The average time in Europe (in 2023) to have access to the new anticancer drugstimes that have lengthened by more than a month compared to 2022, when they were 526 days. Italy is faster than the European average, but cancer patients in our country still have to wait 417 days, that is, almost 14 months, to access innovative anticancer treatments. Just think that in Germany, which ranks first in this ranking, 3 months (93 days) are enough. Hence the need for new models to allow the immediate availability of life-saving therapies, starting with the abolition of the regional therapeutic formularies (Pts), still present in 12 regions (Valle d’Aosta, Autonomous Province of Bolzano, Emilia-Romagna, Marche, Umbria, Molise, Campania, Puglia, Basilicata, Calabria, Sardinia, Sicily). The request comes from the Italian Association of Medical Oncology (Aiom), in the official press conference of the scientific society at the Congress of the European Society of Medical Oncology (Esmo), which opens today in Barcelona.
“Drugs authorized by EMA, the European regulatory agency, are marketed in member states after more or less long periods, which can also be very different – says Francesco Perrone, president of AIOM – The time that passes between the filing of the authorization and evaluation dossier to EMA and the actual availability of a new therapy in the Italian region that first makes the drug available is around 14 months. Times that have decreased compared to 5-10 years ago, when they exceeded 2 years, but are still too long because they can severely penalize cancer patients. To reduce latency times, regional therapeutic formularies must be abolished and immediate availability must be allowed after publication in the Official Journal, even while waiting for regional tenders”. After inclusion in the Regional Therapeutic Formularies – experts argue – further delays can be caused by bureaucratic procedures for inclusion in hospital therapeutic formularies as well.
“We want to collaborate with the Italian Medicines Agency to define new models – continues Perrone -. The president of Aifa, Robert Giovanni Nisticò, also highlighted the importance of ensuring fast, rigorous and efficient procedures and ensuring that authorized drugs are effectively available to the patient quickly in a perspective of appropriateness, sustainability and efficiency. We are also concerned about the long times required for the approval of clinical trials, which make Italian centers less competitive compared to those of other countries. Although there are rules, such as the single contract model, they are not applied in Italy. Therefore, bureaucratic difficulties remain in trials that prolong the approval and activation times”.
“Although European Regulation No. 536 of 2014 for clinical research has established aligned authorization times for all member countries (from a minimum of 60 days to a maximum of 106 from the date of submission), in Italy the administrative approval processes are still longer and more difficult than the European average and until 2025 there will be a transitional period of validity of the old regulation on ongoing studies – explains Massimo Di Maio, president-elect of Aiom – Furthermore, even if there has been a significant reduction in ethics committees, with 40 territorial ones plus 3 with national value, it is important to rethink the processes at the level of the experimentation centers, on which all the administrative aspects fall, to remain competitive”.
In general, “it is crucial – Di Maio underlines – to aim for a harmonization and simplification of the administrative procedures that in many cases involve months of waiting before activating clinical trials in Italian centers: this puts at risk the attractiveness of our country for profit promoters and in any case delays the opportunity for patients to participate in studies”.
In 2022, 663 trials were authorized by Aifa and almost 40% involved oncology, a constant percentage in recent years. “In Italy – continues Di Maio – every year thousands of citizens affected not only by tumors but also by other pathologies, by participating in clinical trials, can benefit from innovative treatments well in advance, compared to their availability and, therefore, greater chances of recovery, obtaining improvements also in terms of quality of life. The advantages of clinical trials are not only for patients and for science, in fact the National Health Service also obtains an economic benefit thanks to the avoided costs for therapies, supported by the companies sponsoring the trials”.
It is proven that one euro invested in a clinical study generates almost 3 (2.95) in terms of benefits for the NHS – they highlight from Aiom – The leverage effect, determined by the costs avoided for the free provision of experimental therapies and diagnostic services to people enrolled in the trials, reaches as much as 3.35 euros in cancer trials. Suffice it to say that the average cost of research in oncology is 512 thousand euros, but those avoided are more than double, equal to 1 million and 200 thousand euros.
“The European Regulation has made European countries uniform but has actually lengthened approval times, making Europe less competitive overall compared to other macro-regions, which is why pharmaceutical companies tend to invest elsewhere – says Giuseppe Curigliano, president-elect of Esmo and member of the Aiom national board – For example, phase I studies increasingly begin in the United States, Australia and Asia. It is important to resolve these problems, because the results of scientific research are evident”.
In Italy, in 2023, 395,000 new cases of cancer were estimated. “In three years, the increase was 18,400 diagnoses – Curigliano recalls – Thanks also to innovative therapies, oncology in our country has made important progress, with thousands of lives saved. From 2007 to 2019, almost 270 thousand cancer deaths were avoided in Italy. And in Europe, from 1988 to today, progress against tumors has saved more than 6 million lives. Cancer is increasingly a curable disease and many patients are recovering”.
At the Esmo Congress “studies are presented that change clinical practice in neoplasms in which there had been no real progress for decades, such as that of locally advanced uterine cervix – Curigliano points out – Much space is reserved for immunotherapy in various tumors, from melanoma to gynecological, breast and bladder tumors. Without forgetting drug conjugated antibodies that are highly selective for tumor cells, minimizing damage to surrounding healthy cells and increasing the effectiveness of treatment. The role of artificial intelligence in molecular diagnostics and therapies is also explored in depth, to identify mechanisms of resistance to treatments and offer new options”.
Screening programs also play a decisive role in reducing mortality. “It is necessary to invest more in secondary prevention,” warns Saverio Cinieri, president of the Aiom Foundation. “In 2023, in Italy, 55% of women underwent mammography for the early diagnosis of breast cancer. 35% of men and women over 50 underwent fecal occult blood testing for colorectal cancer. For cervical cancer, 41.5% of women performed the HPV test or Pap test. These data are improving compared to previous years, but they are not enough because strong regional differences remain.”
“We need information campaigns to raise awareness among the population and new technologies should be used more to involve citizens. The European Union, in fact, requires that 90% of the population that meets the requirements for screening for breast, cervical and colorectal cancer have the possibility of performing these tests by 2025”, he concludes.
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