Cholangiocarcinoma: amendment approved to increase funds for molecular tests
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Under the Christmas tree comes good news for patients affected by cholangiocarcinoma, a rare and aggressive tumor of the liver that has a poor prognosis (overall five-year survival is less than 15-17%). In fact, an amendment was approved tonight in the Chamber which provides for the allocation of 600 thousand euros for the three-year period 2023-2025 to guarantee patients suffering from this tumor access to Next-Generation Sequencing tests (NGS). Tests thanks to which it is possible to personalize therapies more and more by applying precision oncology in practice.
Cholangiocarcinoma in Italy
Cholangiocarcinoma affects over 5,400 men and women in Italy every year. “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”, he says Carmine Pinto, president of FICOG – Federation of Italian Cooperative Oncology Groups. In recent decades in many countries of the world there has been a constant increase in cases of intrahepatic cholangiocarcinomas. This is due to changes in risk factors related to cancer including, in many cases, the presence of infections, inflammatory and environmental factors. “It is the second most common type of primary liver cancer after hepatocellular carcinoma,” he adds Paul Leonardi, President of the Italian Cholangiocarcinoma Patients Association APIC. Surgery is the only possible cure, but less than a third of patients have disease so small that it can be treated with a scalpel. The recidivism rate is also decidedly very high”.
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Molecular target tests and therapies
Up to 35% of patients are carriers of particular genetic alterations on which it is possible to personalize treatment. “Today for cholangiocarcinoma we already have drugs targeted on molecular targets that have been shown to increase the survival of patients with advanced disease. The NGS analysis must be conducted before or during the first line treatment in order to be able to decide the solutions for the second or subsequent lines. Therefore, guaranteeing access to NGS tests for patients with cholangiocarcinoma may allow access to more effective drugs”.
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Access to Ngs and therapies
There are more than 26,000 cancer patients in Italy who need NGS every year. “The allocation of these resources – he explains John Ravasio, Director of Health Economics – is a first and very important step that goes in the direction of strengthening precision 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 inequities in access to drugs with a molecular target, and therefore to the possibilities of treatment for patients”.
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Increase survival rates
Currently, five-year survival still remains 17% for men and 15% for women. “The therapeutic scenario – continues Pinto – is evolving and therefore the availability of NGS molecular tests is essential, allowing access to new and more effective drugs. In Italy, a drug, pemigatinib, has already been reimbursed by our NHS for a few months, 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”.
The Oncological Networks and the Lea
The role of oncological networks is fundamental. “It is essential – adds Pinto – that within the Regional Oncological Networks, reference laboratories of molecular biology are identified and created that are adequate for technological and professional resources, and calibrated on the basis of population volumes. All of this 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 must be updated. Almost 10 years have passed since the establishment of the national nomenclature of specialist assistance services. It is still in force but there is no entry regarding NGS tests in Oncology, just as the rates and costs for genomic profiling exams are evaluated and monetized significantly differently from region to region”.
The Next-Generation Sequencing Test Facility
A Fund for Next-Generation Sequencing tests was already created in the last legislature. “Then though – remember theHon. Ugo Cappellacci, President of the Social Affairs Commission of the Chamber – the Ministry of Health had restricted tests for metastatic non-squamous non-small cell lung cancer only. Now, thanks to this amendment, we are extending the possibility of using the tests for other tumors as well, including rarer and more aggressive ones such as cholangiocarcinoma”.
The amendment approved by the House
“Ensuring innovative treatments for all patients must be one of the priorities of this legislature – they underline Alexander CattaneoParent Company of Forza Italia in the Chamber e Stephen Benigni, Forza Italia parent company in the Social Affairs Commission and first signatory of the bill. New technologies in oncology, as in other branches of medicine, require the use of resources, which we must consider as a valuable investment rather than a cost. For us, this is only an important first step towards structural financing of these tests, as well as the simultaneous provision of drugs and tests to offer patients the best treatments in the shortest possible time and make Italy a model of reference for other European countries”.
The European Beating Cancer Plan
Look beyond our bordersHon. Annarita Patriarca, Member of the Social Affairs Commission of the Chamber. “The road to defeating cancer is still long, but our commitment in this legislature will be to achieve the ambitious goal that the European Commission has also set itself through the European Beating Cancer Plan: to defeat cancer as a cause of death”, he declares. Great patient satisfaction: “As representatives of patients we are proud of this important result and we hope that the Parliament will approve this bill unanimously,” says Leonardi. “Disseminating genetic tests as widely as possible is essential if we want to give new hope to the over 12,000 people in Italy who live with a diagnosis of cancer”.
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