Attruby (acoramidis) — 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
Reauthorization criteria
- 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)
Approval duration
12 months