CurrentCignaPolicy N/A

Nephrology -Xphozah Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for coverage of Xphozah (tenapanor) for adults with hyperphosphatemia in chronic kidney disease on maintenance dialysis. Specifies required prescriber specialty, laboratory thresholds, prior therapy attempts/contraindications, approval duration, and non-covered uses.

Policy Summary

PayerCigna

PolicyNephrology -Xphozah Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised (no material criteria changes)

Effective Date

Next Review Date

Key ActionPrior Authorization is required; approve for 1 year when criteria are met and ensure Xphozah is prescribed by or in consultation with a nephrologist.

SourceLink

POLICY UPDATE CHANGES

Policy review dated 07/23/2025 with no stated criteria changes in history.

1Covered Indication (CKD on dialysis with hyperphosphatemia)

3Key numeric thresholds (age, dialysis duration, serum phosphate)

≥2Minimum phosphate binders to have tried

Coverage Summary

Scope: Defines prior authorization requirements and medical necessity criteria for coverage of Xphozah (tenapanor) for adults with hyperphosphatemia in chronic kidney disease on maintenance dialysis. Coverage stance: Covered with criteria. Approval duration: Approve for 1 year. Intended population: adults (≥18 years) with CKD on maintenance dialysis (≥3 months) with hyperphosphatemia meeting specified serum phosphate thresholds and prior therapy/contraindication requirements. Background context: efficacy demonstrated in three pivotal trials (PHREEDOM, BLOCK, and AMPLIFY) showing statistically significant reductions in serum phosphate in patients on maintenance dialysis for ≥3 months.

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended/required for prescription benefit coverage of Xphozah; approvals provided for 1 year when criteria met.

Documentation Required

Prescriber specialty requirement

Must be prescribed by or in consultation with a nephrologist.

Documentation Required

Prior therapy documentation

Record of trials of phosphate binders (at least two agents and evidence of inadequate response/intolerance OR documented contraindications as specified) must be provided.

Documentation Required

Laboratory documentation

Document serum phosphate value within the specified threshold (≥5.5 and <10.0 mg/dL) and duration of maintenance dialysis (≥3 months).

Background, Evidence & Definitions

Xphozah (tenapanor) is a sodium hydrogen exchanger 3 (NHE3) inhibitor indicated to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy for patients with an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. The efficacy of Xphozah was evaluated in three pivotal trials (PHREEDOM, BLOCK, and AMPLIFY) in patients on maintenance dialysis for ≥3 months, each demonstrating statistically significant reductions in serum phosphate versus placebo.

Label	Value
Pivotal trials	PHREEDOM, BLOCK, AMPLIFY demonstrated statistically significant reductions in serum phosphate vs placebo
Reference - Prescribing Information	Xphozah tablets prescribing information, Ardelyx; June 2025

Term	Definition
Phosphate binders	Examples include sevelamer, lanthanum, ferric citrate, sucroferric oxyhydroxide, calcium carbonate, and calcium acetate.
Contraindications to phosphate binders	Examples include bowel obstruction, iron overload, and hypercalcemia.

Policy Summary

PayerCigna

PolicyNephrology -Xphozah Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised (no material criteria changes)

Effective Date

Next Review Date

Key ActionPrior Authorization is required; approve for 1 year when criteria are met and ensure Xphozah is prescribed by or in consultation with a nephrologist.

SourceLink

On This Page

OpenPayer

Nephrology -Xphozah Prior Authorization Policy

Coverage Summary

Medical Necessity Criteria

Provider Actions & Documentation Requirements

Coding

Background, Evidence & Definitions

Revision History