CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Emicizumab (Hemlibra) for Hemophilia A prophylaxis

Policy governing authorization, dosing, and renewal criteria for emicizumab (Hemlibra) used for routine prophylaxis in patients with congenital Hemophilia A, with or without inhibitors, for Neighborhood Health Plan of Rhode Island (Medicaid, Commercial, Medicare as specified).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEmicizumab (Hemlibra) for Hemophilia A prophylaxis

Policy CodePolicy N/A

Change TypeMinor or no material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization requests monthly for dispensing quantity and include required clinical documentation confirming diagnosis, inhibitor status, prior therapies, and on-hand medication amounts.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial auth period

12 monthsrenewal period

J7170HCPCS code

loading + maintenancedosing overview

D66ICD-10 example

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Coverage Criteria for Emicizumab (Hemlibra)

Initial Approval — Hemophilia A with inhibitors

Covered when ALL of the following are met

Hemophilia A with inhibitors initial criteria

Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing.
Patient has inhibitors to Factor VIII with a current or historical titer of ≥ 5 Bethesda Units (BU).
Patients with inhibitor titer levels >0.6 BU to <5 BU will be evaluated on a case-by-case basis if not responding to or not a candidate for standard factor replacement.
Must be used as routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Prophylaxis indication
- Used as primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level of <1%).
- Used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints.
Not used in combination with Immune Tolerance Induction (ITI).
Prior bleeding or prior therapy
- Patient has at least two documented episodes of spontaneous bleeding into joints.
- Patient has documented trial and failure of Immune Tolerance Induction (ITI).
- Patient has documented trial and failure of or is currently on routine prophylaxis with a bypassing agent (e.g., NovoSeven, FEIBA).

Operational note: Use in combination with other prophylactic hemophilia agents is not permitted; patients with titer >0.6 to <5 BU may be considered case-by-case if not candidates for standard factor replacement.

Initial Approval — Hemophilia A without inhibitors

Covered when ALL of the following are met

Hemophilia A without inhibitors initial criteria

Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing.
Used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Prophylaxis indication
- Primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level of <1%).
- Secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints.

Emicizumab (Hemlibra) must not be used in combination with another agent used as prophylactic therapy for Hemophilia A. An important exception is that prophylactic use of factor VIII (FVIII) products may be continued during the first week of Hemlibra prophylaxis to allow transition per the prescriber’s clinical judgment.

Use of emicizumab in combination with any other prophylactic hemophilia agent is explicitly excluded by the policy. Providers should not prescribe concurrent routine prophylactic therapies alongside Hemlibra except for the limited, time‑bound FVIII overlap described above.

Coding — HCPCS, NDC, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J7170

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

Related Hemophilia Drug Codes (drug chart listings)HCPCS

J7189	Novoseven RT (listed in drug chart)
J7212	Sevenfact (listed in drug chart)
J7198	Feiba (Anti-Inhibitor Coagulant Complex)
J7192	Factor VIII products (Advate, Kogenate FS, Helixate FS, Recombinate)
J7211	Kovaltry
J7205	Eloctate
J7190	Koate / Koate-DVI; Hemofil M
J7182	Novoeight
J7209	Nuwiq
J7188	Obizur

1–10 of 25

1/3

NDCsNDC

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

Diagnosis codes mentionedICD-10

D66	Hereditary factor VIII deficiency

inv-09: Inhibitor titer threshold — Bethesda Units thresholds and case-by-case guidance

Primary thresholdCurrent or historical inhibitor titer ≥ 5 Bethesda Units (BU)

Lower-range cases>0.6 BU to <5 BU — evaluated on a case-by-case basis if not responding to or not a candidate for standard factor replacement

Clinical contextThreshold applies to patients with congenital factor VIII deficiency being considered for routine prophylaxis to prevent or reduce bleeding episodes

Exclusion with ITINot used in combination with Immune Tolerance Induction (ITI); documented trial/failure of ITI is an alternative criterion

Provider Actions, Authorization & Documentation Requirements

Prior Authorization

Authorization Period and Submission

Initial authorizations are provided for a limited period and require ongoing monthly submission for dispensing. Providers must request the initial authorization (standard initial period: 3 months unless otherwise specified for the indication) and submit renewal requests as required. The cumulative on-hand supply will be considered when authorizing or renewing. Authorizations may be renewed every 12 months unless the indication specifies a different interval.

Initial authorization period: typically 3 months (may vary by indication)
Renewal frequency: may be renewed every 12 months unless otherwise specified
Authorization decisions will consider cumulative on-hand medication quantities

Documentation Required

Dispensing Authorization & Monthly Submission (Rendering Providers)

Dispensing of factor products by rendering providers is subject to specific monthly authorization and attestation requirements as part of the Hemophilia Management Program. Prescriptions must not be auto-filled and require an expressed need from the patient, caregiver, or prescriber. Each month the rendering provider must submit a request/attestation for the dispensing quantity prior to delivering product, taking into account the patient’s on-hand supply.

Background — Drug and Indication Overview

Emicizumab (Hemlibra) is a bispecific monoclonal antibody indicated for routine prophylaxis to prevent or reduce bleeding frequency in patients with congenital Hemophilia A. In clinical practice it is used as ongoing prophylaxis in patients with or without inhibitors and is administered following a loading phase into a weight‑based maintenance schedule.

Definitions and Key Terms

inv-19: Factor VIII inhibitor titer (Bethesda Units) — definition and thresholds used in policy

Definition (term)Factor VIII inhibitor titer (Bethesda Units)

Policy threshold≥ 5 Bethesda Units (BU) qualifies as inhibitor-positive for coverage criteria

Case-by-case range>0.6 BU to <5 BU — may be considered on a case-by-case basis if patient is not responding to or not a candidate for standard factor replacement

Use in criteriaRequired to document current or historical titer for Hemophilia A with inhibitors initial approval

inv-20: D66 — ICD-10 definition for hereditary factor VIII deficiency

ICD-10 codeD66