Trikafta Costs to be Subsidized for Eligible Australians

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by Lindsey Shapiro PhD |

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Beginning April 1 the Australian government will subsidize the cost of Trikafta (elexacaftor/tezacaftor/ivacaftor) for patients with cystic fibrosis (CF) under the Australian Pharmaceutical Benefits Scheme (PBS), dramatically reducing out-of-pocket expenses for eligible Australians.

The subsidy was made possible by a reimbursement agreement reached between Trikafta’s developer, Vertex Pharmaceuticals, and the Australian government, which covers a negotiated price for the therapy.

“Without PBS subsidy, around 1,900 Australians would pay more than $250,000 a year for access to Trikafta,” Greg Hunt, the Australian minister for Health and Aged Care, said in a press release from the Australian Government Department of Health.

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“This treatment is out of reach for most Australians, and now that it will be available on the PBS, patients will only pay a maximum of [AU$42.50, or about $32] per prescription, or as little as [AU$6.80, or about $5] with a concession card,”  Hunt added.

Those eligible for the reimbursement include CF patients 12 and older who have at least one F508del mutation — the most common CF-causing mutation — for whom the therapy was approved by regulatory agencies in Australia last year.

“Today’s announcement is a significant milestone in ensuring Australians living with CF receive timely and sustainable access to TRIKAFTA,” Ludovic Fenaux, senior vice president of Vertex International, said in a separate press release.

“This is the fourth treatment we have brought to Australians over the last eight years, working tirelessly alongside the CF patient and clinical communities,” Fenaux added. “We thank the Australian Government for recognizing the significant need for TRIKAFTA and the value it brings.”

CF is caused by mutations in the CFTR gene that affects production of the CFTR protein. In about 90% of cases, the disease-causing mutation is F508delTrikafta is an oral therapy that combines three CFTR modulators. Together, the modulators work to bind to the faulty CFTR protein and increase its functionality.

Australia’s approval of the therapy was, in large part, based on the results of four global Phase 3 clinical trials, which included sites and patients in Australia, Vertex reported. The therapy also is approved for patients ages 6 and up in the U.S. and Europe, where it is marketed as Kaftrio.

“As a genetic disease, cystic fibrosis is a prime candidate for precision medicine. Now, with PBS listing of TRIKAFTA, eligible Australians living with CF ages 12 years and older can broadly access a therapy that treats the underlying cause of their disease,” said John Wilson, head of the cystic fibrosis service at Alfred Health Australia.

“Clinicians across Australia will be excited about this most welcome news,” Wilson added.

Vertex noted that Trikafta is now available for reimbursement in 30 countries, including Denmark, Finland, France, Germany, Italy, Ireland, Israel, Poland, Spain, Switzerland, and the U.K.