by Vera Martinella
Italy is one of the countries that offers the greatest number of innovative medicines and access times have been reduced, but obstacles remain, such as those represented by regional hospital therapeutic handbooks
The new cases recorded in 2023 were 395 thousand, over 1,080 per day. Around 190 thousand deaths per year, but 60% of patients are alive five years after diagnosis and more than one million can be considered definitively cured. A handful of numbers photograph the “cancer” universe in our country and highlight, on the one hand, the important progress made on the survival front, and on the other the strong impact of tumors in terms of the number of people who get sick and deaths that still cause.
The credit for the improvements must be partly attributed to early diagnoses, which allow a neoplasm to be identified when it is small in size, confined to a single organ and without metastases: easier to treat and with a greater chance of recovery. Another large part of the successes, however, is due to the arrival of new therapies and on this front Italy has great merits and great critical issues.
Italy among the best Europeans for survival and access to new drugs
«We have a precious national health system that must be preserved, strengthened, defended so that it continues to be truly universalistic, that is, to treat all citizens throughout the peninsula free of charge, in the best possible way – underlines Francesco Perrone, president of the Italian Association of Medical Oncology (Aiom) —. We are among the best European countries for survival and access to new drugs, but Italian cancer patients still have to wait 419 days, i.e. more than a year, to receive innovative medicines after European approval. Latency times have reduced in recent years: 10 years ago they exceeded 2 years, but we can and must do better.”
In Germany, for example, the wait stops at 102 days, in Denmark at 145, in Austria at 267. From 2018 to 2021, 46 innovative anticancer molecules were marketed in Europe. Italy has guaranteed the availability of 38 of these new drugs, placing itself in third place after Germany (45) and Switzerland (41) and ahead of France (33), Greece (32), Sweden (30), Holland (29) and Spain (26).
Which patients are the innovative therapies reserved for?
«Innovative therapies are largely reserved for patients with advanced or metastatic tumors, who have not received the hoped-for benefits from standard treatments – clarifies Saverio Cinieri, president of the Aiom Foundation -. Sick people for whom time is very precious and the months that pass make the difference in being able to continue living, hoping to make their illness chronic. If the use of the innovative medicine that has received the European green light (from the EMA, European Medicines Agency) has not yet been approved by the regulatory body of our country, i.e. the Italian Medicines Agency (AIFA), and therefore not is reimbursed by the NHS, the matter is very complicated.” In practice, the cure exists, but it cannot be prescribed for free and the cost of these treatments is very high.
Approval times
Some time must necessarily pass from the European approval for Aifa to negotiate the price of the new medicine with the pharmaceutical companies (which will then be paid by our NHS): «Italy is one of the most efficient countries in obtaining advantageous prices and one of the few to guarantee free treatment for everyone – underlines Cinieri -. And negotiations take time.” An additional problem, however, arises for the subsequent steps which in many cases are added at the level of the 19 Italian Regions and 2 Autonomous Provinces «and then even of the individual hospital, which, in turn, can insert certain steps and bureaucratic constraints that can entail further months of delay” specifies Massimo Di Maio, president-elect of Aiom.
Therapeutic Handbooks
In 10 regions there are still Regional Hospital Therapeutic Handbooks, i.e. lists of drugs that can be prescribed within the various facilities (public and accredited private).
«Local therapeutic handbooks, in fact, add a step to the already long process of approval and implementation of a new drug, before it is actually available to the patient – Perrone points out -. This creates unacceptable disparities among patients based on the area in which they live. For this reason we hope that the Aifa reform will be completed as soon as possible and that we can subsequently arrive at the abolition of the Regional Handbooks”.
Burocratic procedures
Meanwhile, for years, particular ‘early access’ rules have been developed to overcome obstacles. «There are rules that allow and regulate the prescription of innovative drugs already approved by EMA, but not yet reimbursed in Italy – concludes Di Maio -. Effective paths, but which cause problems due to complex bureaucratic procedures and which in any case imply a more or less long wait (even several months) for the sick. Rules that for years have blocked a problem that must however be resolved by simplifying the steps that persist at a regional level or, even worse, at the individual hospital”.
Strategies to speed up arrival
What are the current strategies to get innovative drugs to patients sooner? «The first is law 648/1996, which allows the dispensing of a drug in the course of clinical trials or with a different therapeutic indication, having been included in a list approved by Aifa – illustrates Massimo Di Maio -. Then there is the 5% AIFA Fund (law 326/2003) which allows the use of orphan drugs for the treatment of rare pathologies or medicines awaiting marketing.
There is law 94/1998 which authorizes the off label use (outside the ordinary prescriptive rules) of particular treatments under the responsibility of a doctor and, finally, there is legislation on compassionate use (Ministerial Decree 8 May 2003 and Ministerial Decree 7 September 2017), with free supply by the pharmaceutical company: the request is made by a doctor for nominal use (i.e. for a single patient), who submits it to the evaluation of the hospital’s ethics committee, after having had the ok from the manufacturing company”.
Independent trials are decreasing
For a new treatment to reach the patient, a long series of trials must be overcome to establish its effectiveness and safety. In 2022, 663 trials were authorized by the Italian Medicines Agency (Aifa) and almost 40% concerned oncology, a constant percentage in recent years, but in our country public funding in this sector is undersized (we are among the countries Europeans who invest less), and the number of “non-profit” trials, i.e. promoted by public or non-profit research bodies, is decreasing. Independent clinical trials, the non-profit ones, dropped from 185 in 2021 (22.6% of the total) to 98 in 2022 (15%).
Furthermore, Italy, with 99 researchers per 100 thousand inhabitants, is in fourth to last place in Europe and well below the continental average (143). There is a lack of data managers, research nurses, bioinformaticians, budget and contract review experts.
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February 19, 2024 (changed February 19, 2024 | 07:55)
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