Compassionate use
  • AIFA National Fund (Law 326/2003 – “5 % fund”)
  • Non-repetitive use of advanced therapies

Law 648/1996 and the AIFA national Fund provide for the reimbursement of the medicinal product, respectively, by the National Health Service and by AIFA.

Compassionate use involves direct and free delivery of the medicine by the manufacturer.

The non-repetitive use of advanced therapies involves the preparation of the medicinal product directly from a cell factory and the requesting clinical center supports the costs.

The choice of the most suitable route depends on the specific indication; The above tools can also be applied in combination, for access to multi-drug treatment regimens.

Finally, Law 94/98 art.3, paragraph 2 – ex Law Di Bella provides for the possibility to access treatment with a medicinal product regularly on the market but for a different indication from the one for which it was authorised, even in the presence of regularly authorised therapeutic alternatives. In this case, however, the treatment is in charge of the patient or the health care structure in case of hospitalisation.

All these early access routes take place under the responsibility of the prescribing physician.

Uffici di riferimento

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Pre-Authorization Department

Sandra Petraglia

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