Attruby (acoramidis) — Medica
Cardiomyopathy of wild-type or hereditary (variant) transthyretin-mediated amyloidosis (ATTR-CM)
Initial criteria
- age ≥ 18 years
- Diagnosis confirmed by ONE of the following: (i) technetium pyrophosphate scan (nuclear scintigraphy); OR (ii) tissue biopsy with confirmatory transthyretin (TTR) amyloid typing by mass spectrometry, immunoelectron microscopy, or immunohistochemistry; OR (iii) genetic testing identifying a TTR pathogenic variant
- Diagnostic cardiac imaging has demonstrated cardiac involvement (e.g., echocardiogram or cardiac magnetic imaging showing increased thickness of the ventricular wall or interventricular septum)
- 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
- NOT used concurrently with other medications indicated for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis or transthyretin-mediated amyloidosis-cardiomyopathy (e.g., Amvuttra [vutrisiran], Onpattro [patisiran], Tegsedi [inotersen], Wainua [eplontersen], tafamidis products)
Approval duration
1 year