Inotersen (Tegsedi ™)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

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

  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a neurologist, geneticist, or a physician who specializes in the treatment of amyloidosis, AND
  • Patient has a diagnosis of hereditary transthyretin-mediated amyloidosis (hATTR) as confirmed by chart note documentation, AND
  • Patient has a transthyretin (TTR) mutation as confirmed by genetic testing, AND
  • Patient has symptomatic peripheral neuropathy (e.g. reduced motor strength/coordination, impaired sensation [e.g. pain, temperature, vibration, touch]) , AND
  • Patient has tried and failed at least one systemic agent for polyneuropathy from the following classes:
    • Gabapentin-type product (e.g. Gabapentin, Lyrica®), OR 
    • Tricyclic antidepressant (e.g. Amitriptyline, Nortriptyline), AND
  • Patient has not had a liver transplant, AND
  • Patient does not have any of the following contraindications to use: 
    • Platelet count less than 100 x 109/L 
    • History of acute glomerulonephritis caused by Tegsedi™

Dosing: 

  • 284mg subcutaneously once weekly

Approval: 

  • 1 year

Last review date: September 3, 2019