When Ruchi Ambike learned that Novartis received Health Canada approval for Vanrafia, her joy was palpable. This medication has the potential to slow the progression of her IgA Nephropathy (IgAN), a serious condition that can lead to end-stage kidney disease and requires either dialysis or a kidney transplant.

“It’s exciting because we have no IgAN drugs in Canada,” she expressed from her home in Mississauga. IgAN is a rare autoimmune disorder that compromises kidney function, affecting the organ's ability to filter waste. While some patients may progress to end-stage kidney disease, there currently exists no cure for IgAN or kidney disease, which impacts one in ten Canadians.

In the United States, there are six FDA-approved medications for IgAN and two more expected to be approved this year, according to Ambike, but none of these treatments are available in Canada. Following the approval, Novartis issued a media release celebrating the milestone. However, mere weeks later, CityNews reported that the drug would not be reaching Canadian pharmacies, as Novartis opted not to proceed with the approval process for Canadian patients.

In a statement, a Novartis representative indicated, “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.” Thus, they decided against seeking reimbursement for the drug for IgAN at this time.

Dr. Michelle Hladunewich, a nephrologist and the Physician in Chief at Sunnybrook Health Sciences, lamented, “The unfortunate thing is this is not the first time this has happened.” She expressed her discomfort as both a physician and a participant in the trials, noting that such occurrences have become increasingly common with new drugs in Canada.

Dr. Bettina Hamelin, President and CEO of Innovative Medicines Canada, highlighted that Canadians currently have access to only 18% of all innovative medicines available worldwide, while Americans can access over 90%. In comparison, wealthier countries, as categorized by the Organisation for Economic Co-operation and Development (OECD), have access to approximately 28% of innovative medicines.

Dr. Hamelin further explained the significant delays in Canada, where obtaining access to innovative medicines typically takes an average of two and a half years. The process involves several complex steps that must be followed after a drug receives Health Canada approval. This includes price setting by the Patented Medicine Prices Review Board and recommendation for coverage by the Canada Drug Agency (CDA).

The Pan-Canadian Pharmaceutical Alliance negotiates prices on behalf of Canadians, after which individual provinces determine their affordability for inclusion in their formularies. The entire process can take years, sometimes leaving companies with fewer than five years to benefit from patent exclusivity, despite the fact that developing a new drug can entail investments of about $3.5 billion and extensive research over 10 to 20 years.

Data from the CDA indicates that less than 50% of drugs approved by Health Canada proceed to the next stage, limiting their availability through healthcare providers and insurance plans. Dr. Hamelin noted that pharmaceutical companies often refrain from submitting for reimbursement because the lengthy process consumes significant resources, often taking more than two years before patients see the medicine in Canada.

As a result, Canada is increasingly viewed as a “later launch” country, which delays or even prevents access to life-saving and life-extending drugs across various medical fields, including oncology and chronic illnesses.

In response to these challenges, the federal government established a Pharmaceutical and Life Sciences task force last month, which provided recommendations aimed at streamlining the drug approval process and making Canada a more attractive market for drug launches. The implementation of these recommendations remains uncertain, and Health Canada did not respond to inquiries from CityNews by the deadline.

Dr. Hamelin reiterated that improved processes would benefit access to new drugs, underscoring the importance of recognising that medicines save lives and ultimately contribute to healthcare savings and economic growth. However, the issues surrounding costs are likely to persist, particularly in light of the U.S. administration’s “most favored nation policy,” which Dr. Hladunewich warns may further hinder Canadian access to essential medications.

Watch for Part 2 of this multi-part series on Monday on CityNews and citynews.ca.