CurrentViva HealthPolicy N/A

Corifact (Factor XIII Concentrate [human])

Defines utilization management, prior authorization recommendations, approved indication, dosing limits, prescribing specialist requirements, and non-covered circumstances for Corifact (Factor XIII concentrate) on the medical benefit.

Policy Summary

PayerViva Health

PolicyCorifact (Factor XIII Concentrate [human])

Policy CodePolicy N/A

Change TypeAnnual Revision (no criteria changes)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve patients who meet criteria and dosing and ensure prescribing or consultation by a hematologist.

POLICY UPDATE CHANGES

Annual Revision with no criteria changes (Review Date 12/04/2024).

Annual Revision (Review Date 11/08/2023) previously noted with no criteria changes.

1Covered Indications (FDA-approved)

160 IU/kgPer-dose maximum

28 daysMinimum dosing interval

Coverage Summary

Corifact is a human Factor XIII concentrate indicated for the treatment of congenital Factor XIII deficiency. The disorder is rare (estimated ~1 in 2 million for Factor XIIIA deficiency) and is associated with bleeding complications including delayed wound healing, soft tissue and subcutaneous bleeding, central nervous system (CNS) hemorrhage, and recurrent miscarriage. Treatment options include fresh frozen plasma, cryoprecipitate, Corifact, or recombinant Factor XIIIA (Tretten).

Scope and High-level Thresholds

Scope summaryDefines utilization management, prior authorization recommendations, approved indication (congenital Factor XIII deficiency), dosing limits, prescribing specialist requirements, and non-covered circumstances for Corifact (Factor XIII concentrate) on the medical benefit.

Therapeutic target30% Factor XIII clotting activity considered adequate for most patients (prospective data)

Per-dose maximumUp to 160 IU/kg per intravenous infusion

Minimum dosing intervalNo more frequently than once every 28 days

Authorization durationApprove for 1 year (initial authorization) when prescribed by or in consultation with a hematologist

Initial Therapy Criteria

FDA-Approved Indication / Authorization Criteria

Coverage of Corifact is recommended for patients who meet the following criteria:

Diagnosis of Congenital Factor XIII Deficiency (FDA-approved indication).
Prescriber: Agent is prescribed by or in consultation with a hematologist.
Approval duration tied to specialist involvement.
Dosing limit: up to 160 IU/kg by intravenous infusion no more frequently than once every 28 days.<= 160 IU/kg per dose; minimum interval 28 days
Authorization Duration: Approve for 1 year (initial authorization duration).

Continuation Therapy Criteria & Not Recommended Uses

Conditions Not Recommended for Approval

Coverage is not recommended in the following situations:

Conditions Not Recommended for Approval: Circumstances not listed in the Recommended Authorization Criteria.

Criteria will be updated as new published data are available.

Initial authorization for Corifact is for 1 year. Extended approvals are allowed if the patient continues to meet the authorization criteria and dosing specified in the policy; requests for doses outside established dosing will be reviewed case-by-case by a clinician.

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of Corifact; approval is recommended for those meeting the criteria and dosing. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician.

Documentation Required

Specialist Prescription Requirement

Corifact must be prescribed by or in consultation with a hematologist (physician who specializes in the condition being treated).

Billing Rule

Approval Duration and Extensions

Initial approval is for 1 year; extended approvals allowed if patient continues to meet criteria and dosing.

Denial Risk

Non-covered Indications

Coverage is not recommended for uses not listed in the Recommended Authorization Criteria (requests for other indications likely to be denied).

Documentation Required

Dosing Review for Excess Quantity

Doses exceeding the quantity allowing prophylactic dosing plus three days of acute bleeding or perioperative management per 28 days will be reviewed on a case-by-case basis by a clinician.

Background & Definitions

Congenital Factor XIII deficiency is most often caused by mutations in the Factor XIIIA gene and is estimated to occur in about one in 2 million people. Clinical manifestations include delayed wound healing, bleeding of soft and subcutaneous tissues, recurrent spontaneous miscarriage, and potentially life‑threatening CNS bleeding; in severe cases, bleeding may present early such as from the umbilical cord or CNS. Corifact (Factor XIII concentrate [human]) is indicated for routine prophylactic treatment and peri‑operative management of surgical bleeding in patients with congenital Factor XIII deficiency. Treatment options for Factor XIII deficiency include fresh frozen plasma, cryoprecipitate, Corifact, or recombinant Factor XIIIA (Tretten). Dosing is individualized; the policy limits dosing to up to 160 IU/kg by intravenous infusion no more frequently than once every 28 days, and dosing that exceeds prophylactic needs plus three days for acute bleeding or perioperative management per 28 days will be reviewed on a case‑by‑case basis.

Term	Definition
Corifact	Factor XIII Concentrate (human) intravenous infusion, manufactured by CSL Behring.