Over 260 innovative drugs have entered the domestic therapeutic arsenal in five years

According to Infarmed, over the past five years, more than 260 innovative drugs from various fields, primarily oncology, cardiovascular diseases and the central nervous system, have entered the domestic therapeutic arsenal.

Data sent to Lusa by the National Medicines and Health Products Administration (Infarmed) shows that 55 innovative medicines were introduced last year, namely in the areas of oncology, cardiovascular, anti-infective, hematopoietic, hypertensive and pulmonary drugs. In 2021, there were 54.

Over the past five years – a period during which drug spending has been on the rise – the year with the highest number of innovative drug introductions (74) was 2019, the first year of the pandemic.

“Even during the years of the pandemic, Infarmed has worked to ensure that the introduction of new treatments remains affordable for patients who need them,” Infarmed emphasizes.

Innovative drugs have increased the National Health Service’s spending on drugs the most, namely in hospitals. Infarm data shows that in 2018 these costs have already increased by 5.9% at the hospital level, reaching 1,207 million euros, up from 1,760 million last year.

If we add to the costs of medicines at the hospital level, last year they cost more than 3,300 million euros.

Access to therapeutic innovation has contributed greatly to this growth.

When innovative medicines are not yet reimbursed by the National Health Service and the viability of public funding is being assessed, patient access is provided through the Early Access Program (PAP).

These programs allow access to medicines that do not yet have a marketing authorization or that, if they do, can be used to treat other pathologies, provided that the absence of alternatives can be demonstrated.

According to Infarmed, 56 early access requests were allowed last year, up five from a year earlier. Over the past five years, 166 requests have been greenlit.

This year, one of the most high-profile cases was the use of the drug pembrolizumab for metastatic triple-negative breast cancer, as reported by patients and even two petitions were filed, both addressed to Infarmed, which collected more than 50,000 signatures.

Last month, Infarmed said it had already asked the drug’s lab to submit an early access program after it was determined “in light of new data” that the treatment represents a therapeutic asset.

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

After this phase, to be used and funded by the SNS, medicines must demonstrate therapeutic and cost advantages over national clinical practice to ensure that all citizens have access to both innovative treatments and other care they may need in the context of the SNS.

This assessment is conducted by the Infarmed Medical Technology Assessment Panel, which is made up of clinical experts (physicians) with recognized knowledge and experience in treating patients in SNS hospitals.