Vyndamax (tafamidis) — CareFirst (Caremark)

Cardiomyopathy of wild-type or hereditary 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 ONE 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 a test showing absence of monoclonal proteins (serum kappa/lambda free light chain ratio, serum protein immunofixation, or urine protein immunofixation).
For members with hereditary ATTR-CM, presence of a mutation of the TTR gene confirmed.
Member is not a liver transplant recipient.
Requested medication will not be used in combination with inotersen (Tegsedi), patisiran (Onpattro), vutrisiran (Amvuttra), or eplontersen (Wainua).

Member meets all initial authorization criteria.
Member demonstrates a beneficial response to tafamidis therapy (e.g., improvement in rate of disease progression as demonstrated by distance walked on the 6-minute walk test, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score, cardiovascular-related hospitalizations, NYHA classification of heart failure, left ventricular stroke volume, or NT-proBNP level).
Documentation from the medical record must be provided.

12 months