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Trikafta is a transformational drug that can treat up to 90% of Canadians with cystic fibrosis. It is a triple combination precision medicine (ivacaftor, tezacaftor and elexacaftor). Rather than just treating symptoms, Trikafta targets the basic defect from specific genetic mutations that cause CF.
On Friday, June 18th, 2021, Health Canada issued a Notice of Compliance (NOC) approving Trikafta for sale in Canada for people aged 12 and up with cystic fibrosis and at least one F508del mutation.
The approval of Trikafta by Health Canada means that doctors can now prescribe the drug to patients aged 12 and up with cystic fibrosis and at least one F508del mutation.
Trikafta, however, is not yet accessible to those who need it until it is funded by provincial drug plans and private insurers.
A “Notice of Compliance” by Health Canada is one step in Canada’s complex drug approval and reimbursement process. There will be other reviews and approvals before Trikafta is publicly funded and accessible; some of these are already underway. Its cost effectiveness is still being considered by Canada’s health technology assessment bodies, the Canadian Agency for Drugs and Technologies in Health (CADTH), the Institut national d'excellence en santé et services sociaux (INESSS) and BC Pharmacare. They will make non-binding recommendations on whether our governments should pay for the drug. Finally, Canada’s public drug programs must negotiate the price of the drug through the pan-Canadian Pharmaceutical Alliance (pCPA), after which the provinces will decide if they will fund the medication.
Canadians with CF need Trikafta now. The provinces must fund Trikafta immediately, and it must receive expedited negotiations at the pCPA CF can’t wait.
Canadian research published in the Journal of Cystic Fibrosis demonstrates that access to Trikafta in 2021 would result in profound health benefits for Canadians living with cystic fibrosis. By 2030, Trikafta could reduce the number of people living with severe lung disease by 60% and reduce the number of deaths by 15%.
The findings show a significantly slower disease progression with an 18% increase in people with mild lung disease and 19% fewer hospitalizations or home intravenous antibiotics for pulmonary exacerbations. The estimated median age of survival for a child born with cystic fibrosis would increase by 9.2 years. Read more about this research.
Trikafta was fast-tracked for access by the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Trikafta has received regulatory approval in 32 countries, 27 within the EMA centralized regulatory approval in addition to receiving approval in the United States, United Kingdom, Norway, Iceland and Liechtenstein. Trikafta has received public reimbursement in the United States, United Kingdom, Ireland, Austria, Denmark, Germany, and Slovenia.
Stand up and make your voice heard. We need a commitment from provincial governments to immediately fund Trikafta. Ways that you can help:
*Last updated June 2021. Further updates to come.