Ardelyx confirmed on November 8, 2024, that the U.S. District Court for Washington, D.C., granted a motion to dismiss a lawsuit filed by Ardelyx, the American Association of Kidney Patients, and the National Minority Quality Forum. This decision allows the Centers for Medicare and Medicaid Services (CMS) to proceed with including XPHOZAH and other oral-only phosphate lowering therapies (PLTs) in the End-Stage Renal Disease Prospective Payment System (ESRD PPS) starting January 1, 2025.
The inclusion in the ESRD PPS eliminates Medicare Part D coverage for Medicare beneficiaries, posing a significant challenge for patient access to XPHOZAH. Ardelyx expressed disappointment, stating that this policy moves against addressing health disparities and restricts access to important medications for dialysis patients.
Ardelyx is reviewing the District Court’s decision and is considering all options related to the lawsuit. The company reiterated its commitment to protecting patient access to XPHOZAH, including its choice not to apply for TDAPA, and urged Congress to pass the Kidney PATIENT Act.
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