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