CurrentmhnPolicy CP.PHAR.370

Clinical Policy: Emicizumab-kxwh (Hemlibra)

Defines medical necessity criteria, dosing limits, required documentation, approval durations, and coding guidance for coverage of emicizumab-kxwh (Hemlibra) for routine prophylaxis of bleeding episodes in patients with congenital hemophilia A with or without factor VIII inhibitors across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Emicizumab-kxwh (Hemlibra)

Policy CodePolicy CP.PHAR.370

Change Typeclarified; revised; added

Effective DateMar 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, etc.) supporting that member has met all approval criteria; documentation of current body weight in kg required for initial requests and for dose increases.

POLICY UPDATE CHANGES

Respective diagnosis criterion for each Hemlibra indication was clarified to add 'WITH inhibitors' and 'WITHOUT inhibitors' to reduce reviewer confusion

For continued therapy clarified that member's current weight is only needed if a higher dose is being requested

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

2Covered indications (with/without inhibitors)

3Maintenance dosing options

1Not authorized: non-FDA indications without documentation

J7170

Coverage Summary

Scope: This policy defines medical necessity criteria, dosing limits, required documentation, approval durations, and coding guidance for emicizumab-kxwh (Hemlibra) for routine prophylaxis of bleeding episodes in patients with congenital hemophilia A with or without FVIII inhibitors.

Coverage stance: Covered with criteria for the FDA‑approved indication of routine prophylaxis to prevent or reduce bleeding in congenital hemophilia A with or without FVIII inhibitors.

High‑level indication: Hemlibra is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (newborn and older) with hemophilia A (congenital FVIII deficiency) with or without FVIII inhibitors.

Boxed warnings: the policy notes boxed warnings for thrombotic microangiopathy and thromboembolism.

Approval durations: For initial and continued therapy the Commercial approval is 6 months or to the member's renewal date, whichever is longer; Medicaid/HIM initial approvals are generally 6 months (with HIM Texas noted at 12 months for some authorizations) and continued therapy approvals are 12 months for Medicaid/HIM per the policy updates.

Key Thresholds / Dosing

Inhibitor level>= 5 Bethesda units (BU)

Severe hemophilia (FVIII)< 1%

Initial dosing limit<= 3 mg/kg/week for first 4 weeks

Maintenance dosing option 11.5 mg/kg weekly

Maintenance dosing option 23 mg/kg every 2 weeks

Maintenance dosing option 36 mg/kg every 4 weeks

Initial Therapy Criteria

I. Initial Approval Criteria - A. Congenital Hemophilia A Without Inhibitors

must meet all

ALL of the following

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
Member meets one
- Failure of a FVIII product (e.g., Advate, Adynovate, Eloctate) used for routine prophylaxis as assessed and documented by prescriber; Prior authorization is required for FVIII products
- Member has poor venous access, does not tolerate frequent venous access, or has central line or port placement

Continuation Therapy Criteria

II. Continued Therapy Criteria - A. Congenital Hemophilia A With or Without Inhibitors

must meet all

ALL of the following

Member must meet one
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Examples: reduction in number of all bleeds, joint bleeds, or target joint bleeds over time

Unapproved Indications / Exclusions

III. Diagnoses/Indications NOT authorized

Non-FDA approved indications which are not addressed in this policy are not authorized unless sufficient documentation of efficacy/safety per off-label use policies or evidence of coverage documents

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Applicable Codes

HCPCS - Drug J-codeHCPCSCovered

J7170

Injection, emicizumab-kxwh, 0.5 mg

Provider Actions

Prior Authorization

Prior authorization for Hemlibra and FVIII products

Prior authorization is required for Hemlibra and for FVIII products. Approval must be obtained prior to coverage.

J7170

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria. Documentation of the member's current body weight in kilograms is required for initial requests and when requesting a dose increase.

Clinical Evidence & References

Evidence: Hemlibra Prescribing Information, Genentech, January 2024; WFH guidelines (WFH 2020 guidelines referenced).

Note: WFH guidance was used to update sites defined as serious bleed sites and to inform timing of prophylaxis; no trial metric cards are provided in the policy (no trial metrics included).

Background

Background: Emicizumab‑kxwh (Hemlibra) is a bispecific factor IXa‑ and factor X‑directed antibody indicated for routine prophylaxis to prevent or reduce bleeding in patients with congenital hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors.

Product availability/packing update: single‑dose vial strengths include 12 mg/0.4 mL and 300 mg/2 mL among other concentrations per the updated product availability.

Definitions:

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

Spontaneous bleed: A bleeding episode that occurs without apparent cause and is not the result of trauma.

Revision History

10.29.24material_changeLatest

Revised Commercial approval duration to '6 months or to the member's renewal date, whichever is longer;' revised continued approval duration for Medicaid and HIM lines of business from 6 months to 12 months.

05.24clarification

Clarified documentation requirement for continued therapy: member's current weight is only needed if a higher dose is being requested.

02.24added

Policy Summary

Payermhn

PolicyClinical Policy: Emicizumab-kxwh (Hemlibra)

Policy CodePolicy CP.PHAR.370

Change Typeclarified; revised; added

Effective DateMar 1, 2018

Next Review Date

On This Page

For members new to Hemlibra and not previously used FVIII products for routine prophylaxis, member meets one

Member has severe hemophilia (defined as FVIII level of < 1%)
Member has experienced at least one serious spontaneous bleed (see Appendix D)

Provider confirms that member will discontinue any use of FVIII products as prophylactic therapy while on Hemlibra (on-demand usage may be continued)

Documentation of member's current body weight (in kg)

Dose does not exceed 3 mg/kg per week during the first four weeks of therapy, followed by either 1.5 mg/kg per week, 3 mg/kg once every two weeks, or 6 mg/kg once every four weeks thereafterdosing regimens exact

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I. Initial Approval Criteria - B. Congenital Hemophilia A With Inhibitors

must meet all

ALL of the following

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)Inhibitor level >= 5 BU
Provider confirms that member will discontinue any use of bypassing agents or FVIII products as prophylactic therapy while on Hemlibra (on-demand usage may be continued)
Documentation of member's current body weight (in kg)
Dose does not exceed 3 mg/kg per week during the first four weeks of therapy, followed by either 1.5 mg/kg per week, 3 mg/kg once every two weeks, or 6 mg/kg once every four weeks thereafterdosing regimens exact

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I. Initial Approval Criteria - C. Other diagnoses/indications

must meet 1 or 2

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to formulary/no coverage or non-formulary policies as specified (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under section III AND criterion 1 above does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

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Provider confirms that member has discontinued any use of bypassing agents (if member has inhibitors) or FVIII products as prophylactic therapy while on Hemlibra (on-demand usage may be continued)

If request is for a dose increase, both

Documentation of member's current body weight in kg (if requesting a higher dose than previously requested)
New dose does not exceed 3 mg/kg per week during the first four weeks of therapy, followed by either 1.5 mg/kg per week, 3 mg/kg once every two weeks, or 6 mg/kg once every four weeks thereafterdosing regimens exact

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II. Continued Therapy Criteria - B. Other diagnoses/indications

must meet 1 or 2

ANY of the following

If a recent label change not reflected here, refer to formulary/no coverage or non-formulary policies as specified
If requested use not listed under section III and criterion 1 doesn't apply, refer to off-label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53)

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Boxed warnings and safety exclusions: the policy includes boxed warnings for thrombotic microangiopathy and thromboembolism.

Safety‑related exclusions/requirements: concurrent use with certain agents is restricted—specifically there is potential for thrombotic microangiopathy and thrombotic events when used concurrently with FEIBA > 100 U/kg/day for 24 hours or more; additional monitoring is recommended and the policy recommends discontinuation of FEIBA and suspended dosing of Hemlibra if symptoms occur. The policy also requires that providers confirm patients will discontinue or have discontinued use of FVIII products or bypassing agents as prophylactic therapy while on Hemlibra (on‑demand use may continue).

Documentation Required

Discontinue other prophylactic agents

Provider must confirm discontinuation of FVIII products as prophylactic therapy while the member is on Hemlibra; if inhibitors are present, bypassing agents must also be discontinued for prophylaxis. On‑demand use of FVIII products or bypassing agents may be continued.

Documentation Required

Weight documentation for dose increases

When requesting a higher dose than previously approved, the provider must document the member's current body weight in kilograms. Dosing must adhere to the policy limits (loading: ≤3 mg/kg/week for first 4 weeks; maintenance: 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks).

Denial Risk

Off-label or non-FDA indications

Requests for non‑FDA approved indications not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies or evidence of coverage.

CP.CPA.09
HIM.PA.154
CP.PMN.53

Updated product packaging: added new vial strengths 12 mg/0.4 mL and 300 mg/2 mL to product availability.

02.25clarified

Respective diagnosis criterion for each Hemlibra indication was clarified to add 'WITH inhibitors' and 'WITHOUT inhibitors' to reduce reviewer confusion.