Ardelyx has declared that it is filing a lawsuit against the US Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to keep essential phosphate-lowering therapies separate from the CMS’s renal disease payment bundle, claiming that the action could “limit patient choice”.
Ardelyx has teamed up with the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF) to sue the government organisations regarding the CMS’s renal disease payment bundle.
The End Stage Renal Disease (ESRD) Prospective Payment System (PPS) is a bundled payment scheme for renal dialysis services available for Medicare beneficiaries. The ESRD PPS adjusts treatment costs at the patient and facility level for renal dialysis treatment at an ESRD facility or the patient’s home. This payment includes costs for laboratory services, drugs, supplies, and more, as per CMS’s description.
The litigation states that the CMS has “violated its statutory and regulatory authority under the Medicare Improvements for Patients and Providers Act (MIPPA),” as per a 17 July press release. The organisations took issue with CMS’s plan to move Ardelyx’s Xphozah (tenapanor hydrochloride) and all other oral-only phosphate-lowering therapies into the ESRD PPS.
Phosphate-lowering therapies are a commonly used treatment option for end-stage renal disease that helps treat mineral and bone disorders. The drug class has remained separate from the payment bundle since its implementation, but the CMS announced plans to add them to the ESRD PPS in 2025, in a 27 June announcement.
A November 2023 report from the US General Accounting Office (GAO) found that the move would cause dialysis organisations “to expand their capacity to dispense high volumes of the drugs.” The new strategy would aim to promote more efficient care as dialysis facilities could gain the difference if Medicare's bundled payments surpass service costs. In the GAO’s analysis, several interviewed dialysis organisation representatives expressed concerns that the upgraded bundle may not account for the additional costs of “acquiring, shipping, and dispensing phosphate binders.”
The US Food and Drug Administration (FDA) approved Xphozah to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as an add-on therapy in October 2023. This was intended for patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
Other commonly used oral phosphate-lowering therapies for kidney dysfunction include Takeda Pharmaceuticals’ Fosrenol (lanthanum carbonate) and Genzyme’s Renvela (sevelamer), which have several generic versions on the market. According to AAKPI, 80% of patients on dialysis need treatment with phosphate-lowering therapy in combination with a low phosphorus diet.
In a 17 July company press release, Mike Raab, Ardelyx’s CEO said, “It is abundantly clear that moving Xphozah and other phosphate-lowering therapies into the ESRD PPS will result in the imposition of severe care choice and timely access restrictions for all dialysis patients. The planned move by CMS will continue to create disincentives for the development of new and important medicines that can improve patient health and address unmet needs in an already underserved therapeutic area,” said Mike Raab, president and chief executive officer of Ardelyx.”
