Amvuttra (vutrisiran) — Medica
Cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
Initial criteria
- Patient is age ≥ 18 years
- Diagnosis confirmed by ONE of the following: (i) technetium pyrophosphate scan (nuclear scintigraphy); OR (ii) tissue biopsy with confirmatory transthyretin amyloid typing by mass spectrometry, immunoelectron microscopy, or immunohistochemistry; OR (iii) genetic testing identifying a transthyretin pathogenic variant
- Diagnostic cardiac imaging demonstrates cardiac involvement
- Patient has heart failure but does not have New York Heart Association 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