Evrysdi (risdiplam) — Highmark

Initial criteria

• Diagnosis of SMA (ICD-10: G12.9) classified as one of the following: presymptomatic SMA (infants up to 6 weeks of age), infantile-onset (type 1 SMA), or later-onset (type 2 or type 3 SMA)
• Member has at least 2 copies of the SMN2 gene
• Molecular genetic testing of 5q SMA shows one of the following: homozygous gene deletion, homozygous conversion mutation, or compound heterozygote
• Evrysdi is prescribed by or in consultation with a neuromuscular specialist or neurologist
• Baseline documentation of the member’s motor function test results (e.g., MFM, CHOP, HINE, RULM, HFMSE, 6MWT)
• Evrysdi is not used concomitantly with Spinraza
• One of the following: member has not previously received gene replacement therapy for SMA OR member has received gene replacement therapy and has experienced a decline in clinical status since receipt of gene replacement therapy

Reauthorization criteria

• Documentation demonstrating that the member is stable or shows clinically significant improvement in SMA-associated symptoms (e.g., stabilization or decreased decline in motor function compared to predicted natural history)
• OR documentation demonstrating stable or improved motor function test results compared to baseline (e.g., MFM, CHOP, HINE, RULM, HFMSE, 6MWT)
• Evrysdi is not used concomitantly with Spinraza
• One of the following: member has not previously received gene replacement therapy for SMA OR member has received gene replacement therapy and has experienced a decline in clinical status since receipt of gene replacement therapy

Approval duration

6 months (12 months for Delaware Commercial fully-insured and ACA members)