Mitapivat Sulfate Tab Therapy Pack — Blue Cross Blue Shield of Alabama

Initial criteria

• Diagnosis of hemolytic anemia with pyruvate kinase deficiency (PKD) AND ONE of the following: • Genetic testing showing a pathogenic PKLR gene mutation OR • The patient does NOT have two known pathogenic mutations in the PKLR gene AND the patient has a decrease in pyruvate kinase enzyme activity
• The patient is NOT homozygous for the c.1436G > A (p.R479H) variant
• The patient has at least 2 variant alleles in the PKLR gene, of which at least 1 is a missense variant
• The patient does NOT have two non-missense mutations
• If the patient has an FDA labeled indication, then ONE of the following: • The patient’s age is within FDA labeling for the requested indication for the requested agent OR • There is support for using the requested agent for the patient’s age for the requested indication
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist), or has consulted with a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent (e.g., hemoglobin has increased or is within normal range, decrease in red blood cell transfusion burden)
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist), or has consulted with a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 6 months; renewal 12 months