Spinraza™ (nusinersen) [Biogen]
Spinal Muscular Atrophy (SMA)
Approval criteria: • Be prescribed by a neurologist AND prescriber’s specialty must be provided at time of request AND • At time of request, prescriber must confirm whether or not the patient is currently enrolled in clinical trials for Spinraza • Have a diagnosis of SMA AND chart notes confirming: • Homozygous SMN1 gene deletion OR mutation OR • Compound heterozygous SMN1 mutation AND • Have sufficient number of copies of SMN2 gene defined as one of the following genetic tests demonstrating: • If a pre-symptomatic infant, then ≤ 3 copies of SMN2 gene is required OR • If a symptomatic patient, then ≥ 2 copies of SMN2 gene is required AND • Documentation of age of onset of symptoms AND • Provide baseline assessment using at least one of the following: • Hammersmith Functional Motor Scale Expanded (HFMSE) • Hammersmith Infant Neurologic Exam (HINE) • 6-minute walk test (6MWT) • Upper limb module (ULM) score • Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) • Provide baseline: • Complete blood count AND • Quantitative spot urine protein testing AND • Coagulation status
Initial approvals will be limited to 6 months in duration.
Renewal criteria • Absence of toxicity from the drug including serious infections, glomerulonephritis, thrombocytopenia, etc. AND • Patient has demonstrated improvement or lack of progression from baseline in at least one of the following: • Hammersmith Functional Motor Scale Expanded (HFMSE): at least 3 point increase from baseline • Hammersmith Infant Neurologic Exam (HINE): at least 2 point (or maximal score) increase in ability to kick OR at least 1 point increase in any other HINE milestone • 6-minute walk test (6MWT): increase of 30 meters if ambulatory • Upper limb module (ULM) score: at least 2 point increase from baseline • Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND): at least 4 point increase from baseline • Progression has been slower than otherwise would have been expected in this patient population
Renewal approvals will be for 12 months in duration
Denial criteria • Patient is currently enrolled in clinical trials for Spinraza • SMA without chromosome 5q mutations or deletions • SMA pre-symptomatic patients with > 3 copies of SMN2 gene
Quantity limits • Initial Approval: Five 5mL (12mg/5mL) vials for the first 6 months • Renewal Approval: Three 5mL (12mg/5mL) vials for the subsequent 12 months
Spinraza is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.
MHCP Provider Call Center 651-431-2700 or 800-366-5411
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