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Pyrukynd (mitapivat tablets)Cigna

Hemolytic anemia due to pyruvate kinase deficiency

Initial criteria

  • Patient age ≥ 18 years; AND
  • Presence of at least two variant/mutant alleles in the pyruvate kinase liver and red blood cell (PKLR) gene [documentation required]; AND
  • At least one of the variant/mutant alleles is a missense variant [documentation required]; AND
  • Patient has ONE of the following (a or b): a) current hemoglobin level ≤ 10 g/dL; OR b) currently receiving red blood cell transfusions regularly, defined as at least six transfusions within the last year; AND
  • Medication is prescribed by or in consultation with a hematologist

Reauthorization criteria

  • Patient age ≥ 18 years; AND
  • Presence of at least two variant/mutant alleles in the pyruvate kinase liver and red blood cell (PKLR) gene [documentation required]; AND
  • At least one of the variant/mutant alleles is a missense variant [documentation required]; AND
  • According to the prescriber, patient has experienced a benefit from therapy based on ONE of the following (a, b, or c): a) increase in or maintenance of hemoglobin levels; OR b) improvement in or maintenance of hemolysis laboratory parameters; OR c) decrease in or maintenance of transfusion requirements; AND
  • Medication is prescribed by or in consultation with a hematologist

Approval duration

initial: 6 months; reauth: 1 year