CurrentUnitedHealthcarePolicy N/A

Crenessity (crinecerfont) prior authorization and medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for Crenessity (crinecerfont) oral capsule and suspension for patients with classic congenital adrenal hyperplasia (CAH); applies to providers submitting coverage requests to UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyCrenessity (crinecerfont) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeAdded criteria

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documented CAH diagnosis confirmation (17-OHP thresholds or CYP21A2 variant) and endocrinologist prescription; include justification for suspension if patient cannot ingest solids or uses a feeding tube.

SourceLink

POLICY UPDATE CHANGES

Added non-solid dosage form criteria for Crenessity oral suspension.

4 yrsminimum patient age for eligibility

12 moauthorization duration

>3,00017-OHP pretreatment threshold

>10,000Cosyntropin 17-OHP threshold

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genetic confirmation option

Coverage and Medical Necessity Criteria

Initial Authorization

Covered when ALL of the following are met:

Initial criteria

Diagnosis confirmation (one of)
- Pretreatment serum 17-hydroxyprogesterone (17-OHP) level > 3,000 ng/dL.
- Cosyntropin-stimulated 17-OHP level > 10,000 ng/dL.
- Pathogenic genetic variant in the CYP21A2 gene.
Chronic supraphysiologic glucocorticoid regimen
- Ages 4–17: Patient is 4 to 17 years old AND glucocorticoid dose > 12 mg/m2/day (hydrocortisone equivalents).
- Age ≥18: Patient is ≥ 18 years old AND glucocorticoid dose > 13 mg/m2/day (hydrocortisone equivalents).
Prescribed by an endocrinologist.
Oral suspension only (if requested)
- Patient is unable to ingest a solid dosage form (e.g., tablet or capsule) due to age, oral-motor difficulties, or dysphagia.
- Patient utilizes a feeding tube for medication administration.

Reauthorization

Covered when ALL of the following are met:

Reauthorization criteria

Documentation of positive clinical response to Crenessity therapy (e.g., reduction in total glucocorticoid daily dose, decreased androstenedione levels).
Patient will continue to receive concomitant glucocorticoid replacement (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone).
Prescribed by an endocrinologist.
Oral suspension only (if requested)
- Patient is unable to ingest a solid dosage form (e.g., tablet or capsule) due to age, oral-motor difficulties, or dysphagia.

Coverage decisions for Crenessity (crinecerfont) are subject to applicable state mandates, federal regulatory requirements, and the member’s specific benefit plan. UnitedHealthcare may also apply other policies or utilization management programs that could affect coverage, including program-level supply limits. Additionally, UnitedHealthcare may use prior claim or medication history, diagnosis codes, and automated claim/approval logic to approve initial or reauthorization requests in lieu of full documentation depending on the program and therapeutic class.

Diagnostic Thresholds and Dose Criteria

inv-04: Pretreatment 17-hydroxyprogesterone (17-OHP) — numeric diagnostic threshold

ThresholdPretreatment serum 17-hydroxyprogesterone (17-OHP) > 3,000 ng/dL

ContextUsed as one acceptable diagnostic confirmation for classic CAH due to 21-hydroxylase deficiency

Evidence requiredDocument pretreatment (baseline) serum 17-OHP level in chart or laboratory report

inv-05: Cosyntropin-stimulated 17-OHP — diagnostic stimulation threshold

ThresholdCosyntropin-stimulated 17-OHP > 10,000 ng/dL

ContextAcceptable alternative diagnostic confirmation for classic CAH due to 21-hydroxylase deficiency

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Crenessity (oral capsule or oral suspension). Authorization will be issued for 12 months and is granted only when all initial authorization criteria are met.

Applies to Crenessity oral capsule and oral suspension
Authorization duration: 12 months

Documentation Required

Required Documentation

Providers must submit documentation that supports the diagnosis of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency and the diagnostic threshold used. Accepted confirmatory documentation includes pretreatment serum 17-hydroxyprogesterone (17-OHP) > 3,000 ng/dL, cosyntropin stimulation 17-OHP > 10,000 ng/dL, or identification of a pathogenic/likely pathogenic variant in the CYP21A2 gene. For reauthorization, documentation must show a positive clinical response to Crenessity (for example, reduction in total glucocorticoid daily dose or decreased androstenedione levels). If requesting the oral suspension formulation, include documentation that the patient is unable to ingest solid dosage forms (age, oral-motor difficulties, dysphagia) or uses a feeding tube.

Therapeutic Context

Crenessity (crinecerfont) is a corticotropin-releasing factor type 1 (CRF1) receptor antagonist indicated as adjunctive therapy to glucocorticoid replacement to control androgen excess in patients with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. It is indicated for both adult and pediatric patients aged ≥ 4 years and is intended to reduce androgen levels and potentially permit lowering of supraphysiologic glucocorticoid doses while maintaining disease control. As adjunctive therapy, Crenessity is used in combination with ongoing glucocorticoid replacement rather than as monotherapy.

Key Definitions and Operational Terms

inv-13: Classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency — diagnostic definition and acceptable confirmation methods

DefinitionClassic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency: CAH confirmed by elevated 17-OHP, cosyntropin-stimulated 17-OHP, or pathogenic CYP21A2 variant

Acceptable confirmation methodsPretreatment 17-OHP > 3,000 ng/dL; OR cosyntropin-stimulated 17-OHP > 10,000 ng/dL; OR genetic variant in CYP21A2 gene

Clinical useRequired diagnosis for consideration of Crenessity (crinecerfont) therapy

inv-14: Chronic supraphysiologic glucocorticoid regimen — operational definition used for eligibility

Operational definitionChronic supraphysiologic glucocorticoid regimen: ongoing glucocorticoid replacement exceeding physiologic equivalents defined as >12 mg/m2/day hydrocortisone equivalents for ages 4–17, or >13 mg/m2/day for adults ≥18

Policy Summary

PayerUnitedHealthcare

PolicyCrenessity (crinecerfont) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeAdded criteria

Effective DateJun 1, 2025

Next Review DateN/A

SourceLink

On This Page

Patient utilizes a feeding tube for medication administration.

Evidence requiredReport of cosyntropin stimulation test showing peak 17-OHP level

inv-06: Hydrocortisone equivalent glucocorticoid dose (ages 4–17) — dosing threshold

ThresholdHydrocortisone equivalent glucocorticoid dose > 12 mg/m2/day for patients aged 4–17

Age rangeApplies to patients 4 to 17 years old

ContextDefines chronic supraphysiologic glucocorticoid regimen required for coverage

inv-07: Hydrocortisone equivalent glucocorticoid dose (age ≥18) — dosing threshold

ThresholdHydrocortisone equivalent glucocorticoid dose > 13 mg/m2/day for patients age ≥18

Age criterionApplies to patients 18 years and older

ContextDefines chronic supraphysiologic glucocorticoid regimen required for coverage

Diagnosis: classic CAH due to 21-hydroxylase deficiency (ICD-10 diagnosis codes should be submitted)
Confirmatory testing (one required): pretreatment 17-OHP > 3,000 ng/dL; OR cosyntropin-stimulated 17-OHP > 10,000 ng/dL; OR pathogenic/likely pathogenic CYP21A2 variant
Chronic supraphysiologic glucocorticoid regimen documented (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone). For patients 4–17 years old, glucocorticoid dose > 12 mg/m2/day (hydrocortisone equivalents) must be documented
Prescriber specialty: endocrinologist
For oral suspension: documentation of inability to ingest solid dosage form (age, oral-motor difficulty, dysphagia) or feeding tube use
Reauthorization: evidence of positive clinical response (reduced total GC dose, decreased androstenedione, or other objective clinical improvement)

Step Therapy

Step Therapy / Automated Processes

UnitedHealthcare may use prior claim/medication history, diagnosis codes, and automated claim logic to approve initial authorizations or reauthorizations without full clinical documentation. Use of automated approval and re-approval processes varies by program and therapeutic class. Supply limits may apply.

Approvals may be granted based on previous claims/medication history and ICD-10 diagnosis codes alone
Automated approval/re-approval processes vary by program and therapeutic class
Supply limits may be enforced

Included agentsExamples include dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone (dosed in hydrocortisone equivalents)

PurposeUsed to determine eligibility for Crenessity; documentation of dose in mg/m2/day required