Vyndaqel (tafamidis meglumine) — United Healthcare

transthyretin (ATTR)-mediated amyloidosis with cardiomyopathy (ATTR-CM)

Initial criteria

Diagnosis of transthyretin (ATTR)-mediated amyloidosis with cardiomyopathy (ATTR-CM)
AND One of the following: (a) Documentation that the patient has a pathogenic TTR mutation (e.g., V30M) OR (b) Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of ATTR amyloid deposits OR (c) All of the following: i. Echocardiogram or cardiac magnetic resonance imaging suggestive of amyloidosis AND ii. Radionuclide imaging (99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP) showing grade 2 or 3 cardiac uptake AND iii. Absence of light chain amyloidosis
AND Patient has New York Heart Association (NYHA) Functional Class I, II, or III heart failure
AND Physician attests that the patient has an N-terminal pro-B-type natriuretic peptide (NT-proBNP) level that, when combined with signs and symptoms, is considered definitive for a diagnosis of ATTR-CM
AND One of the following: (a) History of heart failure, with at least one prior hospitalization for heart failure OR (b) Presence of clinical signs and symptoms of heart failure (e.g., dyspnea, edema)
AND Prescribed by or in consultation with a cardiologist
AND Patient is not receiving Vyndaqel/Vyndamax in combination with an RNA-targeted therapy for ATTR amyloidosis [i.e., Amvuttra (vutrisiran), Attruby (acoramadis), Onpattro (patisiran), Tegsedi (inotersen), or Wainua (eplontersen)]

Documentation that the patient has experienced a positive clinical response to Vyndaqel/Vyndamax (e.g., improved symptoms, quality of life, slowing of disease progression, decreased hospitalizations, etc.)
AND Documentation that patient continues to have New York Heart Association (NYHA) Functional Class I, II, or III heart failure
AND Prescribed by or in consultation with a cardiologist
AND Patient is not receiving Vyndaqel/Vyndamax in combination with an RNA-targeted therapy for ATTR amyloidosis [i.e., Amvuttra (vutrisiran), Attruby (acoramadis), Onpattro (patisiran), Tegsedi (inotersen), or Wainua (eplontersen)]

12 months