Briumvi (ublituximab-xiiy) prior authorization
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This policy governs prior authorization for Briumvi (ublituximab-xiiy) for treatment of relapsing forms of multiple sclerosis for Alaska Medicaid enrollees and specifies approval, denial, duration, dosing, and precautions that affect prescribers and patients.
No material clinical or coverage changes in this revision.
Coverage Criteria for Briumvi (ublituximab-xiiy)
Initial Approval
Covered when ALL of the following are met
All conditions required
Reauthorization
Covered when ALL of the following are met
Reauthorization up to 12 months when criteria met
Concurrent administration of Briumvi with other disease‑modifying therapies for multiple sclerosis is an exclusion and will result in denial of prior authorization. Providers must not request Briumvi if the patient is receiving another disease‑modifying MS therapy at the same time; concurrent prescriptions are a specific denial trigger.
Briumvi is contraindicated for patients with an active hepatitis B infection for the purposes of coverage under this policy. Use in patients with active hepatitis B will be denied and should not be requested for authorization.
Coding and Dosing Information
| J3590 | Unclassified biologics (HCPCS) — listed in document for Briumvi |
Provider Requirements, Authorization, and Denials
Prior authorization required; duration limits
Prior authorization is required for Briumvi (HCPCS J3590). Initial approvals are allowed for up to 6 months; reauthorization may be granted for up to 12 months when the prescriber documents disease improvement or stabilization.
- HCPCS code: J3590
- Initial Approval: up to 6 months
- Reauthorization: up to 12 months with documented improvement or stabilization
Prior therapies required (step therapy)
Before initiating Briumvi, the patient must have had an ineffective response, intolerance, or contraindication to two or more disease‑modifying therapies for multiple sclerosis within the prior 12 months.
- Ineffective response defined as continued clinical relapse
- Intolerance or documented contraindication to prior MS therapy
- Required number of prior MS drugs: two or more within the last 12 months
Required documentation to support authorization
Document the patient meets all approval elements: age 18 or older; diagnosis of a relapsing form of MS; prescriber is a neurologist or in consultation with an MS specialist; prior inadequate response/intolerance/contraindication to ≥2 MS drugs in the last 12 months; and for women of reproductive potential, attestation patient is not pregnant and will not become pregnant while treated. Include relevant pre‑treatment and safety information such as quantitative serum immunoglobulin test results, infection status, premedication plan, and for reauthorization, objective documentation of disease improvement or stabilization.
- Patient age (≥18 years)
- Diagnosis: relapsing form of multiple sclerosis
- Prescriber specialty: neurologist or MS specialist (or documented consultation)
- Prior therapy history: ineffective response/intolerance/contraindication to ≥2 MS drugs within prior 12 months
- For women of reproductive potential: pregnancy attestation
- Pre‑treatment tests: quantitative serum immunoglobulins; infection status
- Premedication plan (eg, corticosteroid and antihistamine)
- Reauthorization: documentation of disease improvement or stabilization
Denial triggers and contraindications
Deny authorization when approval criteria are not met; concurrent use with other disease‑modifying therapies for MS or active hepatitis B infection are specific denial triggers.
- Failure to meet all approval criteria
- Concurrent prescription of Briumvi with other disease‑modifying MS therapies
- Active hepatitis B infection
Indications and Precautions
Background
Briumvi (ublituximab‑xiiy) is a CD20‑directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease. Clinical use is intended for adults who have had inadequate response, intolerance, or contraindication to prior MS therapies and is administered per the dosing schedule described in the policy.
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