The 5% fund for rare diseases, which allows access to medicines that are not yet marketed in Italy and which represent a hope of cure for patients suffering from rare and serious diseases, is fed by the marketing expenses of pharmaceutical companies (congresses, medical-scientific information, etc.), expenses which, due to the pandemic, have been greatly reduced, making 'only' 10.5 million available in 2021 compared to, for example, 20 million in 2010.
Recall that in November 2021, the agency's evaluation activity was temporarily suspended precisely to cope with the increase in applications and the decrease in the fund.
The determination published on 30/03/22 in the OJ serves to recover unused resources in relation to treatments that were never started or stopped early, in respect of which reimbursement or only partial reimbursement was never requested.
What does the recently issued 5% fund access authorisation measure say
For fund authorisations authorised up to 31/12/2019 and for which reimbursement (full or partial) has not yet been requested ➜ AUTHORISATION REVOKED
For fund authorisations authorised between 1/1/2020 and 30/09/2021 ➜ may request partial or full reimbursement by 31/05/2022
For fund authorisations authorised as from 1/10/2021 ➜ must request reimbursement within 60 days of treatment and no later than 8 months after authorisation
