Medsafe Consents Trikafta

Vertex today announced it has gained consent from Medsafe for the use of Trikafta® (elexacaftor/tezacaftor/ ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in patients in New Zealand, ages six and over who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

“We appreciate Trikafta receiving a Priority Review and the subsequent completion of the review in just six months is extraordinary,” said Simon Lem, Regional Vice President Northern Europe, Australia and New Zealand, “This is a significant milestone in our efforts to bring our medicines to eligible New Zealanders with CF.”

More than 350 patients are now eligible for treatment for the first time, bringing Vertex another step closer to our goal of providing a treatment option to all people with this devastating disease. Importantly, this is the first regulatory approval outside the U.S. for Trikafta for use in patients ages six and over.

Vertex made a reimbursement application in July 2021 for the medicine to be funded for use by New Zealand patients ages six and over, at which time, Pharmac committed to a parallel review. Pharmac’s Respiratory sub-committee recently recommended it as a high priority for funding[2].

Vertex is committed to ensuring New Zealanders with CF have sustainable access to our triple combination treatment as soon as possible. We stand ready to offer flexible and innovative funding arrangements to enable timely access to Trikafta. We have demonstrated this flexibility in securing reimbursement agreements for Trikafta in more than 25 other nations and look forward to doing the same in New Zealand.

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