Fewer than half of Health Canada approved drugs reach patients, and access keeps narrowing
Novartis Canada will not pursue reimbursement for Vanrafia, its newly approved treatment for a rare kidney disease, meaning the drug will not reach pharmacies across the country despite receiving Health Canada approval.
The company confirmed the decision in a statement to CityNews Toronto, which reported that the drug would not become available to Canadian patients weeks after Novartis announced the approval.
A Novartis spokesperson told CityNews that the company had determined the likelihood of securing reimbursement for Vanrafia is limited under the current Canadian access environment, and that Novartis Canada had decided not to seek reimbursement for Vanrafia in IgAN at this time.
Health Canada approved Vanrafia (atrasentan tablets) for proteinuria reduction in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, Novartis said in its media release.
The approval was based on a prespecified interim analysis at 36 weeks of the Phase III ALIGN study, a randomized, double-blind, placebo-controlled trial in adults with biopsy-proven primary IgAN, Novartis said in the release.
IgAN is an autoimmune disorder that limits the kidneys' ability to filter waste, and some patients progress to end-stage kidney disease requiring dialysis or a transplant.
The disease has no cure, and kidney disease affects one in 10 Canadians.
Novartis said the condition occurs when clumps of immunoglobulin A and antibodies deposit in the kidneys, causing inflammation and damage that lead to blood and protein leaking into the urine.
Fewer than 50 percent of drugs approved by Health Canada advance to the reimbursement stage that determines their availability through hospitals and public and private insurance plans, according to Canada Drug Agency data cited by CityNews.
Canadians can access 18 percent of the innovative medicines available worldwide, compared with more than 90 percent for Americans and about 28 percent across member countries of the Organisation for Economic Co-operation and Development, Bettina Hamelin, president and chief executive officer of Innovative Medicines Canada, told CityNews.
Canadians wait an average of two and a half years before they can access innovative medicines, said Hamelin, whose organization represents Canadian pharmaceutical companies.
After Health Canada approves a drug, the Patented Medicine Prices Review Board sets a price ceiling by comparing prices with other OECD countries, according to CityNews.
The Canada Drug Agency then recommends whether the drug should be covered by federal or provincial health plans, the Pan-Canadian Pharmaceutical Alliance negotiates prices on behalf of the country, and provinces decide whether they can afford to list the drug on their formularies.
Some companies benefit from patent exclusivity for fewer than five years in Canada, where developing a single drug can cost $3.5bn and take 10 to 20 years of research and testing, Hamelin told CityNews.
Companies decide against submitting for reimbursement because sustaining operations for two and a half years before a drug becomes available to Canadians costs money, she said.
The federal government created a Pharmaceutical and Life Sciences task force that delivered recommendations on streamlining approvals and making Canada more appealing for drug launches, according to CityNews, though it remains unclear how many recommendations will be adopted.
Health Canada did not respond to CityNews by deadline.
Hamelin said the recommendations would help if implemented ambitiously, since several target the lengthy sequential process and call for parallel steps.
The sector needs to "look beyond cost" and recognise that medicines "save lives, save money to the healthcare system, and builds our economy," she told CityNews.
The outcome was not unusual, said Michelle Hladunewich, a nephrologist and physician-in-chief of the department of medicine at Sunnybrook Health Sciences Centre who participated in the trial.
It "doesn't sit well" with her as a physician or a participant, she told CityNews, but it reflects "the way it's happening lately, especially with new drugs in Canada."
Ruchi Ambike, an IgAN patient in Mississauga who had welcomed the approval, told CityNews that six medications for the disease have received United States Food and Drug Administration approval, with two more expected this year, none of which are available in Canada.
"It's exciting because we have no IgAN drugs in Canada," she told CityNews.
Hladunewich said the United States administration's most favoured nation drug pricing policy could further restrict access.
"The side effect of that policy is just going to be that we're not going to be able to access drugs," she told CityNews.
