Ublituximab-xiiy (Briumvi™)

Restricted Product(s):

• ublituximab-xiiy (Briumvi™) intravenous infusion for administration by a healthcare professional

FDA Approved Use:

• For treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of a relapsing form of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease; AND 
3. The patient must still either be able to walk at least a few steps with or without aid, or alternatively must have some functional arm/ hand use consistent with performing activities of daily living; AND 
4. ONE of the following: 
   1. The patient has highly active MS disease activity AND BOTH of the following [medical record documentation required]: 
      1. The patient has greater than or equal to 2 relapses in the previous year; AND 
      2. ONE of the following: 
         1. The patient has greater than or equal to 1 gadolinium enhancing lesion on MRI; OR 
         2. The patient has a significant increase in T2 lesion load compared with a previous MRI; OR 
   2. ONE of the following: 
      1. The patient has tried and had an inadequate response to ONE of the following: dimethyl fumarate (generic Tecfidera), fingolimod (generic Gilenya), glatiramer acetate (generic Copaxone or Glatopa), or teriflunomide (generic Aubagio) [medical record documentation required]; OR
      2. The patient has an intolerance or hypersensitivity to ONE of the following: dimethyl fumarate (generic Tecfidera), fingolimod (generic Gilenya), glatiramer acetate (generic Copaxone or Glatopa), or teriflunomide (generic Aubagio) [medical record documentation required]; OR 
      3. The patient has an FDA labeled contraindication to ALL of the following: dimethyl fumarate (generic Tecfidera), fingolimod (generic Gilenya), glatiramer acetate (generic Copaxone or Glatopa), and teriflunomide (generic Aubagio) [medical record documentation required]; OR
   3. The patient has been treated with at least three MS agents from different drug classes (see “MS Disease Modifying Agents drug classes” table below) [medical record documentation required]; AND 
5. The patient is NOT receiving concurrent therapy with two or more disease-modifying drugs for multiple sclerosis, including glatiramer (Copaxone, Glatopa), interferon beta-1b (Betaseron, Extavia), interferon beta-1a (Avonex, Rebif), peginterferon beta-1a (Plegridy), fingolimod (Gilenya, Tascenso ODT), teriflunomide (Aubagio), dimethyl fumarate (Tecfidera), monomethyl fumarate (Bafiertam), ofatumumab (Kesimpta), alemtuzumab (Lemtrada), siponimod (Mayzent), cladridine (Mavenclad), ocrelizumab (Ocrevus, Ocrevus Zunovo), ponesimod (Ponvory), natalizumab (Tysabri, Tyruko), diroximel fumarate (Vumerity), ozanimod (Zeposia), and ublituximab-xiiy (Briumvi); AND 
6. The prescriber is a specialist in the area of the patient’s diagnosis (i.e., neurologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND 
7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
8. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)* 

Duration of Approval: 365 days (1 year)

Continuation Criteria for Approval:

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
2. The patient would have met initial criteria for approval at the time they started therapy; AND 
3. The patient has had clinical benefit while receiving treatment with the requested agent (e.g., disease stability and/or improvement); AND 
4. The patient is NOT receiving concurrent therapy with two or more disease-modifying drugs for multiple sclerosis, including glatiramer (Copaxone, Glatopa), interferon beta-1b (Betaseron, Extavia), interferon beta-1a (Avonex, Rebif), peginterferon beta-1a (Plegridy), fingolimod (Gilenya, Tascenso ODT), teriflunomide (Aubagio), dimethyl fumarate (Tecfidera), monomethyl fumarate (Bafiertam), ofatumumab (Kesimpta), alemtuzumab (Lemtrada), siponimod (Mayzent), cladridine (Mavenclad), ocrelizumab (Ocrevus, Ocrevus Zunovo), ponesimod (Ponvory), natalizumab (Tysabri, Tyruko), diroximel fumarate (Vumerity), ozanimod (Zeposia), and ublituximab-xiiy (Briumvi); AND 
5. The prescriber is a specialist in the area of the patient’s diagnosis (i.e., neurologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND 
6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
7. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)* 

Duration of Approval: 365 days (1 year)

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met: 
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
   5. Requirement of a change in the requested restricted product formulation; AND 
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional. 

References:

all information referenced is from FDA package insert unless otherwise noted below.

1. Steinman L, Fox E, Hartung HP, et al., for the ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2022 Aug 25;387(8):704-714.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

October 2024: Criteria update: Updated list of disease-modifying drugs for MS not to be used concomitantly and reference table with drug classes of MS disease modifying agents for clarity.

September 2023: Criteria update: Adjusted initial and continuation criteria for no combination use with two or more disease-modifying drugs for MS for clarity with no change to policy intent. Updated list of disease-modifying drugs for MS not to be used concomitantly and reference table with drug classes of MS disease modifying agents for clarity.

July 2023: Coding change: Added HCPCS code J2329 to dosing reference table effective 7/1/2023; deleted C9399, J3490, and J3590 termed 6/30/2023.

July 2023: Criteria change: Added teriflunomide (generic Aubagio) as an option for required trial and failure of one generic product. Updated generic glatiramer acetate (generic Copaxone) to include Glatopa as an option. Removed criteria from policy regarding no presence of FDA labeled contraindications to the requested agent. Updated list of disease-modifying drugs for MS not to be used concomitantly for clarity.

March 2023: Original medical policy criteria issued.