CurrentMass General Brigham Health PlanPolicy N/A

FEIBA (anti-inhibitor coagulant complex) coverage

Defines prior authorization criteria for FEIBA under the pharmacy benefit for Mass General Brigham Health Plan Commercial/Exchange members, including indications, required documentation, and approval durations. Specialty medication must be filled at a contracted specialty pharmacy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFEIBA (anti-inhibitor coagulant complex) coverage

Policy CodePolicy N/A

Change TypeRevised (benefit designation changed)

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization under the plan's pharmacy benefit with documentation of diagnosis and inhibitor titer ≥ 5 BU/mL and prescriber hematology involvement or meet the 90-day new-to-plan continuation criteria.

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate it no longer applies to the medical benefit and is pharmacy benefit only.

12Initial and reauthorization approval duration

≥5Inhibitor titer threshold (BU/mL)

PharmacyBenefit designation

SpecialtyDispensing requirement

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General Authorization rules

Authorization may be granted for members new to the plan within past 90 days who are currently receiving treatment OR when all criteria below are met.

Eligibility pathways

Member new to plan within past 90 days who is currently receiving treatment with requested medication (excluding samples or manufacturer patient assistance program supplies).
Standard prior authorization
- Member meets indication-specific criteria for Hemophilia A with inhibitors, Hemophilia B with inhibitors, or Acquired Hemophilia A (see respective sections).

Hemophilia A With Inhibitors — Authorization criteria

Authorization granted when ALL of the following are met:

ALL of the following

Member has a diagnosis of Hemophilia A with inhibitors (see Appendix).
Inhibitor titer requirement
- Inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL).≥ 5 BU/mL
- Member has a history of an inhibitor titer ≥ 5 BU.≥ 5 BU/mL
Requested medication is prescribed by or in consultation with a hematologist.

Hemophilia B With Inhibitors — Authorization criteria

Authorization granted when ALL of the following are met:

ALL of the following

Member has a diagnosis of Hemophilia B with inhibitors (see Appendix).
Inhibitor titer requirement
- Inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL).≥ 5 BU/mL
- Member has a history of an inhibitor titer ≥ 5 BU.≥ 5 BU/mL
Requested medication is prescribed by or in consultation with a hematologist.

Acquired Hemophilia A — Authorization criteria

Authorization granted when ALL of the following are met:

ALL of the following

Member has a diagnosis of acquired hemophilia A.
Requested medication is prescribed by or in consultation with a hematologist.

Continuation of Therapy (Reauthorization)

Reauthorization will be approved when the following is met:

ALL of the following

Member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds).

Limitations

Policy limits and general constraints:

ALL of the following

Initial approvals and reauthorizations will be granted for 12 months.
Medication is designated specialty and must be filled at a contracted specialty pharmacy.

Thresholds

Inhibitor titer (Bethesda Units)≥ 5 BU/mL

Threshold noteHigh-titer definition per policy (listed under Inhibitors - Bethesda Units)

Context of useRequired for authorization for Hemophilia A and Hemophilia B with inhibitors or documented history of such titer

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is required for FEIBA under the plan's pharmacy benefit; prescriber must be a hematologist or consult with a hematologist for approval unless member is within 90-day new-to-plan continuation criteria.

Medication is designated specialty and must be filled at a contracted specialty pharmacy.
New-to-plan continuation pathway: member within past 90 days currently receiving the medication (excluding samples or manufacturer assistance) may be eligible without additional criteria.

Documentation Required

Inhibitor titer documentation

Provider must document diagnosis and inhibitor titer ≥ 5 BU/mL or history of such titer for Hemophilia A/B with inhibitors; documentation that treatment is prescribed by/with hematology consultation is required.

For Hemophilia A with inhibitors: document diagnosis and either current inhibitor titer ≥ 5 BU/mL or history of ≥ 5 BU.
For Hemophilia B with inhibitors: document diagnosis and either current inhibitor titer ≥ 5 BU/mL or history of ≥ 5 BU.
Requests for acquired hemophilia A require documentation of diagnosis and that the medication is prescribed by or in consultation with a hematologist.

Denial Risk

Denial risk for non-indicated use

FEIBA is not indicated for bleeding due to factor deficiencies in the absence of inhibitors to factor VIII or IX — requests for such use are not consistent with this policy.

Requests for treatment of bleeding from coagulation factor deficiencies without documented inhibitors to factor VIII or IX may be denied as not meeting policy indications.

Clinical and Administrative Context

FEIBA (anti-inhibitor coagulant complex) is indicated to control and prevent bleeding episodes, for perioperative management, and for routine prophylaxis in patients with Hemophilia A or Hemophilia B who have inhibitors. Use in acquired hemophilia A is supported by compendia and included as an authorization indication when prescribed by or in consultation with a hematologist.

Authorization pathways allow short-term continuation for members new to the plan within the past 90 days who are currently receiving FEIBA, or full prior authorization when all indication-specific criteria are met. For Hemophilia A or B with inhibitors, the policy requires documentation of an inhibitor titer of ≥ 5 BU/mL or a history of such a titer, and the medication must be prescribed by or in consultation with a hematologist. Reauthorization is based on demonstrated clinical benefit (for example, reduced frequency or severity of bleeds), and approvals (initial and reauthorization) are granted for 12 months.

FEIBA has been designated as a specialty medication under the pharmacy benefit only and must be dispensed through a contracted specialty pharmacy. The policy specifies that FEIBA is not indicated for treatment of bleeding caused by coagulation factor deficiencies in the absence of inhibitors to factor VIII or IX; requests for use in that setting are not consistent with this policy.

Per the review history, the policy was updated effective 01/01/2026 to clarify benefit designation (no longer applicable to the medical benefit) and to reflect current program and specialty dispensing requirements.

Policy Changes

2026-01-01revisedLatest

Policy updated to indicate it no longer applies to the medical benefit and is pharmacy benefit only.

2025-10-08reviewed

Reviewed and updated at October P&T (update noted that the policy no longer applies to the medical benefit; effective 01/01/2026).

2025-05-14reviewed

Reviewed at May P&T with no changes (effective 06/01/2025).

2024-12-11reviewed

Reviewed at December P&T with no changes (effective 01/01/2025).

2023-12-13reviewed

Reviewed at December P&T; switched from SGM to Custom (effective 01/01/2024).

D66	Hereditary factor VIII deficiency (Hemophilia A) - conceptual reference
D67	Hereditary factor IX deficiency (Hemophilia B) - conceptual reference
D68.311	Acquired hemophilia (example conceptual code)

OpenPayer

FEIBA (anti-inhibitor coagulant complex) coverage

Authorization & Medical Necessity Criteria for FEIBA

Referenced Diagnosis Codes (Conceptual)

What Providers Must Do

Clinical and Administrative Context

Key Terms

Policy Changes