A 14 month long wait to be able to hope to survive the tumor. In Italy, in fact, it takes more than a year from the approval of the European Medicines Agency to be able to access new therapies: too long considering that they are often life-saving drugs capable, in some cases, of making advanced cancer chronic. or to heal. For this reason, the Italian Association of Medical Oncology (Aiom) calls for the abolishment of Regional Therapeutic Handbooks which lengthen the availability times of therapies. The appeal arrives on the opening day of the XXV National Congress of the scientific society in Rome.
Reduced times compared to the past
In three years (2018-2021), 46 innovative anticancer molecules have been 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). Cancer patients in our country, however, still have to wait 419 days, i.e. more than a year, to access innovative anti-cancer drugs (102 in Germany, 145 in Denmark, 267 in Austria). Latency times have reduced in recent years: in fact, they exceeded 24 months a decade ago. But they are still too long.
Survival is getting longer
In our country, every day, 1,070 people fall ill with cancer. In 2022, there were 390,700 new cases. Five-year survival is 65% in women and 59% in men, and reaches 90% in very frequent tumors such as those of the breast and prostate. “These data – he underlines Saverio Cinieri, president of Aiom – place Italy at the top in the world and demonstrate the great level reached by Italian oncology. However, in our country, citizens affected by cancer still have to wait 14 months to be treated with innovative therapies already approved at European level. In fact, the period between the filing of the authorization dossier with evaluation at the European regulatory agency and the actual availability of a new therapy in Italy is more than a year. This long process can severely penalize patients. It is therefore essential to guarantee more timely access to innovative molecules.”
Abolish regional differences
How to resolve this impasse? “To reduce latency times – replies Cinieri – the Regional Therapeutic Handbooks must be abolished and immediate availability must be allowed after publication in the Official Journal, even pending regional tenders”. Today in Italy, alongside the National Health Service, 19 Regions and 2 autonomous Provinces coexist. And in 10 Regions there are still Regional (Hospital) Therapeutic Handbooks (PTR/PTOR), i.e. lists of drugs that can be prescribed within accredited regional, public and private hospitals.
The abolition of regional therapeutic handbooks
The scientific society has repeatedly documented how in Italy there are territorial disparities in access to medicines, also due to the regionalization of healthcare. 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. “Many Regions – he underlines Francesco Perrone, president-elect Aiom – have attributed a binding nature to their Handbook, obliging the structures to choose the drugs to be included in the Hospital Therapeutic Handbooks only within a limited list which also takes into account the effects of the hospital prescription on local consumption”. In some Regions, although present, they are not binding for the purchase of oncology drugs. Other Regions, however, do not have a Regional Handbook with immediate availability of therapies, which translates into wide interregional variability. “These are unacceptable disparities. We hope that the Aifa reform will be completed as soon as possible. A defined structure of the regulatory agency will in fact be able to help resolve these problems”, adds Perrone.
Early access to therapies
In some cases, the times have been shortened with various provisions that regulate the access and prescription of drugs already approved by the European regulatory body, before reimbursement by the National Health Service. It is the so-called early access, i.e. early access to therapies. “The main paths that allow access to therapies, without their cost having to burden the requesting hospital, are made up of the 5% AIFA Fund and law 648/1996, which allow full reimbursement by the Service National Health, and for compassionate/nominal use, with free supply from the pharmaceutical company,” he explains Massimo Di MaioAIOM Secretary.
The delays of bureaucracy
According to a survey promoted by AIOM, as many as 90% of oncologists have had direct experience with early access to obtain anti-cancer drugs in advance. However, a significant share faced problems caused by bureaucratic procedures. “For example – underlines Di Maio – in the context of requests to the 5% Fund, AIFA must necessarily answer each question by evaluating the individual case. The feedback can arrive in variable times, sometimes even after more than a month, and in some cases this risks resulting in too long a waiting time. Furthermore, the change in the rules for accessing this fund has made the actual eligibility of patients much more difficult”. “Our hope – concludes the President Cinieri – is that AIFA speeds up the approval times for early access. Early access to some therapies represents a great opportunity and a right for patients.”