CurrentMedical Mutual - OhioPolicy 201805 MRx

Hemlibra (emicizumab-kxwh) prophylaxis for Hemophilia A

Policy governs prior authorization, coverage criteria, dosing, and renewal for Hemlibra (emicizumab-kxwh) used as routine prophylaxis in patients with congenital hemophilia A, including those with and without inhibitors; applies to Medical Mutual - Ohio members and providers seeking medical-benefit coverage.

Policy Summary

PayerMedical Mutual - Ohio

PolicyHemlibra (emicizumab-kxwh) prophylaxis for Hemophilia A

Policy CodePolicy 201805 MRx

Change TypeMinor/administrative — no material clinical changes

Effective Date02/18/2018

Next Review DateJun 19, 20266d

Key ActionObtain prior authorization for HCPCS J7170 and submit required documentation supporting trials of other agents when noted in the criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial authorization duration

J7170HCPCS code

690 unitsloading dose x4

1380 unitsmaintenance (28 days)

D66covered diagnosis

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Coverage Criteria for Hemlibra (emicizumab-kxwh)

inv-01: Initial Approval Criteria

Covered when ALL of the following are met for the specified Hemophilia A populations

Universal

Dosing options: Loading and maintenance dosing per policy: loading 3 mg/kg subcutaneously once weekly for 4 weeks; maintenance: 1.5 mg/kg weekly OR 3 mg/kg every 2 weeks OR 6 mg/kg every 4 weeks.
See dosage/administration section (weight-based).

With inhibitors: Patient has current or historical inhibitor titer ≥ 5 Bethesda Units (BU) (patients with >0.6 to <5 BU may be evaluated case-by-case); used as routine prophylaxis to prevent or reduce bleeding episodes; used as primary prophylaxis if severe (factor VIII <1%) OR as secondary prophylaxis after ≥2 documented spontaneous joint bleeds; not used in combination with Immune Tolerance Induction (ITI); alternatively qualifies with documented trial/failure of ITI or documented trial/failure of, or current use of, routine prophylaxis with a bypassing agent (e.g., NovoSeven, Feiba).>= 5 BU (inhibitor titer)

Patients with >0.6 to <5 BU evaluated case-by-case.

Without inhibitors: Used for routine prophylaxis to prevent or reduce bleeding episodes; indicated as primary prophylaxis in severe disease (factor VIII level <1%) OR secondary prophylaxis after ≥2 documented spontaneous joint bleeds; patient must be unsuitable for shorter half-life recombinant FVIII products at a total weekly dose ≤ 100 IU/kg (prescriber attestation required).factor VIII < 1% for severe disease

Prescriber must attest unsuitability for shorter half-life FVIII when applicable.

inv-02: Renewal Criteria

Renewal is permitted when ALL of the following are met

Renewal: Patient continues to meet the universal and indication-specific criteria from initial approval (including concomitant therapy requirements where applicable); there is absence of unacceptable toxicity to the drug (examples: thrombotic microangiopathy, thromboembolic events, development of neutralizing antibodies/inhibitors); and the patient has demonstrated a beneficial response to therapy (decreased frequency of bleeding episodes from pre-treatment baseline).

Examples of unacceptable toxicity listed are illustrative, not exhaustive.

Hemlibra (emicizumab) must not be used in combination with another prophylactic Hemophilia A agent. An exception is that prophylactic factor VIII (FVIII) products may be continued during the first week of emicizumab prophylaxis to allow for limited overlap. This restriction applies to all patients considered for routine prophylaxis under this policy and is a requirement of the universal coverage criteria.

The Company may deny reimbursement when services are determined to be not medically necessary, investigational or experimental, not within the scope of benefits, or when a pattern of billing or practice is inappropriate or excessive. Additional documentation supporting medical necessity must be made available upon request and may include patient records, test results, and/or provider credentials. The Company reserves the right to modify or interpret this policy and to request whatever documentation is necessary to make a coverage determination.

Use of Hemlibra in combination with another prophylactic Hemophilia A agent is not permitted except for the limited overlap allowing continuation of prophylactic FVIII during the first week of emicizumab initiation. Combination with Immune Tolerance Induction (ITI) is explicitly prohibited for patients with inhibitors.

Charges may be denied and must be written off if the service is determined to be not medically necessary. Prior approval requests that do not meet policy criteria may be escalated, forwarded for physician review, and ultimately denied; participating providers may be required to write off charges denied as not medically necessary. The Company may also request additional documentation to support medical necessity as part of the review process.

Coding — HCPCS, NDC, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J7170

Injection, emicizumab-kxwh, 0.5 mg; 1 billable unit = 0.5 mg

NDCsNDC

50242-0927-xx	Hemlibra 12 mg/0.4 mL SDV (example NDC format)
50242-0920-xx	Hemlibra 30 mg/mL SDV
50242-0921-xx	Hemlibra 60 mg/0.4 mL SDV
50242-0922-xx	Hemlibra 105 mg/0.7 mL SDV
50242-0923-xx	Hemlibra 150 mg/mL SDV
50242-0930-xx	Hemlibra 300 mg/2 mL SDV

Covered Diagnosis CodesICD-10Covered

D66	Hereditary factor VIII deficiency

Prior authorization required HCPCSHCPCSCovered

J7170

Hemlibra (emicizumab) - HCPCS code requiring prior approval

Covered Diagnosis CodesICD-10Covered

D66	Hereditary factor VIII deficiency

Inhibitor titer threshold

Inhibitor titer thresholdPatients with inhibitors defined as current or historical titer ≥ 5 Bethesda Units (BU).

Borderline titersPatients with inhibitor titers >0.6 BU to <5 BU will be evaluated on a case‑by‑case basis.

Unit of measureTiter measurement reported in Bethesda Units (BU).

Severe factor VIII level

Severe factor VIII levelSevere disease defined as factor VIII level < 1%.

Use in primary prophylaxis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Documentation

Prior approval is required for some or all procedure codes listed in this Corporate Medical Policy. Initial and renewal requests for the medication(s) listed in this policy are subject to site of care management. When billed under the medical benefit, administration of the medication will be restricted to a non-hospital facility-based location (i.e., home infusion provider, provider's office, free-standing ambulatory infusion center) unless the member meets the site of care exception criteria. To view the exception criteria and a list of medications subject to site of care management please click here.

Prior authorization recommended/required for medical benefit coverage of Hemlibra; initial and renewal requests are subject to site-of-care management.
Prescriber must provide written documentation supporting trials of other agents when noted in criteria (chart notes, prescription claims records, and/or prescription receipts).
The Company may request additional documentation to support medical necessity (patient records, test results, provider credentials).
A participating provider will be required to write off charges denied as not medically necessary.

Prior Authorization

Definitions and Usage

Routine prophylaxis

DefinitionRoutine prophylaxis: use of Hemlibra to prevent or reduce the frequency of bleeding episodes in congenital hemophilia A patients administered per specified loading and maintenance dosing regimens.

Loading regimen3 mg/kg subcutaneously once weekly for the first 4 weeks (loading phase).

Maintenance optionsMaintenance dosing options: 1.5 mg/kg once weekly, OR 3 mg/kg every 2 weeks, OR 6 mg/kg every 4 weeks.

IndicationsApplicable for patients with or without inhibitors when coverage criteria are met.

Inhibitor titer

Measurement unitInhibitor titer reported in Bethesda Units (BU).

Background

Hemlibra (emicizumab) is a bispecific antibody that binds activated factor IX (FIXa) and factor X (FX) and is indicated for routine prophylaxis to prevent or reduce bleeding episodes in congenital Hemophilia A, including patients with and without inhibitors. Dosing options described in the policy include a loading phase followed by weight-based maintenance regimens; the policy also specifies use restrictions such as prohibition of combination prophylactic Hemophilia A agents (with allowance for brief FVIII overlap during the first week) and prohibition of combination with Immune Tolerance Induction (ITI) in inhibitor-positive patients.

Revision History

06/19/2025policy_revisionLatest

Policy last revised and annual review completed; Last Revised Date and Annual Review Date recorded as 06/19/2025.

02/18/2018initial_effective_date

Policy initial effective date established (201805 MRx).