For over a year the drug has not been refunded
Clinical benefit, survival. The crux is all in these few words, behind which a world is hidden for patients. Especially those affected by complicated and bad diseases, such as metastatic adenocarcinoma of the pancreas. And it is precisely on the meaning attributed to these definitions that the fate of a therapy for people with the mutation of the BRCA1/2 genes, made famous by the actress Angelina Jolie, affected by this form of cancer was played: reimbursement denied by the Agency of the drug for the drug olaparib, now over a year ago. The theme has returned to the spotlight in recent days – in the wake of the attention to the issue of pancreatic cancer, ignited by the death of the footballer Gianluca Vialli – and Aifa firmly reiterated its decision in a note. The hope of the oncologist Michele Reni, member of the board of directors of the Italian Association for the study of pancreas (Aisp), questioned by Adnkronos Salute on the matter, however, remains that the question can be reconsidered.
“It would be absolutely necessary – he replies – Today in Europe the drug is reimbursed in France, Austria, Belgium, Germany, Holland. If it were so objective that it has not demonstrated either prolonging survival or improving the quality of life of patients and there is sufficient clinical benefit, as AIFA concludes, it would be strange for 5 countries to reimburse the drug.And it is also strange that 230 oncologists who deal with pancreas have written a letter saying they are not so convinced of what they it has been decided, or that two scientific societies that deal with the pancreas raise similar concerns, that the associations of patients with pancreatic cancer also claim that there is a benefit. All this – he underlines – at least a minimum of doubt should raise him “.
The expert, who directs the strategic clinical coordination program of the Pancreas Center at the San Raffaele hospital in Milan, says he “obviously agrees that a drug must have a clinical benefit to be approved. But the benefit is one thing clinical, survival is one thing.Clinical benefit, in the case of pancreatic cancer treatment, was well established 25 years ago and has to do with clinical condition and weight, but in any case it is simply some something positive that is not necessarily linked to the prolongation of life. In my opinion, it is an aspect to keep in mind. The two things are not necessarily connected”, he reasons.
Reni discusses the data available on olaparib for this neoplasm and the Polo study, published in the ‘New England Journal of Medicine’, which effectively led to the drug’s approval and reimbursement in various European countries. Aifa says that from a statistical point of view with this therapy there is no prolongation of survival. But the specialist invites us to go deeper.
“We are talking – the expert points out – of metastatic pancreatic cancer and, 5 years after the start of therapy (5 years is a rather unusual unit of measurement in the case of this tumor), we have exactly twice as many living people among those who received olaparib, compared to the group who received placebo: more than 30% versus about 18%.This is extraordinary and has never happened in the history of pancreatic cancer.It is a bit difficult to argue that this does not is a prolongation of survival, albeit limited to one person in 3 of those who received the drug.Moreover, the gap between the two groups of patients would be even wider if one considers that among those who received the placebo more than 30% then took olaparib later”.
“But even if there weren’t a survival benefit, and for me this is a hypothetical period of unreality – continues the oncologist’s reasoning – the clinical benefit is also linked to other factors that are very clear for those involved in cancer of the pancreas: if a patient does not take chemotherapy, with all the related toxicities, it is a clinical benefit.In the case of the study in question the primary objective was to demonstrate that the moment of disease progression and the reuse of chemo could be delayed. And this has been amply demonstrated, because the times” taken by the disease to recover “are doubled compared to the placebo group. It is an undeniable clinical benefit. Perhaps part of the problem is that one should have specific expertise on the subject, why not all cancers are the same.”
Quality of life issue
On the other hand, he adds, “who better than patients can know whether or not there is a clinical benefit? We doctors or technicians can say what we want, but perhaps it would be appropriate to hear the voice of the patients. If we ask them whether it is preferable to have intravenous chemo with all the known side effects it causes, or to take a pill by mouth, which basically does not cause side effects, I think the answer could be quite obvious”. Even the improvement in quality of life parameter “is a false problem” for Reni. “The quality of life, in patients who have undergone chemo and have concluded it obtaining a benefit in terms of reduction of the disease, is something that is in fact already present. The concept is in fact to maintain it, not improve it, precisely in the case of a maintenance therapy such as the one we are discussing”.
Ultimately, observes the oncologist, we cannot forget that “the quality of life is conditioned by the regrowth of the disease, which in the case of pancreatic cancer creates big problems, big damages. Having it postponed is another sign of an indisputable clinical benefit “. This, concludes Reni, “is a different tumor, the same mental categories that apply to other neoplasms cannot be applied. And it requires specific competence, so much so that within the Lombardy Region and also nationally we are moving towards establishment of the Pancreas Units, along the lines of the Breast Units for the breast, precisely as evidence of the fact that specific skills are indispensable and patients affected by this disease cannot be managed by generic oncologists.There are working tables in place and at least for as far as Lombardy is at an advanced stage, there is also a strong political will on this subject, so I am confident – he adds – that it will be concluded as soon as possible”.
“On March 1st it will be 4 years since the diagnosis of pancreatic cancer”, which arrived in 2019. “Overall I’m fine. No complications. I continue to take the drug olaparib, the tests continue to go well, the quality of life is good, more I’m doing everything I used to. I can’t complain. Not doing chemo is always a beautiful thing.” You explain it in a few words to Adnkronos Salute Mario Sala, trader from Desio: taking a pill is “very different” from facing chemotherapy. “It’s like day and night”, he underlines on the day in which the Italian drug agency Aifa once again reiterated the reasons for its decision not to admit olaparib to reimbursement for this neoplasm, a verdict arrived in November 2021. From 28 then, in February 2022, the compassionate use program was also closed, with suspension of the distribution of the drug to new patients with pancreatic cancer and the BRCA1/2 gene mutation, made famous by actress Angelina Jolie.
We have returned to talk on the wave of the echo aroused by the death of the footballer Gianluca Vialli, precisely from pancreatic cancer, which had the effect of rekindling the spotlight on the disease and, in the debate on the prospects for these patients, the issue of no to olaparib in Italy was also touched upon. Mario has been taking the drug for some time now and highlights a “precious”, often “underestimated” value: that of quality of life. He knows it well, as last year he managed to lead the way in the Italian Masters Championships in Santa Caterina Valfurva, on a track – the one dedicated to the Olympic athlete Deborah Compagnoni – created for the 2005 Alpine Ski World Championships and theater of different competitions of the white circus. “I plan to do it again this year,” he says.
But in the meantime, next week, when he turns 57, he will return to the mountains in Folgaria on his beloved skis. And for the 4 years since the diagnosis, the plan is to go there again, “to make another video on the track”. A full life, hers. And not only of snow, but also of the sea in the summer and of commitments to raise awareness of cancer. Last November, for example, says Mario, “we organized a charity walk in Limbiate. The goal: to raise funds for the Italian association Aisp for the study of the pancreas. It went very well”.
After the diagnosis Mario experienced chemotherapy, underwent surgery and much more. Since Christmas evening 2020 he has been taking olaparib, daily tablets to be taken at home, “a huge difference with chemo”, he assures. “Like darkness and light – he repeats – Going to the hospital, undergoing therapy, is a great inconvenience. In addition to my example, I can give that of other people who have been using olaparib for years and have had results in terms of quality of life, survival to keep the disease under control”.
The patient also talks about the emotional impact caused by Vialli’s death. “The patient community has suffered a lot. In the chats many have commented, they were shocked, frightened, worried. We do not forget that each case is unique”, he specifies, but the reflections on the state of the art of the fight against pancreatic cancer they are inevitable. “A lot of research is still needed – he observes – The weapons available to be able to defend against this disease are not many, especially when the most important therapies start to fail, as oncologists explain to us. My hope for this new year that has begun is that there are more funds to advance science and more attention for doctors, researchers, nurses”.
The Italian no to the reimbursement of olaparib for pancreatic cancer Mario can’t explain it: “Sometimes not being in a situation can make it difficult to understand – he reflects – Perhaps having a relative or friend who goes through this experience instead can change the point of sight. If you are not touched personally, you live it differently. I don’t think it is an economic question, also because there are not many people in Italy who could take advantage of this therapeutic option. And then – he concludes – it is not possible to understand why abroad and throughout Europe the therapy in question is reimbursed and not in Italy. The data are the same. Faced with this, it is difficult to understand why patients cannot access the drug only here”.