Emicizumab-kxwh (Hemlibra) (ARCHIVED)

Policy ID: I-9010-007

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 22, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-9010-007

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 22, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Emicizumab-kxwh (Hemlibra ^® ) is a humanized monoclonal modified immunoglobulin G4(IgG4) antibody with a bispecific antibody structure binding factor IXa and factor X. Emicizumab bridges activated factor IX and factor X to restore the function of activated factor VIII.

NOTE: Emicizumab-kxwh (Hemlibra) is a pharmacy benefit as an individual may be taught to self-inject ¹ . Emicizumab-kxwh (Hemlibra) may be a medical benefit for pediatric individuals less than seven (7) years of age as self-administration is not recommended for this population ¹ .

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Emicizumab-kxwh (Hemlibra) may be considered medically necessary when the following criteria are met:

ONE (1) of the following:
- There is information that the individual has been treated with emicizumab-kxwh (Hemlibra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with emicizumab-kxwh (Hemlibra) (starting on samples is not approvable) within the past 90 days and is at risk if therapy is changed; or
- The individual has a diagnosis of hemophilia A with or without inhibitors; and
Emicizumab-kxwh (Hemlibra) will be used as prophylaxis to prevent or reduce the frequency of bleeding episodes; and
The prescriber is a specialist in the area of the individual's diagnosis [e.g., prescriber working in a hemophilia treatment center (HTC), hematologist with hemophilia experience] or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with any of the following while on maintenance dosing with the requested agent:
- Prophylaxis with a Factor VIIa product (e.g., NovoSeven RT); or
- Prophylaxis with a Factor VIII product (e.g., Advate, Adynovate, Eloctate, Nuwiq, Recombinate, Xyntha); or
- Prophylaxis with a bypassing agent (e.g., Feiba, NovoSeven); or
- Immune tolerance therapy (ITT) (immune tolerance induction [ITI]); and
If the individual is receiving Feiba [activated prothrombin complex concentrate (aPCC)] for breakthrough bleeds, BOTH of the following:
- The individual will be monitored for thrombotic microangiopathy and thromboembolism; and
- The prescriber has counseled the individual on the maximum dosages of Feiba to be used (i.e., no more than 100 u/kg/24 hours); and
The individual does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).

Reauthorization Criteria

Reauthorization of emicizumab-kxwh (Hemlibra) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for emicizumab-kxwh (Hemlibra) through Blue Cross Blue Shield of North Dakota's Prior Authorization process; and
ONE (1) of the following:
- The individual has had improvements or stabilization since starting emicizumab-kxwh (Hemlibra) indicated by less breakthrough bleeds as reported in the treatment log and/or chart notes (medical records including treatment log and/or chart notes required); or
- There is support for the continued use of emicizumab-kxwh (Hemlibra) (medical record required); and
If the individual is receiving Feiba [activated prothrombin complex concentrate (aPCC)] for breakthrough bleeds, the individual will be monitored for thrombotic microangiopathy and thromboembolism; and
The prescriber is a specialist in the area of the individual's diagnosis [e.g., prescriber working in a hemophilia treatment center (HTC), hematologist with hemophilia experience] or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with any of the following:
- Prophylaxis with a Factor VIIa product (e.g., NovoSeven RT); or
- Prophylaxis with a Factor VIII product (e.g., Advate, Adynovate, Eloctate, Nuwiq, Recombinate, Xyntha); or
- Prophylaxis with a bypassing agent (e.g., Feiba, NovoSeven); or
- Immune tolerance therapy (ITT) (immune tolerance induction [ITI]); and
The individual does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).

The use of emicizumab-kxwh (Hemlibra) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J7170

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

D66

Professional Statements and Societal Positions Guidelines

FDA Labeled Contraindication(s)

None

ND Committee Review

Internal Medical Policy Committee 1-19-2021

Adopted medical policy to mirror currently available pharmacy policy

Internal Medical Policy Committee 1-20-2022

Updated initial and reauthorization criteria

Internal Medical Policy Committee 9-28-2022

Added criteria 'The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with nonsteroidal anti-inflammatory agents (NSAIDS) (e.g., aspirin, ibuprofen);'

Internal Medical Policy Committee 1-26-2023 Effective February 01, 2023

Updated initial and reauthorization criteria
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023 Effective October 01, 2023

Updated combination therapy criteria

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Removed NSAID criteria

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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