Crenessity - NC Standard

Restricted Product(s)

• Crenessity™ (crinecerfont)

FDA Approved Use

• Indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH)

Criteria for Approval of Restricted Product(s)

1. The patient is 4 years of age or older; AND
2. The patient has confirmed diagnosis of classic 21-hydroxylase deficiency classic congenital adrenal hyperplasia (CAH) (medical record documentation required); AND
3. The patient will continue to use glucocorticoid replacement therapy for the adrenal insufficiency associated with congenital adrenal hyperplasia (CAH) (medical record documentation required); AND
4. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
5. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, urologist, and geneticist); AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies

Duration of Approval: 180 days (6 months)

Continuation Criteria

1. The patient has been previously approved for Crenessity with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has experienced clinical benefit since initiation of therapy defined by an improvement in androgen control and enable patient to reduce glucocorticoid dose maintaining androgen control (medical record documentation required); AND
3. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
4. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, urologist, and geneticist)

Duration of Approval: 365 days (1 year)

Quantity Limitations

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

January 2025: Original utilization management policy issued.