INESSS restricts access to drug that treats early breast cancer

In an effort to save costs, the National Institute of Excellence in Health and Social Services (INESSS) published a recommendation on Wednesday to restrict access to reimbursement for ribociclib tablets, brand name Kisqali, which is used in particular to treat early breast cancer. 

Ribociclib helps slow the progression of cancer by inhibiting two proteins that can allow cancer cells to grow and divide too rapidly. By targeting these proteins (CDK4/6), it helps stop the uncontrolled replication of cancer cells. 

In an opinion sent to the Minister of Health, INESSS explains that “in a context of limited resources, he must formulate recommendations so that these resources are invested responsibly throughout the health system.” 

For this reason, INESSS recommends that the Minister reimburse ribociclib only for patients with early-stage cancer who have the highest risk of recurrence, specifically those with involvement of four or more lymph nodes or involvement of one to three lymph nodes, combined with grade 3 disease or a tumor of five centimetres or more.

The minister will have to decide whether or not to proceed with the INESSS recommendation. It is not known when he will make his decision. 

Dr. Nathaniel Bouganim, an oncologist at the McGill University Health Centre (MUHC), is concerned that access is restricted for a segment of the population. “It’s never good for women with breast cancer,” he commented. He cited the Kisqali study to explain that a minority of women with negative lymph nodes, but who have certain aggressive risk factors, will have a similar risk of breast cancer recurrence to those with lymph node involvement. “For these patients, their prognosis was similar to those with positive lymph nodes,” he said. 

Another medication requiring less monitoring

The INESSS acknowledges that the evaluation of ribociclib’s effectiveness is based on a high-quality study. However, while the Institute states that it recognizes the importance of providing patients with access to different treatment options, it emphasizes that abemaciclib is another effective product also used in preventing recurrence of certain breast cancers.

“The overall data suggests that adding ribociclib to hormone therapy similarly reduces the risk of recurrence compared to abemaciclib in patients at higher risk of recurrence, who can currently receive abemaciclib, in Quebec,” writes INESSS. 

He adds that the cost of ribociclib treatment in combination with hormone therapy is high, but lower than that of abemaciclib for health benefits considered similar. However, ribociclib is administered for a year longer than abemaciclib, which leads to “a slight increase in the resources needed for patient follow-up, resulting in additional costs for the healthcare system,” argues INESSS. 

On this point, Dr. Bouganim believes that if the drug is better tolerated, an extra year should not generate additional costs for the system. “Because when there is no tolerance, there is safety, and that’s really where it costs much more,” he explains. 

He points out that the two drugs do not have the same side effects. Abemaciclib is more often associated with gastrointestinal problems, while ribociclib lowers neutrophil (a type of white blood cell) levels. 

“An extra year for a patient who tolerates the medication and whose follow-ups are every three months, it’s just a blood test, I think it won’t cost society as much as a patient who has gastrointestinal problems who goes to the hospital, who needs to be hydrated or who needs to take other medications to stop diarrhea,” he explains. 

Dr. Bouganim hopes there will be a review so that all women at risk of relapse have different medication options to reduce relapses. “At the end of the day, that’s what we all want and desire,” he says. 

Kisqali received initial approval from Health Canada in 2018 for use in combination with letrozole to treat metastatic or advanced HR+/HER2- breast cancer in postmenopausal women. Last summer, Health Canada expanded its approval to include the prevention of recurrence for certain breast cancers. 

According to INESSS, approximately 70 per cent of breast cancers detected at an early stage express hormone receptors (HR+) but not HER2- (hormone receptor-positive and human epidermal growth factor receptor 2-negative). The Institute indicates that this subtype of breast cancer (HR+/HER2-) is associated with a lower risk of recurrence and better survival compared to other subtypes. 

—The Canadian Press’s health coverage is supported by a partnership with the Canadian Medical Association. The Canadian Press is solely responsible for this journalistic content.

–This report by La Presse Canadienne was translated by CityNews