Biopharmaceutical company Vertex is providing refunds to 340B covered entities for overcharges on its cystic fibrosis (CF) combination medicine Trikafta for the period from Q2 2021 through Q4 2021, according to a public notice on the U.S. Health Resources and Services Administration website.
Vertex said the credits are “due to the recalculation of an estimated provisional 340B ceiling price.” The U.S. Food and Drug Administration initially approved Trikafta in October 2019 for patients 12 years and older. Vertex announced in June 2021 that the FDA approved its use by children ages 6 through 11.
Vertex said in the notice that it has determined the credit amount owed to each affected covered entity and is working with Apexus, the 340B prime vendor, to issue the refunds. The notice includes contact information for entities that think they are owed a refund but are not contacted by Apexus by March 31.
Vertex announced a limited distribution network for Trikafta and its other three CF medicines—Kalydeco, Orkambi, and Symdeko—in 2020.
