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
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
Months to Review and Receive Approval from Health Canada (Approval: July, 2014)
Months Estimated to Complete COMMON DRUG REVIEW process (Application Submitted: August, 2014)
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
STEP 1 - Approval By Health Canada
Biomarin submits VIMIZIM to Health Canada for review and approval for use in Canada. The review was considered a “priority” review because of the potential impact the therapy could have on patients. Submission took place in December of 2013, and approved by Health Canada in July of 2014.
STEP 2 - Submission and Review to the Common Drug Review (CDR)
The Common Drug Review is a “process for conducting objective, rigorous reviews of the clinical, cost-effectiveness, and patient evidence for drugs.” The CDR completes their review and recommends to provinces whether a drug should be reimbursed or not.
STEP 3 - Negotiations Begin With the Pan-Canadian Pricing Alliance (PCAP)
The Pan-Canadian Pricing Alliance works to capitalize “on the combined ‘buying power’ of drug plans across multiple provinces and territories” to bring the cost of expensive treatments down.