Nisticò (AIFA): “The review of the formulary will be targeted, with fast-track procedures for innovative medicines”
Pharmaceutical expenditure covered by the National Health Service is rising and is approaching 25 billion. The aim is to ‘streamline’ the list of reimbursable medicines by excluding those that are no longer useful
Robert Nisticò is the president of the Italian Medicines Agency and, halfway through his term of office, finds himself grappling with the thorny issue of pharmaceutical expenditure, which continues to rise and must be managed to ensure access to treatment for all – particularly innovative therapies – whilst at the same time adhering to the challenging principle of sustainability.
The NHS’s expenditure on medicines is now approaching 25 billion.
It is unstoppable because innovation never stops: today we have increasingly sophisticated medicines, and between now and 2030 there will be many new gene therapies and CAR-T treatments. And innovation comes at a cost, because behind it there are also many research failures, and companies have to recoup those losses. Moreover, rare diseases are now better understood and diagnosed, with at least 16–17 orphan drugs – often very expensive – being approved. And then, of course, there is the major issue of an ageing population and chronic conditions, with patients who are increasingly complex to manage. This is leading to a significant rise in expenditure, though not one that is out of control. The question is how to manage it.
But is there a risk that innovative medicines will arrive late following Trump’s clause on Most Favoured Nation?
Yes, there is a real risk, and delays are already being seen in the launch of new treatments in Italia and across Europe. That is why we must be careful about the measures we put in place to contain spending.


