Briumvi (ublituximab-xiiy) — Medica
Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing remitting disease, active secondary progressive disease)
Initial criteria
- Patient is age ≥ 18 years; AND
- Patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease); AND
- Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
Reauthorization criteria
- Patient is age ≥ 18 years; AND
- Patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease); AND
- Patient meets ONE of the following: (1) Patient experienced a beneficial clinical response when assessed by at least one objective measure (e.g., stabilization or reduced worsening in disease activity as evaluated by MRI, EDSS, NEDA-3 or NEDA-4, FSIQ-RMS, reduction in relapses, improvement or maintenance on six-minute walk test or 12-Item Multiple Sclerosis Walking Scale, improvement on MSFC, or attenuation of brain volume loss); OR (2) Patient experienced stabilization, slowed progression, or improvement in at least one symptom such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation; AND
- Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
Approval duration
1 year