Pharmacy Prior Authorization Criteria

Phosphate Binders - ST, NF

Indications for Prior Authorization

Fosrenol (lanthanum carbonate)

• For diagnosis of Hyperphosphatemia
  Indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD).

Velphoro (sucroferric oxyhydroxide)

• For diagnosis of Hyperphosphatemia
  Indicated for the control of serum phosphorus levels in adult and pediatric patients 9 years of age and older with chronic kidney disease on dialysis.

Xphozah (tenapanor)

• 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.

Criteria

Velphoro

Step Therapy

Length of Approval: 12 Month(s)

• Both of the following:
• Diagnosis of hyperphosphatemia in chronic kidney disease on dialysis
AND
• One of the following:
• Trial and failure of a minimum 30-day supply, contraindication, or intolerance to two of the following:
• calcium carbonate
• calcium acetate
• sevelamer carbonate
• sevelamer HCl
• Auryxia
OR
• Patient is younger than or equal to 12 years of age

Brand Fosrenol

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure of a minimum 30-day supply, contraindication, or intolerance to two of the following:
• calcium carbonate
• calcium acetate
• sevelamer carbonate
• sevelamer HCl

Xphozah

Step Therapy

Length of Approval: 12 Month(s)

• Diagnosis of hyperphosphatemia in chronic kidney disease
AND
• Patient is on dialysis
AND
• Trial (minimum 30-day supply) and inadequate response, contraindication or intolerance to two of the following: [A-B, 4-5]
• calcium carbonate
• calcium acetate
• sevelamer carbonate
• sevelamer HCl
• Auryxia

Xphozah

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
• Patient is on dialysis
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, 4-5]
• calcium carbonate
• calcium acetate
• sevelamer carbonate
• sevelamer HCl
• Auryxia

P & T Revisions

2026-01-07, 2025-12-18, 2025-12-02, 2024-08-26, 2024-05-18, 2023-05-24, 2022-05-31

References

1. Velphoro Prescribing Information. Fresenius Medical Care North America. Waltham, MA. July 2024.
2. Fosrenol Prescribing Information. Takeda Pharmaceutical Company Limited. Lexington, MA. May 2020.
3. Xphozah [prescribing information]. Waltham, MA. Ardelyx Inc. June 2025.
4. 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=hyperphosphatemia%20treatment&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2#H3642287144. Accessed January 1, 2026.
5. 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://kdigo.org/wp-content/uploads/2017/02/2017-KDIGO-CKD-MBD-GL-Update.pdf. Accessed January 1, 2026.

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End Notes

1. Phosphate binders are categorized as calcium-containing and non-calcium-containing. All are equivalently effective in lowering phosphate. [4]
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 [5]

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Revision History

• 2026-01-07: 2026 Annual Review.
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-12-02: Removed Phoslyra as a target drug
• 2024-08-26: update guideline
• 2024-05-18: 2024 Annual Review
• 2023-05-24: 2023 Annual Review.
• 2022-05-31: New Program

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