CurrentCentenePolicy CP.PHAR.217

Anti-Inhibitor Coagulant Complex, Human (Feiba)

Governs coverage and medical necessity criteria for Feiba (anti-inhibitor coagulant complex, human) for members with hemophilia A or B with inhibitors and related indications across Centene lines of business.

Policy Summary

PayerCentene

PolicyAnti-Inhibitor Coagulant Complex, Human (Feiba)

Policy CodePolicy CP.PHAR.217

Change TypeNo material changes

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionProvider must submit documentation (office notes, lab results or other clinical information) showing the member meets all approval criteria, including current body weight and dosing within FDA limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

200max daily dose (units/kg/day)

85routine prophylaxis dose

J7198HCPCS code

3 monthssurgical/acute approval

12 monthsMedicaid prophylaxis approval

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Initial Therapy

Covered when ALL of the following are met:

Hemophilia A or B with inhibitors initial criteria: 1. Diagnosis of hemophilia A or B with inhibitors; 2. Prescribed by or in consultation with a hematologist; 3. Request is for one of the following uses: (a) control and prevention of bleeding episodes; (b) perioperative management; (c) routine prophylaxis to prevent or reduce the frequency of bleeding episodes; 4. Documentation of member's current body weight (in kg); 5. Dose does not exceed the FDA approved maximum recommended dose for the relevant indication.

Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Documentation of member's current body weight (in kg); 4. If request is for a dose increase, the new dose does not exceed the FDA approved maximum recommended dose for the relevant indication.

Approval Duration

Approval durations: Surgical/acute bleeding: 3 months; Prophylaxis: Medicaid/HIM - 12 months; Commercial - 6 months or to the member's renewal date, whichever is longer.

This policy governs coverage and medical necessity criteria for Feiba (anti-inhibitor coagulant complex, human) when used for members with hemophilia A or B who have developed inhibitors, including use for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis as described in the FDA-approved labeling. Requests for uses that are not FDA-approved and are not specifically addressed in this policy are excluded unless sufficient supporting documentation is provided according to the applicable off-label use policies (see related policy CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage is available.

Contraindications include a history of anaphylactic or severe hypersensitivity reactions to Feiba or any of its components (including factors of the kinin-generating system), disseminated intravascular coagulation (DIC), and acute thrombosis or embolism (including myocardial infarction). The product labeling also contains a boxed warning for thromboembolic events.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers should follow the member's specific state guidance and Medicaid manual provisions when applicable.

Feiba is not indicated for treatment of bleeding episodes that result from coagulation factor deficiencies in the absence of inhibitors to factor VIII or factor IX; such uses are outside the FDA-approved indications and are considered not indicated per product labeling.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include the diagnosis, prescriber specialty or consultation, and supporting clinical documentation to demonstrate the member meets approval criteria.

Required diagnosis: Hemophilia A or B with inhibitors (or other requested diagnosis per policy sections).
Prescriber: Prescribed by or in consultation with a hematologist when applicable.
Supporting documentation: Office chart notes, relevant lab results, current body weight (kg), dosing rationale and any other clinical information demonstrating criteria are met.

Prior Authorization

Prior Authorization and Approval Durations

Approval durations vary by indication and line of business. Historic changes extended prophylaxis durations for Medicaid/HIM and adjusted commercial durations; verify the current approval period for the member's plan.

Surgical/acute bleeding: 3 months
Prophylaxis — Medicaid/HIM: 12 months (initial and continued authorization)
Prophylaxis — Commercial: 6 months or to the member's renewal date, whichever is longer

Billing Rule

Formulary / Non‑Formulary Routing

Follow formulary/no-coverage or non-formulary pathways when the requested drug or use is not listed on the applicable formulary/PDL for the line of business.

For drugs on the formulary or PDL, see the no coverage criteria policy for the relevant line of business: CP.CPA.190 (commercial), HIM.PA.33 (HIM), CP.PMN.255 (Medicaid).
For drugs NOT on the formulary or PDL, see the non-formulary policy for the relevant line of business: CP.CPA.190 (commercial), HIM.PA.103 (HIM), CP.PMN.16 (Medicaid).
If a recent label change is not reflected in this policy, follow the formulary/non-formulary routing above.

Step Therapy

Step Therapy Not Specified

No step therapy requirements are specified in this policy.

Documentation Required

Required Documentation

Providers must submit documentation (office notes, lab results, weight, dosing information, and other clinical records) supporting that the member meets all approval criteria.

Examples: office chart notes, inhibitor testing results, current body weight (kg), documentation of dosing and response to therapy.
If requesting an off‑label use, include sufficient evidence of efficacy and safety per the applicable off‑label use policy.

Billing Rule

Coding and Billing Considerations

Coding referenced in this policy is informational only. Inclusion or exclusion of codes does not guarantee coverage and coding may affect reimbursement.

Providers should reference the most up-to-date professional coding guidance prior to claim submission.
HCPCS example listed in policy: J7198 = Anti-inhibitor, per IU — verify current code sets and payer-specific billing rules.

Denial Risk

Off‑Label and Non‑Covered Indications

Off‑label or non‑FDA indications that are not addressed in this policy may be denied without sufficient supporting documentation per the applicable off‑label use policy.

Refer to off‑label use policies when the requested use is not listed: CP.CPA.09 (commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid).
Provide evidence of efficacy and safety to support coverage for non‑FDA uses.

Definitions and Prescribing Information

Feiba — product definition and indicated uses

Product descriptionFeiba (anti-inhibitor coagulant complex, human) is a human plasma fraction with factor VIII inhibitor bypassing activity that contains mainly non-activated factors II, IX, X and activated factor VII.

FDA‑approved indicationsControl and prevention of bleeding episodes; Perioperative management; Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors.

Limitation of useNot indicated for treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to factor VIII or IX.

Manufacturer prescribing informationSee Feiba Prescribing Information (Baxter Healthcare Corporation).

Product prescribing information

Referenced prescribing informationFeiba Prescribing Information. Baxter Healthcare Corporation; December 2024. Available at the manufacturer PI (link in references).

Reference listingPolicy references include Feiba Prescribing Information (December 2024) among other clinical guidelines and publications.

Access noteConsult the full Feiba Prescribing Information for complete prescribing, dosing, contraindications, and safety details.

OpenPayer

Anti-Inhibitor Coagulant Complex, Human (Feiba)

Coverage Criteria for Feiba (Anti-inhibitor Coagulant Complex)

Coding and Dosing References

Provider Actions, Authorization, and Documentation

Background

Definitions and Prescribing Information

Revision History