Kesimpta (ofatumumab subcutaneous injection) — Medica

Initial criteria

• Patient is age ≥ 18 years
• Patient has a relapsing form of multiple sclerosis (clinically isolated syndrome, relapsing remitting disease, or active secondary progressive disease)
• 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 (clinically isolated syndrome, relapsing remitting disease, or active secondary progressive disease)
• 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, stabilization or reduced worsening on the Expanded Disability State Scale score, achievement of No Evidence of Disease Activity criteria, improvement on fatigue or walking measures, reduction or absence of relapses, or improvement on functional scales) 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 sensation
• Patient is age ≥ 18 years
• 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