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the portfolio update order is still pending

The definition of a portfolio of biomarkers in the National Health System (SNS) it is still waiting for an update order in progress. This incorporates an express mention of genetic or genomic studies in pathologies, hereditary and otherwise, which may benefit from the medical point of view of the search for therapeutic targets. Thus underlines the Government in a written answer member of the Congress of Deputiesin which he replies to the VOX group detailing the process that is taking place in a document of more than two pages.

In particular, the question posed questioned the forecasts regarding the promotion of the establishment of a “standardized procedure and a regulatory framework for the presence and adequate funding of breast cancer biomarkers nationwide”.

According to the Executive, a Working group dependent on the Benefits, Insurance and Financing Committee “in which professionals and scientific societies involved”, is the one who is working on updating and specifying the common portfolio of services in the area of ​​genetics, through the development of a catalog of genetic tests. The ultimate goal, they explain, is none other than “to guarantee all patients who request it a more homogeneous and equitable access to them within the context of the NHS”.

Once the catalog has been finalized, it is expected to tackle the identification of the authorized health centers that carry out these tests

The oncology is recognized in this answer as a priority area, as they specify that it is one of the first in which work is being done to develop the proposal for a catalog of genetic tests, covering solid and hematological tumors, pediatric cancer and hereditary cancer. Once the catalog has been finalized, they anticipate that it would face identifying the authorized health centers that carry out each of these tests, a process in which the quality criteria that these centers must respect.

Similarly, the text recognizes the clinical utility of determining diagnostic, prognostic or predictive biomarkers of response to treatment, highlighting the fundamental role they also play in management of cancer patients. “It was a request from both the NHS Cancer Strategy and the main scientific societies involved, the approach, within the common portfolio of services, of the identification and specification of oncological biomarkers essential for the stratification of diagnostic, prognostic or therapeutic decisions” , they have to remember.

Financing and monitoring

The Government underlined in the aforesaid reply that the National cancer strategy It already establishes the need to agree on the organizational model for precision oncology in the SNS. In this regard, they highlight the provision of “a finalist background which arises from the execution of the Agreement signed between Farmaindustria and the Ministries of Finance and Public Administration and the Ministry of Health”. It is a question of 40 million euros to promote the development and implementation of personalized medicine and the related catalog of genetic tests “in an effective and homogeneous way”.

Instead, they point out that the Ministry of Health is preparing the RD which creates the State Network for Public Health Surveillance which will include cancer surveillance. “Currently we are awaiting the elaboration of the rules that will regulate the creation of this system and establish the notification obligation within it, according to the priorities established in the various protocols by the working groups that will develop the system”, they underline. .

Finally, they recall that there is already a Spanish network of cancer registries (Redecan), made up of all population cancer registries in Spain and which “constitutes an important source of data”.


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