Tegsedi (inotersen) — Point32Health
polyneuropathy of hereditary transthyretin-mediated amyloidosis
Initial criteria
- Documented diagnosis of hereditary transthyretin-mediated amyloidosis with polyneuropathy
- Documentation in the Member’s medical record of transthyretin (TTR) genetic mutation
- Patient age ≥ 18 years
- Prescribed by or in consultation with a neurologist or a provider who specializes in amyloidosis
- Documentation of baseline polyneuropathy disability (PND) score ≤ IIIb
- Documentation the patient has not had a prior liver transplant
- Documentation the requested medication will not be used concomitantly with another medication indicated for the management of cardiomyopathy or neuropathy of transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Vyndamax)
Reauthorization criteria
- Documented diagnosis of hereditary transthyretin-mediated amyloidosis with polyneuropathy
- Documentation in the Member’s medical record of transthyretin (TTR) genetic mutation
- Patient age ≥ 18 years
- Prescribed by or in consultation with a neurologist or a provider who specializes in amyloidosis
- Documentation the requested medication will not be used concomitantly with another medication indicated for the management of cardiomyopathy or neuropathy of transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Vyndamax)
- Documentation of both of the following: (a) Polyneuropathy disability (PND) score has remained ≤ IIIb AND (b) Positive clinical response as evidenced by improved or stable motor function, neurologic impairment, and quality of life
Approval duration
12 months initial, 12 months reauthorization