Anthem: Briumvi Payer Policy (Beta Access)
HCPCS Code(s): | J2329 |
Precertification Required? | ✅ Yes(Click Here for Full Policy) |
Step Therapy Required? | ✅ Yes (Click Here for Full Policy) |
Provider Fax Form: | ✅ Available in SamaCare |
FDA Approved Indications: | Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults |
Recommended Dosage: | Initiation of therapy for Briumvi: May approve 150 mg (1 vial) on day 1 and 450 mg (3 vials) two weeks after the first dose for initiation of therapy. |
Note: When Briumvi (ublituximab) is deemed approvable based on the clinical criteria referenced, the benefit plan may have additional criteria requiring the use of a preferred1 agent or agents.
Briumvi (ublituximab) may not be approved for the following:
- Use in combination with other MS disease modifying agents (including Aubagio, Avonex, Bafiertam, Betaseron, Copaxone/Glatiramer/Glatopa, Extavia, Gilenya, Kesimpta, Lemtrada, Mavenclad, Mayzent, Ocrevus, Plegridy, Ponvory, Rebif, Tascenso ODT, Tecfidera, Tysabri, Vumerity and Zeposia);
OR
- Individual is using to treat non-active secondary progressive multiple sclerosis;
OR
- Individual is using to treat primary progressive multiple sclerosis; OR IV. Individual has active hepatitis B or another active infection at initiation of therapy; OR V. May not be approved when the above criteria are not met and for all other indications.
Quantity Limits:
- Briumvi (ublituximab) 150 mg/6 mL vial - 450 mg (3 vials) every 24 weeks
Initial Approval Criteria
Requests for Briumvi (ublituximab) may be approved if the following criteria are met:
- Individual has a diagnosis of relapsing multiple sclerosis (RMS) (including clinically isolated syndrome, relapsing-remitting disease or active secondary progressive disease); AND
- Individual is able to ambulate without aid or rest for at least 100 meters; AND
- If initiating therapy, individual has experienced at least two relapses within the previous two years or one relapse within the previous year or at least one T1 gadolinium-enhancing lesion on MRI within the previous year.
- Individual is able to ambulate without aid or rest for at least 100 meters; AND
Briumvi Step Therapy
Requests for Briumvi (ublituximab) may be approved when the following criteria are met:
Documentation is provided that individual has been on Briumvi (ublituximab); OR
Documentation has been provided that individual has had a trial and inadequate response (including but not limited to clinical relapse, new or enlarged lesions on MRI or confirmed disability progression) or intolerance to the following:
A. Preferred fumaric acid derivative; OR
Documentation is provided that individual has high disease activity despite treatment with fingolimod (Gilenya, Tascenso ODT) defined as the following (AAN 2018, Devonshire 2012):
A. At least one relapse in the previous year while on therapy; AND
B. At least 9 T2-hyperintense lesions in cranial MRI;
OR
C. At least one Gadolinium-enhancing lesion.
Preferred, as used herein, refers to agents that were deemed to be clinically comparable to other agents in the same class or disease category but are preferred based upon clinical evidence and cost effectiveness.
Sources: https://files.providernews.anthem.com/4281/CC-0227_Pub-03-01-2024.pdf
Additional Resources
Medical Specialty Precertification Drug List: https://file.anthem.com/06347MUPENABS.pdf
Medical Step Therapy Drug List: https://file.anthem.com/A02605ANPENABS.pdf
Site of Care Drug List: https://file.anthem.com/06346MUPENABS.pdf
⚠️ Disclaimer: This article is a policy summary and does not guarantee coverage or approval.
Policies may vary based on plan, payer-specific rules, state or regional requirements, benefit structure, formulary placement, and patient-specific considerations like diagnosis or clinical history. Always review the full policy and confirm details directly with the payer to ensure compliance.
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