Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today confirmed that Judge Beryl Howell from the U.S. District Court for Washington, D.C. has granted defendants’ motion to dismiss the lawsuit filed by Ardelyx, the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF), permitting the Centers for Medicare and Medicaid Services (CMS) to proceed with its plan to include XPHOZAH® (tenapanor) and other oral-only phosphate lowering therapies (PLTs) in the End-Stage Renal Disease Prospective Payment System (ESRD PPS).
“We are disappointed and saddened by the Court’s decision to grant defendants’ motion to dismiss allowing CMS to bring PLTs into the Medicare ESRD PPS beginning on January 1, 2025. This will result in incredible harm to dialysis patients who, as a result of the bundled payment system, are unable to access the best care and medicine they require. Dialysis patients are among those who have historically experienced poorer health outcomes due to negative social determinants of health. And, while addressing health disparities has been a stated goal for CMS, this policy moves us in the opposite direction, resulting in severely restricted access to important medications,” said Mike Raab, president and chief executive officer of Ardelyx.
Raab continued, “Today’s decision reinforces our commitment to pursue all means for protecting patient access to XPHOZAH, including our choice not to apply for TDAPA in order to preserve the shared decision-making process between patients and healthcare providers who can best determine the best course of therapy to manage hyperphosphatemia. We also urge Congress to act swiftly on the overwhelming pleas from patients, physicians, faith leaders, labor unions and health equity advocates across the nation to pass the Kidney PATIENT Act.”
Ardelyx is currently reviewing the District Court’s decision and will consider all options related to the lawsuit.
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