The Fund 5% for rare diseases, which allows access to medicines which do not have a MA in Italy, and which represent a hope of cure for patients suffering from rare and serious diseases, is fueled by the marketing expenses of pharmaceutical companies (congresses, scientific medical information, etc.). These expenses, because to the pandemic, have been greatly reduced and in 2021 “only” 10.5 million were available compared, for example, to 20 million in 2010.
Reminder – In November 2021 the Agency’s evaluation work was temporarily suspended in order to cope with the increase in applications and the decrease in the fund.
The decree published yesterday in the Official Journal serves to recover unused resources in relation to treatments never started or interrupted earlier than which has never been asked for reimbursement or only partial reimbursement.
Authorisation for access to Fund 5%
Adopted up to 31st December 2019 in relation to which are request of partial or full reimbursement have not yet been submitted ➜ AUTHORIZATION WITHDRAWN
Adopted from 1st January 2020 to 30th September 2021 ➜ may request partial or full refund by 31st May 2022.
Adopted from 1st October 2021 ➜ may request a refund within 60 days of treatment and in any case no later than 8 months after authorization.