A common catalogue of biomarkers in the National Health System is a great step forward for patients because it improves access to personalised medicine.
Farmaindustria welcomes the presentation by the Ministry of Health of the harmonised catalogue of genetic tests for the whole country.
For this catalogue to become a useful tool for patients, it requires a standard that regulates its use and updating adapted to the approval of new therapies and the guarantee that it is implemented fairly throughout the NHS.
Farmaindustria.es
The use of biomarkers has become one of the most important clinical tools for the application of precision personalised medicine, especially in cancer, but also in the diagnosis and treatment of rare diseases. These genetic tests that analyse biological material from the patient allow for improved diagnosis and a precise and personalised approach to treatment. This approach to diseases allows the best results to be obtained, with greater safety and efficient use of resources.
In Spain, the Ministry of Health, in the Interterritorial Council, approved in June 2023 the first proposal for a biomarker catalogue, focusing on 8 areas out of the 19 planned. This catalogue is the one presented today at the Ministry to scientific societies, patient associations and industry representatives. “Having a common catalogue of biomarkers in the National Health System is great news for patients, because it allows harmonising and improving access to diagnosis and personalised medicine”, explains Isabel Pineros, Director of Farmaindustria’s Access Department.
Farmaindustria had already raised with the Ministry of Health since 2021 the need to include molecular diagnostics and biomarkers in the National Health System’s Portfolio of Services. In addition, the industry sees the need to deploy an accelerated procedure to reduce the timeframes for the inclusion of these tests, so that they can be brought into line with the approval of new therapies that require biomarker diagnostics.
“The catalogue is a very useful tool that now needs to be regulated to ensure that it is used and updated in line with the approval of new therapies. This is critical because we currently have some drugs included in the funding, and many others that are still to come, which pose difficulties for patients to access them in an equitable way because we do not have the biomarkers,” Pineros points out.
The catalogue includes the areas of oncohematology, pharmacogenomics, heart disease and circulatory system disorders, ophthalmological diseases, hereditary and mitochondrial metabolic diseases, neurological and neuromuscular diseases, and neurodevelopmental disorders (including neurocognitive deficits).
Subsequently he will work on skin diseases; digestive diseases (including liver diseases); renal diseases and urogenital disorders; respiratory diseases; bone diseases (including craniofacial anomalies); otorhinolaryngological diseases; immunodeficiencies, autoimmune, autoinflammatory and connective tissue diseases; endocrine diseases (including disorders of sexual differentiation); hereditary haematological diseases, foetal abnormalities and fertility disorders; and finally, other complex diseases that cannot be grouped into the other categories.
In the process for the regulation and effective inclusion of the catalogue of biomarkers in the healthcare provision – Draft Order amending Annexes I, II, III, VI and VII of Royal Decree 1030/2006, of 15 September, which establishes the portfolio of common services of the National Health System and the procedure for its updating – Farmaindustria has submitted written allegations which include the contributions made by its member companies and expects it to be published shortly.
“We need the updating procedure to be transparent, agile and evidence-based. We must ensure that the catalogue is implemented fairly in all the Autonomous Regions and that the ministry coordinates and measures indicators.
In addition, it would be advisable to publish a list of centres with the capacity to carry out genetic testing and counselling and the types of tests available at each centre, so that these advances can effectively reach patients in order to transform the course of the disease,” says Pineros.
