Vyndaqel — Point32Health

Initial criteria

• Documented diagnosis of wild type or hereditary (variant) transthyretin amyloid cardiomyopathy confirmed by one of the following: cardiac scintigraphy with technetium-99m-labeled bone-seeking agent, endomyocardial biopsy, or 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: the patient has not had a prior cardiac or liver transplant OR 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)

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: the patient has not had a prior cardiac or liver transplant OR 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)
• Documentation the patient has experienced a positive therapeutic response as evidenced by one of the following: improvement in distance walked on the 6-minute walk test (6MWT) compared to baseline, decreased number of cardiovascular-related hospitalizations, improvement in Kansas City Cardiomyopathy Questionnaire & Overall Summary (KCCQ-OS) score, or clinical improvement in symptoms or slowing of disease progression

Approval duration

initial 6 months, reauth 12 months