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Evrysdi (risdiplam) — Medica

Spinal muscular atrophy

Initial criteria

  • Baseline motor ability assessment that suggests spinal muscular atrophy has been performed using ONE of the following: Bayley Scales of Infant and Toddler Development; OR CHOP INTEND; OR HFMSE; OR HINE-2; OR MFM-32; OR RULM test; OR WHO motor milestone scale
  • Patient has had a genetic test confirming the diagnosis of spinal muscular atrophy with biallelic pathogenic variants in the SMN1 gene (may include homozygous deletion, compound heterozygous mutation, or other rare mutations)
  • Patient has TWO or THREE SMN2 gene copies; OR has FOUR SMN2 gene copies AND has objective signs consistent with spinal muscular atrophy Types 1, 2, or 3
  • Patient has not received Zolgensma (onasemnogene abeparvovec-xioi) in the past (verified in claims history or confirmed by prescriber)
  • Medication is prescribed by a physician who has consulted with or who specializes in the management of spinal muscular atrophy or neuromuscular disorders

Reauthorization criteria

  • Patient has had a genetic test confirming the diagnosis of spinal muscular atrophy with biallelic pathogenic variants in the SMN1 gene
  • Patient has TWO or THREE SMN2 gene copies; OR has FOUR SMN2 gene copies AND has objective signs consistent with spinal muscular atrophy Types 1, 2, or 3
  • Medication is prescribed by a physician who has consulted with or who specializes in the management of spinal muscular atrophy or neuromuscular disorders
  • Patient has had a positive clinical response (improvement or stabilization) from pretreatment baseline status within the past 4 months documented in ONE of the following: Bayley Scales of Infant and Toddler Development; OR CHOP INTEND; OR HFMSE; OR HINE-2; OR MFM-32; OR RULM; OR WHO motor milestone scale; OR according to the prescribing physician, patient has responded to Evrysdi and continues to benefit from ongoing treatment based on recent physician monitoring/assessment (e.g., improved pulmonary or bulbar function, reduced need for respiratory support, fewer respiratory infections, or prevention of permanent assisted ventilation)

Approval duration

4 months