MHCP Enrolled Providers – Pharmacies

Fee-for-Service PA Criteria Sheet – Spinraza™

(June 2017)

Drug

Spinraza (nusinersen) [Biogen]

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 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
  • Background information

    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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