RNA-Targeted Therapies (Amvuttra® and Onpattro®) – Commercial Medical Benefit Drug Policyopen_in_new

Amvuttra is covered for wild‑type or hereditary ATTR cardiomyopathy and Amvuttra or Onpattro are covered for hereditary ATTR polyneuropathy when genetic, biopsy, or specified imaging confirmation (including grade 2–3 radionuclide cardiac uptake and exclusion of light‑chain amyloidosis) and required functional/biomarker thresholds are met; coverage is limited to adults, excludes post‑liver‑transplant polyneuropathy and use in non‑hATTR or leptomeningeal/primary amyloidosis, and prohibits combination with other RNAi agents or transthyretin stabilizers. Key requirements include specialty prescriber (cardiologist for cardiomyopathy, neurologist for polyneuropathy), NYHA I–III plus NT‑proBNP/heart‑failure history or intolerance/progression on tafamidis/acoramidis for cardiomyopathy, baseline PND/FAP/NIS/KPS criteria for polyneuropathy, dosing per FDA, documentation of clinical benefit for continuation, and authorizations limited to ≤12 months.

"Radionuclide imaging showing grade 2 or 3 cardiac uptake 'may require prior authorization and notification'."