New criteria for access to the 5% fund of Law 326/2003

On 30 November 2021, AIFA defined the new access criteria for Law 326/2003.

This law was supplemented by Law No. 175 of 10 November 2021 on the treatment of rare diseases.

We have produced a summary in graphical format of the inclusion and exclusion criteria for access to the 326 fund, highlighting some of the elements that can be an obstacle to a clinician's successful application.

For Aifa, a repeat use is the request of a drug, for the same indication, to different patients.

Operational procedures include:
1. The centre of documented experience verifies the inclusion and exclusion criteria.
2. If the inclusion and exclusion criteria match, the centre can send its request for access to the fund to AIFA.

The Orphan Drug Comparator: a survey to identify challenges in price negotiations with AIFA

In collaboration with Rarelab, we launched a survey with the aim of assessing the actual impact of the use of comparators in the negotiation of orphan drugs, drugs that for

AIFA meets

On 12 September, the 'AIFA Incontra' initiative was held at the agency's institutional headquarters in Via del Tritone, a new way of dialogue in transparency

Special Commission Update No. 3 - Towards the reform of the governance of the Italian Medicines Agency and the Single Commission: where are we?

Update 20 November 2023 The extraordinary State-Regions Conference held on 16 November 2023 sanctioned the long-awaited agreement on the Minister of Health's draft regulation,