With molecular analyzes every year 20,600 patients with specific types of cancer can access the most suitable therapy. In Italy only 2% of the tests are performed with the most advanced technology
Today, more than 25% of cancer patients could receive targeted therapy based on genomic analyzes. Knowing the DNA mutations present in a patient’s neoplasm is fundamental today to identify specific alterations that can guide therapeutic choices: target therapyin fact, they can only be used if the presence of specific markers is detected in the tumor cells (or, in some cases, in the blood or in other biological samples taken from the patient). And if in Italy the national network of high-tech laboratories capable of identifying the molecular alterations that can affect the choice of the “best” therapy in the individual patient is today a consolidated reality, for patients affected by certain types of tumors (adenocarcinoma of the lung, cholangiocarcinoma and advanced neoplasms of other sites) additional funding of € 24 million is needed to the one already destined for molecular diagnostics by the 2020 Budget Law.
A fund for Next Generation Sequencing (NGS) testing
«The choice of the most effective anti-cancer therapy, in some selected neoplasms, depends on specific molecular analyzes – he underlines Francesco De Lorenzo, president of the Italian Federation of Voluntary Associations in Oncology (Favo) -. But, in Italy, only 2% of all biomarker research tests are performed with the most advanced technology (NGS, Next generation sequencing, next generation sequencing) which allows to evaluate several molecular targets at the same time, against a European average of 10%. Laboratory networks are immediately needed in the context of regional cancer networks, to guarantee access to these tests by promoting the development of technical skills and accelerating response times ». National and international guidelines suggest the use of NGS technologies for extended sequencing in selected neoplasms and a fund of 24 million euros would cover the cost for the NGS test of 1,150 euros (rate produced by the evaluation in Italian hospitals) for approximately 20,600 cancer cases to be tested per year: 14,500 of metastatic lung adenocarcinoma, 136 of advanced cholangiocarcinoma and 6,000 of advanced cancer of other sites not amenable to effective treatments beyond the third line of therapy.
Unequal access to the test for Italian patients
The proposal emerges from a conference organized in recent days by Favo, in collaboration with Aiom (Italian association of medical oncology), Ficog (Federation of italian cooperative oncology groups), SIAPEC-IAP (Italian society of pathological anatomy and diagnostic cytopathology), IQN Path (International quality network for pathology) and Ecpc (European cancer patient coalition). Research conducted by IQN Path, ECPC and EFPIA (European Federation of Pharmaceutical Industries) at European level found significant limitations in access to biomarker testing in many countries, including Italy. “Once again, patient associations, both at European level and in Italy, in close synergy with scientific societies, are at the forefront to document the inequality of access of cancer patients to biomarkers and therefore to personalized medicine, therapy also considered life-saving for some of them – adds De Lorenzo -. The articulated and detailed knowledge that emerges from the survey provides indications to immediately ensure that these patients have the right to have access to quality molecular tests and wherever they reside, through an adequate legislative and regulatory intervention, which also includes economic resources necessary to allow the execution of the individual tests in sequence “.
Few laboratories in the South
In our country there are still too many territorial differences in the distribution of specialized laboratories that belong to the network: 80% of the structures are in fact located in the Center / North. “The availability of access to the genomic profiling test with extended sequencing technology in patients with metastatic lung adenocarcinoma allows the use of the most effective therapy available for the individual patient – underlines Giordano Beretta, past president Aiom -. Indeed, molecularly targeted drugs are capable of significantly prolong survival, while ensuring a good quality of life thanks to the lower toxicity compared to conventional therapies. Similarly, a less frequent pathology, but with an important therapeutic need such as cholangiocarcinoma, as well as selected cases of advanced cancers for which effective treatments beyond the third line of therapy are not available, can gain clinical benefit from extended genomic profiling using NGS. But precision medicine cannot be assured to the patient if he does not have access to biomarker testing necessary to determine if you are eligible for personalized therapies. In addition to the increased resources, regional laboratory networks are needed in the context of oncology networks, to manage the costs of these tests more efficiently, promote the development of technical skills, invest in diagnostic technologies and accelerate response times regardless of volumes of samples “.
Only 2% of the analyzes made with NGS in Italy
«The survey conducted by IQN Path, ECPC and EFPIA – he explains Nicola Normanno, president of IQN Path – was designed with the aim of identifying barriers to access to tests for biomarker research in all Member States of the European Union, including Italy, and in the United Kingdom, and to elaborate strategic recommendations to ensure that all eligible cancer patients have access to the ideal paradigmatic model of diagnostic tests: High-quality tests for biomarker research that are readily available to all, while ensuring the rapid integration of new tests into conventional diagnostics. The identification of biomarkers is in fact essential to be able to achieve precision oncology in clinical practice. Our investigation found limitations in accessing biomarker testing in many European countries. The main critical issues for Italy are the absence of regional laboratory networks and a dedicated budget, with particular regard to NGS tests ». The summary of the survey results and strategic recommendations is contained in a document that proposes regulatory and legislative initiatives to regulate and facilitate access to biomarkers in our country. Most molecular tests in Italy are focused on finding a single marker. NGS sequencing analyzes are used less frequently due to inability to access specialized facilities, staff shortages and non-reimbursement. Although Italy has good skills in applying NGS technology, having all three ways to perform it, a fairly low percentage of laboratories (67% compared to 83% of the European average), located mainly in the North, provide NGS tests directly or through partner laboratories. As regards the timing for integration into clinical practice, our country introduced most of the NGS technologies more than 5 years ago, but their diffusion is still modest. Only 2% of all analyzes today are performed with this technology.
Authorize new drugs and related tests
“Another survey carried out by SIAPEC has shown that the diagnostic activity through NGS on the national territory is present, but heterogeneous, both for the geographical distribution and the characteristics of the reference laboratories and for the activity implemented – underlines Anna Sapino, president of SIAPEC-IAP -. However, the foundations already exist for the planned creation of oncology networks, of regional networks of centers for the execution of panels large enough to cover the needs of clinical diagnostics on companion diagnostic. For larger NGS analyzes for agnostic treatments it will be critical a precise definition of the regional networks of NGS in order to activate an institutionalized national network “. “Access to a genomic tumor profiling test using NGS is negatively conditioned by the resources available for dedicated laboratories – he concludes Carmine Pinto, president Ficog -. This requires a specific fund, which laboratories can directly access in situations of clinical appropriateness. The availability of access to the extended profiling test in oncology would allow both the use of the most effective therapy available for the individual patient, and an advantage in terms of expenditure for the National Health Service, avoiding the use of a less effective treatment with the related costs. Furthermore, although the reimbursement of drugs is established at a national level, that of diagnostic tests is delegated to the regions. It is important that it be introduced into the regulatory framework a process that allows you to authorize the drug and the associated test at the same time, ensuring that these procedures are implemented uniformly at the regional level. In this way, the test to search for a biomarker will be available, ie authorized and reimbursed, when the corresponding drug is introduced on the market ».
November 2, 2021 (change November 2, 2021 | 16:51)
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