The call for the National Health Service (SNS) to provide an innovative breast cancer drug has already spawned two petitions and led the Socialist Party parliamentary group to question the government.
The drug in question is pembrolizumab, and the petitions seek to review a decision not to include it in the Early Access Program (PAP) in the case of patients with triple-negative breast cancer.
Both addressed to the National Medicines and Health Products Authority (Infarmed), the petition organized by health professionals, now closed, has received nearly 30,000 signatures (29,875), while that of a patient, Sandra Gomes, has already obtained 19,286. can still be drawn.
The parliamentary group of the Socialist Party, in turn, asked the government questions about “what is the time perspective” so that the drug “with proven effectiveness” can be made available and reimbursed for users with triple-negative breast cancer”, as well as about the measures that must be taken, “immediately, so that all users in this situation can access reimbursement of this therapy”.
The letter from deputies to the President of the Assembly of the Republic, last Friday, is addressed to the Ministry of Health.
In the petition, the group of health professionals expresses its support for “Vera Lúcia Domingos de Almeida, pediatrician at Espírito Santo de Évora Hospital, diagnosed in September 2022 with locally advanced triple-negative breast cancer”, since “in the subtype of breast cancer with the worst prognosis in In terms of recurrences and survival expectancy, new therapeutic options, demonstrating efficacy and ensuring safety for these patients, are an emerging need”.
“We therefore contest the 7/21/2022 decision regarding the pembrolizumab early access program,” he added.
“It is not acceptable, neither ethically nor morally, that a drug that has proven to be a new effective and safe therapy, and which improves the prognosis of this disease worldwide, should be denied to the many women who are currently fighting for their lives and are unfairly they are completely unaware of it. Equally unacceptable is the justification for refusing PAP. There is no therapeutic alternative equivalent to this drug in terms of prognosis”.
Sandra Gomes, age 40, was diagnosed with locally advanced metastatic triple-negative breast cancer in 2016, which she treated, and was diagnosed with ganglion recurrence in November 2022.
The patient states in the petition that the request for prescribing pembrolizumab, made by the attending physician on January 5 and approved by the Director of the Medical Oncology Service of the Centro Hospitalar Universitário Lisboa Norte on the same day, was sent to the pharmacy and Therapeutics Commission, which submitted a request to Infarmed on January 9, which was denied on April 17.
Questioned by the Lusa agency, Infarmed explained that that drug’s access to the PAP had a negative opinion from its Health Technologies Assessment Committee – which consists of clinical experts with recognized knowledge and experience in treating patients in SNS disorders. hospitals – because she believes there are therapeutic alternatives for these patients.
However, he adds that in view of “new data”, the National Medicines Authority “has begun to assess the suitability of PAP in this therapeutic indication”.
Obtaining a marketing authorization for innovative medicines is normally granted by the European Commission, after advice from the European Medicines Agency.
After this phase, and in order to be used and funded by the SNS, medicines must have a therapeutic and economic advantage over national clinical practice, to ensure access for all citizens to both innovative therapies and other care needed .
Source: DN
