Press release n. 11/2024 - Pierluigi Russo, AIFA Scientific Technical Director: "Behind the increase of 1.1 billion in 2023 there is no inappropriateness but the use of innovative and life-saving drugs subject to prescription control".

“The overrun in spending on medicine purchased directly by the Local Health Authorities (ASLs), largely for hospital use, is hardly attributable to inappropriate use, as it is due to innovative medicines for rare, oncological, autoimmune, cardiovascular diseases, or latest-generation antidiabetics. Medicines that are in many cases life-saving and for the most part subject to instruments for controlling their appropriate use, such as the AIFA Notes that circumscribe their reimbursability, treatment plans or computerised monitoring registers”. Commenting on the factors that led to a 3.287 billion overrun of the expenditure ceiling for direct-purchase medicines in 2023 is AIFA's Scientific Technical Director, Pierluigi Russo.

Expenditure for direct purchases last year was 1.1 billion higher than the previous year, only partly offset by the 383 million increase in the expenditure ceiling for 2023. A ceiling that had already been exceeded by 2.706 billion in 2022. “Due to the carry-over effect of the overspending in previous years and the further increase in spending on essential and innovative drugs, we have thus arrived at an overspending of almost 3.2 billion in 2023. But a more in-depth analysis of the drugs that have had the greatest increase in spending - explains Russo - shows that this is an expense that is difficult to compress”.

 “Over 40% of the increase (equal to 410 million euros) is in fact due to 12 antineoplastic and immunomodulatory medicines, mainly indicated for the treatment of oncological pathologies and autoimmune diseases, which include high-cost drugs; among these, the presence of 4 innovative medicines stands out, two of which are used for the treatment of serious rare diseases, such as cystic fibrosis and spinal muscular atrophy”, explains AIFA's Scientific Technical Director.

 “For most of these drugs, the admission to reimbursement of new therapeutic indications during 2023 could also have led to greater use and consequently an increase in spending, as in the case of an advanced cell therapy, so-called CAR-T”, adds Russo.

Just over 30% of the increase (over 307 million euros) is then attributable to 9 medicines indicated for the treatment of cardiovascular diseases or that impact cardiovascular risk, such as the latest antidiabetics recently introduced on the market, which alone are responsible for an increase of 144 million euros and which are for chronic treatment. Among these, only the now well-known semaglutide, an anti-diabetic drug that is also effective in reducing body weight, represents 8.2% (+82.9 million euros) of the overall increase in spending recorded. The remaining 30% is represented by 8 medicines, half of which are innovative drugs for ultra-rare diseases. "Finally - Russo explains - we should also mention remdesivir, an antiviral for the treatment of COVID-19, whose purchase in 2022 was carried out by the commissarial structure of the Ministry of Health for the purchase of vaccines and anti-COVID-19 drugs and whose expenditure (53 million) is now accounted for in the flow of direct purchases".