CurrentNeighborhood Health Plan of Rhode IslandPolicy Cmp_M_Factor_Xiii_20240814

Hemophilia Products - Factor XIII: Corifact (Intravenous)

Covers clinical use, dosing, authorization, dispensing, and renewal criteria for Corifact (Factor XIII concentrate) for Medicaid, Commercial, and Medicare-Medicaid members; applies to medical and pharmacy benefits as specified.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products - Factor XIII: Corifact (Intravenous)

Policy CodePolicy Cmp_M_Factor_Xiii_20240814

Change TypeNo material changes

Effective DateOct 1, 2019

Next Review DateJan 29, 2020

Key ActionDocument confirmed diagnosis of congenital Factor XIII deficiency with blood coagulation testing when submitting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40 IU/kg/28drecommended routine prophylaxis dose

3 monthsstandard initial authorization period

5 dosesmaximum permitted extra doses

J7180HCPCS J-code

D68.2covered ICD-10

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Coverage Criteria for Corifact (Factor XIII concentrate)

inv-01: Indications Covered

Covered when ALL of the following are met

Congenital FXIII deficiency - prophylaxis or perioperative: Diagnosis of congenital factor XIII deficiency has been confirmed by blood coagulation testing; AND used for routine prophylactic treatment OR used for perioperative management of surgical bleeding

Authorizations for perioperative management valid for 1 month

inv-02: Renewal Criteria

Renewal criteria

General renewal: Patient continues to meet initial criteria; absence of unacceptable toxicity (examples include allergic/anaphylaxis, hypersensitivity, thromboembolic events, development of neutralizing antibodies); any increases in dose must be supported by acceptable clinical rationale (e.g., weight gain, half-life study results, increased breakthrough bleeding despite adherence); the cumulative amount of medication on-hand will be considered (authorization may allow up to 5 on-hand doses for acute bleeding)<= 5 on-hand doses allowed

Routine prophylaxis renewals approved for 12 months; perioperative management is not renewable

inv-03: Dosage/Administration

Dosing recommendations

Routine prophylaxis dosing: 40 IU/kg every 28 days given at a rate not to exceed 4 mL/min; adjust dose ±5 IU/kg to maintain FXIII trough activity between 5% and 20%FXIII trough 5% to 20%

Perioperative dosing individualized based on FXIII activity, type of surgery, and timing since last prophylactic dose; dosing guidance by interval since last dose provided (within 7 days: additional dose may not be needed; 8–21 days: partial or full dose may be needed based on activity; 21–28 days: full prophylactic dose)

inv-04: General coverage criteria

Covered when ALL of the following are met

Criteria: Use is consistent with FDA-approved labeling and relevant clinical literature

Plan prefers cost-effective alternatives when appropriate and gives individual consideration to requests based on submitted clinical information; for INTEGRITY Medicare-Medicaid members, plan criteria apply only in absence of applicable NCD or LCD

Perioperative use of Corifact for management of surgical bleeding is allowed as a short-term indication; however, coverage may NOT be renewed for perioperative management once the initial authorization period has ended.

For members of the INTEGRITY (MedicareMedicaid Plan), these plan-specific coverage criteria apply only when there is no applicable CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD). Where an NCD or LCD exists, the CMS guidance supersedes the plan criteria. The plan will review requests in the context of FDA labeling and relevant clinical literature and will give individual consideration to requests based on prescriber-submitted information and other information available to the plan.

Coding, Quantity Limits, and Regulatory References

Covered HCPCSHCPCSCovered

J7180

Corifact, 1 billable unit = 1 IU

NDCNDC

63833-0518-xx

Corifact NDC

Covered Diagnosis Codes (ICD-10)ICD-10Covered

D68.2

Hereditary deficiency of other clotting factors

Covered Diagnosis CodesICD-10Covered

D68.2

Hereditary deficiency of other clotting factors

CMS NCD/LCA/LCD document references and MAC jurisdictionsmixed

A56065	CMS NCD/LCA/LCD document identifier listed
A56433	CMS NCD/LCA/LCD document identifier listed
A56482	CMS NCD/LCA/LCD document identifier listed

Quantity limits — Pharmacy and Medical quantity limits

Pharmacy quantity limitCorifact 1000-1600 IU vial: 5 vials per 28-day supply

Medical quantity limit4,600 billable units per 28-day supply

Supply intervalLimits apply per 28-day supply period

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Initial authorizations are generally provided for 3 months unless otherwise specified; initial and renewal periods may vary by indication. The cumulative amount of medication the patient has on-hand will be considered when authorizing — up to 5 on‑hand doses for treatment of acute bleeding episodes may be permitted. For perioperative management authorizations are valid for 1 month.

Initial authorization period: 3 months (unless otherwise specified)
Perioperative management authorizations: 1 month
Plan will account for on‑hand inventory; ≤5 extra doses allowed on authorization

Step Therapy

Step Therapy Exception for Recent Users

Step Therapy Exception — MMP members who have received this medication within the past 365 days are exempt from step therapy requirements.

MMP recent-user exemption: prior receipt within 365 days

Background and Clinical Context

Corifact is a plasma-derived Factor XIII concentrate indicated for treatment of congenital Factor XIII deficiency, including routine prophylaxis and for perioperative management of surgical bleeding. Neighborhood's Pharmacy & Therapeutics Committee reviewed Corifact and adopted coverage criteria to align use with FDA-approved labeling and relevant clinical literature. Clinical trial data cited in the rationale supported routine prophylaxis (recommended dose 40 IU/kg every 28 days), which demonstrated reduced spontaneous bleeding compared with historical on‑demand therapy and maintained target FXIII activity with minimal dose adjustments.

Definitions

Congenital Factor XIII deficiency — confirmation by blood coagulation testing

Diagnostic confirmation requiredDiagnosis of congenital Factor XIII deficiency must be confirmed by blood coagulation testing

IndicationsRoutine prophylactic treatment and peri-operative management of surgical bleeding for congenital FXIII deficiency

Supporting evidenceClinical trial (41 subjects) showed routine prophylaxis (40 IU/kg every 28 days) reduced annualized spontaneous bleeding rate to 0

D68.2 — Hereditary deficiency of other clotting factors

ICD-10 codeD68.2

DescriptionHereditary deficiency of other clotting factors