United Healthcare: Briumvi Payer Policy

Created by C. Denise Burrell, Modified on Mon, 24 Feb at 10:35 AM by C. Denise Burrell

United Healthcare: Briumvi Payer Policy (Beta Access)

TABLE OF CONTENTS

United Healthcare: Briumvi Payer Policy (Beta Access)

MEDICARE PART B

HCPCS Code(s):	J2329
Precertification Required?	✅ Yes (Click Here for Full Policy)
Step Therapy Required?	✅ Yes (Click Here for Full Policy)
Provider Fax Form:	Generic Form (✅ Available in SamaCare) Though this form is available in SamaCare, UHC may not accept faxed submissions. Instead, practices are encouraged to use the payer portal, which can be accessed directly through SamaCare!
FDA Approved Indications:	Briumvi is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including: Clinically isolated syndrome Relapsing-remitting disease Active secondary progressive disease
Recommended Dosage:	Initial infusion: 150 mg IV Second infusion (two weeks later): 450 mg IV Maintenance dose: 450 mg IV every 24 weeks

Other Pertinent Information:

Briumvi is a CD20-directed monoclonal antibody that depletes B-cells.
It should not be used in combination with other disease-modifying therapies, B-cell targeted therapies, or lymphocyte trafficking blockers.

Quantity Limits:

Coverage is limited to dosing in accordance with FDA-approved labeling.
Initial authorization is for 12 months.

Exclusion(s):

Patients receiving Briumvi in combination with:
- Disease-modifying therapies (e.g., interferon beta, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide).
- B-cell targeted therapies (e.g., rituximab, belimumab, ofatumumab, ocrelizumab).
- Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone).

Initial Approval Criteria:

Briumvi is medically necessary for patients who meet all the following criteria:

Diagnosis of a relapsing form of MS (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses).
Patient is not receiving concurrent therapy with other MS disease-modifying treatments, B-cell therapies, or lymphocyte trafficking blockers.
Dosing aligns with FDA-approved guidelines.
Initial authorization period: Up to 12 months.

Continuation Criteria:

For continued coverage, all the following must be met:

Patient has previously received Briumvi.
Documented positive clinical response to treatment.
Patient is not receiving concurrent therapy with excluded treatments.
Dosing remains in accordance with FDA labeling.
Reauthorization period: Up to 12 months.

Sources:

Briumvi [package insert]. TG Therapeutics, Inc.; December 2022.
Steinman L, Fox E, Hartung HP, et al. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022;387(8):704-714.
UnitedHealthcare Community Plan Medical Benefit Drug Policy (Effective 05/01/2024).

COMMERCIAL

HCPCS Code(s):	J329
Precertification Required?	✅ Yes (Click Here For Full Policy)
Step Therapy Required?	✅ No (Click Here For Full Policy)
Provider Fax Form:	Generic Form (✅ Available in SamaCare) Though this form is available in SamaCare, UHC may not accept faxed submissions. Instead, practices are encouraged to use the payer portal, which can be accessed directly through SamaCare!
FDA Approved Indications:	Briumvi is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including: Clinically isolated syndrome Relapsing-remitting disease Active secondary progressive disease
Recommended Dosage:	Initial infusion: 150 mg IV Second infusion (two weeks later): 450 mg IV Maintenance dose: 450 mg IV every 24 weeks