(by correspondent Manuela Correra) (ANSA) – BARCELONA, SEPTEMBER 13 – From over 24 months 5-10 years ago to 14 months today: the time that Italian cancer patients have to wait to be able to have innovative drugs has decreased, and is also below the European average, but the wait is still too long. This is due to excessive bureaucracy that oncologists are fighting against, aiming for closer collaboration with the Italian Medicines Agency (AIFA) in order to abolish the Regional Therapeutic Formularies (PTR), which significantly lengthen the times for authorizations. The request comes from the Italian Association of Medical Oncology (AIOM) on the occasion of the congress of the European Society of Medical Oncology (ESMO), which opens today in Barcelona.
In Europe, the average time (in 2023) to have new anticancer drugs is about a year and a half – 18 months – a time that has increased by over a month compared to 2022. Italy is faster than the EU average, but cancer patients still have to wait 417 days, or 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 PTRs, still present in 12 Regions (Valle d’Aosta, Autonomous Province of Bolzano, Emilia-Romagna, Marche, Umbria, Molise, Campania, Puglia, Basilicata, Calabria, Sardinia, Sicily). The wait, says Aiom president Franco Perrone, “is still too long and can severely penalize cancer patients. To reduce the time, the immediate availability of new drugs must also be allowed after publication in the Official Journal, even while waiting for regional tenders”. Not to mention that after inclusion in the PTR, further delays can be caused by bureaucratic procedures for inclusion in the Hospital Therapeutic Formularies. “We want to collaborate with Aifa to define new models”, underlines Perrone. Another critical issue is that of clinical studies: “We are concerned about the long times required for approval of trials, which make Italian centers less competitive than those in other countries”, he states. In 2022, 663 trials were authorized by Aifa and almost 40% concerned oncology. In Italy, notes the elected president of Aiom Massimo 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, with respect to their availability and, therefore, greater chances of recovery. And the advantages of clinical trials are also for the National Health Service, which obtains an economic benefit thanks to the avoided costs for therapies, supported by the companies sponsoring the trials”. It is demonstrated that one euro invested in a clinical trial generates almost 3 (2.95) in terms of benefits for the NHS. The leverage effect, determined by the avoided costs 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 the avoided costs are more than double, equal to 1 million and 200 thousand euros. But if the 2014 European Regulation “has made European countries uniform, on the other hand – highlights Giuseppe Curigliano, president-elect of Esmo and member of the Aiom national board – it has actually lengthened approval times, making Europe less competitive overall, so pharmaceutical companies tend to invest elsewhere. For example, phase I studies increasingly begin in the USA, Australia and Asia”. It is “urgent to resolve these problems, because the results of scientific research – the specialists conclude – are increasingly evident”. (ANSA).
2024-09-13 19:47:29