Pyrukynd — Medical Mutual

Initial criteria

• Patient age ≥ 18 years
• Presence of at least two variant/mutant alleles in the pyruvate kinase liver and red blood cell (PKLR) gene
• At least one of the variant/mutant alleles is a missense variant
• Patient meets one of the following: current hemoglobin level ≤ 10 g/dL OR 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

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

Approval duration

initial 6 months; reauth 1 year