Crenessity (crinecerfont capsules and oral solution) — Cigna

Initial criteria

• Patient is age ≥ 4 years; AND
• Medication will be taken in combination with a systemic glucocorticoid (e.g., hydrocortisone, prednisone, prednisolone, or dexamethasone); AND
• Patient has a 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; AND
• 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 currently receiving Crenessity; AND
• According to the prescriber, the patient is continuing to derive benefit from Crenessity as demonstrated by response indicators such as reduced androstenedione levels, decreased 17-hydroxyprogesterone levels, reduction in glucocorticoid dose from baseline, or improved/stabilized clinical signs or symptoms of CAH (e.g., decrease in body mass index standard deviation scores, improved insulin resistance, reduction of hirsutism, or improvement in androstenedione-to-testosterone ratio).

Approval duration

initial 6 months; reauthorization 1 year