J2329 — Injection, ublituximab-xiiy, 1mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- For initial therapy: documentation of diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses).
- For initial therapy: documentation that patient is not receiving Briumvi in combination with the listed disease modifying therapies, B cell targeted therapies, or lymphocyte trafficking blockers.
- For initial therapy: documentation that Briumvi dosing will be in accordance with the United States Food and Drug Administration approved labeling (dosing schedule: 150 mg first infusion, 450 mg two weeks after first infusion, then 450 mg every 24 weeks).
- For continuation of therapy: documentation that the patient has previously received Briumvi.
Key Coverage Criteria
- Briumvi (ublituximab-xiiy) is proven for the treatment of relapsing forms of multiple sclerosis (MS).
- For initial therapy, all of the following: Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses); and Patient is not receiving Briumvi in combination with any of the following: Disease modifying therapy (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide) B cell targeted therapy (e.g., rituximab, belimumab, ofatumum [...]
- For continuation of therapy, all of the following: Patient has previously received treatment with Briumvi; and Documentation of positive clinical response to Briumvi therapy; and Patient is not receiving Briumvi in combination with any of the following: Disease modifying therapy (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide) B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ocrelizumab) [...]
- FDA indication (informational): Briumvi is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- Covered ICD-10 diagnosis codes listed in the policy as referenced (for coverage consideration): G35.A (Relapsing-remitting multiple sclerosis), G35.B0 (Primary progressive multiple sclerosis, unspecified), G35.B1 (Active primary progressive multiple sclerosis), G35.B2 (Non-active primary progressive multiple sclerosis), G35.C0 (Secondary progressive multiple sclerosis, unspecified), G35.C1 (Active secondary progressive multiple sclerosis), G35.C2 (Non-active secondary progressive multiple sclero [...]
- Applicable HCPCS code for billing reference: J2329 Injection, ublituximab-xiiy, 1mg.
14 Active Policies
UHC-POL-briumvi — Briumvi (Ublituximab-Xiiy)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-briumvi — Briumvi (Ublituximab-Xiiy)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-briumvi — Briumvi (Ublituximab-Xiiy)
Related Codes
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