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    Spinraza

    Drug - Spinraza™ (nusinersen) [Biogen]

    January 2020

    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 

    AND

    • The combination treatment of SMA with concomitant SMN modifying therapy/therapies will not be approved; OR
    • Spinraza must not be used in combination with Zolgensma or any SMN modifying therapy:
      • Current authorization for any SMN modifying therapy (e.g., nusinersen) will be discontinued upon Zolgensma approval
      • Request for nusinersen or any SMN modifying therapy subsequent to Zolgensma will not be approved
        • Current authorization for nusinersen may be continued if the prescribing practitioner provides published peer-reviewed clinical research documenting a superior clinical outcome with the combination therapy of Zolgensma and nusinersen vs. monotherapy with nusinersen

    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

    AND

    • The combination treatment of SMA with concomitant SMN modifying therapy/therapies will not be approved; OR
    • Spinraza must not be used in combination with Zolgensma or any SMN modifying therapy:
      • Current authorization for any SMN modifying therapy (e.g., nusinersen) will be discontinued upon Zolgensma approval
      • Request for nusinersen or any SMN modifying therapy subsequent to Zolgensma will not be approved
        • Current authorization for nusinersen may be continued if the prescribing practitioner provides published peer-reviewed clinical research documenting a superior clinical outcome with the combination therapy of Zolgensma and nusinersen vs. monotherapy with nusinersen

    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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