ModifiedCentenePolicy CP.PHAR.370

Clinical Policy: Emicizumab-kxwh (Hemlibra)

Defines medical necessity and prior authorization requirements for Hemlibra used as routine prophylaxis to prevent or reduce bleeding in patients with congenital hemophilia A, with or without FVIII inhibitors, for Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Emicizumab-kxwh (Hemlibra)

Policy CodePolicy CP.PHAR.370

Change TypeClarifications and duration revisions (authorization durations extended to 12 months for some linesdocumentation and inhibitor criteria clarified).

Effective DateMar 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation including indication, hematology consultation, current weight when required, inhibitor level when applicable, and evidence of prior FVIII failure or contraindication when applicable.

SourceLink

POLICY UPDATE CHANGES

Clarified that for continued therapy the member's current weight is only needed if a higher dose is being requested.

For hemophilia A with inhibitors removed the requirement for FVIII activity level or documentation of bleed history.

Added new vial strengths including 12 mg/0.4 mL and 300 mg/2 mL to product availability.

Changed continuation of therapy language from 'will discontinue' to 'has discontinued' use of bypassing agents or fFVIII products as routine prophylaxis while on Hemlibra therapy.

Extended initial and continued authorization durations for hemophilia prophylaxis from 6 months to 12 months for specified lines of business.

J7170HCPCS code for emicizumab-kxwh (0.5 mg)

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Coverage Criteria for Hemlibra (Emicizumab-kxwh)

Initial Therapy (Without Inhibitors)

Covered when ALL of the following are met:

Initial Criteria Without Inhibitors

Prescribed for routine prophylaxis of bleeding episodes in patients with congenital hemophilia A (FVIII deficiency) WITHOUT inhibitors.
Prescribed by or in consultation with a hematologist.
Step therapy or venous access exception
- Failure of a FVIII product used for routine prophylaxis as assessed and documented by prescriber (unless clinically significant adverse effects or contraindications).
- Poor venous access, intolerance of frequent venous access, or presence of a central line/port.
New-to-Hemlibra requirements
- Severe hemophilia (FVIII level < 1%).
- At least one serious spontaneous bleed (see Appendix D for sites that constitute serious bleeding).
Hemlibra is not prescribed concurrently with another hemophilia prophylaxis agent (on-demand FVIII usage may be continued).
Documentation of member's current body weight in kg.
Dose does not exceed loading and maintenance regimens specified: 3 mg/kg per week for the first four weeks, followed by either 1.5 mg/kg per week, 3 mg/kg once every two weeks, or 6 mg/kg once every four weeks.

Initial Therapy (With Inhibitors)

Covered when ALL of the following are met:

Initial Criteria With Inhibitors

Prescribed for routine prophylaxis of bleeding episodes in patients with congenital hemophilia A (FVIII deficiency) WITH inhibitors.
Prescribed by or in consultation with a hematologist.
Member has inhibitor level ≥ 5 Bethesda units (BU).
Hemlibra is not prescribed concurrently with another hemophilia prophylaxis agent (examples include bypassing agents and prophylactic FVIII products); on-demand FVIII usage may be continued.
Documentation of member's current body weight in kg.

Continuation Therapy

Covered when ALL of the following are met:

Continuation Criteria

Continuation eligibility
- Currently receiving medication via the Centene benefit or previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state addendums).
Member is responding positively to therapy (examples include reduction in total bleeds, joint bleeds, or target joint bleeds).
Hemlibra is not prescribed concurrently with another hemophilia prophylaxis agent (on-demand FVIII usage may be continued).
Dose increase requests

Initial and Continued Therapy Criteria — Documentation and Prior Authorization

Covered when documentation and prior authorization requirements specific to hemophilia A WITH or WITHOUT inhibitors are met and exclusions are avoided.

General prerequisites: Prior authorization obtained; provider documents discontinuation of bypassing agents or full‑length FVIII products when used as routine prophylaxis while patient is on Hemlibra; appropriate clinical indication of hemophilia A (WITH or WITHOUT inhibitors).

Documentation differences by inhibitor status: For hemophilia A WITH inhibitors: FVIII activity level or bleed history documentation is not required. For hemophilia A WITHOUT inhibitors: FVIII activity level or documentation of bleed history may be required for new starts without prior FVIII routine prophylaxis.

Authorization durations differ by line of business; initial and continued authorization durations were extended to 12 months for certain lines (e.g., Medicaid/HIM); commercial duration is 6 months or to the member's renewal date, whichever is longer.

Non–FDA approved indications for emicizumab‑kxwh (Hemlibra) that are not specifically addressed in this policy are not authorized unless the provider submits sufficient clinical documentation of efficacy and safety in accordance with applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

Concurrent use of routine hemophilia prophylaxis agents (for example, bypassing agents or full‑length/extended‑release FVIII products) with Hemlibra is excluded. Providers must confirm that such prophylactic agents have been discontinued prior to, or while, the member is receiving Hemlibra; failure to confirm discontinuation may result in denial of the request.

Hemlibra is not appropriate for on‑demand treatment of acute bleeding episodes because of its long elimination half‑life (~27.8 ± 8.1 days). Use of Hemlibra for the treatment of hemophilia B (with or without inhibitors) is unsupported by available data and is therefore not authorized under this policy.

Coding and Billing

HCPCS CodesHCPCSCovered

J7170

Injection, emicizumab-kxwh, 0.5 mg

Covered HCPCS Codes (informational)HCPCS

J7170

Injection, emicizumab-kxwh, 0.5 mg

Inhibitor level

Inhibitor level (threshold)≥ 5 Bethesda units (BU)

Context where usedRequired for initial approval in congenital hemophilia A WITH inhibitors

Documentation requirementProvider must submit documented inhibitor level as part of prior authorization

Provider Actions and Documentation Requirements

Documentation Required

Documentation Required; Documentation Insufficiency

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, and current weight when a higher dose is requested) supporting that the member has met all approval criteria. Lack of submitted documentation or requests for non‑FDA indications without sufficient evidence may result in denial.

Submit office notes and relevant lab results (e.g., inhibitor titer for hemophilia A WITH inhibitors when applicable).
Include current body weight in kg — required for initial approval; for continued therapy, weight is required only if a higher dose is requested.

Step Therapy

Step Therapy Requirement (Congenital Hemophilia A WITHOUT Inhibitors)

Hemlibra prescriptions must be by or in consultation with a hematologist. For congenital hemophilia A WITHOUT inhibitors, step therapy applies: member must have failed routine prophylaxis with an FVIII product (e.g., Advate, Adynovate, Eloctate) as assessed and documented by the prescriber, unless clinically significant adverse effects or contraindications exist; OR the member has poor venous access or central line/port justification. Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395 (effective 1/1/2026).

Background

Emicizumab‑kxwh (Hemlibra) is a bispecific antibody that binds activated factor IX and factor X to restore hemostatic activity in patients with congenital hemophilia A. It is FDA‑approved for routine prophylaxis to reduce bleeding in patients with hemophilia A, both with and without factor VIII inhibitors. Hemlibra has a long elimination half‑life (approximately 27.8 ± 8.1 days), which informs its use as a prophylactic agent rather than for acute, on‑demand bleed management.

Definitions

Hemlibra (emicizumab-kxwh)

Drug nameHemlibra (emicizumab-kxwh)

Mechanism of actionBispecific factor IXa- and factor X-directed antibody that bridges activated factor IX and factor X

IndicationRoutine prophylaxis to reduce bleeding in congenital hemophilia A (with or without FVIII inhibitors)

Not appropriate forOn-demand treatment of acute bleeding episodes due to long half-life

Serious bleeding episode

DefinitionBleeds in sites such as intracranial; neck/throat; gastrointestinal; joints (hemarthrosis); muscles (especially deep compartments such as iliopsoas, calf, forearm); or mucous membranes of the mouth, nose, and genitourinary tract.

Policy Summary

PayerCentene

PolicyClinical Policy: Emicizumab-kxwh (Hemlibra)

Policy CodePolicy CP.PHAR.370

Change TypeClarifications and duration revisions (authorization durations extended to 12 months for some linesdocumentation and inhibitor criteria clarified).

Effective DateMar 1, 2018

Next Review DateN/A

SourceLink

On This Page

Denial Risk

Concurrent Prophylaxis Exclusion Risk

Concurrent routine use of bypassing agents or FVIII products as prophylaxis with Hemlibra is not permitted. Provider must confirm that bypassing agents or factor VIII (fFVIII) products used for routine prophylaxis have been discontinued prior to, or will be discontinued while on, Hemlibra therapy. On‑demand (episodic) use of FVIII products is allowed.

Examples of prohibited concurrent prophylaxis agents: bypassing agents, FVIII products used for prophylactic therapy, Qfitlia, Hympavzi, Alhemo.
On‑demand usage of FVIII products for treatment of breakthrough bleeds may continue.

Prior Authorization

Required Clinical Documentation and Diagnostic Clarifications

For congenital hemophilia A WITH inhibitors: documentation of inhibitor level (≥ 5 Bethesda units) is required per criteria; FVIII activity level or bleed history is not required for hemophilia A WITH inhibitors. For congenital hemophilia A WITHOUT inhibitors: new starts who have not previously used FVIII products for routine prophylaxis must have either severe hemophilia (FVIII level < 1%) or a history of at least one serious spontaneous bleed documented. Hemlibra dosing limits and weight documentation requirements apply.

WITH inhibitors: require inhibitor level ≥ 5 BU; FVIII activity or bleed history not required.
WITHOUT inhibitors (new to prophylaxis): require FVIII level < 1% OR ≥1 documented serious spontaneous bleed.
Dose limits: do not exceed 3 mg/kg/week during first 4 weeks; maintenance options: 1.5 mg/kg/week, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks.