Medicines, expenditure soars above 25 billion: revision of the formulary on track

The pharmaceutical expenditure of the National Health Service - that which guarantees (free or with co-payment) citizens medicines in pharmacies and hospitals - is about to exceed the record figure of 25 billion. A mountain that continues to grow by now at the rate of 6-7% per year, as certified by the latest report just published by the Italian Medicines Agency on expenditure in 2025, which, according to official data for the first 10 months, has already exceeded 21 billion (+6.9% compared to the same period in 2024) and if it continues at this rate will close just above 25 billion, a peak - it was 21,7 billion in 2023, then rising to 23.7 billion in 2024 - that will actually break through by more than 4 billion over the overall resources ceiling reserved for medicines, which last year was worth 15.3% of the entire National Health Fund, but which in ten months (up to October) had already absorbed 18.63% of the overall cake available to the NHS for medicines.

A surge linked first and foremost to a demand for health that is exploding with the ageing of the population - even in other European countries, expenditure on drugs is rising, AIFA itself emphasises - and in which the arrival of many innovative drugs and therapies for rare and often costly diseases that have been approved but are now presenting the bill is weighing heavily. A bill that will also be very high for the pharmaceutical companies called upon to cover - through the payback mechanism - half of the overrun of the expenditure ceiling on direct purchases of drugs (those dispensed in hospitals): here the overrun from the special ceiling (which is worth 8.3% of the Fund and in the first 10 months already touches 12.06%) is as much as 4.243 million that in the twelve months could reach 5 billion of which 2.5 billion borne by the companies, an increasingly heavy boulder if one thinks that in 2021 the payback was worth 1.195 billion. On the other hand, as always, the ceiling on contracted medicine (expenditure in pharmacies) in the first 10 months of 2025 leaves a surplus, for now more than 400 million, with an incidence on the health fund of 6.39% against a ceiling of 6.8%. But on these figures one still awaits the definitive effect of the switch of glyphozines from the hospital channel to the pharmacy channel.

So far, these are the numbers that take a snapshot of the pharmaceutical expenditure race and confirm once again that there is an objective underfunding of pharmaceutical expenditure in relation to demand. But that is not enough to explain everything. Hence the strong fibrillation among the Ministry of Health, with Minister Schillaci, who in recent weeks has asked for explanations from the top management of Aifa in a fiery letter (the hypothesis of a commissioner was also aired) on this growth that is not sufficiently governed. And in the last few days - on the eve of the new report on expenditure - the Medicines Agency has responded with a dossier of about ten pages listing the interventions and price renegotiations already carried out, but above all indicating the countermeasures being studied to stem the growth in expenditure: from the safeguard clause to the revision of the formulary.

For the moment, the Ministry of Health is studying the dossier and is also considering a new response soon, but what is certain is that at the moment the only measure that could really go through is that relating to the revision of the handbook, which contains the list of medicines reimbursed by the SSN and which, as provided for by the last manoeuvre, must be reviewed annually so that the Agency identifies 'the medicines to be included, maintained, reclassified or excluded from the handbook, as well as those for which to renegotiate the price and reimbursement conditions'. If the safeguard clause should end up in the drawers - there are many doubts on the legal knots linked to the introduction of a price cut - on the formulary the Ministry is aiming to see the details of the possible interventions to be triggered next January: AIFA's Scientific and Economic Commission is already studying the possible maximum savings to be obtained in the various therapeutic categories (a first taste was in recent weeks for proton pump inhibitors), perhaps by eliminating some 'duplicates'. The idea under consideration, particularly for off-patent medicines, is to establish a reference reimbursement price for each therapeutic area (and therefore also with different active ingredients) to which to adjust. But the pharmaceutical companies are already on the warpath and it is not certain that in the end the difference in prices will not all fall on the pockets of citizens because the companies, even in the face of pressure from overseas with Trump's pressure, are anything but inclined to lower them. In short, the game is only just beginning and the outcome is still very uncertain.