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
Last review date: September 3, 2019