Crenessity™

Drug - Crenessity™ (crinecerfont) [Neurocrine Biosciences, Inc.]

July 2025

Therapeutic Area - Congenital adrenal hyperplasia (CAH)

Initial approval criteria

  • Patient is ≥ 4 years of age; AND
  • The patient has a diagnosis of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency as confirmed by ONE of the following: 
    • Positive infant screening with secondary tier 2 confirmatory testing; OR 
    • Elevated serum 17-hydroxyprogesterone level (17OHP) above the upper limit of normal (ULN); OR
    • Cosyntropin (adrenocorticotropic hormone [ACTH]) stimulation test; OR
    • Genetic testing for mutation in the СΥΡ21Α2 gene consistent with CAH; AND
  • Patient does NOT have a hypersensitivity to Crenessity or any excipients of the product; AND
  • The patient is currently treated with glucocorticoid replacement therapy (e.g., hydrocortisone, prednisone, prednisolone, dexamethasone); AND 
  • The patient will continue glucocorticoid at a dosage that is required for replacement therapy (e.g., hydrocortisone, prednisone, prednisolone, dexamethasone) in combination with Crenessity; AND
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient has had clinical benefit with Crenessity; AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., clinically significant hypersensitivity reactions).

Quantity limits

  • 25 mg, 50 mg and 100 mg: 60 capsules/30 days
    • If a higher dose is requested due to concomitant use with strong or moderate CYP3A4 inducers, provide the name(s) of concomitant strong or moderate CYP3A4 inducers at time of request
    • For requested quantity based on weight, provide patient’s weight (in kg) at the time of request
  • 50 mg/mL: 120 mL/30 days
    • If a higher dose is requested due to concomitant use with strong or moderate CYP3A4 inducers, provide the name(s) of concomitant strong or moderate CYP3A4 inducers at time of request
    • For requested quantity based on weight, provide patient’s weight (in kg) at the time of request

Questions

Provider Call Center (844) 575-7887