CurrentCareSourcePolicy N/A

Hemophilia FEIBA Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing limits, and prescriber requirements for FEIBA (aPCC) for hemophilia A and B patients with inhibitors for acute treatment, perioperative management, and routine prophylaxis. Applies to CareSource medical benefit reviews.

Policy Summary

PayerCareSource

PolicyHemophilia FEIBA Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals typically issued for 1 year when criteria and dosing limits are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2,390max dosing /28 days

1 yearapproval duration

hemophilia specialistprescriber requirement

≥5 BUinhibitor threshold

Recommended Authorization and Coverage Criteria

FDA‑Approved Indications

Coverage of FEIBA is recommended when ALL of the following are met for the FDA‑approved indications:

Hemophilia A with inhibitors - approval

A: Evidence of inhibitor or clinical history: Patient has a positive inhibitor titer >= 5 Bethesda Units OR history of an inhibitor with anamnestic response to Factor VIII replacement that, according to the prescriber, precludes the use of Factor VIII replacement to treat bleeding episodes OR history of an inhibitor with refractory hemostatic response to increased Factor VIII dosing that, according to the prescriber, precludes the use of Factor VIII replacement to treat bleeding episodes
B: Prescriber requirement: Medication is prescribed by or in consultation with a hemophilia specialist

Hemophilia B with inhibitors - approval

Policy Summary

PayerCareSource

PolicyHemophilia FEIBA Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals typically issued for 1 year when criteria and dosing limits are met.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Dosing Limits and Laboratory Thresholds

inv-03: Inhibitor titer — >= 5 Bethesda Units

Defined threshold>= 5 Bethesda Units

PurposeThreshold used to identify a positive inhibitor titer for approval of FEIBA in hemophilia A and B with inhibitors

Policy action when metMeets one of the required clinical criteria to support 1‑year approval when combined with prescriber requirement

inv-04: Maximum dosing per 28 days — 2,390 units/kg per 28 days

Maximum allowed dosing2,390 units/kg per 28 days

RationaleAllows prophylactic dosing plus treatment for up to three acute episodes or perioperative management per 28 days per MASAC-informed guidance

Requests exceeding limitDoses exceeding 2,390 units/kg/28 days will be reviewed on a case‑by‑case basis by a clinician

Prior Authorization, Prescriber Requirements, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical benefit coverage of FEIBA. Approvals are typically granted for 1 year when the patient meets the authorization criteria and dosing is within the policy limits. Extended approvals may be allowed if the patient continues to meet the criteria and dosing. Requests for dosing outside the established limits will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist).

Approval duration: 1 year for eligible indications
Dosing limit: up to a maximum of 2,390 units/kg IV per 28 days (per policy dosing)
Exceptions to dosing limits considered on a case-by-case basis by clinician review

Step Therapy

Step from Replacement Therapy to Bypass Agent

For hemophilia A or B with inhibitors, Factor VIII or IX replacement may be used for low‑titer inhibitors; bypass agents such as aPCC (FEIBA) are recommended for high‑titer inhibitors or when replacement therapy is ineffective or anamnestic response occurs. Treatment choice should consider inhibitor titer, history of response to replacement therapy, bleed location, and prior clinical response.

Low‑titer inhibitors: consider Factor VIII/IX replacement
High‑titer inhibitors or ineffective replacement/anamnestic response: use bypass agent (aPCC)

Documentation Required

Prescriber and Dosing Documentation

FEIBA must be prescribed by, or in consultation with, a physician who specializes in the condition being treated (e.g., a hemophilia specialist). Clinician review is required for reauthorization and for requests that deviate from policy dosing or indications. Documentation should include inhibitor titers, history of response to replacement therapy (including anamnestic responses), and rationale when replacement therapy is not appropriate.

Prescriber requirement: hemophilia specialist or consult documented
Reauthorization: clinician review required to confirm continued criteria/dosing
Documentation: inhibitor titer and clinical history (response to replacement, anamnestic events)

Denial Risk

Unsupported Indications Not Recommended

Requests for indications not listed in the Recommended Authorization Criteria are not recommended for approval. Criteria will be updated as new published data become available; out‑of‑criteria requests may be considered only with supporting clinical justification and clinician review.

Not recommended: coverage for situations outside the listed criteria
Policy updates: criteria subject to change with new evidence

Key Definitions

inv-10: aPCC (activated prothrombin complex concentrate) — definition of product composition and use

Product classActivated prothrombin complex concentrate (aPCC)

CompositionPlasma‑derived product containing activated and inactivated Factors II, VII, IX, and X

Clinical useUsed to control and prevent bleeding in hemophilia A and B patients with inhibitors for acute bleeding, perioperative management, and routine prophylaxis

inv-11: Positive inhibitor titer — Defined in this policy as ≥ 5 Bethesda Units for purposes of approval

Policy definitionPositive inhibitor titer is defined in this policy as >= 5 Bethesda Units

Use in approvalsA positive titer (>= 5 BU) satisfies the evidence criterion for 1‑year approval for hemophilia A and B with inhibitors

Alternative evidenceIf titer is not available, a qualifying clinical history (anamnestic response or refractory hemostatic response to factor replacement) may substitute

OpenPayer

Hemophilia FEIBA Utilization Management Medical Policy

Recommended Authorization and Coverage Criteria

Dosing Limits and Laboratory Thresholds

Prior Authorization, Prescriber Requirements, and Step Therapy

Clinical Background

Key Definitions