TORONTO, October 28 2021 – Trikafta has been submitted to Health Canada for children ages six to 11. In a press release on October 27 by the manufacturer of Trikafta, Vertex Pharmaceuticals, the company announced that its supplementary application has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 6-11 years. A priority status for a Health Canada review means that it should be completed within 180 days, or before the end of April 2022.
Vertex has also stated they are seeking an aligned review with health technology assessment (HTA) bodies the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et en services sociaux (INESSS) in Quebec. An aligned review will allow CADTH and INESSS to complete their reviews during Health Canada’s priority review period.
Health Canada’s priority review and HTA aligned reviews were granted for the 12+ year old application for Trikafta in late 2020 and were completed in six months.
In a letter received by Cystic Fibrosis Canada from Vertex Pharmaceuticals, the manufacturer also stated that “Following the completion of these assessments, the Letter of Intent (LOI) we recently signed with the pan-Canadian Pharmaceutical Alliance (pCPA) may extend to include TRIKAFTA for patients ages 6-11.” The LOI in question was initially signed for Kalydeco and Orkambi before being extended for Trikafta for people aged 12 or older in September 2021. A further extension of this LOI to include Trikafta for people ages six to 11 could mean no further negotiations would be necessary between the pCPA and Vertex Pharmaceuticals, further hastening the path to potential access for Canadian children ages six to 11 who need the drug. We are investigating further.
We’re incredibly relieved at the possibility of children ages 6 to 11 getting access to Trikafta in Canada.” says Kelly Grover, President and CEO, Cystic Fibrosis Canada. “We know that preventing the disease progression is so important and starting as early as possible matters. There is the potential here to completely transform the lives of children with CF to the point that they could have a normal childhood and even a normal life, rather than a shortened life of illness, hospitalizations and progressively declining health.”
“We know that it will be a fight to make this drug accessible to all those who need it, but we’re ready and our community is ready and we won’t stop until every Canadian who can benefit from Trikafta has access to it” says Grover.
Trikafta was approved by Health Canada on June 18, 2021, for people aged 12 and up with cystic fibrosis and at least one F508del mutation. All provinces and one territory have since either committed to or commenced public funding of the drug, yet restrictive criteria and problems with the processes of public and private payers means that countless Canadians who are eligible by Health Canada standards still cannot access it. Additionally, two territories and federal drug funding programs have not yet committed to listing Trikafta. Cystic Fibrosis Canada is calling on the Northwest Territories, Nunavut and the Non-Insured Health Benefits (NIHB) Program to immediately fund the drug under public drug programs using Health Canada’s indications and Cystic Fibrosis Canada’s clinician-developed guidelines for access and continuation, as well as Canada’s private insurers. We urge all drug plans – public and private – to ensure swift and broad access for all who could benefit from the drug as recommended by their physician.
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