Vialli died of pancreatic cancer, a patients' association attacks: "Aifa does not unlock the reimbursement of the drug Olaparib"

The Codice Viola association returns to the attack on the case of the drug Olaparib and Aifa responds: "It does not improve quality of life"

ROME – These are emotional days following the passing of Gianluca Vialli, killed by pancreatic cancer. Very few effective treatments exist for this disease, as explained by Professor Michele Reni, one of the leading experts. Yet for people carrying the BRCA mutation there is a drug that provides a therapeutic benefit. It is called Olaparib, it has been authorized as a maintenance therapy by the FDA and EMA, while AIFA has decided it is not reimbursable, placing the drug in class C: that is, it can be prescribed but the patient must bear the cost, which is 4,000 euros per month.

“The green light on the drug's effectiveness came from a Phase III randomized study published in the New England Journal of Medicine, a leading scientific journal, this is not the ‘Di Bella cure’ to be clear, and the aim of the study was to show that using Olaparib there was a prolongation of the period free from disease progression and this was demonstrated.” So says Piero Rivizzigno, president of the Codice Viola association representing pancreatic cancer patients, who indignantly retraces the process of what is to date one of the few therapies available for a category of patients who would greatly benefit from it.

“Vialli's death has left great dismay among patients,” he emphasizes, “and we are evaluating all possible initiatives in response to this denied reimbursement of Olaparib by AIFA. Among these stands out a joint letter sent in March 2022 by two scientific societies, oncologists, and five patient associations (Codice Viola, aBRCAdabra, FAVO, Oltre la ricerca, and My Everest) to request clarification, to which no response was given. It is outrageous, it is bureaucratic cynicism,” thunders again the president of Codice Viola, who these days is dealing with the fear and anxiety of those living with this disease and know they cannot access this drug. “AIFA,” he specifies, “did not even respond to the request to know the doctors who were members of the Committee that made this decision.”

“Olaparib,” clarifies Rivizzigno, “is indicated for patients carrying the inherited BRCA mutation with pancreatic adenocarcinoma, a subgroup that represents about 8% of all patients with the exocrine tumor that Vialli had and which accounts for 95% of all pancreatic cancers. The drug can be used when a first line of platinum-based chemotherapy protocols has been administered and when the disease is stable. For patients with hereditary BRCA mutation, the availability of Olaparib therefore represents—he further explains—an important option in the overall treatment path as the Phase III POLO study demonstrated a prolongation of the period free from disease progression and a better quality of life. Just think that the drug is taken orally and there is no need to go to the hospital for infusions. However, in November 2021, this negative evaluation by AIFA arrived, not based on the study's achieved objectives—prolongation of the period free from disease progression—but on the lack of impact on overall survival. Only those who had already started therapy could continue it, but not new patients.”

Sick patients who would have, as BRCA carriers, one more option—men and women, often very young—have thus been left stranded. “Extending the period of life free from disease for these people has great value,” concludes Piero Rivizzigno, “we do not want to doubt AIFA tout court, but to understand and discuss the reasons and know who made this decision. We fear that the drug was evaluated without considering the overall context of the patient's treatment path. Moreover, this decision may also impact the nationwide application of the Aiom guidelines for exocrine pancreatic cancer, which provide for hereditary BRCA mutation testing for all patients. There is a study showing that 5% of patients did not know they had the inherited BRCA mutation. This is a further reason why we are committed to ensuring all patients are tested for BRCA. Firstly, so they can benefit from the best treatment path with targeted therapies, but also to identify those patients who were unaware of the mutation and whose family members can enter appropriate screening programs. Many talk about screening for pancreatic cancer without any knowledge of the specific issues; this is one of the very few cases where screening should be done. On these issues,” assured the president of Codice Viola, who today must deal with the fear of the patients he represents through the association, “we will continue to be committed.”

PANCREATIC CANCER, AIFA: OLAPARIB NOT REIMBURSABLE DOES NOT IMPROVE QUALITY OF LIFE

“Pancreatic carcinoma represents a serious clinical condition for which satisfactory therapeutic options are not yet available. Aifa always evaluates every new treatment with attention and scientific rigor that can provide patients with real clinical benefit, especially in the presence of a high therapeutic need, as in the case of this type of tumor. Since recent news has drawn public attention to Aifa's decision not to admit Olaparib for reimbursement for pancreatic carcinoma, the Agency wishes to point out that this drug was evaluated very thoroughly, acquiring the opinion of several expert oncologists and allowing the company to intervene in a hearing. At the end of the long evaluation process and the numerous in-depth analyses carried out, and in line with the unanimous opinion of the Aifa Oncology Advisory Committee, the Scientific Technical Commission (Cts) established that the drug could not be admitted for reimbursement as it had not demonstrated either a prolongation of survival or an improvement in patients' quality of life.”

So reads an Aifa statement, responding to the requests presented by the Codice Viola association, which brings together patients affected by this disease. “Based on these data, while recognizing the high therapeutic need related to this disease, the Cts considered that the inevitable increase in toxicity associated with the treatment was not offset by sufficient clinical benefit. Olaparib—Aifa concludes—is currently admitted for reimbursement for other therapeutic indications for which it has demonstrated that the benefits outweigh the risks for patients.”

Original Article: https://www.dire.it/09-01-2023/858401-vialli-cancro-pancreas-associazione-codice-viola-aifa-rimborsa...