Nusinersen (Spinraza)

OFFICE ADMINISTRATION [medical benefit]

Indications for Prior Authorization:

  • Spinal muscular atrophy (SMA)

Patients must meet the following criteria for the indication(s) above:

  • Molecular genetic testing to confirm diagnosis in infants and children with suspected SMA is required.  In patients with suspected SMA who have a normal SMN1 gene by molecular genetic testing, the diagnosis of SMA is made clinically by electromyography, nerve conduction studies, and muscle biopsy.  However, absence of a deletion in SMN1 casts serious doubt on the diagnosis.

  • Lab testing for platelet count, prothrombin time, activated partial thromboplastin time, and quantitative spot urine protein is to be done at baseline and prior to each dose.

The following conditions do not meet the criteria for use as established by WHA P&T committee:

  • All non-FDA approved uses not listed in the approved indications

Dosing:

  • Intrathecal:

    • Loading dose: 12mg once every 14 days for 3 doses, then 12mg once 30 days after the third dose
    • Maintenance: 12mg once every 4 months

Approval:

  • 1 year

Last review date: March 22, 2017