dimethyl fumarate delayed-release capsules — Medica
Relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease)
Initial criteria
- 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 has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease); AND
- Patient experienced a beneficial clinical response when assessed by at least one objective measure (e.g., stabilization or reduced worsening in disease activity by MRI, EDSS, NEDA-3/NEDA-4, FSIQ-RMS, relapse rate, walking tests, MSFC, or brain volume loss) OR 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; 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