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Spinraza

DrugSpinraza™ (nusinersen) [Biogen]

January 2018

Therapeutic Area - 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 supporting documentation 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

Background information

Spinraza is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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