In a statement to CityNews, a spokesperson writes: \u201cWhile 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.\u201d<\/p>\n
\u201cThe unfortunate thing is this is not the first time this has happened,\u201d says Dr. Michelle Hladunewich, a nephologist and the Physician in Chief at the Department of Medicine at Sunnybrook Health Sciences.<\/p>\n
\u201cIt doesn\u2019t 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.\u201d<\/p>\n
\u201cCanadians have only access to 18\u00a0per cent of all innovative medicines that are available around the world. Americans have access to over 90 per cent,\u201d explains Dr. Bettina Hamelin, President and CEO of Innovative Medicines Canada, which represents Canadian pharmaceutical companies. \u00a0<\/p>\n
\u201cOrganisation 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],\u201d Hamelin says from her Toronto office, explaining that the big problems are time and money.<\/p>\n
\u201cRight now, Canadians wait an average of two and half years before they can access innovative medicines,\u201d Hamelin explains. <\/p>\n
Drug companies have to follow a complex sequential process after getting Health Canada approval before making it into patient\u2019s medicine cabinets.<\/p>\n
After a drug is approved by Health Canada, the Patented Medicine Prices Review Board sets a drug ceiling \u2013 the most a drug can cost \u2013 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.<\/p>\n
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 \u2013 where developing a single drug can cost $3.5 billion in investment and 10-20 years of research and testing.<\/p>\n
Data available through the CDA reveals that fewer than 50 per cent of drugs approved by Health Canada go onto the next stage, limiting its availability through hospitals, private and public insurances.<\/p>\n
\u201cCompanies 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,\u201d Hamelin says.<\/p>\n
Essentially, Canada doesn\u2019t 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 \u201cearly launch\u201d country Canada becomes a \u201clater launch\u201d country, which delays\u00a0or even prevents access to innovative new drugs in oncology, organ diseases and non-life ending disorders and diseases.<\/p>\n
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