Infarmed approved a record number of 91 new innovative medicines in 2024

Last year, Infarmed approved 91 new innovative medicines, a record number, out of a total of 376 completed financing processes by the National Health Service (SNS), according to data released today.

The information to which Lusa had access indicates that the Oncology area is the most representative, with 30 new drugs financed, followed by Cardiology (10), central nervous system (9) and anti-infectives (8).

Data from the National Authority for Medicines and Health Products indicate an increase in the availability of new medicines in the NHS. In 2023, 55 were approved, in 2022 the same number and in 2021, 54 new medicines were introduced.

The year that came closest to the values ​​achieved in 2024 was 2019, with 74 new innovative medicines financed.

The average assessment time last year was 416 days, a value which Infarmed acknowledges will still be high “due to the conclusion of older processes”.

“Although this value is still not in line with what the institution is aiming for, we highlight the 217-day assessment period for processes that were filed after January 1, 2023,” the institution states in a note sent to Lusa.

The National Medicines Authority also recalls that the evaluation times are associated both with the scientific requirements in the pharmacotherapeutic and pharmacoeconomic evaluation, and with the “need to obtain the best financing conditions for the NHS through negotiation processes, which are sometimes complex, but necessary to ensure the sustainability” of the National Health Service.

However, even during the evaluation period, it is possible to access medicines through the Early Access Programme (PAP), with an average decision time recorded by Infarmed of seven days (one less than the previous year) for the 3,521 exceptional use authorisations requested under the PAP.

Infarmed data also indicate that in 2024, the co-payment of 175 generic medicines and 18 biosimilar medicines was approved, with an average evaluation time of 16 and 23 days, respectively.

Infarmed also says that it “remains committed to ensuring timely access to new medicines”, explaining that, last year, the reinforcement of human resources allowed this activity to be intensified.