SBR-759

Ardelyx has filed a lawsuit against the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) over their decision to include Xphozah (tenapanor) and other oral-only phosphate-lowering therapies (PLTs) in the bundled payment system for dialysis recipients. Starting January 1 next year, CMS plans on moving Xphozah and other PLTs to the End-Stage Renal Disease Prospective Payment System (ESRD PPS), thereby ending their coverage under Medicare Part D. However, Ardelyx claims these drugs are not administered at dialysis centres and cannot be taken during maintenance dialysis sessions, making it crucial for patients to obtain them through outpatient pharmacy benefit plans. Earlier this month, the drugmaker decided against filing for Transitional Drug Add-on Payment Adjustment (TDAPA) to preserve patient access to its medication.The suit – also backed by the advocacy groups American Association of Kidney Patients (AAKP) and National Minority Quality Forum (NMQF) – contests that the CMS’ decision is likely to “significantly and negatively impact patient choice of and timely access to important medications.” The planned move will also disincentivise “development of new…medicines that can…address unmet needs in an already underserved therapeutic area,” said Mike Raab, chief executive of Ardelyx. The company has remained a strong supporter of bipartisan legislation, dubbed the Kidney PATIENT Act, introduced to the US Senate to delay the inclusion of oral PLTs in the ESRD PPS. Jefferies analysts said the “uncertainty around Congress' ability to delay oral phosphate binders from moving into the dialysis bundle” was likely to hurt investors’ sentiment on Xphozah, adding that an expert predicted a 65% to 75% chance of Congress passing the legislation by the year-end.Ardelyx, which inhibits phosphate absorption through its primary pathway, was cleared in the US last year after a previous regulatory hurdle, as an add-on therapy to lower serum phosphorus in patients on dialysis who are refractory or intolerant to phosphate-binder therapies alone. Such patients now risk losing access to an “FDA-approved therapy that is providing them a meaningful clinical benefit,” Raab added. In a FirstWord poll of US nephrologists conducted last year, over 60% of respondents said they would consider switching patients to Ardelyx from another drug for hyperphosphataemia.