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Amvuttra (vutrisiran) — Medical Mutual

Cardiomyopathy of Wild Type or Hereditary Transthyretin-Mediated Amyloidosis (ATTR-CM)

Initial criteria

  • Patient is at least age ≥ 18 years
  • Patient is receiving supplementation with vitamin A at the recommended daily allowance
  • Must not be used in combination with other transthyretin (TTR) reducing or stabilizing agents (e.g., tafamidis, patisiran, acoramidis, etc.)
  • Patient has evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12 mm
  • Patient has a definitive diagnosis of Wild Type or Hereditary ATTR-CM as confirmed by laboratory testing (e.g., stannous pyrophosphate (PYP) scanning, monoclonal antibody studies, biopsy, scintigraphy, genetic testing [TTR genotyping])
  • Patient has a medical history of heart failure which required at least 1 prior hospitalization OR Patient has clinical evidence of heart failure (with or without hospitalization) manifested by signs and symptoms of volume overload or elevated intracardiac 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
  • Patient has New York Heart Association (NYHA) Class I or II heart failure OR Class III heart failure that is not considered high risk (i.e., excludes patients with NYHA high risk Class III disease and Class IV disease)
  • Patient has a baseline 6-minute walk-test (6MWT) distance of ≥150 meters

Reauthorization criteria

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III
  • Absence of unacceptable toxicity from the drug (examples include ocular symptoms related to vitamin A deficiency such as night blindness)
  • Disease response compared to pre-treatment baseline as evidenced by stabilization or improvement in one or more of the following: Frequency of cardiovascular-related hospitalizations or urgent heart failure visits; Total distance walked during 6-minute walk test (6MWT)

Approval duration

6 months initial, 12 months renewal