Ruchi Ambike's excitement was palpable when she learned that Novartis received Health Canada approval for Vanrafia, a drug that potentially slows the progression of her Immunoglobulin G A nephropathy (IgAN) and could delay the onset of end-stage kidney disease. She expressed her enthusiasm from her home in Mississauga, emphasizing the lack of available IgAN treatments in Canada.
IgAN is a rare autoimmune disorder that impairs kidney function, leading to the inability to filter waste effectively. In some cases, the disease progresses to end-stage kidney disease, requiring patients to undergo dialysis or seek kidney transplants. Currently, there is no cure for either IgAN or kidney disease, which affects one in ten Canadians.
Ambike pointed out that while the United States has six FDA-approved medications specifically for IgAN, with two additional treatments on the way, Canada remains without options. Despite Novartis’ initial media release celebrating the approval of Vanrafia, CityNews reported that the drug would not be available in Canadian pharmacies, as Novartis chose not to pursue the reimbursement process for Canadian patients.
A spokesperson for Novartis stated, “While Novartis remains committed to expanding access to our medicines for patients in Canada, we have determined that under the current Canadian access environment, the likelihood of successfully securing reimbursement for Vanrafia is limited.” This decision underscores a trend that has become increasingly common regarding new drug availability in Canada.
Dr. Michelle Hladunewich, a nephrologist and Physician in Chief at Sunnybrook Health Sciences, expressed her discontent with the situation, highlighting that this setback is not an isolated incident. “It doesn’t sit well with me as a physician or as somebody who participated in the trial, but it seems to be the way it’s happening lately,” she noted.
Dr. Bettina Hamelin, President and CEO of Innovative Medicines Canada, explained that Canadians have access to only 18 percent of all innovative medicines available globally, in stark contrast to the 90 percent access that Americans enjoy. In comparison, OECD countries access about 28 percent of innovative drugs, highlighting significant discrepancies in availability.
Hamelin elaborated that Canadians wait an average of two and a half years to access innovative medicines. After a drug secures approval from Health Canada, a series of complex steps must ensue before it is available to patients. The Patented Medicine Prices Review Board sets a drug ceiling price by comparing it to other OECD nations. Subsequently, the Canada Drug Agency (CDA) makes a recommendation on coverage and pricing for federal and provincial health plans. Negotiations then occur through the Pan-Canadian Pharmaceutical Alliance, followed by provincial assessments of affordability.
The entire process can consume years, often resulting in fewer than 50 percent of drugs approved by Health Canada proceeding to the next stage, thereby limiting their availability through hospitals and insurance plans. According to Hamelin, companies sometimes choose not to submit for reimbursement due to the high costs associated with this lengthy availability process. Consequently, Canada shifts from being an “early launch” country to a “later launch” one, delaying access to potentially life-saving medications across various health challenges.
The federal government recently established a Pharmaceutical and Life Sciences task force, which proposed recommendations to streamline the approval process and encourage new drug launches in Canada. However, it remains uncertain how many of these recommendations will be enacted or the timeline for their implementation, as Health Canada did not respond to inquiries from CityNews.
Hamelin remarked that if the task force recommendations are implemented effectively, they might alleviate some of the delays in the drug approval pathway, advocating for a more integrated approach to the process. She emphasized the vital importance of recognizing that effective medicines not only save lives but also contribute positively to the economy and healthcare system.
The ongoing issue of costs remains significant, particularly in light of the U.S. administration's “most favored nation policy,” which Hladunewich cautioned could further inhibit Canadian access to newer drugs.
