Ardelyx chooses not to file for TDAPA for XPHOZAH

Ardelyx announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH, the Company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services End-Stage Renal Disease Prospective Payment System Transitional Drug Add-on Payment Adjustment. Ardelyx’s analysis of the CMS policy to include oral-only medicines in the PPS and the Calendar Year 2025 ESRD PPS Proposed Rule released on June 27, 2024, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients, irrespective of insurance coverage, because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients.