The President of the Medicines Agency

"Spending on medicines will continue to grow. Medicines should be reimbursed according to how they cure'

For Aifa president Robert Nisticò, action must also be taken on too many prescriptions of medicines by white-collar workers

Variety of medicines and drugs.Medicine and healthcare concept.

3' min read

3' min read

"The growth of pharmaceutical expenditure is a physiological phenomenon in all countries. Putting in more money is one solution, but it will never be enough. Spending will continue to grow no matter how much more money you put in. One solution could be to calibrate the price at which a drug is reimbursed by the SSN on the basis of what the therapy actually cures, imagining a sort of adjustment: if it is really effective in curing diseases, I pay the company more, otherwise I ask you for that money back, at least in part. Robert Nisticò is the president of the Italian Medicines Agency whose job it is to try to govern pharmaceutical spending, which has skyrocketed to a record figure of almost 24 billion by 2024, as well as the main task of deciding which drugs to authorise and have reimbursed by the health service. Deciding on countermeasures to try and stop this speeding train is up to politics, but Aifa as a scientific technical body can help find the right course.

Let's start at the beginning. Why is it that in the last 4-5 years expenditure has been growing so much? .

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There are several reasons for this. On the one hand, the population is ageing more and more and this brings with it an increase in the costs of the therapies needed to treat it. But then there is the impact of the arrival of many innovative drugs: I am thinking of the orphan drug sector, which between 2023 and 2024 has seen 26 authorised by Europe, or biological drugs such as monoclonal antibodies or other advanced therapies such as Car-t or gene therapies.

With what costs?  

These therapies are more expensive than traditional ones. I give the example of Hemgenix, a gene therapy drug indicated for the treatment of haemophilia, which is the most expensive in the world and is priced at $3.5 million in the US. It is a one-shot therapy that we approved at the end of July and which avoids transfusions. Like others of this kind, they often modify the course of the disease or even eradicate its causes. It is true that they cost more, but they bring with them an important potential for cure and therefore also a saving in the end because they eliminate all other costs of managing the disease. In short, they are an investment.

How to make ends meet without stopping innovation? 

All therapies, even innovative ones, must be well tested because they can carry with them uncertainties about their outcomes. Only time will tell if that therapy was truly revolutionary. That is why they must be evaluated with data from the real world and with pharmacoeconomics studies that can tell us whether what you spend is more of a cost than an investment.

And then how should one act?  

I believe that we should begin to calibrate and negotiate the price of drugs on the basis of the outcomes of the therapies, that is, verifying how much they impact on the progressive slowing down of diseases and how much they impact on improving the quality of life of patients and their families. In this sense, one could set a reimbursement price for the drug at the beginning and then, on the basis of the outcomes and by evaluating the data, think about a balance: if it works I will pay you even more, otherwise you will pay me back at least part of the investment.

Other measures?

Too many drugs are prescribed, especially to the elderly; more appropriateness is needed, otherwise it cannot be explained why drug consumption among regional populations is often very different. There is also a need to tighten price re-negotiations for older drugs and those that benefit from the expansion of reimbursable therapeutic indications.

The increased expenditure also causes a cost for the companies that have to pay the payback.

Until now it has been a balancing element, a buffer between patients' needs, public accounts and the legitimate interests of companies. However, now that the government is working on the single text on medicines, it may be the right historic moment to try to revise it.

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