Vyndaqel (tafamidis meglumine capsules – Pfizer) — Cigna
Cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
Initial criteria
- Patient age ≥ 18 years; AND
- Diagnosis confirmed by ONE of the following (i, ii, or iii): i) A technetium pyrophosphate scan (nuclear scintigraphy); OR ii) A tissue biopsy with confirmatory transthyretin (TTR) amyloid typing by mass spectrometry, immunoelectron microscopy, or immunohistochemistry; OR iii) Patient had genetic testing which, according to the prescriber, identified a transthyretin (TTR) pathogenic variant (e.g., Val122Ile variant, Thr60Ala variant); AND
- Diagnostic cardiac imaging has demonstrated cardiac involvement (e.g., echocardiogram or cardiac magnetic imaging showing increased thickness of the ventricular wall or interventricular septum); AND
- Patient has heart failure, but does not have New York Heart Association class IV disease; AND
- Medication is prescribed by or in consultation with a cardiologist or a physician who specializes in the treatment of amyloidosis
Approval duration
1 year