CurrentCignaPolicy IP0608

Xphozah (tenapanor) — Coverage Criteria for Hyperphosphatemia in CKD on Dialysis

Defines Cigna's prior authorization and coverage criteria for Xphozah (tenapanor) as add-on therapy to reduce serum phosphorus in adults with chronic kidney disease on maintenance dialysis who have inadequate response or intolerance to phosphate binders.

Policy Summary

PayerCigna

PolicyXphozah (tenapanor) — Coverage Criteria for Hyperphosphatemia in CKD on Dialysis

Policy CodePolicy IP0608

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals are for 12 months when all coverage criteria are met and the medication is prescribed by or in consultation with a nephrologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration for covered indication

≥18minimum patient age for coverage

≥3 monthsdialysis duration requirement

≥5.5–<10 mg/dLrequired serum phosphate range

Prior Authadministrative requirement

Coverage Criteria for Xphozah (tenapanor)

Initial approval criteria

Approve for 12 months if ALL of the following are met (A through F):

FDA-Approved Indication — all criteria: A) Patient is ≥ 18 years of age; AND B) Patient has chronic kidney disease (CKD); AND C) Patient has been on maintenance dialysis for ≥ 3 months; AND D) Patient's serum phosphate level is ≥ 5.5 mg/dL and < 10.0 mg/dL; AND E) Patient meets ONE of the following (i or ii):; AND F) The medication is prescribed by or in consultation with a nephrologist.

See nested logic for E

Phosphate binder trial/contraindication logic

Criterion E — meets ONE of the following:

E: Patient meets ONE of i or ii

E.i:

Policy Summary

PayerCigna

PolicyXphozah (tenapanor) — Coverage Criteria for Hyperphosphatemia in CKD on Dialysis

Policy CodePolicy IP0608

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals are for 12 months when all coverage criteria are met and the medication is prescribed by or in consultation with a nephrologist.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Key Clinical and Coding Thresholds

inv-05: Serum phosphate — required range for coverage

Required serum phosphate rangeSerum phosphate ≥ 5.5 mg/dL and < 10.0 mg/dL

Clinical trial ranges (supporting)PHREEDOM and BLOCK: 6.0–10.0 mg/dL; AMPLIFY: 5.5–10.0 mg/dL

Purpose of thresholdDefines eligibility for Xphozah as add-on therapy in CKD on dialysis with hyperphosphatemia

inv-06: Dialysis duration requirement — maintenance dialysis for ≥ 3 months

Maintenance dialysis duration requirementPatient has been on maintenance dialysis for ≥ 3 months

Definition sourceAll three pivotal trials enrolled patients on maintenance dialysis ≥ 3 months

Role in approval criteriaOne of the required criteria (C) for 12‑month approval

inv-07: Age — minimum patient age for coverage

Minimum patient agePatient is ≥ 18 years of age

Approval criterion referenceListed as criterion A in FDA‑Approved Indications for Xphozah

Applies toAdults with CKD on maintenance dialysis considered for Xphozah

Provider Requirements and Actions

Denial Risk

Coding-based denials

Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service; submissions using codes not covered under this policy are subject to coding-based denials.

Prior Authorization

Prior Authorization and Prescriber Requirement

Prior authorization is required for benefit coverage of Xphozah. All approvals are provided for 12 months when the patient meets the policy criteria and prescriber requirements are fulfilled. Because of the specialized skills required for evaluation and monitoring, Xphozah must be prescribed by or in consultation with a physician who specializes in the condition being treated (nephrologist for the CKD indication).

Prior authorization approvals valid for 12 months when criteria met
Medication must be prescribed by or in consultation with a specialist (nephrologist for CKD indication)

Step Therapy

Phosphate binder trials required

For approval of Xphozah for hyperphosphatemia in CKD on dialysis, the patient must have trialed phosphate binders per the policy: either tried at least two phosphate binders with documented inadequate response and/or intolerance, or have contraindications to at least two binders, or a combination of trial/intolerance to one binder plus contraindication to another as specified.

Examples of phosphate binders: sevelamer, lanthanum, ferric citrate, sucroferric oxyhydroxide, calcium carbonate, calcium acetate
Documented inadequate response and/or intolerance required when trials are used
Contraindications include bowel obstruction, iron overload, or hypercalcemia

OpenPayer

Xphozah (tenapanor) — Coverage Criteria for Hyperphosphatemia in CKD on Dialysis

Coverage Criteria for Xphozah (tenapanor)

Key Clinical and Coding Thresholds

Provider Requirements and Actions

Background on Xphozah (tenapanor)

Definitions