CurrentCignaPolicy IP0552

Corifact (Factor XIII concentrate) coverage

Defines medical necessity, dosing, authorization duration, and coding for Corifact (Factor XIII concentrate [human]) for treatment of congenital Factor XIII deficiency for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCorifact (Factor XIII concentrate) coverage

Policy CodePolicy IP0552

Change TypeNo material changes

Effective Date3/1/2025

Next Review Date

Key ActionObtain prior authorization; approvals (initial and reauthorization) may be granted for up to 12 months when medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 160 IU/kg/28dmaximum dosing allowed

Up to 12 moauthorization duration

1 in 2Mprevalence

J7180covered code

Coverage Criteria for Corifact (Factor XIII concentrate)

Medical Necessity Criteria - Initial

Covered when ALL of the following are met

Congenital Factor XIII deficiency criteria: Patient has congenital Factor XIII deficiency and all subcriteria below are met

Indication subcriteria A: One of: peri-operative management of bleeding; routine prophylaxis to reduce frequency of bleeding episodes; treatment of bleeding episodes

From criteria A.i-iii

Prescriber requirement: Medication is prescribed by or in consultation with a hematologist

Criteria B

Reauthorization Criteria

Policy Summary

PayerCigna

PolicyCorifact (Factor XIII concentrate) coverage

Policy CodePolicy IP0552

Change TypeNo material changes

Effective Date3/1/2025

Next Review Date

Key ActionObtain prior authorization; approvals (initial and reauthorization) may be granted for up to 12 months when medical necessity criteria are met.

SourceLink

On This Page

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Coding and Therapeutic Targets

Considered Medically Necessary when criteria metHCPCSCovered

J7180

Injection, Factor XIII (antihemophilic factor, human), 1 IU

Therapeutic target and dosing considerations

Therapeutic targetApproximately 30% Factor XIII clotting activity (adequate therapeutic target for most patients)

Dosing individualizationDosing is highly individualized; number of required doses varies with severity and regimen

Provision for breakthrough/acute needsPolicy allows prophylactic dosing plus three days of acute bleeding or perioperative management per 28 days

Excess dose reviewDoses exceeding the allowed quantity will be reviewed case-by-case by a clinician

Prescriber, Authorization, and Dosing Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required. Initial and reauthorization approvals are up to 12 months in duration when medical necessity criteria are met.

Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months

Billing Rule

Dose Limit and Review

Dosing allowance accounts for prophylaxis plus three days of acute bleeding or perioperative management per 28 days. Doses exceeding this quantity will be reviewed on a case-by-case basis by a clinician.

Up to 160 IU/kg by intravenous infusion per 28 days (per dosing guidance)
Allows prophylactic dosing plus three days of acute/perioperative management per 28 days
Excess doses reviewed case-by-case

Documentation Required

Prescriber and Reauthorization Documentation

Medication must be prescribed by or in consultation with a hematologist. Reauthorization requires documentation of beneficial response to therapy.

Prescriber requirement: hematologist or in consultation with a hematologist
Reauthorization: documentation of beneficial response

Denial Risk

Excluded Uses

Use for any indication other than congenital Factor XIII deficiency is considered experimental, investigational, or unproven and is not covered.

Covered indication: congenital Factor XIII deficiency only
All other uses: experimental, investigational, or unproven

Background

Congenital Factor XIII deficiency is a rare autosomal disorder, most often due to variants in the FXIII‑A (Factor XIIIA) gene, that leads to severe bleeding manifestations including delayed wound healing, soft tissue bleeding, recurrent miscarriage, and life‑threatening central nervous system hemorrhage. The therapeutic goal for most patients is approximately 30% Factor XIII clotting activity. Treatment options referenced in the policy include plasma products, Corifact (Factor XIII concentrate, human), and recombinant FXIII‑A (Tretten).

OpenPayer

Corifact (Factor XIII concentrate) coverage

Coverage Criteria for Corifact (Factor XIII concentrate)

Coding and Therapeutic Targets

Prescriber, Authorization, and Dosing Requirements

Background

Definitions