Updated procedures for accessing the AIFA National Fund (5% Fund)

AIFA has published updates to procedures for clinicians to access the 5% Fund.

The 5% Fund is a national fund to which companies are required to donate 5% of their promotional expenditure, by 30th April each year.  Each year, half of this fund is used to reimburse orphan and life-saving drugs which have not been marketed yet, while the other half of the fund is aimed at supporting independent research, drug information programs and pharmaceutical vigilance.

Prospective applicants are informed that the following must be adhered to in order for their requests to be accepted for review:

  • Applications must be made using the correct forms and using the updated instructions
  • The medicine being requested must have been previously assessed for provision pursuant to the Ministerial Decree of 7th September 2017
  • Applications should contain sufficient clinical data to justify the therapeutic regime being requested and demonstrate the absence of valid therapeutic alternatives already available on the NHS

Requests for access to the 5% Fund must be received by the 10th day of each month in order to be evaluated within that month; requests received after day 10 will be evaluated the following month.

To renew access to the 5% Fund, applications must be sent by the 10th day of the month preceding expiry of the existing authorisation. Renewals must include a clinical report detailing the clinical parameters indicative of improvement of the patient’s condition and relative efficacy and safety of the treatment.

The aim of these updates is to ensure an accurate assessment of the many applications received by AIFA and ensure a careful use of the resources available to facilitate patient early access to treatments.

AIFA anticipate that requests received from 15th July 2019 will be evaluated in September.

In an emergency, please contact the Pre-Authorisation Area via: 648.fondo5@aifa.gov.it.

To read more about the AIFA 5% Fund, please see our Early Access section on MAP Italy.

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Published 12. July 2019 in News, News Italy