Italian Medicines Agency

The monitoring of pharmaceutical expenditure that AIFA periodically publishes is an essential prerequisite for the planning of pharmaceutical assistance in Italy.

AIFA carries out monthly monitoring of pharmaceutical expenditure data and communicates the related results to the Ministry of Health and the Ministry of Economy and Finance with the same frequency. On May 31, October 30 and December 31 of each year, the Agency checks whether the expenditure ceilings have been exceeded at national level, both for NHS pharmaceutical expenditure (7.96% of the national health needs) and for direct purchases (6.69% + 0.2% of the national health needs).

The monitoring of pharmaceutical expenditure is carried out on the basis of the NHS pharmaceutical expenditure data and the Summary Accounting Lists (Distinte Contabili Riepilogative) acquired by the Regions, as well as the data acquired by the New National Health Information System (SIS) of the Ministry of Health, relating to drug traceability (DM July 15, 2004).

Starting from 1 January 2017, a Fund for participation in the reimbursement to the Regions for the purchase of innovative non-oncological medicines was established in the forecast of the Ministry of Health, with an endowment of 500 million euros per year, as well as a Fund for the contribution to the reimbursement to the Regions for the purchase of innovative oncological medicines, with an endowment of 500 million euros per year.