Reimbursement for Rare Diseases in Canada – A Long and Arduous Process
From an access standpoint, there is no reason for delay, and no reason why patients who need access can’t receive it soon after regulatory approval from Health Canada. Patients suffering from these rare and progressive diseases don’t have the luxury of time on their side, and the current process is long and arduous. Andrew McFadyen, Executive Director, The Isaac Foundation
Unfortunately, any approval by Health Canada for treatments for a Rare Disease doesn’t mean that patients can begin receiving therapy immediately. Canada’s lack of an Orphan Drug Plan, coupled with a very illogical approval process that differs in individual provinces, often leaves patients lacking the treatment they desperately need. The reason? While Health Canada may approve a treatment for use, it’s still up to individual provinces to decide whether they will pay for the treatment or not. This leaves Canadians with inequitable access to our health care system, with some patients receiving treatment for their conditions based solely on what part of the country they happen to live in.
Physicians with patients suffering from a rare disease need to fill out a request for reimbursement application and submit it to the provincial Ministry of Health. From there, the application is reviewed and a decision to cover the cost of treatment is either approved or, in most cases, denied. Most reasons governments provide for denial are due to a lack of evidence of the benefits these treatments provide patients, even when significant data exists to show such benefits exist. The true reason these therapies are denied is cost – provinces feel the cost to treat individuals is a burden on their health care budgets.
More often than not, patients and their families are forced to advocate and lobby provincial governments to cover the cost of the treatments they need. Grassroots social media campaigns, press releases, and demonstrations are all common mechanisms that people use during their lobbying efforts. Sometimes they are successful, oftentimes they are not, and many patients needing therapy go untreated. In Canada, organizations like The Isaac Foundation and RQMO work with families and governments to help ensure patients needing treatment for rare diseases gain access in a timely and equitable manner.
Beaurocratic Path to Reimbursement – Information and Estimated Timelines
7
Months to Review and Receive Approval from Health Canada
6
Months Estimated to Complete COMMON DRUG REVIEW process
12
Months Estimated to Negotiate Reimbursement Cost through the Pan-Canadian Pricing Alliance (Submission after CDR is completed)
Beaurocratic Path to Reimbursement Could Take 20 Months or More
