Insurers Will Likely Require Step Therapy for New Schizophrenia Drug

Bristol Myers Squibb on March 18 completed its $14 billion acquisition of Karuna Therapeutics, Inc., whose lead drug, KarXT (xanomeline-trospium), is expected to gain FDA approval for treating schizophrenia later this year. That deal and results from clinical trials suggest KarXT could gain significant market share in a crowded schizophrenia medication marketplace.

However, two drug pricing experts tell AIS Health that it remains to be seen how payers will cover KarXT, especially if it’s priced significantly higher than its generic competitors, as it is expected to be. KarXT, an oral medication, has an FDA Prescription Drug User Fee Act data of Sept. 24, meaning the FDA will make an approval decision by then.

© 2024 MMIT
Tim Casey

Tim Casey

Tim has worked as a reporter and editor for more than 20 years. Before joining AIS Health in December 2021, he was a business reporter covering the commercial real estate industry’s capital markets for four years. He previously covered health care business issues for two medical publishing companies and high school, college and professional sports for the Sacramento Bee newspaper. Tim has a B.A. in Psychology from the University of Notre Dame and an M.B.A. from Georgetown University.

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