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Bafiertam (monomethyl 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: clinically isolated syndrome, relapsing remitting disease, 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: clinically isolated syndrome, relapsing remitting disease, active secondary progressive disease); AND
  • Patient meets ONE of the following: (a) experienced a beneficial clinical response when assessed by at least one objective measure (e.g., stabilization or reduced worsening in MRI activity, EDSS score, NEDA-3/4, or other listed functional measures); OR (b) 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