When Ruchi Ambike found out that Novartis got Health Canada approval for Vanrafia she was ecstatic. The drug can possibly slow down the progression of her Immunoglobulin gA nephropathy, (IgAN) and ultimately, end-stage kidney disease.
“It’s exciting because we have no IgAN drugs in Canada,” she says from her Mississauga home.
IgAN is a rare autoimmune disorder affecting the kidneys, limiting their ability to filter waste properly. Some patients progress to end-stage kidney disease which means a life on dialysis or a kidney transplant. There is no cure for igAN and no cure for kidney disease – which impacts one in 10 Canadians.
“There are six FDA-approved medications specifically for igAN in the States and two more on the way this year,” Albike explains, none of which are available in Canada.
Novartis issued a media release celebrating its Health Canada approval, but just weeks later CityNews learned the drug wouldn’t be making it to pharmacies in the country because Novartis decided not to continue with the approval process for Canadian patients.
In a statement to CityNews, a spokesperson writes: “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. As such, Novartis Canada has made the decision not to seek reimbursement for Vanrafia in IgAN at this time.”
“The unfortunate thing is this is not the first time this has happened,” says Dr. Michelle Hladunewich, a nephologist and the Physician in Chief at the Department of Medicine at Sunnybrook Health Sciences.
“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 its happening lately, especially with new drugs in Canada.”
“ Canadians have only access to eighteen per cent of all innovative medicines that are available around the world. Americans have access to over 90 per cent,” explains Dr. Bettina Hamelin, President and CEO of Innovative Medicines Canada, which represents Canadian pharmaceutical companies.
“Organisation for Economic Co-operation and Development (OECD) countries, which are the richer countries in this world, have access to about 28 per cent [of innovative medicines]”, Hamelin says from her Toronto office, explaining that the big problems are time and money.
“Right now, Canadians wait an average of two and half years before they can access innovative medicines,” Hamelin explains.
Drug companies have to follow a complex sequential process after getting Health Canada approval before making it into patient’s medicine cabinets.
After a drug is approved by Health Canada, the Patented Medicine Prices Review Board sets a drug ceiling – the most a drug can cost – by comparing prices with other OECD countries. Then the Canada Drug Agency (CDA) makes a recommendation on cost and if the drug should be covered by federal and/or provincial health plans. The Pan-Canadian Pharmaceutical Alliance begins to negotiate drug prices on behalf of the entire country, and then provinces have to determine whether or not they can afford to list the drug on their formularies.
The entire process can take years, and according to Hamellin, can result in some companies reaping the benefits of patent exclusivity for fewer than five years in Canada – where developing a single drug can cost $3.5 billion in investment and 10-20 years of research and testing.
Data available through the CDA reveals that fewer that fifty per cent of drugs approved by Health Canada go onto the next stage, limiting its availability through hospitals, private and public insurances.
“Companies make a decision to not submit for reimbursement because it costs money to drive your business for two and a half years before you can actually make that drug available to Canadians,” Hamelin says.
Essentially, Canada doesn’t have a big enough market for some life-saving and life-extending drugs to justify the expense for some pharmaceutical companies. Therefore instead of an “early launch” country Canada becomes a “later launch” country, which delays or even prevents access to innovative new drugs in oncology, organ diseases and non-life ending disorders and diseases.
The federal government created a Pharmaceutical and Life Sciences task force last month, which delivered several recommendations on how to streamline the approval process and make Canada more appealing for drug launch. It’s unclear how many of these recommendations will be adopted and how soon. Health Canada did not respond to CityNews’ request by deadline.
“If the recommendations by the task force are implemented, ambitiously, they will help the process, because a number of recommendations address this lengthy sequential process. It calls for doing things more in parallel, “ explains Hamelin.
“We need to look beyond cost to recognise that medicines save lives, save money to the healthcare system, and builds our economy.”
But costs are going to be an ongoing issue particularly because of the U.S. administration’s “most favored nation policy.”
“The side effect of that policy is just going to be that we’re not going to be able to access drugs,” says Hladunewich.
Watch for Part 2 of this multi-part series on Monday on CityNews and citynews.ca.
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