Attruby — Medical Mutual

Cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)

Initial criteria

Patient is age ≥ 18 years; AND
Diagnosis 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 TTR pathogenic variant; AND
Presence of clinical signs and symptoms of the disease (e.g., peripheral/autonomic neuropathy, motor disability, cardiovascular dysfunction, renal dysfunction); AND
Patient has NT-proBNP ≥ 600 pg/mL; AND
Patient has EITHER NYHA Functional Class I or II OR NYHA Functional Class III AND patient can ambulate ≥ 100 meters in 6 minutes; AND
Patient has a prior hospitalization for heart failure OR clinical evidence of heart failure requiring diuretic treatment; AND
Evidence of cardiac involvement by echocardiography OR MRI with end-diastolic interventricular septal wall thickness > 12 mm; AND
Medication is prescribed by or in consultation with a cardiologist or physician specializing in amyloidosis

Patient has previously received treatment with the medication; AND
Patient has demonstrated a beneficial response to treatment (e.g., reduction in hospitalizations, improvement or stabilization in 6-Minute Walk Test, improvement in symptom burden or frequency); AND
Patient continues to have NYHA Functional Class I, II, or III heart failure; AND
Medication is prescribed by or in consultation with a cardiologist or physician specializing in amyloidosis

1 year