Inebilizumab-cdon (Uplizna) (ARCHIVED)

Policy ID: I-227-007

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 16, 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**This policy has been Archived effective December 08, 2024.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-227-007

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Inebilizumab-cdon (Uplizna ^TM ) is a CD-19 directed monoclonal antibody. Inebilizumab (Uplizna) is presumed to bind to CD-19 receptors on pre-B and mature B lymphocytes leading to antibody-dependent cellular cytolysis.

Inebilizumab (Uplizna) requires hepatitis B and tuberculosis screening prior to the first dose. It also requires premedication with a corticosteroid, an antihistamine and an antipyrectic prior to each dose.

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.

Inebilizumab (Uplizna) may be considered medically necessary when the following criteria are met:

Individual 18 years of age or older; and
Individual diagnosed with neuromyelitis optica spectrum disorder (NMOSD) as confirmed by ANY of the following:
- Optic neuritis; or
- Acute myelitis; or
- Area postrema syndrome: episode of otherwise unexplained hiccups or nausea and vomiting; or
- Acute brainstem syndrome; or
- Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions; or
- Symptomatic cerebral syndrome with NMOSD-typical brain lesions; and
Individual is anti-aquaporin-4 (AQP4) antibody positive; and
Diagnosis of multiple sclerosis (MS) or other diagnoses have been ruled out; and
Prescribed by or in consultation with a neurologist or other healthcare provider experienced in treating NMOSD; and
Individual is not concomitantly being treated with disease modifying therapies for MS or NMOSD.

Reauthorization Criteria

Reauthorization of inebilizumab (Uplizna) may be considered medically necessary when the following criteria are met:

Individual diagnosed with AQP4 antibody positive NMOSD; and
Prescribed by or in consultation with a neurologist or other healthcare provider experienced in treating NMOSD; and
Individual has demonstrated a positive clinical response from baseline as demonstrated by a documented reduction in the signs and symptoms of NMOSD and/or reduction in the number and/or severity of relapses.

The use of inebilizumab (Uplizna) 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

J1823

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

G36.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020

Adopted pre-certification policy, was previously policy number I-9009

Internal Medical Policy Committee 1-19-2021

Added new code J1823

Internal Medical Policy Committee 3-17-2021 No clinical content change

Internal Medical Policy Committee 3-23-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 5-24-2022

Updated the experimental/investigational statement

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Removed authorization time frame criteria
Updated E/I statement

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Annual review no clinical content change

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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