TAFAMIDIS CAP,ORAL
Clinical Criteria Summary
Indication
- Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Provider Requirements
- Provider is a VA or VA Community Care cardiologist or locally designated ATTR-CM provider
Diagnostic & Laboratory Criteria
- Diagnosis of wild type or hereditary TTR genotype ATTR-CM based on 1) endomyocardial biopsy OR 2) echo/MRI suggestive of amyloidosis confirmed with radionuclide imaging (e.g., technetium-pyrophosphate [Tc99-PYP] scintigraphy)
- Assessment of monoclonal protein screen for and exclusion of light chain (AL) amyloidosis
Clinical Presentation
- History of symptomatic heart failure (at least one hospitalization for heart failure OR clinical evidence of heart failure manifested by signs and symptoms of volume overload or elevated intracardiac pressures)
Counseling & Documentation
- Discussion with patient/caregiver/family member regarding realistic treatment expectations and discontinuation should be documented
- For females who can become pregnant: Counseling provided on potential risks vs. benefits of treatment
Exclusion Criteria
- Heart failure without definitive evidence of transthyretin-mediated amyloidosis (ATTR) (e.g., heart failure secondary to ischemic heart disease)
- Patient receiving concomitant therapy for ATTR amyloidosis (e.g., patisiran, eplontersen, inotersen, vutrisiran, acoramidis)
- End stage heart disease and anticipated survival < 1 year