Pharmacy Prior Authorization Criteria

Xphozah (tenapanor) - ST, NF

For diagnosis of Hyperphosphatemia in Chronic Kidney Disease on Dialysis
Indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Step Therapy

Length of Approval: 12 Month(s)

AND

AND

Trial (minimum 30-day supply) and inadequate response, contraindication or intolerance to two of the following: [A-B, 2-3]

Non Formulary

Length of Approval: 12 Month(s)

Submission of medical records (e.g., chart notes) confirming diagnosis of hyperphosphatemia in chronic kidney disease

AND

AND

Submission of medical records (e.g., chart notes) or paid claims confirming trial (minimum 30-day supply) and inadequate response, contraindication or intolerance to two of the following: [A-B, 2-3]

2024-12-21, 2024-08-26, 2024-04-08, 2024-01-17, 2023-12-19

Xphozah [prescribing information]. Waltham, MA. Ardelyx Inc. October 2023.
UptoDate. Management of hyperphosphatemia in adults with chronic kidney disease. Available at: https://www.uptodate.com/contents/management-of-hyperphosphatemia-in-adults-with-chronic-kidney-disease?search=dialysis%20in%20chronic%20kidney%20disease&source=search_result&selectedTitle=4~150&usage_type=default&display_rank=4#H169682201. Accessed December 11, 2023.
KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340919/. Accessed December 11, 2023.

Phosphate binders are categorized as calcium-containing and non-calcium-containing. All are equivalently effective in lowering phosphate. [2]
The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines do not strongly prefer 1 type of phosphate binder over another for adults and have noted that the selection of an appropriate phosphate binder should be individualized and based on various clinical parameters, not phosphorus lowering alone. All phosphate binders are efficacious in reducing serum phosphate levels; one product has not been found to be superior over another and therapy should be individualized to meet the patient’s unique medical needs [3]