Claudia Garimberti -

Changes have recently been introduced by AIFA concerning the procedure for the request of access to the so-called “AIFA 5% fund”, a national fund introduced by law 326/2003 for the use, at AIFA’s expenses, of orphan drugs for serious diseases and of drugs which represent the hope of treatment for particular and serious diseases, awaiting marketing in Italy.

The request for access to this fund is patient-specific and is submitted to AIFA by the Centre of Reference. If approved, the cost of the treatment for that specific patient is reimbursed to the hospital by AIFA.

Compared with the previous procedure, the main changes concern the following:

  • Introduction of specific forms to be used for the submission of the request to AIFA;
  • Possibility of requesting an urgent assessment by AIFA, within 10 days of submission;
  • Need to communicate to AIFA the beginning and the end of the treatment according to law 326/2003.


Regulatory Pharma Net is available to support physicians who would like to request the access to the AIFA 5% fund or renew a previously approved request.

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