CurrentCignaPolicy IP0553

Tretten (coagulation Factor XIII A‑Subunit recombinant) Coverage Policy

Defines medical necessity criteria, dosing, authorization durations, reauthorization requirements, and coding for Tretten (Factor XIII A‑subunit recombinant IV) for congenital Factor XIII A‑subunit deficiency for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyTretten (coagulation Factor XIII A‑Subunit recombinant) Coverage Policy

Policy CodePolicy IP0553

Change TypeAnnual revision — no criteria changes

Effective DateMar 1, 2025

Next Review Date

Key ActionReview requests against the policy criteria and, when met, authorize up to 12 months; ensure prescription is by or in consultation with a hematologist and document beneficial response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Annual Revision dated 5/1/2024 notes no criteria changes; policy updated again 3/1/2025 with no criteria changes.

1Covered Indication (congenital Factor XIII A‑subunit deficiency)

1Not Covered (Factor XIII B‑subunit deficiency)

140Max dose per 28 days (IU/kg)

Coverage Summary

Scope: Defines medical necessity criteria, dosing limits, authorization durations, reauthorization requirements, and coding for Tretten (coagulation Factor XIII A‑subunit recombinant IV) when used for routine prophylaxis and other indicated uses in congenital Factor XIII A‑subunit deficiency. Background: Tretten is indicated for routine prophylaxis in congenital Factor XIII A‑subunit deficiency and may be used peri‑operatively or to treat bleeding episodes when criteria are met. Coverage stance: covered_with_criteria. Effective date: 2025-03-01. Last review: 2024-05-01.

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.

Medical-Necessity Criteria

Medically Necessary Criteria

Tretten is considered medically necessary when ALL of the following criteria are met:

ALL of the following

ONE of the following conditions is met
- Peri-operative management of bleeding
- Routine prophylaxis to reduce the frequency of bleeding episodes
- Treatment of bleeding episodes
Medication is prescribed by or in consultation with a hematologist
Prescription must be by or in consultation with a hematologist

Reauthorization Criteria

Continuation is considered medically necessary when the initial criteria are met AND there is documentation of beneficial response.

ALL of the following

Original medical necessity criteria are still met
Documentation of beneficial response to therapy

Not Medically Necessary / Not Covered

Uses considered experimental, investigational, or unproven (not all-inclusive):

ANY of the following

Any use other than congenital Factor XIII Asubunit deficiency
Congenital Factor XIII B-Subunit Deficiency
Tretten will not work in patients who only lack Factor XIII-B subunit

Provider Actions

Prior Authorization

Medical necessity review required

Coverage requires review against the policy medical necessity criteria. When the criteria are met, authorization may be granted for up to 12 months (initial and reauthorization).

Affected code: J7181
Authorization duration: up to 12 months

Documentation Required

Hematologist involvement and response documentation

The medication must be prescribed by or in consultation with a hematologist. For reauthorization, documentation of a beneficial response to therapy is required.

Billing Rule

Dose and frequency limits

Dosing is limited to up to 140 IU/kg by intravenous infusion per 28 days. Doses exceeding this quantity will be reviewed on a case-by-case basis by a clinician.

Affected code: J7181
Dosing threshold: up to 140 IU/kg per 28 days

Background & Evidence

Disease and mechanism: Congenital Factor XIII deficiency results from defects in the Factor XIIIA and XIIIB genes, with most cases due to genetic alterations in the Factor XIIIA gene; Tretten is a recombinant Factor XIII A‑subunit replacement indicated for patients who lack the A‑subunit. Prevalence and clinical features: Estimated prevalence of Factor XIIIA deficiency is approximately 1 in 1–2 million; clinical manifestations include delayed wound healing, soft tissue and subcutaneous bleeding, recurrent miscarriage, and potentially life‑threatening CNS bleeding. Alternatives and other treatments: Treatment options include fresh frozen plasma, cryoprecipitate, Corifact (Factor XIII concentrate), or Tretten. Additional notes: dosing is individualized per guidance and the policy limits dosing to support prophylaxis plus short‑term acute/ perioperative needs.