Wainua (eplontersen) — CareFirst (Caremark)
polyneuropathy of hereditary transthyretin-mediated amyloidosis (transthyretin-type familial amyloid polyneuropathy, ATTR-FAP)
Initial criteria
- Diagnosis is confirmed by detection of a mutation in the TTR gene
- Member exhibits clinical manifestations of ATTR-FAP (e.g., amyloid deposition in biopsy specimens, TTR protein variants in serum, progressive peripheral sensory-motor polyneuropathy)
- Member is not a liver transplant recipient
- Requested medication will not be used in combination with any other medication approved for the treatment of hereditary transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Tegsedi, Vyndamax, Vyndaqel)
- Medication is prescribed by or in consultation with a neurologist, geneticist, or physician specializing in the treatment of amyloidosis
Reauthorization criteria
- Member has met all initial authorization criteria
- Member has demonstrated a beneficial response to treatment compared to baseline (e.g., improvement of neuropathy severity and rate of disease progression as demonstrated by mNIS+7 composite score, Norfolk QoL-DN total score, PND score, FAP disease stage, manual grip strength)
Approval duration
12 months