Vyndaqel — Medica
cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
Initial criteria
- Patient is age ≥ 18 years
- Diagnosis is confirmed by ONE of the following: technetium pyrophosphate scan (nuclear scintigraphy) OR tissue biopsy with confirmatory transthyretin (TTR) amyloid typing by mass spectrometry, immunoelectron microscopy, or immunohistochemistry OR genetic testing identifying a transthyretin (TTR) pathogenic variant
- Diagnostic cardiac imaging has demonstrated cardiac involvement
- Patient has heart failure but does not have New York Heart Association (NYHA) class IV disease
- Medication is prescribed by or in consultation with a cardiologist or a physician who specializes in the treatment of amyloidosis
Approval duration
1 year