Endari — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Diagnosis of sickle cell disease AND
• Patient is using the requested agent to reduce acute complications of sickle cell disease AND
• Patient's age is within FDA labeling for the requested indication OR there is support for use for the patient’s age for the indication AND
• Patient has tried and had inadequate response after ≥6 months of therapy with maximally tolerated hydroxyurea OR has intolerance or hypersensitivity to hydroxyurea OR has an FDA labeled contraindication to hydroxyurea AND
• Patient will NOT use requested agent in combination with Adakveo (crizanlizumab-tmca) OR there is support for combination use AND
• For brand Endari when a generic equivalent (L-glutamine) exists: ONE of the following – member plan type qualifies (BCBS IL Fully Insured, HIM, Non‑ERISA ASO/Self‑insured Municipalities/Counties) OR patient is stable on brand OR inadequate response to generic OR generic discontinued due to lack of efficacy/adverse event OR intolerance/hypersensitivity/contraindication to generic OR generic expected ineffective/adherence barrier/comorbid impact OR generic not in best interest/medical necessity OR prior failure to another same‑class agent OR support for brand over generic AND
• Patient has no FDA labeled contraindications to requested agent AND
• Requested dose ≤ FDA labeled maximum
• For NM fully insured/HIM or OH fully insured/HIM Shop members: rare disease indication with no contraindications AND either (another FDA labeled indication OR indication supported in compendia OR prescriber provides ≥2 peer‑reviewed journal articles demonstrating safety and efficacy)

Reauthorization criteria

• Patient previously approved through plan’s prior authorization process AND
• Patient has had clinical benefit (e.g., reduction in acute complications of sickle cell disease) AND
• Patient will NOT use in combination with Adakveo OR support exists for combination use AND
• For brand Endari when generic available: same criteria as initial brand vs. generic rationale AND
• Patient has no FDA labeled contraindications AND
• Requested dose ≤ FDA labeled maximum

Approval duration

12 months