Pyrukynd (mitapivat tablets) — Medica

Initial criteria

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

Reauthorization criteria

• age ≥ 18 years
• Presence of at least two variant/mutant alleles in the pyruvate kinase liver and red blood cell (PKLR) gene [documentation required]
• At least one of the variant/mutant alleles is a missense variant [documentation required]
• According to the prescriber, the patient has experienced a benefit from therapy based on an increase or maintenance of hemoglobin levels OR improvement or maintenance of hemolysis laboratory parameters (e.g., indirect bilirubin, lactate dehydrogenase, haptoglobin) OR decrease or maintenance of transfusion requirements
• Medication is prescribed by or in consultation with a hematologist

Approval duration

Initial: 6 months; Reauthorization: 1 year