Crenessity (crinecerfont) oral capsule — United Healthcare

Initial criteria

• Diagnosis of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
• Diagnosis confirmed by ONE of the following: (1) Pretreatment serum 17-hydroxyprogesterone (17-OHP) level > 3,000 ng/dL OR (2) Cosyntropin stimulation 17-OHP level > 10,000 ng/dL OR (3) Genetic variant in CYP21A2 gene
• age ≥ 4 years
• Chronic treatment with a supraphysiologic glucocorticoid regimen (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone) defined as ONE of the following: (1) BOTH (a) age 4–17 years AND (b) Glucocorticoid dose > 12 mg/m2/day in hydrocortisone dose equivalents OR (2) BOTH (a) age ≥ 18 years AND (b) Glucocorticoid dose > 13 mg/m2/day in hydrocortisone dose equivalents
• Prescribed by an endocrinologist
• If request is for Crenessity oral suspension, ONE of the following must apply: (1) Patient unable to ingest a solid dosage form due to age, oral-motor difficulties, or dysphagia OR (2) Patient utilizes a feeding tube for medication administration

Reauthorization criteria

• Documentation of positive clinical response to Crenessity therapy (e.g., reduction in total glucocorticoid daily dose, decreased androstenedione levels)
• Patient will continue concomitant glucocorticoid replacement therapy (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone)
• Prescribed by an endocrinologist
• If request is for Crenessity oral suspension, ONE of the following must apply: (1) Patient unable to ingest a solid dosage form due to age, oral-motor difficulties, or dysphagia OR (2) Patient utilizes a feeding tube for medication administration

Approval duration

12 months