230 oncologists appeal to Aifa: “Reassess no drug against pancreatic cancer”

The date of February 28, the day on which the distribution of the drug olaparib to new patients with pancreatic cancer and with the mutation of the Brca1 / 2 genes, made famous by the actress Angelina Jolie, is now near. A therapy that delays the progression of the disease and avoids chemo. In two years it has been used to treat a total of “101 patients” with these characteristics, “so about 50 per year”. “The chapter was closed by the Italian drug agency Aifa in November, when the CTS expressed itself saying that the drug was not of interest to patients”. After the regulator’s no to reimbursement, the compassionate use program will close. For this reason, 230 oncologists from 77 Italian centers are now asking AIFA to retrace its steps, to re-evaluate the position expressed on the drug. The appeal is in a letter addressed to the president of Aifa, Giorgio Palù. “The initiative was taken by the Aisp Oncology Task Force, the Italian Pancreas Study Association, which then shared the letter with colleagues from various centers in the Peninsula – explains Michele Reni to Adnkronos Salute, who is on the board of directors of the association and at the San Raffaele hospital in Milan he directs the strategic clinical coordination program of the Pancreas Center – but this same request had already arrived through several channels. Patient associations and other scientific societies have also asked the regulatory body to reflect with the sick and with the doctors who deal with the pathology “. The number of signatures collected “is high and there are many cancer centers that have participated. The judgment of considering this drug worthless is in fact not shared. We ask the AFA to reflect by considering the question also from different points of view. It is a question of deciding what the value of a drug is. We underline in the letter that the value of the drug is also in the time free from chemotherapy. We consider olaparib of considerable clinical relevance in a pathology with a poor prognosis and with a limited therapeutic armamentarium, and we ask to rethink also in consideration of the few patients who would be candidates. Even assuming that the survival benefit is not already acquired, we ask Aifa to allow our patients to have the possibility of obtaining the related benefit. that freedom of choice is left and the patient could be informed about the pros and cons and risks and benefits and decide with him whether it is appropriate or not to administer it “. Today, continues Reni, we” can only reassure those who are already being treated “, because they will be able to continue taking the drug. “But the new candidate patients will not be able to have this opportunity and it becomes difficult for them too because we find ourselves in the embarrassment of not being able to give the drug. The problem of how to explain to those who are already under treatment that we are giving them a drug that the AIFA considers irrelevant. It is not a trivial question. We ask the regulatory body to consider a different point of view that is not only that of the value of survival, which is then all to be discussed if it does not exist “. The specialist points out: “The fact that there are so many oncologists and centers who have expressed themselves in this request has a weight and we hope that Aifa will answer us. We hope we can find a solution that works well. Given the low number of patients “interested and” considering that on average about 7-8 months of treatment are done, the economic impact would not be so high. If we want to see it only from an economic point of view it is not an additional cost, moreover, because how alternative these patients have progression of the disease, they have to start chemo – which has its cost – and first have effects related to the tumor and then to the treatments (pain, intestinal blockages) and this too has an important cost between visits and access to the emergency room rescue and hospital. Not to mention the importance of delaying the patient’s suffering and the need to start toxic chemo. I don’t know what economic value we can give to this. We should hear what they think. patients who took the drug and previously had chemo. Maybe they too should have a say on these things. “