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Vyndaqel® & Vyndamax™

DrugVyndaqel® & Vyndamax™ (Tafamidis) [Pfizer Inc.]

January 2020

Therapeutic area - ATTR Amyloidosis

Initial approval criteria

  • Patient is ≥ 18 years of age; AND
  • Patient has a definitive diagnosis of ATTR amyloidosis as documented by amyloid deposition on tissue biopsy AND identification of a pathogenic TTR variant and/or TTR precursor using molecular genetic testing (e.g., immunohistochemical analysis, scintigraphy, or mass spectrometry); AND
  • Patient has evidence of cardiac involvement as documented by echocardiography (ECG) with an end-diastolic interventricular septal wall thickness > 12 mm; AND
  • Patient has a history of heart failure (HF) which required ≥ 1 hospitalization; OR
  • Patient has clinical evidence of HF, without a prior history of hospitalization for disease, manifested by signs or symptoms of volume overload or elevated cardiac pressure (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) which requires/required treatment with a diuretic; AND
  • Patient has a baseline 6 minute walk test (6MWT) distance > 100 m; AND
  • Patient should NOT have any of the following:
    • New York Heart Association (NYHA) classification of III or IV; AND
    • Primary (light chain) amyloidosis; AND
    • Prior liver transplant; AND
    • Implanted cardiac mechanical-assist device (implanted cardioverter defibrillator, pacemaker, left-ventricular assist device, etc); AND
  • Tafamidis must NOT be used in combination with other transthyretin (TTR) reducing agents (e.g., inotersen, patisiran, etc.)
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet approval criteria above; AND
  • Patient has demonstrated absence of unacceptable toxicity from the drug; AND
  • Patient demonstrates disease response compared to pre-treatment baseline as evidenced by:
    • Decreased frequency of cardiovascular-related hospitalizations; OR
    • Improvement in the total distance walked during the 6MWT as compared to baseline
  • Renewal approval is for 12 months

Quality limits

  • Tafamidis meglumine (Vyndaqel) 20 mg capsule: 120/30 days
  • Tafamidis (Vyndamax) 61 mg capsule: 30/30 days
  • Vyndaqel and Vyndamax are not substitutable on a per mg basis
  • A new prior authorization for Vyndamax is required when patient is switched from Vyndaqel


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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