Medicines: statins also in the firing line – companies and the public face the risk of a hefty bill

The revision of the Pharmaceutical Formulary currently being undertaken by the Italian Medicines Agency risks turning into a deadly boomerang for citizens and businesses. The stopgap measure that AIFA is trying to ‘stitch together’ to plug the gap in spending on medicines – which is growing at a rate of 7 per cent – risks, in fact, creating a rift that will be difficult to mend. The idea is as simple as it is explosive: to set the reference price for reimbursed medicines whose patents have expired not amongst those with the same active ingredient, but within a broader therapeutic group, with the National Health Service reimbursing the cost only up to the threshold of the cheapest active ingredient.

The effect could be twofold: for companies – in many cases the flagship names of the ‘Made in Italy’ pharmaceutical sector – this would amount to a severe blow, with price cuts of as much as 30–40 per cent to bring prices into line with the reference price, a target that is virtually impossible to meet, particularly given the explosion in costs that has caused expenditure on raw materials and energy to soar in recent years; whilst for citizens, the risk is that they will have to give up the medicine they are ‘fond of’ in favour of another with a different active ingredient but which is fully reimbursed. Unless the patient decides to pay the price difference out of their own pocket, should the company have been unable to lower the price because it was unsustainable. In short, the National Health Service’s cost-saving target could end up being borne by patients.

This dangerous scenario is one that could unfold in the coming months if the revision of the Prontuario – the list of medicines covered by the National Health Service – provided for in the latest Budget Law goes ahead in the form it is currently taking shape. As the AIFA leadership wrote in a letter sent in recent days to the Minister of Health, Orazio Schillaci, and the Under-Secretary, Marcello Gemmato, to request a sort of political and legal ‘endorsement’ – are in fact aiming to implement the revision, which will begin with off-patent medicines included on the transparency list, before moving on to those still under patent. This procedure is now under scrutiny by Schillaci, who – on this issue as on that of the safeguard clause – does not appear at all convinced, to the extent that he is prepared to seek further clarification in the coming days.

Meanwhile, in recent weeks, AIFA has sent a series of letters to pharmaceutical companies that produce various categories of medicines, including some very popular ones such as proton pump inhibitors, sartans and statins, which are used by millions of Italians to treat common cardiovascular conditions such as high cholesterol or high blood pressure. These letters are far from being merely technical information; rather, they are a sort of ‘notice’ informing the ‘Dear Company’ of the grouping of active ingredients – for statins, for example, there are six – ‘with similar conditions of use and therapeutic indications’, with the specific aim of identifying ‘the active ingredient with the lowest NHS reimbursement price, taking into account the number of dosage units per pack. This is in order to identify the pack offering the most favourable cost-effectiveness for the NHS’. These assessments were carried out by the CSE – AIFA’s Scientific and Economic Commission – which, as explained in one of the letters sent to companies, ‘recommends the implementation of this measure, providing for a reasonable lead-in period to allow marketing authorisation holders to adjust/align their retail prices with the new reference price’ or, alternatively, to allow GPs to direct prescriptions towards those active ingredients that ‘minimise any further financial burden on the public’. This is the dual impact on companies and the public. Incidentally, this first revision of the Formulary would affect one component of pharmaceutical expenditure – that covered by the National Health Service, namely medicines dispensed in pharmacies – which is not in deficit but in surplus.

The latest AIFA monitoring report, published a few days ago and covering the first 11 months of 2025, shows expenditure of 23.131 billion (+7.2% compared with 2024), with an overspend of 4.147 billion, all of which relates to direct purchases (medicines in hospitals). Meanwhile, expenditure within the National Health Service reached 7.732 billion, with a surplus of 498 million euros. This item therefore falls within the planned spending limits, but would now be penalised by the severe cuts resulting from the revision of the Formulary.