CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Emicizumab (Hemlibra) for Hemophilia A prophylaxis — Coverage Criteria

Covers use of Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A when approval criteria are met; applies to prescribers and members of Neighborhood Health Plan of Rhode Island (per document).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEmicizumab (Hemlibra) for Hemophilia A prophylaxis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; up to 12 months may be granted when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

3maintenance dosing options

induction+maintenanceincludes induction

hematologistprescriber requirement

FDA onlyindications limited to

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Coverage Criteria for Emicizumab (Hemlibra)

Initial and continuation therapy

Covered when ALL of the following are met

Hemophilia A diagnosis and indication: Member has hemophilia A (congenital factor VIII deficiency) and the requested medication is being used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; indication is FDA‑approved or a compendial use and the member has no exclusions to the prescribed therapy

Supported by policy indications and Section IV

Disease severity and desmopressin requirement

Moderate or severe disease: Member has moderate or severe hemophilia A (see Appendix A)
Chunk 4
Mild disease with desmopressin failure or contraindication: Member has mild hemophilia A and has had an insufficient response to desmopressin or there is a documented clinical reason for not using desmopressin (see Appendix B)
Chunk 4

Prophylactic factor VIII discontinuation: Prophylactic use of factor VIII products will be discontinued after the first week of starting the requested therapy; member must not be using Hemlibra in combination with factor VIII products for prophylactic use

Concurrent prophylactic factor VIII use is not allowed

Authorization duration and demonstrated benefit: Authorization of up to 12 months may be granted for initial or continued treatment when the member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds)12 months

Chunks 4 and 6

Exclusions and investigational uses: All other indications (not FDA‑approved or compendial) are considered experimental/investigational and not medically necessary

Chunk 1

All indications other than FDA-approved indications and compendial uses are considered experimental/investigational and not medically necessary.

Use of Hemlibra (emicizumab) for indications that are not FDA-approved is considered not medically necessary.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hemlibra (emicizumab‑kxwh). Authorization may be granted for up to 12 months when criteria are met.

Authorization duration: up to 12 months when criteria are met
Prior authorization required for routine prophylaxis in Hemophilia A

Prior Authorization

Desmopressin Trial or Contraindication

For members with mild hemophilia A, a documented trial showing insufficient response to desmopressin or a documented clinical reason for not using desmopressin is required.

Desmopressin trial or documented clinical reason for not using desmopressin (see Appendix B)

Documentation Required

Required Documentation for Prior Authorization and Continuation

Submit the following documentation to initiate prior authorization review. For continuation (reauthorization) requests, provide chart notes documenting clinical benefit from therapy (for example, reduced frequency or severity of bleeds) and evidence that the member is not receiving concurrent prophylactic factor VIII products.

Initial requests: clinical documentation supporting diagnosis of hemophilia A and need for routine prophylaxis
Continuation requests: chart notes documenting benefit (reduced frequency or severity of bleeds)
Documentation that prophylactic use of factor VIII products will be discontinued after the first week of starting Hemlibra and that Hemlibra is not being used in combination with prophylactic factor VIII products

Denial Risk

Non–FDA‑Approved Indications

Requests for indications that are not FDA‑approved and not supported by compendia are considered experimental, investigational, and not medically necessary.

Hemlibra is FDA‑approved for routine prophylaxis to prevent or reduce bleeds in patients with hemophilia A (with or without inhibitors). All other indications are not medically necessary.

Denial Risk

Concurrent Prophylactic Factor VIII Use Not Permitted

Concurrent prophylactic use of factor VIII products (e.g., Advate, Adynovate, Eloctate) with Hemlibra for routine prophylaxis is not allowed; combination prophylactic use may result in denial.

Prophylactic factor VIII products must be discontinued after the first week of Hemlibra initiation
Requests indicating concurrent prophylactic use of factor VIII products may be denied

Hemophilia Severity Definitions

Severe hemophilia

Factor VIII activity<1%

Bleeding patternSpontaneous bleeding episodes, predominantly into joints and muscles

Bleeding severitySevere bleeding with trauma, injury, or surgery

Moderate hemophilia

Factor VIII activity1% to 5%

Bleeding patternOccasional spontaneous bleeding episodes

Bleeding severitySevere bleeding with trauma, injury, or surgery

Mild hemophilia

Factor VIII activity6% to 40%

Bleeding patternSevere bleeding primarily with serious injury, trauma, or surgery

Spontaneous bleedingNot typical as primary presentation

OpenPayer

Emicizumab (Hemlibra) for Hemophilia A prophylaxis — Coverage Criteria

Coverage Criteria for Emicizumab (Hemlibra)

Product and Dosing Coding

Prior Authorization, Documentation, and Provider Requirements

Background

Hemophilia Severity Definitions