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Drugmaker Ardelyx Inc (NASDAQ:ARDX) has reportedly taken legal action against the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) regarding their decision to incorporate its kidney disease treatment drug, Xphozah, into the Medicare payment bundle system.
The lawsuit contends that including Xphozah and other oral-only phosphate-lowering therapies in the End-Stage Renal Disease Prospective Payment System (ESRD PPS) will severely limit patient access and choice of crucial medications.
Ardelyx argues that such medications, including Xphozah, are not administered during dialysis sessions and cannot feasibly be provided by dialysis facilities.
The ESRD PPS is designed to reimburse facilities offering renal dialysis services, a critical component in managing end-stage renal disease.
In October 2023, the FDA approved Xphozah (tenapanor). It’s the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
Xphozah is a single tablet taken twice daily that blocks phosphate absorption through its primary pathway.
In 2021, the FDA declined approval for Xphozah (tenapanor). It noted the magnitude of the treatment effect as “small and of unclear clinical significance.”
However, the CMS’s recent regulatory update aims to include oral-only ESRD drugs and therapies in the bundled payment system starting January 1, 2025.
Reuters highlights that the move threatens timely access to essential medications for patients who rely on these therapies outside the dialysis setting.
Ardelyx’s lawsuit underscores broader concerns within the pharmaceutical industry regarding regulatory decisions that impact drug accessibility and patient care standards.
Price Action: ARDX stock is down 2% at $5.64 at last check Thursday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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