More than 260 innovative medicines have entered the national therapeutic arsenal in 5 years


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More than 260 innovative medicines from various areas, mainly oncology, cardiovascular disease and the central nervous system, have entered the national therapeutic arsenal in the last five years, according to Infarmed.

The data sent to Lusa by the National Authority for Medicines and Health Products (Infarmed) indicate that, last year, 55 innovative medicines were introduced, namely in the areas of oncology, cardiovascular, anti-infectives, blood, hypertension and pulmonary. In 2021 there were 54.

In the last five years – a period during which spending on medicines has been constantly growing – the year with the highest number of innovative medicines introduced (74) was 2019, the first year of the pandemic.

“Even in pandemic years, Infarmed worked to ensure that the introduction of new therapies remained available to patients who need them”, underlines Infarmed.

Innovative drugs are the ones that have increased the expenditure of the National Health Service on medicines, particularly in hospitals. Infarmed data indicate that, in 2018, this expenditure already grew 5.9% at hospital level, reaching 1,207 million euros, a figure that last year exceeded 1,760 million.

If you add inpatient and outpatient spending on medicines, the figure last year exceeded €3.3 billion.

Access to therapeutic innovation has greatly contributed to this growth.

When innovative medicines are not yet reimbursed by the National Health Service, and while the feasibility of public funding is assessed, patients access them through an Early Access Program (PAP).

These programs allow access to medicines that do not yet have a marketing authorization or that, having one, can be used for other conditions, provided it is demonstrated that there are no alternatives.

According to Infarmed data, 56 early access requests were authorized last year, five more than the previous year. In the last five years, 166 applications were given the green light.

This year, one of the most well-known cases was the use of the drug pembrolizumab in metastatic triple negative breast cancer, which was demanded by patients and even led to two petitions, both addressed to Infarmed, which gathered more than 50 thousand signatures.

Last month, Infarmed revealed that it had already asked the drug’s owner laboratory to submit an early access program, after considering that, “in light of the new data”, this treatment was found to be of added therapeutic value.

Marketing authorization for innovative medicines is usually granted by the European Commission, following an opinion from the European Medicines Agency.

After this phase, and in order to be used and financed by the SNS, medicines must demonstrate therapeutic advantage and economic advantage in relation to national clinical practice, in order to guarantee access for all citizens both to innovative therapies and to the other care they need in the context of the SNS.

This assessment is carried out by Infarmed’s Health Technology Assessment Committee, which includes clinical experts (doctors) with recognized knowledge and experience in treating patients in NHS hospitals.

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