CurrentNeighborhood Health Plan of Rhode IslandPolicy Cmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Cmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Medical-benefit policy for Feiba NF/VF (anti-inhibitor coagulant complex) governing authorization, quantity limits, dispensing and clinical criteria for treatment of Hemophilia A and B with inhibitors across Medicaid, Commercial, and Medicare-Medicaid Plan members (medication available on Medical Benefit).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Policy CodePolicy Cmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Change TypePeriodic review / references updated

Effective DateJan 1, 2020

Next Review Date

Key ActionMonthly, rendering provider must submit authorization for dispensing quantity before delivering factor product including original prescription, requested amount, vial sizes, patient clinical history, product inventory and bleed history.

SourceLink

POLICY UPDATE CHANGES

Review dates updated through 08/14/2024 and references updated (package insert March 2024 and MASAC April 2024).

2Covered Indications (Hemophilia A and B)

3Authorized Use Types

274/137/55Vial quantity limits per 28 days (500/1000/2500 IU)

136.850

Max billable units per 28 days

Coverage Summary

coverage_stance: covered_with_criteria; scope_summary: Medical-benefit policy for Feiba NF/VF (anti-inhibitor coagulant complex) governing authorization, quantity limits, dispensing and clinical criteria for treatment of Hemophilia A and B with inhibitors across Medicaid, Commercial, and Medicare-Medicaid Plan members (medication available on the Medical Benefit); subject: Feiba (anti-inhibitor coagulant complex). Permitted uses (criteria_trees[0] 'Permitted uses' branch): Control and prevention of acute bleeding episodes (episodic treatment); Perioperative management (authorizations valid for 1 month); and Routine prophylaxis to prevent or reduce frequency of bleeding episodes (with prophylaxis-specific additional criteria such as primary prophylaxis for severe deficiency, secondary prophylaxis after ≥2 spontaneous joint bleeds, trial/failure of ITI, and trial/failure or contraindication to Hemlibra). Quantity limits and vial sizing are addressed separately.

Initial Therapy Criteria

Initial Approval Criteria

Coverage requires ALL of the following unless otherwise noted:

ALL of the following

Member population: Hemophilia A (congenital factor VIII deficiency) or Hemophilia B (congenital factor IX deficiency)
See Appendix diagnosis codes D66 and D67
Diagnosis confirmation: Diagnosis confirmed by blood coagulation testing
Inhibitor titer requirement
- Hemophilia A inhibitor titer: Patient has inhibitors to Factor VIII (for Hemophilia A) with a current or historical titer of ≥ 5 Bethesda Units (BU)≥ 5 BU
- Hemophilia B inhibitor titer: Patient has inhibitors to Factor IX (for Hemophilia B) with a current or historical titer of ≥ 5 Bethesda Units (BU)≥ 5 BU
Permitted uses
- Episodic treatment: Control and prevention of acute bleeding episodes (episodic treatment of acute hemorrhage)
- Perioperative management
  Authorizations valid for 1 month
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Prophylaxis-specific additional criteria (when used as prophylaxis)
- Primary prophylaxis in patients with severe deficiency (factor VIII or IX level of <1%)factor level <1%
- Secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints>= 2 documented spontaneous joint bleeds
- ITI failure: Patient has a documented trial and failure of Immune Tolerance Induction (ITI)
- Hemlibra trial failure or contraindication: Patient has documented trial and failure or contraindication to Hemlibra (emicizumab-kxwh) therapy
  Specific Hemlibra requirement is listed under Hemophilia A criteria

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Exceptions / Case-by-case

ALL of the following

Case-by-case evaluation: Patients with inhibitor titer levels >0.6 BU to <5 BU who are not responding to or are not a candidate for standard factor replacement will be evaluated on a case-by-case basis>0.6 BU to <5 BU
MMP step therapy exemption: MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirementswithin past 365 days

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Authorization & Renewal Rules

Length of Authorization

Default authorization and duration rules:

Initial authorization: 3 months (unless otherwise specified by indication)3 months
Renewal durations vary by indication

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

Renewal requirements

Continues to meet initial criteria: Patient continues to meet initial criteria (Section IV)

Applicable Codes

HCPCS - J-code for Feiba NFHCPCSCovered

J7198

Anti-inhibitor coagulant complex (AICC), per unit (Feiba NF), 1 IU = 1 billable unit

NDCsNDC

64193-0426-xx	Feiba NF, vial size 500 units
64193-0424-xx	Feiba NF, vial size 1000 units
64193-0425-xx	Feiba NF, vial size 2500 units

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

D66	Hereditary factor VIII deficiency
D67	Hereditary factor IX deficiency

Provider Actions & Billing Rules

Prior Authorization

Authorization required for dispensing

Monthly authorization is required from the rendering provider before dispensing Feiba (J7198). Submitted materials must include the original prescription, requested amount to be dispensed, vial sizes available from the manufacturer, patient clinical history, current product inventory, and bleed history.

Affected code: J7198
Required submission items: original prescription, requested amount, vial sizes, patient clinical history, product inventory, bleed history

Documentation Required

Clinical documentation for diagnosis and inhibitor titer

Provide clinical documentation confirming diagnosis by blood coagulation testing and documentation of current or historical Bethesda inhibitor titer.

Clinical Evidence

93%Bleeds controlled in 93% of episodes (randomized trial)

78%Hemostasis achieved within 36 hours in 78% of episodes

44Study enrolled 44 Hemophilia A subjects (plus 3 Hem B, 2 acquired FVIII)

Feiba package insert (Takeda, March 2024).

Brief summary: Efficacy demonstrated in a randomized multicenter trial with bleeds controlled in 93% of episodes and hemostasis achieved within 36 hours in 78% of episodes; serious risks include hypersensitivity reactions and thromboembolic events (including stroke, pulmonary embolism, and deep vein thrombosis).

Background & Definitions

Feiba (anti-inhibitor coagulant complex) is indicated for treatment and prevention of bleeding in Hemophilia A and B patients with inhibitors for control and prevention of acute bleeding episodes, perioperative management, and routine prophylaxis. Dosing varies by indication (examples: 50–100 units/kg IV every 12 hours for joint hemorrhage; routine prophylaxis ~85 units/kg IV every other day). Serious risks noted with the product include hypersensitivity reactions and thromboembolic events (venous thrombosis, pulmonary embolism, myocardial infarction, stroke), which are considered when determining renewal and monitoring requirements.

Term	Definition
BU
Bethesda Units, measure of inhibitor titer
Primary prophylaxis
Regular preventive dosing in patients prior to occurrence of target bleeds; here defined for severe deficiency (factor level <1%)
Secondary prophylaxis
Regular preventive dosing after defined bleeding episodes (e.g., >=2 spontaneous joint bleeds)

Medicare & LCD/NCD Determinations

Effective Date	Name	Number	Type
2022-11-24
Anti-Inhibitor Coagulant Complex (AICC)
110.3 (A56065)
NCD
2023-10-01
Billing and Coding: Hemophilia Clotting Factors
A56482
LCD
2022-11-24
Guidance for Anti-Inhibitor Coagulant Complex (AICC)
A56065
LCD

Revision History

2024-08-14revisedLatest

Review dates updated through 08/14/2024 and references updated (package insert March 2024 and MASAC April 2024).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Policy CodePolicy Cmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Change TypePeriodic review / references updated

Effective DateJan 1, 2020

Next Review Date

SourceLink

On This Page

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Absence of unacceptable toxicity (examples: severe hypersensitivity, embolic and thromboembolic events including venous thrombosis, pulmonary embolism, myocardial infarction, stroke)

Dose increase rationale: Any increases in dose must be supported by acceptable clinical rationale (e.g., weight gain, half-life study results, increased breakthrough bleeding when fully adherent)

On-hand medication accounting: Authorization will account for cumulative on-hand medication; authorization allows up to 5 doses on-hand for treatment of acute bleeding episodesUp to 5 doses on-hand

Renewal Duration by Indication

Episodic treatment renewal: Control and prevention of acute bleeding episodes: Renewals approved for a 6-month authorization period6 months
Perioperative management renewal: Perioperative management of surgical bleeding: Coverage may NOT be renewedno renewal
Routine prophylaxis renewal: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes: Renewals approved for a 12-month authorization period AND patient has demonstrated a beneficial response (frequency of bleeding decreased from pre-treatment baseline)12 months
Patient must demonstrate benefit

Blood coagulation testing confirmation of diagnosis
Documentation of current or historical Bethesda titer

Billing Rule

Dose dispensing constraints

Dispensing must follow dose and vial constraints: factor dose should not exceed +1% of the prescribed dose; a maximum of three vials may be dispensed per dose. If the exact threshold cannot be met, dispense the lowest possible dose above +1%. Do not increase the prescribed dose to meet assay management requirements.

+1% dose limit relative to prescribed dose
Maximum three vials dispensed per dose
If threshold can't be met, dispense lowest possible dose above +1%
Do not increase prescribed dose to meet assay requirements

Documentation Required

On-hand inventory accounting

Authorizations and dispensing must account for the cumulative amount of medication the patient has on-hand. Patients should not have more than five extra doses on-hand for treatment of acute bleeding episodes.

Consider cumulative on-hand inventory when authorizing and dispensing
Allow up to 5 extra doses on-hand for acute bleeding treatment

Prior Authorization

Renewal documentation and toxicity monitoring

For renewals, submit evidence of continued benefit, documentation of absence of unacceptable toxicity, and clinical justification for any dose increases (for example: weight change, pharmacokinetic/half-life data, or increased breakthrough bleeding).

Evidence of continued clinical benefit
Documentation that unacceptable toxicity is absent (e.g., severe hypersensitivity, thromboembolic events)
Justification for dose increases (weight change, PK data, increased breakthrough bleeding)