Pyrukynd (mitapivat) — Highmark
Hemolytic anemia due to pyruvate kinase deficiency (PKD)
Initial criteria
- age ≥ 18 years
- Diagnosis of PKD with hemolytic anemia (ICD-10: D55.21)
- Documentation of at least two mutant alleles in the PKLR gene, with at least one being a missense mutation
- Member is not homozygous for the R479H mutation
- Member does not have two non-missense variants without the presence of another missense variant in the PKLR gene
- Hemoglobin level ≤ 10 g/dL OR at least 6 transfusions in the previous year
- Receiving concomitant treatment with folic acid
Reauthorization criteria
- Prescriber attests that the member has experienced a therapeutic response defined as ONE of the following: Hemoglobin increase ≥ 1.5 g/dL from baseline OR decrease in transfusion burden from baseline
- Member will continue to receive concomitant treatment with folic acid
Approval duration
Initial: 24 weeks; Reauthorization: 12 months