Ardelyx sues US health department over kidney disease drug

Ardelyx

17/07/2024 23:42

July 17 (Reuters) - Drugmaker Ardelyx  ARDX.O  said on
Wednesday that it has filed a lawsuit against the U.S.
Department of Health and Human Services and the Centers for
Medicare and Medicaid Services (CMS) over their plan to include
its kidney disease drug in the Medicare payment bundle system.
    The lawsuit claims that CMS's plan to include the drug,
Xphozah, along with all other oral-only phosphate lowering
therapies in the End-Stage Renal Disease Prospective Payment
System (ESRD) will "significantly and negatively impact patient
choice of and timely access to important medications."
    ESRD is a payment system to reimburse the facilities that
provide renal dialysis services.
    Ardelyx claims drugs like Xphozah and other similar
therapies are not administered by dialysis providers and cannot
be taken during the delivery of maintenance dialysis.    
    Xphozah was approved in the US last year to treat high
phosphate levels in patients with chronic kidney disease.
    The CMS updated regulations to include oral-only end-stage
renal disease drugs and therapies into the bundled payment
beginning January 1, 2025. 

 (Reporting by Sneha S K in Bengaluru; Editing by Shailesh
Kuber)
 ((Sneha.SK@thomsonreuters.com;))