Medicines: NHS spending soars to 25 billion, coming soon with automatic price cuts

A cutback on drugs, already after the second year, that would trigger price discounts in proportion to the growth in sales, excluding from this automatic cutback all those drugs that demonstrate on 'real world' data - i.e. on the actual use among patients - a positive impact with benefits on quality of life, fewer hospitalisations and costs for the public health system. This is the mechanism that is about to see the light of day that the Italian Medicines Agency is working on, which could bring the dossier on the so-called 'safeguard clause' to the next Board meeting at the end of the month. This is a mechanism that the AIFA has been working on for some time to try to defuse the time bomb of pharmaceutical expenditure borne by the health service, the one that guarantees (free or with co-payment) medicines to citizens in pharmacies and hospitals and that has been running for at least three years. Spending - driven by the treatment needs of an increasingly ageing population and by the rising cost of innovative therapies - according to official data for the first six months of 2025 could close at the record figure of more than 25 billion (after six months it is close to 12.7 billion), it was 21.766 billion two years earlier (in 2023) and then rose to 23.226 billion in 2024. An annual growth rate of 6-7% that risks breaking the bank and that must also be governed by new instruments.

In the meantime, an Aifa decision implementing a provision of the budget manoeuvre has just recently brought back into force a 5% cut on the price to the public of SSN medicines as an advance payment, which until now it was possible for companies to postpone until the payback payment, which by the way could exceed the monstrous figure of 2.5 billion in 2025. But the idea is also to introduce a sort of double price cut in light of the fact that on average the turnover of a drug on the market doubles from the third year that it is on the market: the idea is to trigger an initial mini-discount equal for all at the end of the second year and then from the third to imagine automatic price reductions and proportional to increases in turnover - which will be certified - without engaging the AIFA in exhausting renegotiations with companies: "In order to refine spending control tools," warns Aifa President Robert Nisticò, "we are working on a 'safeguard clause', which envisages automatic price renegotiation, with discounts in proportion to any growth in the companies' turnover on the individual product. The state is the largest purchaser of medicines, so it is logical to say that if it doubles the value of purchases it will also get an appropriate discount. Even if the mechanism we are putting in place also provides for rewards for those who have achieved those sales increases by bringing greater therapeutic benefits, reducing hospitalisations and high social costs'. 'That said,' Nisticò adds, 'I recall that Italy is among the countries that have the lowest prices in Europe on average, and that we recontract. Last year this happened for 60 drugs, although in 40 per cent of the cases the recontracting was not successful, and in the remaining 60 per cent of the cases the discounting was not always proportional to the increase in sales. With the clause that we are in the process of finalising, we would instead avoid the long recontracting times, with respect to which AIFA may today find itself in an inferior position when it finds itself in the uncomfortable position of having to deal with companies that hold the patent on a highly effective drug and perhaps without adequate therapeutic alternatives'.

The Agency is also studying the possibility of rewarding drugs that have been on the market for the longest time and that have brought real and important therapeutic benefits for innovative medicines, 'in a logic of early access to the drug, thus rewarding real innovation and not that which brings few improvements in terms of survival or quality of life but at high costs,' Nisticò specifies. But among the other instruments of expenditure governance, the 'premium price', introduced many years ago but never applied in Italy, could also make a comeback. A measure that would be compensated by growth in employment and GDP, which in turn would generate higher tax revenues. In short, the idea is, on the one hand, to contain prices that do not correspond to an equally high therapeutic value or that register such increases in turnover as to maximise the result of the investment, and on the other hand, to reward companies that invest in the country or that introduce medicines that have a great impact both on patients and on possible savings for the SSN.