Vyndamax (tafamidis) — Highmark

cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)

Initial criteria

age ≥ 18 years
prescribed by or in consultation with a cardiologist or physician who specializes in the treatment of amyloidosis
prescriber submits clinical documentation supporting diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) including BOTH:
1. Member meets ONE of the following:
a. Amyloid deposits on cardiac biopsy OR
b. Scintigraphy with radiotracers (e.g., technetium pyrophosphate) showing ONE of the following: heart to lung contralateral > 1.5 (grade 3) OR visual grade 2–3
2. Cardiac involvement supported by ONE of the following: cardiac magnetic resonance OR echocardiography OR serum cardiac biomarker (e.g., B-type natriuretic peptide, cardiac troponin)
member has New York Heart Association (NYHA) Class I, II, or III
member is NOT simultaneously utilizing transthyretin-lowering agents other than the requested drug (e.g., Amvuttra, Attruby, Vyndaqel, Vyndamax, Onpattro, Wainua)
member does NOT have primary (light chain) amyloidosis

prescriber documents disease improvement or delayed disease progression from baseline in ONE of the following: 6-minute walk test OR cardiac function (global longitudinal strain, LVEF, NYHA class) OR Kansas City Cardiomyopathy Questionnaire-Overall Summary OR number of cardiovascular-related hospitalizations OR serum cardiac biomarker (B-type natriuretic peptide, cardiac troponin)
member is NOT simultaneously utilizing transthyretin-lowering agents other than the requested drug (e.g., Amvuttra, Attruby, Vyndaqel, Vyndamax, Onpattro, Wainua)

12 months