Canadians Lobby Government to Reassess Proposed Regulations Affecting Access to Trikafta

Iqra Mumal MSc avatar

by Iqra Mumal MSc |

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Canadian patient advocates and leaders in the field of cystic fibrosis (CF) are meeting with Canadian government officials to lobby for changes to proposed regulatory reforms that are preventing CF patients from accessing Vertex’s new breakthrough therapy, Trikafta.

Trikafta, Vertex’s most recent FDA-approved medication for the treatment of CF, is a triple combination composed of elexacaftortezacaftor, and ivacaftor. The therapy can potentially treat up to 90% of CF patients.

Trikafta is not available to Canadians at this time.

In the United States, the treatment is available and considered by some to be  “life-transforming.

Vertex believes that changes proposed to the Canadian regulations for patented medicines is the reason why Trikafta has yet to be launched in Canada.

Cystic Fibrosis Canada is calling on the Canadian government to reassess the proposed changes to regulations so that Canadian CF patients can get access to this potentially life-changing medicine.

The regulatory changes in question were proposed originally in 2017 by the Patented Medicines Prices Review Board (PMPRB). The proposed regulations are poised to change the way the PMPRB determines whether a medicine is being sold at an “excessive” cost.

Estimates indicate that these new regulations may force patented drug manufacturers to reduce their prices by as much as 45–75%.

Over the past two years, patient groups and health charities have constantly raised concerns about changes that will decrease the availability of novel, expensive therapies.

“Despite repeated assurances from the PMPRB and the federal government that these proposed changes would not impact the availability of new medications, we are here to say today that not only have the proposed changes delayed access to a life-saving treatment for cystic fibrosis patients, but the changes will affect other Canadians living with different illnesses and diseases in the future,” Kelly Grover, CEO of Cystic Fibrosis Canada, said in a press release.

“We appreciate the need to limit excessive pricing, but any changes must not create additional barriers to access to life-saving drugs for Canadians,” Grover said.

Cystic Fibrosis Canada is calling on Canadian governments, regulators and Vertex to collaborate in order to accelerate the approval of Trikafta, so that it can be made available to patients there.