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SYMDEKO® is a precision medicine that is used to treat cystic fibrosis in people who have a particular set of genetic mutations. A disease-modifying therapyeutic, it is a combination of two drugs, ivacaftor and tezacaftor.
In Canada, Symdeko is approved for use in people ages 12 and older who have people who have the F508del mutation in both of their cystic fibrosis transmembrane conductance regulator (CFTR) genes, or who have one copy of the F508del mutation plus one of the following mutations in the CFTR gene: P67L, D110H, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
Symdeko may be available through some private insurance plans, as the manufacturer has thus far declined to put the medicine through Canada’s challenging drug review and reimbursement system for precision medicines.
Following Health Canada approval, granted in June 2018, for a drug to be covered by provincial health plans, it has to be submitted for review to the Canadian Agency for Drugs and Technologies in Health (CADTH) and, in Quebec, to Institut national d'excellence en santé et services sociaux INESSS. These agencies make recommendations to the provincial, territorial and federal drug programs.
Symdeko’s manufacturer, Vertex Pharmaceuticals, has not made the necessary submissions. Until they do, it is unlikely that our governments will provide public coverage of Symdeko.
Cystic Fibrosis Canada continues to push the manufacturer to put Symdeko through Canada’s drug review and reimbursement processes.
At this critical time, access to life-changing CF medications, like Symdeko, is one of our most important priorities.
Our CEO, our Chief Scientific Officer, our advocacy team, volunteers and Board continue to work, together with the CF community to ensure people living with CF in Canada have access to these medications.
Find out more about Cystic Fibrosis Canada’s work to gain access to life-changing medications, including an advocacy toolkit that you can use.