Tegsedi (inotersen) — United Healthcare

Initial criteria

• Diagnosis of hATTR amyloidosis with polyneuropathy
• Documentation that the patient has a pathogenic TTR mutation (e.g., V30M)
• Prescribed by or in consultation with a neurologist
• Documentation of one of the following: (a) baseline polyneuropathy disability (PND) score ≤ IIIb OR (b) baseline FAP Stage 1 or 2 OR (c) baseline neuropathy impairment (NIS) score ≥ 10 and ≤ 130
• Patient has not had a liver transplant
• Presence of clinical signs and symptoms of the disease (e.g., peripheral sensorimotor polyneuropathy, autonomic neuropathy, motor disability, etc.)
• Patient is not receiving Tegsedi in combination with either of the following: (a) Oligonucleotide agents [e.g., Onpattro (patisiran), Amvuttra (vutrisiran)] OR (b) Tafamidis (e.g., Vyndaqel, Vyndamax)

Reauthorization criteria

• Documentation that the patient has experienced a positive clinical response to Tegsedi therapy (e.g., improved neurologic impairment, motor function, quality of life, slowing of disease progression, etc.)
• Patient is not receiving Tegsedi in combination with either of the following: (a) Oligonucleotide agents [e.g., Onpattro (patisiran), Amvuttra (vutrisiran)] OR (b) Tafamidis (e.g., Vyndaqel, Vyndamax)

Approval duration

12 months