crinecerfont — Medica

Initial criteria

• age ≥ 4 years
• Medication will be taken in combination with a systemic glucocorticoid (e.g., hydrocortisone, prednisone, prednisolone, or dexamethasone)
• Diagnosis of 21-hydroxylase deficiency CAH confirmed by ONE of the following: elevated 17-hydroxyprogesterone level OR confirmed cytochrome (CYP)21A2 genotype OR positive newborn screening with confirmatory second-tier testing OR diagnostic results after cosyntropin stimulation
• Medication is prescribed by or in consultation with an endocrinologist, urologist, or a physician who specializes in the treatment of adrenal hyperplasia

Reauthorization criteria

• Patient is continuing to derive benefit from Crenessity therapy as determined by the prescriber (e.g., reduced androstenedione levels, decreased 17-hydroxyprogesterone levels, reduced glucocorticoid dose from baseline, improved or stabilized clinical signs or symptoms such as decreased BMI standard deviation scores, improved insulin resistance, reduction of hirsutism, or improved androstenedione-to-testosterone ratio)

Approval duration

Initial: 6 months; Reauthorization: 1 year