Cholangiocarcinoma, amendment approved for more funds to genomic tests

Thanks to precision oncology, new treatment perspectives are opening up for patients affected by cholangiocarcinoma, a rare and aggressive tumor of the liver that has a poor prognosis (overall 5-year survival is less than 15-17%). Stefano Benigni, Forza Italia group leader in the Social Affairs Commissions, presented an amendment to the Budget law, approved by the Chamber, which provides for the allocation of 600 thousand euros for the three-year period 2023-2025 to guarantee patients suffering from cholangiocarcinoma access to Next -Generation Sequencing (Ngs) test.

With these tests it is possible to refine the selection of treatments, thanks to the simultaneous evaluation of the different molecular alterations involved in the development of the neoplasm. Four out of 10 patients are in fact carriers of genetic alterations and thanks to tests for the simultaneous evaluation of the various molecular alterations it is now possible to administer personalized treatments. To favor precision oncology, therefore, the ad hoc amendment was presented today and received the go-ahead from the Chamber. “Excellent news and a great opportunity for these patients”, say the representatives of clinicians, patients and national health authorities, meeting today in Rome for a press conference in the Chamber.

“Cholgiocarcinoma affects over 5,400 men and women every year in Italy – says Carmine Pinto, president of Ficog (Federation of Italian Cooperative Oncology Groups) – It is a neoplastic pathology most often diagnosed in a phase that is more insensitive to surgery, and which can be contrasted with greater success thanks to precision oncology.Up to 35% of patients carry particular genetic alterations on which it is possible to personalize treatment.Today, for cholangiocarcinoma, we already have targeted drugs available on molecular targets that have proven to increase survival of patients with advanced disease.NGS analysis should be conducted before or during first-line treatment, in order to be able to decide solutions for second or subsequent lines.Then, ensure access to tests NGS for patients with cholangiocarcinoma may allow access to more effective drugs”.

“There are more than 26 thousand cancer patients in Italy who need NGS every year – underlines Giovanni Ravasio, director of ‘Health Economy’ – The allocation of these resources is a first and very important step that goes in the direction of strengthening oncology There is still a long way to go to make increasingly important exams available to everyone and throughout the country. In Italy there is still a lack of governance for NGS tests, with marked inequalities between the various regions, which obviously translate into inequality in accessing drugs with a molecular target and therefore to the possibilities of treatment for patients”.

“It is essential – adds Pinto – that within the regional oncological networks, reference laboratories of molecular biology are identified and created suitable for technological and professional resources, and calibrated on the basis of population volumes and the logistics of the territories. All this it requires vision, strategy, resources and programming. It is a gap that we must fill, just as the price list of the essential levels of assistance needs to be updated. Almost 10 years have passed since the establishment of the national Nomenclator of specialist assistance services. It is still in progress force, but there is no entry regarding NGS tests in oncology, just as the rates and costs for genomic profiling exams are valued and monetized in a significantly different way from region to region”.

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“In the last legislature a fund was created for Next-Generation Sequencing tests – recalls Ugo Cappellacci, president of the Social Affairs Commission of the Chamber – which however the Ministry of Health had linked to tests for non-small cell lung cancer only non-squamous metastatic Now, thanks to this amendment, we are extending the possibility of using the tests also for other tumours, including rarer and more aggressive ones such as cholangiocarcinoma”.

Cholangiocarcinoma “is the second most common type of primary liver tumor after hepatocellular carcinoma – adds Paolo Leonardi, president of the Apic Italian Cholangiocarcinoma Patients Association – Surgery is the only possible cure, but less than a third of patients has such small disease that it can be treated with a scalpel. The recurrence rate is also very high. As patient representatives, we are proud of this important achievement and we hope that Parliament will approve this bill unanimously. Spread the word genetic testing as much as possible is essential if we want to give new hope to the more than 12,000 people in Italy who live with a diagnosis of cancer”.

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“To date, 5-year survival still remains 17% for men and 15% for women – remarks Pinto – The therapeutic scenario is evolving and therefore the availability of NGS molecular tests is essential, which allow access to the new and more effective drugs.In Italy a drug, pemigatinib, has already been reimbursed for a few months by our National Health Service, indicated in patients in progression after a line of chemotherapy, who present precisely one of these molecular alterations, a fusion of the Fgfr2 gene, which is found in 10-12% of patients with cholangiocarcinoma.Other drugs targeted on molecular targets are already available in the United States and in some European countries and will also be evaluated by the Italian regulatory body”.