Pharmacologic Treatment of Transthyretin-Mediated Amyloidosis
Defines medical necessity and authorization criteria for specific drugs (Amvuttra, Attruby, Onpattro, Vyndamax/Vyndaqel, Wainua) used to treat hereditary and wild-type transthyretin-mediated amyloidosis for adults, and indicates benefit management (medical vs pharmacy). Affects prescribing providers, neurologists, cardiologists, and payers.
Added coverage criteria for Wainua (eplontersen) for the treatment of certain adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis.
Added coverage criteria for Attruby (acoramidis) for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults.
Updated coverage criteria for Amvuttra, Onpattro, and Tegsedi to allow confirmation of diagnosis by tissue biopsy or genetic testing and added exclusions (e.g., NYHA class III or IV heart failure, unrelated neuropathy, prior liver transplantation).
Updated Vyndamax and Vyndaqel coverage criteria for ATTR-CM: allowed tissue biopsy or genetic testing confirmation, specified echocardiographic wall thickness >12 mm, history of heart failure, baseline NT-proBNP thresholds, removed NYHA class IV exclusion (later removed in 2025 update), added 6-minute walk test requirement and quantity limits.
Removed Tegsedi (inotersen) from the medical policy because the product was withdrawn from the market.
Added a new indication to Amvuttra (vutrisiran) for the treatment of ATTR-CM (effective 07/01/25 interim review).
Clarified that medications listed are subject to the product's FDA dosage and administration prescribing information and that non-formulary exception authorizations may be approved up to 12 months.
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