Wainua (eplontersen) — Point32Health
treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
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 the patient is currently experiencing signs and symptoms of polyneuropathy defined as one of the following: baseline polyneuropathy disability (PND) score ≤ IIIb OR baseline familial amyloid polyneuropathy Stage 1 or 2 OR baseline neuropathy impairment score between 10 and 130
- 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 a positive clinical response to therapy as evidenced by improved or stable disease as defined by one of the following scales: Modified Neuropathy Impairment Scale+7 composite score OR Norfolk Quality of Life-Diabetic Neuropathy total score
Approval duration
12 months initial, 12 months reauthorization