Attruby (acoramidis) — Point32Health

Initial criteria

• Documented diagnosis of wild type or hereditary (variant) transthyretin amyloid cardiomyopathy confirmed by one of the following: a. Cardiac scintigraphy with technetium-99m-labeled bone-seeking b. Endomyocardial biopsy c. Genetic testing
• Documentation demonstrating the absence of monoclonal protein in serum and urine, obtained through laboratory work, to rule out light chain amyloidosis cardiomyopathy
• Documentation of diagnostic cardiac imaging (e.g., echocardiogram, cardiac magnetic imaging) demonstrating cardiac involvement (e.g., increased thickness of the ventricular wall or interventricular septum)
• Patient age ≥ 18 years
• Prescribed by or in consultation with a cardiologist
• Documentation the patient has New York Heart Association (NYHA) functional class I, II, or III of heart failure
• Documentation of one of the following: a. The patient has not had a prior cardiac or liver transplant b. Evidence of amyloid deposits post cardiac or liver transplantation
• Documentation the requested medication will not be used concomitantly with another medication indicated for the management of cardiomyopathy or neuropathy of transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Tegsedi, Vyndamax/Vyndagel, Wainua)

Reauthorization criteria

• Documented diagnosis of wild type or hereditary (variant) transthyretin amyloid cardiomyopathy
• Documentation demonstrating the absence of monoclonal protein in serum and urine, obtained through laboratory work, to rule out light chain amyloidosis cardiomyopathy
• Documentation of diagnostic cardiac imaging (e.g., echocardiogram, cardiac magnetic imaging) demonstrating cardiac involvement (e.g., increased thickness of the ventricular wall or interventricular septum)
• Patient age ≥ 18 years
• Prescribed by or in consultation with a cardiologist
• Documentation the patient has New York Heart Association (NYHA) functional class I, II, or III of heart failure
• Documentation of one of the following: a. The patient has not had a prior cardiac or liver transplant b. Evidence of amyloid deposits post cardiac or liver transplantation
• Documentation the requested medication will not be used concomitantly with another medication indicated for the management of cardiomyopathy or neuropathy of transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Tegsedi, Vyndamax/Vyndagel, Wainua)
• Documentation the patient has experienced a positive therapeutic response as evidenced by one of the following: a. Improvement in the distance walked on the 6-minute walk test (6MWT) as compared to baseline b. Decreased number of cardiovascular-related hospitalizations c. Improvement in Kansas City Cardiomyopathy Questionnaire & Overall Summary (KCCQ-OS) score d. Clinical improvement in symptoms or slowing of disease progression

Approval duration

initial 6 months, reauth 12 months