CurrentNeighborhood Health Plan of Rhode IslandPolicy Cmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Feiba (anti‑inhibitor coagulant complex) coverage for hemophilia with inhibitors

This policy governs medical benefit coverage, authorization, dispensing, dosing, and renewal criteria for Feiba (anti‑inhibitor coagulant complex) for members with hemophilia A or B with inhibitors across Medicaid, Commercial, and Medicare‑Medicaid Plan (MMP) lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFeiba (anti‑inhibitor coagulant complex) coverage for hemophilia with inhibitors

Policy CodePolicy Cmp_M_Factor_Anti_Inhibitor_Coagulant_Complex_20240814

Change TypeRoutine review — no material changes

Effective DateJan 1, 2020

Next Review Date

Key ActionSubmit prior authorization with diagnosis confirmation, inhibitor titer documentation (≥5 BU or qualifying rationale), and required dispensing details to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial auth period

≥5 BUinhibitor titer threshold

136.850max units/28d

J7198HCPCS

5 doses

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Coverage Criteria for FEIBA (Anti‑Inhibitor Coagulant Complex)

Hemophilia A (congenital factor VIII deficiency)

Covered when ALL of the following are met

Hemophilia A coverage criteria: Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing; AND patient has inhibitors to Factor VIII with a current or historical titer of >= 5 Bethesda Units (BU) (patients with >0.6 to <5 BU evaluated case-by-case); AND used as treatment for at least one of: control and prevention of acute bleeding episodes (episodic treatment of acute hemorrhage) OR perioperative management (authorizations valid for 1 month) OR routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND additional prophylaxis conditions: used as primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level <1%) OR used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints OR patient has documented trial and failure of Immune Tolerance Induction (ITI) AND patient has documented trial and failure or contraindication to Hemlibra (emicizumab) therapy.

Hemophilia B (congenital factor IX deficiency)

Covered when ALL of the following are met

Hemophilia B coverage criteria: Diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing; AND patient has inhibitors to Factor IX with a current or historical titer of >= 5 Bethesda Units (BU) (patients with >0.6 to <5 BU evaluated case-by-case); AND used as treatment for at least one of: control and prevention of acute bleeding episodes (episodic treatment of acute hemorrhage) OR perioperative management (authorizations valid for 1 month) OR routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND additional prophylaxis conditions: used as primary prophylaxis in patients with severe factor IX deficiency (factor VIII level <1%) OR used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints OR patient has documented trial and failure of Immune Tolerance Induction (ITI).

Renewal and Duration criteria by indication

Renewal allowed when ALL of the following are met

General renewal: Patient continues to meet initial criteria; AND absence of unacceptable toxicity (examples: severe hypersensitivity reactions, embolic/thromboembolic events); AND any increases in dose must be supported by acceptable clinical rationale; AND cumulative on-hand supply considered (authorization allows up to 5 doses on-hand).

Renewal durations by indication: Control/prevention of acute bleeding episodes: renewals approved for 6 months; Perioperative management: coverage may NOT be renewed; Routine prophylaxis to prevent or reduce bleeding frequency: renewals approved for 12 months provided patient has demonstrated a beneficial response (reduction in bleeding frequency from baseline).

Perioperative management authorizations for FEIBA NF/VF are limited to short-term coverage. Perioperative management coverage may NOT be renewed; authorizations for this indication are valid for 1 month only.

For members enrolled in the INTEGRITY (Medicare Medicaid Plan) product, the plan’s clinical coverage criteria for FEIBA NF/VF will be applied only when there is no applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD). The plan will consider prescriber-submitted information and give individual consideration where appropriate.

Renewal of FEIBA NF/VF may be denied if the member experiences unacceptable toxicity. Examples of such toxicities include severe hypersensitivity reactions (for example anaphylactoid reactions, angioedema, bronchospasm) and embolic or thromboembolic events (for example venous thrombosis, pulmonary embolism, myocardial infarction, stroke).

Coding, Quantity Limits, and CMS References

Covered HCPCS CodesHCPCSCovered

J7198

Feiba NF (anti‑inhibitor coagulant complex), 1 IU = 1 billable unit

NDCsNDC

64193-0426-xx	Feiba NF NDC (500 units vial)
64193-0424-xx	Feiba NF NDC (1000 units vial)
64193-0425-xx	Feiba NF NDC (2500 units vial)

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

D66	Hereditary factor VIII deficiency
D67	Hereditary factor IX deficiency

Medicare NCD/LCA/LCD Documents (examples)mixed

A56065

NCD/LCA/LCD Document referenced for Medicare Part B covered diagnosis codes

Medicare NCD/LCA/LCD Documents (examples)mixed

A56433

NCD/LCA/LCD Document referenced for Medicare Part B covered diagnosis codes

Medicare NCD/LCA/LCD Documents (examples)mixed

A56482

NCD/LCA/LCD Document referenced for Medicare Part B covered diagnosis codes

Inhibitor titer threshold

Inhibitor titer thresholdCurrent or historical titer ≥ 5 Bethesda Units (BU); patients with >0.6 to <5 BU may be evaluated case‑by‑case.

Measurement unitBethesda Unit (BU) — standard unit for inhibitor titer measurement as used in this policy.

Requirement for coverageDocumentation of inhibitor titer required for initial approval and renewal; lack of ≥5 BU without case‑by‑case rationale risks denial.

Quantity limits

Vial quantity limits (500 IU)274 vials per 28‑day supply (500 IU vial).

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Timing and Step Therapy Note

Prior authorization is required for FEIBA NF/VF. Unless otherwise specified, initial authorizations are generally provided for 3 months and may be renewed. The cumulative amount of medication the patient has on-hand will be taken into account when authorizations are issued. For members in the Hemophilia Management Program (HMP/MMP), prior receipt of the medication within the past 365 days exempts the member from step therapy requirements.

Initial authorizations: typically 3 months (may vary by indication)
Renewals: based on renewal criteria and cumulative on-hand inventory
MMP members with prior receipt within 365 days: exempt from step therapy

Documentation Required

Clinical Justification Required

Requests for FEIBA NF/VF will be reviewed against the clinical coverage criteria adopted by the plan's P&T Committee and described in this policy. The prescriber must submit clinical information demonstrating that requested use aligns with FDA labeling and the applicable clinical literature. Neighborhood will consider individual clinical circumstances when reviewing requests and, for Medicare-Medicaid Plan (MMP/INTEGRITY) members, will defer to applicable NCD/LCD where present.

Background — Drug and Clinical Context

FEIBA (anti‑inhibitor coagulant complex, AICC) is indicated for use in persons with hemophilia A or B who have inhibitors to factor VIII or IX and is used to control and prevent bleeding. The plan’s criteria reflect the drug’s clinical role for episodic bleeding control, perioperative management, and routine prophylaxis, and were adopted by the P&T Committee to align use with FDA labeling and relevant clinical literature.

Definitions and Key Terms

Feiba — Anti‑inhibitor coagulant complex (AICC)

DefinitionFeiba — anti‑inhibitor coagulant complex (AICC) used to control and prevent bleeding in patients with hemophilia A or B who have inhibitors.

Indications notedUsed for episodic treatment of acute hemorrhage, perioperative management, and routine prophylaxis to prevent/reduce bleeding frequency.

Evidence summaryEfficacy demonstrated in multicenter randomized prospective trial; 93% of bleeding episodes controlled in studied population.

Inhibitor titer — Bethesda Unit (BU)

TermInhibitor titer — Bethesda Unit (BU).

Policy thresholdPolicy uses a coverage threshold of ≥ 5 BU for routine coverage; patients with >0.6 to <5 BU evaluated case‑by‑case.