Vutrisiran

This policy covers Vutrisiran for treatment of hereditary transthyretin‑mediated (hATTR) amyloidosis in adults per the FDA‑approved label, including polyneuropathy and cardiomyopathy manifestations. Coverage requires confirmatory TTR genetic testing (and biopsy-proven amyloid when indicated), baseline neuropathy within specified stages (PND ≤ IIIb or FAP Stage 1–2), authorization limited to 12 months with continuation only if disease stability or improvement is documented, and excludes use with other TTR‑reducing agents or in ineligible conditions (e.g., NYHA class III/IV heart failure, prior liver transplant); off‑label use is allowed only if supported by accepted compendia or two peer‑reviewed articles.

"Coverage for FDA-approved drugs when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by HHS."