Crenessity (crinecerfont) capsule 25 mg — Blue Cross Blue Shield of Oklahoma

Initial criteria

• 1. BOTH of the following:
• A. The patient has a diagnosis of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency as confirmed by ONE of the following:
• 1. Positive infant screening with secondary tier 2 confirmatory testing OR
• 2. Elevated serum 17-hydroxyprogesterone (17OHP) above the upper limit of normal OR
• 3. Cosyntropin (ACTH) stimulation test OR
• 4. Genetic testing for mutation in the CYР21A2 gene consistent with CAH AND
• B. If the patient has an FDA labeled indication, then ONE of the following:
• 1. The patient's age is within FDA labeling for the requested indication for the requested agent OR
• 2. There is support for using the requested agent for the patient's age for the requested indication AND
• 2. The patient is currently treated with glucocorticoid replacement therapy (e.g., hydrocortisone, prednisone, prednisolone, dexamethasone) AND
• 3. The patient will continue glucocorticoid replacement therapy in combination with the requested agent AND
• 4. The prescriber is a specialist in the area of the patient's diagnosis (e.g., endocrinologist, geneticist), or the prescriber has consulted with such a specialist AND
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternative approval also allowed when ONE of the following is met:
• 1. For BCBS NM Fully Insured or NM HIM member: ALL of - (A) No FDA labeled contraindications; (B) Requested indication is a rare disease; (C) ONE of - (1) Applicant has another FDA labeled indication for requested agent and route OR (2) Applicant has another indication supported in compendia for requested agent and route.
• 2. For Ohio member in Fully Insured or HIM Shop (SG) plans: ALL of - (A) Member resides in Ohio; (B) Plan is Fully Insured or HIM Shop (SG); (C) No FDA labeled contraindications; (D) ONE of - (1) patient has another FDA labeled indication for requested agent and route OR (2) patient has another compendia supported indication OR (3) prescriber submits two acceptable peer-reviewed journal articles supporting proposed use.

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan's Prior Authorization process AND
• 2. The patient has had clinical benefit with the requested agent AND
• 3. The patient is currently treated with glucocorticoid replacement therapy AND
• 4. The patient will continue glucocorticoid replacement therapy in combination with the requested agent AND
• 5. The prescriber is a specialist in the area of the patient's diagnosis (e.g., endocrinologist, geneticist), or has consulted such a specialist AND
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months