The Chair of the Medicines Agency

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 Nistico

3' min read

Translated by AI
Versione italiana

3' min read

Translated by AI
Versione italiana

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.

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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.

So what are you going to do about the revision of the Handbook, which has been the subject of much discussion?

At the request of Minister Schillaci and following the provision included in last year’s budget, we have examined various possible measures. However, in light of the current international geopolitical situation, we now aim to introduce a more targeted revision by the autumn.

So no more lowest reference price per therapeutic area, then?

We have received clear policy guidance on this matter, namely that we must not run the risk of citizens having to pay a co-payment in order to continue receiving their medication. However, we are looking into ‘streamlining’ the formulary to exclude those reimbursed medicines that may have been approved 30 years ago, or which lack solid scientific evidence, or have not passed rigorous regulatory scrutiny, and which have proven not to be particularly useful.

Are you hoping to make some savings with this ‘clear-out’?

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There are categories such as Omega-3s, which alone account for 120 million, and this could be the first category to be scrutinised amongst those to be excluded, perhaps because they are not useful or have become obsolete. But even by pushing for price renegotiations, we aim to achieve savings of several hundred million.

But isn’t there also an issue of appropriateness?

This is a crucial issue in a country where so many medicines are consumed, with an ageing population and doctors finding it increasingly difficult to resist patients’ requests for medication. In terms of innovation, appropriateness means looking at the value of real-world treatment outcomes and, based on that, negotiating the price – either lowering or raising it. For widely used medicines, such as those for heart patients, we need to focus on algorithms and pharmacogenomics to help determine the right medicine for the right patient, and then consider interactions with other medicines, given that older people today take as many as 10–15 medicines a day – which is madness.

What are your priorities for the remaining two and a half years of your term of office?

I would like to see fast-track procedures to ensure early access to promising innovative medicines that have not yet been approved, so as to counteract Trump’s MFN policy, and then assess their value based on treatment outcomes. I would like to see more digitalisation and artificial intelligence in regulatory assessments, and to leave behind a stronger, more robust AIFA with more staff and expertise.

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