TEGSEDI (inotersen)

TEGSEDI (inotersen)

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