Vertex Pharmaceuticals announced that a reimbursement program covering Orkambi (lumacaftor/ivacaftor) and Symdeko (tezacaftor/ivacaftor combo) will be opening for eligible cystic fibrosis patients (CF) living in Switzerland.
Eligible patients include those ages 2 and older with two copies of the F508del mutation in the CFTR gene who can be treated with Orkambi, as well as those ages 12 and older, who have at least one F508del mutation in one copy of CFTR, who can be treated with Symdeko.
The new reimbursement agreement also covers future extensions of patients, by age, who may be treated with Symdeko.
Additionally, the agreement will enable quicker access to Trikafta — Vertex’s next-generation, triple combination therapy of elexacaftor (VX-445), tezacaftor (VX-661), and ivacaftor — once the therapy is approved in Switzerland.
Trikafta is a CFTR modulator that combines two CFTR correctors — elexacaftor and tezacaftor — with ivacaftor, a CFTR potentiator. CFTR correctors are designed to help the CFTR protein — the protein that is defective in CF patients — to fold correctly, while CFTR potentiators keep it in a stable conformation at the cell surface to facilitate the transport of molecules in and out of cells. Together, these therapies aim to help defective CFTR proteins to work more efficiently and alleviate CF symptoms.
Access to Trikafta is pending on the decision of Swissmedic, the Swiss regulatory agency for therapeutic products, to approve the triple combo therapy. Vertex submitted an application to the agency requesting its approval on March 24.
Trikafta is approved in the U.S. to treat CF patients carrying at least one F508del mutation, which make up 90% of all those with the disease.
“This agreement is an important milestone for the cystic fibrosis community in Switzerland. Access to Orkambi and Symdeko is especially important at this time given the COVID-19 outbreak and that people with CF are vulnerable to infections,” Ludovic Fenaux, senior vice president of Vertex International, said in a press release.
“We are pleased that Vertex and the Swiss authorities have been able to work closely and flexibly to enable this agreement, so that almost 400 eligible Swiss patients will now have access to CFTR modulators to treat the underlying cause of their disease,” Fenaux added.
With this agreement, Switzerland joins more than 20 countries worldwide, including Australia, France, Germany, Italy, Spain, Sweden, the U.K., and the U.S., that reimburse Vertex’s CF therapies.
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