CurrentNeighborhood Health Plan of Rhode IslandPolicy Cmp_M_Factor_Xiii_20240814

Hemophilia Products -Factor XIII: Corifact® (Intravenous)

Policy governs coverage, authorization, dispensing, quantity limits, dosing, renewal criteria, and billing codes for Corifact (Factor XIII concentrate) for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members. Includes hemophilia management program requirements and provider dispensing rules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCorifact (Factor XIII concentrate) coverage and dosing policy

Policy CodePolicy Cmp_M_Factor_Xiii_20240814

Change TypeClarified review dates (no material clinical changes)

Effective DateOct 1, 2019

Next Review Date

Key ActionRendering providers must submit monthly authorization prior to dispensing including original prescription, requested amount, vial sizes, and patient clinical history (product inventory and bleed history).

SourceLink

POLICY UPDATE CHANGES

Review dates updated through 08/14/2024; policy reviewed by P&T committee with criteria adopting FDA labeling and clinical literature.

1Covered ICD-10 diagnosis codes

5Max on-hand doses permitted

4600Max billable units per 28 days

1000-1600Vial sizes referenced (IU)

Coverage Summary

Coverage - Corifact

Coverage is provided when ALL of the following are met:

ALL of the following

Diagnosis of congenital factor XIII deficiency has been confirmed by blood coagulation testing
Indication
- Routine prophylaxis: Used for routine prophylactic treatment
  Authorizations for routine prophylaxis may be issued per policy
- Perioperative management: Used for perioperative management of surgical bleeding
  Authorizations for perioperative management are valid for 1 month and may not be renewed

MMP member note: MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements

applies to MMP members only

Coverage stance: covered_with_criteria for Corifact. Scope: policy governs coverage, authorization, dispensing, quantity limits, dosing, renewal criteria, and billing codes for Corifact for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members. Indication (one line): Corifact is a Factor XIII concentrate indicated for congenital Factor XIII deficiency for routine prophylaxis and perioperative management.

Initial Therapy & Renewal Criteria

Authorization length and renewal

Initial and renewal rules:

Authorization length: Unless otherwise specified, initial authorization provided for 3 months and may be renewed

Initial and renewal periods may vary by specific indication

On-hand medication: Cumulative on-hand medication will be taken into account for authorizations; up to 5 on-hand doses for treatment of acute bleeding episodes are permitted at the time of the authorization request and may be allowed for the duration of authorizationUp to 5 doses on-hand

Dosage, Administration, and Program Requirements

Dosage/Administration

Approved dosing regimens and adjustments:

Routine prophylaxis dose = 40 IU/kg every 28 days; infusion rate not to exceed 4 mL per minute; adjust dose ±5 IU/kg to maintain 5% to 20% trough FXIII activity40 IU/kg every 28 days; trough 5%-20%

Hemophilia Management Program requirements

Program requirements that impact dosing/authorization:

Half-life study requirements: Half-life study required if requested routine prophylaxis dose exceeds dosing limits under part II; and required for members with BMI ≥ 30 to determine appropriate dose and dosing intervalBMI ≥ 30

Dispensing, Inventory & Hemophilia Program Operations

Dispensing requirements for rendering providers

Monthly dispensing and documentation requirements (Hemophilia Management Program):

Monthly authorization for dispensing: Monthly, rendering provider must submit authorization of dispensing quantity before delivering factor product

Prescriptions cannot be auto-filled; must have an expressed need from patient, caregiver, or prescribing practitioner

Required documentation elements: Authorization must include original prescription information, requested amount to be dispensed, vial sizes available from manufacturer, and patient clinical history (including product inventory and bleed history)

Vial and dose limits per dispense: Factor dose dispensed should not exceed +1% of prescribed dose and a maximum of three vials may be dispensed per dose; if unable to meet threshold, dispense lowest possible dose above +1%Max 3 vials per dose; +1% dosing limit

Applicable Codes

HCPCS - drug billingHCPCSCovered

J7180

Corifact, 1 IU (1 billable unit = 1 IU)

NDCNDCCovered

63833-0518-xx

Corifact NDC (manufacturer CSL Behring LLC)

ICD-10 - covered diagnosis codesICD-10Covered

D68.2

Hereditary deficiency of other clotting factors

Corifact quantity and dispensing thresholds

Max vials (pharmacy benefit)Corifact 1000-1600 IU vial: 5 vials per 28-day supply

Max units (medical benefit)4,600 billable units per 28 day supply

On-hand doses permittedUp to 5 extra doses on-hand for treatment of acute bleeding episodes

Vial sizes referenced (IU)1000-1600 IU

Authorization considerationCumulative on-hand medication will be taken into account when authorizing/dispensing

Dispensing per-dose limitMaximum of three vials may be dispensed per dose (Hemophilia Management Program)

Clinical Evidence & Supporting References

41Clinical trial subjects received 40 U/kg every 28 days

0Annualized bleeding rate (trial): 0 episodes/year

52Trial duration: 52 weeks

Clinical trial evidence: 41 subjects received 40 U/kg every 28 days for 52 weeks; annualized bleeding rate = 0 episodes/year on prophylaxis compared to 2.5 episodes/year with historical on-demand treatment.

Package insert citation: Corifact package insert, CSL Behring LLC, September 2020 (accessed May 2024).

Background & Definitions

Corifact is a Factor XIII concentrate indicated for congenital Factor XIII deficiency for routine prophylaxis and perioperative management of surgical bleeding.

Efficacy context: routine prophylactic Corifact (40 IU/kg every 28 days) prevented spontaneous bleeding in a trial population, reducing the annualized bleeding rate to 0 versus historical on‑demand treatment; dosing maintained FXIII activity within the desired range for most subjects.

Term	Definition
{"text":"Billable unit","status":""},{"text":"1 billable unit equivalent = 1 IU of Corifact","status":"covered"}
{"text":"Minimally treated patients","status":""},{"text":"< 50 exposure days to factor products","status":""}

Medicare Determinations

2022-11-24 — Billing and Coding: Guidance for Anti-Inhibitor Coagulant Complex (AICC) NCD — A56065 — LCA

2023-10-01 — Billing and Coding: Hemophilia Factor Products — A56433 — LCA

2023-10-01 — Billing and Coding: Hemophilia Factor Products — A56482 — LCA

Revision History

2024-08-14reviewLatest

Review dates updated through 08/14/2024; policy reviewed by P&T committee with criteria adopting FDA labeling and clinical literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCorifact (Factor XIII concentrate) coverage and dosing policy

Policy CodePolicy Cmp_M_Factor_Xiii_20240814

Change TypeClarified review dates (no material clinical changes)

Effective DateOct 1, 2019

Next Review Date

SourceLink

On This Page

Authorization required and length

Initial authorization is generally provided for 3 months; routine prophylaxis renewals are approved for 12 months when criteria and clinical benefit are met. Perioperative (surgical) approvals are valid for 1 month and may not be renewed.

Denial Risk

Renewal denial conditions

Renewal may be denied for unacceptable toxicity (for example allergic/anaphylactic or hypersensitivity reactions, thromboembolic events) or development of neutralizing antibodies (inhibitors). Renewals may also be denied if increases in dose are not supported by an acceptable clinical rationale.

Inhibitor testing for minimally treated patients:

For minimally treated patients (<50 exposure days to factor products) previously receiving a different factor product, inhibitor testing is required at baseline, then at every comprehensive care visit (yearly for mild/moderate, semi-annually for severe)

Routine prophylaxis dosing: 40 IU/kg every 28 days; adjust dose by ±5 IU/kg to maintain trough FXIII activity of 5%–20%.

BMI threshold for half-life study: BMI ≥ 30 (half-life study required to determine appropriate dose/dosing interval).

Infusion rate limit: administer at a rate not to exceed 4 mL per minute.

Prescribed dose should not be increased to meet assay management requirements

On-hand dose limits: Patients should not have more than 5 extra doses on-hand for treatment of acute bleeding episodes; cumulative on-hand amounts considered when dispensing/authorizingUp to 5 extra doses on-hand

Documentation Required

Monthly dispensing authorization documentation

Rendering provider must submit a monthly authorization prior to dispensing. Submitted information must include the original prescription information, the requested amount to be dispensed, vial sizes available from the manufacturer, and the patient clinical history (including product inventory and bleed history). Prescriptions may not be auto-filled.

Original prescription information
Requested amount to be dispensed
Vial sizes available from manufacturer
Patient clinical history (product inventory and bleed history)

Billing Rule

Dose dispensing limits

Factor dose dispensed should not exceed +1% of the prescribed dose. A maximum of three vials may be dispensed per dose. If assay or dosing constraints prevent exact dosing within the +1% threshold, dispense the lowest possible dose above +1%. Billing code J7180 applies for Corifact (1 IU = 1 billable unit).

Documentation Required

Hemophilia management testing requirements

Hemophilia Management Program testing requirements: a half-life study is required if the requested routine prophylaxis dose exceeds dosing limits or for members with BMI ≥ 30 to determine appropriate dose and interval. For minimally treated patients (defined as < 50 exposure days to factor products) who previously received a different factor product, inhibitor testing is required at baseline and thereafter at every comprehensive care visit (yearly for mild/moderate, semi-annually for severe).

Half-life study if dose exceeds dosing limits or BMI ≥ 30
Inhibitor testing for minimally treated patients (< 50 exposure days) at baseline and per visit schedule

Prior Authorization

Cumulative on-hand medication considered

Authorization and dispensing decisions will take into account the cumulative amount of medication the patient has on-hand. The plan permits up to 5 on-hand doses for treatment of acute bleeding episodes at the time of authorization/dispensing.