Wainua (eplontersen) — Highmark

Initial criteria

• age ≥ 18 years
• Prescribed by or in consultation with a neurologist or physician who specializes in the treatment of amyloidosis
• Diagnosis of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (hATTR)
• Mutation in the TTR gene confirmed by genetic testing
• Complete neurologic examination performed showing clinical signs and symptoms of disease (e.g., peripheral/autonomic neuropathy, motor disability, carpal tunnel, etc.)
• Prescriber attests that member is ambulatory (stage 1) OR ambulatory with assistance (stage 2)
• Prescriber attests that member has NIS ≥ 10 OR PND score of I, II, IIIa, or IIIb
• Member is not simultaneously utilizing transthyretin-lowering agents other than the requested drug (for example, Amvuttra, Attruby, Vyndaqel, Vyndamax, or Onpattro)

Reauthorization criteria

• Prescribed by or in consultation with a neurologist or physician who specializes in the treatment of amyloidosis
• Member is not simultaneously utilizing other gene targeted therapy for polyneuropathy of hATTR
• Prescriber attests that member has experienced positive clinical response to therapy defined as improvement or stabilization of one of the following: FAP status/stage, NIS score, or PND score

Approval duration

12 months