CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hemlibra (emicizumab-kxwh) for Hemophilia A prophylaxis

Defines coverage and prior authorization criteria for Hemlibra used as routine prophylaxis to prevent or reduce bleeding episodes in members with hemophilia A, including documentation, prescriber specialty, dosing, and continuation requirements. Applies to Neighborhood Health Plan of Rhode Island members subject to plan exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemlibra (emicizumab-kxwh) for Hemophilia A prophylaxis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation; for continuation include chart notes showing benefit (reduction in frequency or severity of bleeds).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

3 optionsmaintenance dosing options

Hematologistprescriber restriction

Coverage Criteria for Hemlibra (emicizumab-kxwh)

Initial and continuation coverage criteria

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Eligibility and indication: Member has hemophilia A (congenital factor VIII deficiency) and Hemlibra is being used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes (includes FDA‑approved indications and compendial uses).

Based on FDA‑approved indication and policy introductory statements

Disease severity: Member has moderate or severe disease OR member has mild disease with insufficient response to desmopressin or a documented clinical reason for not using desmopressin.

Severity definitions in Appendix A; Appendix B lists clinical reasons for not using desmopressin

Factor VIII prophylaxis discontinuation: Prophylactic use of factor VIII products (e.g., Advate, Adynovate, Eloctate) will be discontinued after the first week of starting Hemlibra.

Prevents concurrent prophylactic factor VIII use

Prescriber requirement: Medication must be prescribed by or in consultation with a hematologist.

Prescriber specialty requirement

Dosing limits: Induction: 3 mg/kg subcutaneously once weekly for the first 4 weeks. Maintenance: 1.5 mg/kg once weekly, or 3 mg/kg once every 2 weeks, or 6 mg/kg once every 4 weeks; dosing must not exceed these schedules.

Specified in dosing and administration

Continuation criteria: For reauthorization, member must demonstrate benefit from therapy (e.g., reduced frequency or severity of bleeds) and must not be using Hemlibra in combination with factor VIII products for prophylactic use; reauthorization may be granted for 12 months.

Documentation required per continuation section

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hemlibra when used for routine prophylaxis in hemophilia A. Hemlibra is covered for FDA-approved indications and compendial uses only; requests for other indications are considered experimental/investigational and are not covered.

Authorization duration: up to 12 months for eligible members
Not covered for off-label indications

Prior Authorization

Desmopressin Trial or Documented Reason for Avoidance

Members with mild hemophilia A must have had an insufficient response to desmopressin or have a documented clinical reason for not using desmopressin prior to approval of Hemlibra for routine prophylaxis. Acceptable clinical reasons include the listed items in Appendix B (e.g., age <2 years, pregnancy, fluid/electrolyte imbalance, predisposition to thrombosis, high cardiovascular/cerebrovascular risk, trauma requiring surgery, contraindication or intolerance to desmopressin, life‑threatening bleed, or product shortage).

Appendix B acceptable reasons: pregnancy; age < 2 years; fluid/electrolyte imbalance; predisposition to thrombus formation; high cardiovascular/cerebrovascular risk; trauma requiring surgery; contraindication or intolerance to desmopressin; life‑threatening bleed; Stimate nasal spray unavailable due to shortage.
For mild disease, documentation of desmopressin trial and response or documentation of specific clinical reason to avoid desmopressin must be submitted.

Documentation Required

Required Documentation for Prior Authorization and Reauthorization

Submission of documentation is required to initiate prior authorization and reauthorization reviews. For continuation requests, chart notes must document clinical benefit from therapy (for example, reduced frequency or severity of bleeds). Reauthorization may be granted for up to 12 months when benefit is documented and the member is not using Hemlibra in combination with factor VIII products for prophylactic use.

Provide chart notes showing reduced bleed frequency/severity for reauthorization
Confirm Hemlibra is not being used concomitantly with prophylactic factor VIII products

Denial Risk

Off‑Label Indications Not Covered

Requests for indications other than FDA‑approved indications and compendial uses will be considered experimental/investigational and are not covered.

Background

Hemophilia A is a congenital deficiency of factor VIII. Disease severity is classified by baseline factor VIII activity: severe disease corresponds to <1% activity and is associated with spontaneous bleeding episodes (typically into joints and muscles), moderate disease corresponds to 1–5% activity with occasional spontaneous bleeding and pronounced bleeding with trauma or surgery, and mild disease corresponds to 6–40% activity with bleeding mainly related to significant injury, trauma, or surgery. Hemlibra is indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A, with or without factor VIII inhibitors.

Hemophilia A Severity Definitions

Severe hemophilia A — key clinical features

Clotting factor VIII activity<1%

Bleeding patternSpontaneous bleeding episodes, predominantly into joints and muscles

Bleeding severity with trauma/surgerySevere bleeding with trauma, injury, or surgery

Moderate hemophilia A — key clinical features

Clotting factor VIII activity1% to 5%

Bleeding patternOccasional spontaneous bleeding episodes

Bleeding severity with trauma/surgerySevere bleeding with trauma, injury, or surgery

Mild hemophilia A — key clinical features

Clotting factor VIII activity6% to 40%

Bleeding patternSevere bleeding mainly associated with serious injury, trauma, or surgery

Spontaneous bleedingNot typically spontaneous; bleeding occurs primarily with significant provocation