Ardelyx, AAKP, and NMQF Sue to Protect Dialysis Patient Medicine Access

Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company committed to discovering and developing innovative medicines, has announced a lawsuit against the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS). Partnering with the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF), Ardelyx is challenging CMS’s decision to incorporate oral-only phosphate-lowering therapies (PLTs), including XPHOZAH® (tenapanor), into the End-Stage Renal Disease Prospective Payment System (ESRD PPS).

The dispute centers on CMS's plan to include XPHOZAH and other oral-only PLTs in the ESRD PPS starting January 1, 2025. This decision will shift these therapies from being covered under outpatient pharmacy benefit plans, such as Medicare Part D, to being part of the bundled ESRD PPS for dialysis services. Ardelyx and its partners argue that this move will severely restrict patient choice and timely access to essential medications. According to the lawsuit, CMS's plan contradicts the statutory provisions of the Medicare Improvements for Patients and Providers Act (MIPPA) and violates CMS’s own regulations.

Mike Raab, the president and CEO of Ardelyx, emphasized the negative impact of CMS's decision on patients' access to cutting-edge treatments. He pointed out that XPHOZAH, a first-in-class phosphate absorption inhibitor, has been instrumental in helping patients maintain phosphorus levels within the target range since its approval by the U.S. Food and Drug Administration in October 2023. Raab warned that CMS’s plan would disincentivize the development of new therapies, leaving patients with elevated phosphorus levels with fewer treatment options.

XPHOZAH is designed to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis who have not responded adequately to phosphate binders or who are intolerant to these therapies. Approximately 80% of CKD patients on dialysis need prescription therapies to manage high serum phosphorus levels, but existing phosphate binders often fall short. XPHOZAH offers a unique mechanism of action, blocking phosphate absorption through its primary pathway, and is taken as a single tablet twice daily.

The lawsuit seeks judicial relief under the Administrative Procedure Act to prevent CMS from including XPHOZAH in the ESRD PPS. The plaintiffs argue that this inclusion would not only limit patient access to important medications but also stifle innovation in an already underserved therapeutic area.

Ardelyx, founded to address significant unmet medical needs, has two approved commercial products in the United States: IBSRELA® and XPHOZAH®. Ardelyx collaborates with international partners for the development and commercialization of its therapies outside the U.S. For instance, Kyowa Kirin markets PHOZEVEL® in Japan, and a New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma.

The AAKP, established in 1969, is the largest independent kidney patient organization in the U.S., advocating for patient care choice and innovations. NMQF is a not-for-profit organization focused on reducing patient risk and ensuring optimal care for all, particularly minority populations.

This lawsuit highlights a significant controversy in healthcare policy, where regulatory decisions potentially clash with patient needs and the advancement of medical treatments. The outcome could have far-reaching implications for how essential medications are managed and accessed by patients with chronic kidney conditions in the future.