Infarmed has authorised the use of the medicine pembrolizumab for the treatment of metastatic triple-negative breast cancer, metastatic colorectal cancer, persistent cervix, metastatic oesophagus, renal cell carcinoma in adults, and some cases of melanoma.
Access to pembrolizumab for triple-negative breast cancer cases was shrouded in controversy last month, giving rise to two petitions, both addressed to the National Authority for Medicines and Health Products (Infarmed), which gathered more than 50,000 signatures.
In a response sent to media outlet, Lusa, at the time, Infarmed admitted the authorisation for patients with metastatic triple-negative breast cancer, claiming that there was “new data” resulting from the pharmacotherapeutic evaluation report of the drug that allowed to verify that pembrolizumab would be eligible to be authorised in these cases.
According to the information available on Infarmed’s website, the drug, for use in hospitals, is now authorised in the treatment of various types of cancer, in some cases in monotherapy and in others in conjunction with other medicines.
According to Infarmed data, more than 260 innovative medicines from various areas, especially oncology, cardiovascular disease, and central nervous system, have entered the national therapeutic arsenal in the last five years.
Marketing authorisation for innovative medicines is normally granted by the European Commission, following the opinion of the European Medicines Agency.
After this phase, and in order to be used and financed by the NHS, medicines must demonstrate therapeutic advantage and economic advantage over national clinical practice, in order to guarantee access for all citizens to both innovative therapies and other care they need in the context of the NHS.
This evaluation is carried out by the Health Technology Assessment Commission (CATS of Infarmed, which integrates clinical (medical) experts with recognised knowledge and experience in the treatment of patients in NHS hospitals.
Samantha Gannon
info at madeira-weekly.com
