Ublituximab-xiiy (Briumvi) (ARCHIVED)

Policy ID: I-9031-005

Section: Injections

Effective Date: April 01, 2023

Revised Date: October 20, 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**This policy has been Archived effective December 08, 2024.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-9031-005

Section: Injections

Effective Date: April 01, 2023

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Ublituximab-xiiy (Briumvi) is a CD20-directed cytolytic antibody indicated for the treatmentof relapsing forms of multiple sclerosis (MS).

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.

Ublituximab-xiiy (Briumvi) may be considered medically necessary when ALL of the following criteria are met:

ONE of the following:
- Information has been provided that the individual has been treated with ublituximab-xiiy (Briumvi) within the past 210 days OR
- The prescriber states the individual has been treated with ublituximab-xiiy (Briumvi) within the past 210 days AND is at risk if therapy is changed OR
- BOTH of the following:
  - ONE of the following:
    - The individual has a diagnosis of a relapsing form of multiple sclerosis (MS) OR
    - The individual has another FDA approved indication for ublituximab-xiiy (Briumvi) and route of administration AND
  - If the individual has an FDA approved indication, ONE of the following:
    - The individual's age is within FDA labeling for the requested indication for ublituximab-xiiy (Briumvi) OR
    - The prescriber has provided information in support of using ublituximab-xiiy (Briumvi) for the individual's age for the requested indication AND
The prescriber is a specialist in the area of the individual's diagnosis (i.e., neurologist), or the prescriber has consulted with a specialist in the area of the individual's diagnosis AND
The individual will NOT be using ublituximab-xiiy (Briumvi) in combination with another disease modifying agent (DMA) for the requested indication.

The use of ublituximab-xiiy (Briumvi) for all other indications not listed in this policy or for any other body joint other than the knee 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

J2329

Reauthorization Criteria

Ublituximab-xiiy (Briumvi) may be considered medically necessary when the following criteria are met:

The individual has previously been approved for ublituximab-xiiy (Briumvi) through Blue Cross Blue Shield of North Dakota's precertification process AND
The individual has had clinical benefit from treatment with ublituximab-xiiy (Briumvi) AND
The prescriber is a specialist in the area of the individual's diagnosis (i.e., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis AND
The individual will NOT be using ublituximab-xiiy (Briumvi) in combination with another disease modifying agent (DMA) for the requested indication.

Procedure Code

J2329

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

G35

Professional Statements and Societal Positions Guidelines

Contraindicated as Concomitant Therapy

MS Disease Modifying Agents

Aubagio (teriflunomide)
Avonex (interferon b-1a)
Bafiertam (monomethyl fumarate)
Betaseron (interferon b-1b)
Briumvi (ublituximab-xiiy)
Copaxone (glatiramer)
Dimethyl fumarate
Extavia (interferon b-1b)
fingolimod
Gilenya (fingolimod)
Glatopa (glatiramer)
Glatiramer
Kesimpta (ofatumumab)
Mavenclad (cladribine)
Mayzent (siponimod)
Plegridy (peginterferon b-1a)
Ponvory (ponesimod)
Rebif (interferon b-1a)
Tascenso ODT (fingolimod)
Tecfidera (dimethyl fumarate)a
Vumerity (diroximel fumarate)
Zeposia (ozanimod)

Class

Class Drug Agents

CD20 monoclonal antibody

CD20 monoclonal antibody

BRIUMVI*ublituximab-xiiy soln for iv infusion

CD20 monoclonal antibody

KESIMPTA*Ofatumumab Soln Auto-Injector

CD20 monoclonal antibody

OCREVUS*Ocrelizumab Soln For IV Infusion

CD52 monoclonal antibody

CD52 monoclonal antibody

LEMTRADA*Alemtuzumab IV Inj

Fumarates

Fumarates

BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release

Fumarates

TECFIDERA*Dimethyl Fumarate Capsule Delayed Release

Fumarates

VUMERITY*Diroximel Fumarate Capsule Delayed Release

Glatiramer

Glatiramer

COPAXONE*Glatiramer Acetate Soln Prefilled Syringe

Glatiramer

GLATOPA*Glatiramer Acetate Soln Prefilled Syringe

IgG4k monoclonal antibody

IgG4k monoclonal antibody

TYSABRI*Natalizumab for IV Inj Conc

Interferons

Interferons

AVONEX*Interferon beta-1a injection

Interferons

BETASERON*Interferon beta-1b injection

Interferons

EXTAVIA*Interferon beta-1b injection

Interferons

PLEGRIDY*Peginterferon beta-1a injection

Interferons

REBIF*Interferon beta-1a injection

Purine antimetabolite

Purine antimetabolite

MAVENCLAD*Cladribine Tab Therapy Pack

Pyrimidine synthesis inhibitor

Pyrimidine synthesis inhibitor

AUBAGIO*Teriflunomide Tab

Sphingosine 1-phosphate (SIP) receptor modulator