Medical Drug Criteria (MDC)

Policy Num:       P1.001.010
Policy Name:     BRIUMVI^® (ublituximab-xiiy)
Policy ID:          [P1.001.010][Ac/L /MDC/ P+ ][0.00.00]

Last Review:       October 9, 2024
Next Review:      September 20, 2025
 

Related MDC: NONE

BRIUMVI^® (ublituximab-xiiy)

Summary

Ublituximab-xiiy is monoclonal antibody that is used to reduce the frequency of relapses and delay the accumulation of physical disability in patients with RRMS. It exerts its physiologic effects through binding to CD20 on the surface of B lymphocytes which results in antibody-dependent and complement mediated cell lysis. 

Ublituximab is Food and Drug administration (FDA) approved for the treatment of relapsing forms of MS to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Policy Statements

Initiation of Ublituximab-xiiy (Briumvi) meets the definition of medical necessity when all the criteria below is met.

Policy Guidelines

Authorization of 12 months may be granted for Ublituximab-xiiy (Briumvi) when prescribed for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults; and the criteria below is met.

DOSAGE/ADMINISTRATION

• Hepatitis B virus screening and quantitative serum immunoglobulin screening are required before first dose.

• Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion.

• Administer BRIUMVI by intravenous infusion.

o First Infusion: 150 mg intravenous infusion

o Second Infusion: 450 mg intravenous infusion two weeks after the first infusion

o Subsequent Infusions: 450 mg intravenous infusion 24 weeks after the first infusion and every 24 weeks thereafter.

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

Initiation of ublituximab-xiiy (Briumvi) meets the definition of medical necessity when ALL of the following criteria are met:

1.    The member is diagnosed with ONE of the following forms of multiple sclerosis (MS):

a.    Relapsing remitting multiple sclerosis [RRMS]

b.   Active secondary progressive MS [SPMS]

c.   First clinical episode and member has MRI features consistent with MS

2.    Ublituximab will not be used in combination with ANY of the following:

a. Alemtuzumab (Lemtrada)

b. Cladribine (Mavenclad)

c. Dimethyl fumarate (Tecfidera)

d. Diroximel fumarate (Vumerity)

e. Fingolimod (Gilenya, Tascenso ODT)

f. Glatiramer acetate (Copaxone, Glatopa)

g. Interferon beta-1a (Avonex, Rebif)

h. Interferon beta-1b (Betaseron, Extavia)

i. Mitoxantrone (Novantrone)

j. Monomethyl fumarate (Bafiertam)

k. Natalizumab (Tysabri)

l. Ocrelizumab (Ocrevus)

m. Ofatumumab (Kesimpta)

n. Ozanimod (Zeposia)

o. Peg-interferon beta-1a (Plegridy)

p. Ponesimod (Ponvory ODT)

q. Rituximab (Rituxan or biosimilars)

r. Siponimod (Mayzent)

s. Teriflunomide (Aubagio)

3. The member does not have an active Hepatitis B viral (HBV) infection

4. The initial dosage does not exceed 150 mg at week 0, followed by 450 mg at week 2 and then 450 mg every 24 weeks thereafter
 
 

Renewal Approval Criteria 

Continuation of ublituximab therapy meets the definition of medical necessity when ALL of the following criteria are met:

1.    Member has demonstrated a beneficial response to therapy for treatment of RRMS, active SPMS, or clinically isolated syndrome

2.    Ublituximab will not be in combination with ANY of the following:

a.    Alemtuzumab (Lemtrada)

b.    Cladribine (Mavenclad)

c.    Dimethyl fumarate (Tecfidera)

d.    Diroximel fumarate (Vumerity)

e.    Fingolimod (Gilenya, Tascenso ODT)

f.    Glatiramer acetate (Copaxone, Glatopa)

g.    Interferon beta-1a (Avonex, Rebif)

h.    Interferon beta-1b (Betaseron, Extavia)

i.    Mitoxantrone (Novantrone)

j.    Monomethyl fumarate (Bafiertam)

k.    Natalizumab (Tysabri)

l.    Ocrelizumab (Ocrevus)

m.    Ofatumumab (Kesimpta)

n.    Ozanimod (Zeposia)

o.    Peg-interferon beta-1a (Plegridy)

p.    Ponesimod (Ponvory)

q.    Rituximab (Rituxan or biosimilars)

r.    Siponimod (Mayzent)

s.    Teriflunomide (Aubagio)

3.    The dose does not exceed 450 mg every 24 weeks
 

EXCLUSION CRITERIA

•    Active hepatitis B virus infection
•    History of life-threatening infusion reaction to ublituximab

BENEFIT APPLICATION

BlueCard/National Account Issues:

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Population Reference No. 1 Policy Statement

OTHER CRITERIA

Text

References

1.    Briumvi (ublituximab) [prescribing information]. Morrisville, NC: TG Therapeutics Inc; December 2022.
2.    Drug Facts and Comparisons online, Facts and Comparisons eAnswers online. Waltham, MA: UpToDate Inc. https://fco.factsandcomparisons.com. Accessed August 29, 2023.
3.    Florida Blue medical coverage guideline. http://mcgs.bcbsfl.com/MCG

Codes

Applicable Modifiers

N/A

Policy History