Attruby — CareFirst (Caremark)

Cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM)

Initial criteria

Member exhibits clinical symptoms of cardiomyopathy and heart failure (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema).
Diagnosis is confirmed by either of the following:
1) Presence of transthyretin amyloid deposits on analysis of biopsy from cardiac or noncardiac sites AND presence of transthyretin precursor proteins confirmed by immunohistochemical analysis, mass spectrometry, tissue staining, or polarized light microscopy.
OR
2) Positive technetium-labeled bone scintigraphy tracing AND systemic light chain amyloidosis ruled out by absence of monoclonal proteins (serum kappa/lambda free light chain ratio, serum protein immunofixation, or urine protein immunofixation).
For members with variant ATTR-CM, presence of a mutation of the TTR gene is confirmed.
Member is not a liver transplant recipient.
Requested medication will not be used in combination with inotersen (Tegsedi), patisiran (Onpattro), vutrisiran (Amvuttra), eplontersen (Wainua), tafamidis meglumine (Vyndaqel), or tafamidis (Vyndamax).

Member continues to meet all initial coverage criteria.
Member has demonstrated a beneficial response to treatment with acoramidis therapy (e.g., improvement in rate of disease progression as demonstrated by distance walked on the 6-minute walk test, Kansas City Cardiomyopathy Questionnaire–Overall Summary [KCCQ-OS] score, cardiovascular-related hospitalizations, NYHA classification of heart failure, left ventricular stroke volume, N-terminal B-type natriuretic peptide [NT-proBNP] level).

12 months