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KALYDECO® (ivacaftor) is a precision medicine for the treatment of cystic fibrosis. It is a pill taken twice a day, with fat-containing food, that helps the protein made by the CFTR gene function better and, as a result, improves lung function and other aspects of cystic fibrosis such as increasing weight.

Kalydeco is approved in Canada, for the treatment of patients with cystic fibrosis (CF) aged:

In Canada, the number of people with these mutations is over 200, or 4% of the cystic fibrosis population.

Who can benefit from Kalydeco? Kalydeco can treat people who are:

How can Kalydeko be accessed in Canada?

The Common Drug Review’s (CDR) Canadian Drug Expert Committee (CDEC) recommended in 2013 that Kalydeco be listed on the formulary listing of publicly funded drug plans for the treatment of cystic fibrosis in patients age six and older who have the G551D mutation in the CFTR. Cystic Fibrosis Canada submitted patient input to Canada’s Common Drug Review for the additional mutations on July 22, 2014 and it received a positive recommendation on December 19, 2014.

Following the CDR recommendation for G551D, Kalydeco was subject to the Pan-Canadian Pharmaceutical Alliance (PCPA), where negotiations with the manufacturer – Vertex - were led by Alberta on behalf of the provinces (with the exception of Quebec). A letter of intent was entered into between the participating pCPA jurisdictions (Quebec excluded) on a pricing agreement for Kalydeco on June 16, 2014. A letter of intent typically sets out the standard terms for health ministries and Vertex when considering provincial coverage for Kalydeco. Unfortunately, the additional gating mutation indications did not make it through the pCPA negotiations at that time.

CF Canada has continued to push for the remaining mutations to be covered. In the summer of 2019 – five years after the addition of the remaining mutations - the pCPA and the manufacturer completed price negotiations on these mutations. To our knowledge, only British Columbia and Alberta moved to cover these mutations. CF Canada has encouraged all other governments to fast-track coverage of the remaining mutations.

For more information on access through provincial, territorial or federal coverage of Kalydeco, please speak to your CF clinical team. You may also wish to contact kalydeCARE™, a Patient Assistance Program which can help navigate the reimbursement system. For more information please call: 1-855-CARE-571 (1-855-227-3571).


On June 12, 2020 the pan-Canadian Pharmaceutical Alliance (pCPA) agreed to enter negotiations with Vertex Pharmaceuticals on Orkambi and Kalydeco.

One year later, the pCPA announced that they have agreed on a negotiated price for both drugs, for all Health Canada approved mutations. Although Orkambi and Kalydeco were held up in negotiations for quite some time, this is a step in the right direction for the CF community. The next step is for all the provinces in Canada to immediately fund Orkambi and Kalydeco, in their provincial drug plans. For more information please see the Q&A.

Cystic Fibrosis Canada remains committed to advocating for access to medicines for Canadians with CF. We want to thank all our advocates, especially those patients and families personally impacted by Kalydeco for their tenacity and courage in the fight for access.