Currentmedical mutual - ohioPolicy N/A

Crenessity

Defines prior-authorization–recommended coverage criteria, initial and continued approval durations, prescribing specialist requirements, documentation expectations, and conditions not recommended for approval for Crenessity (crinecerfont) for treatment of classic CAH in patients ≥ 4 years.

Policy Summary

Payermedical mutual - ohio

PolicyCrenessity

Policy CodePolicy N/A

Change TypeAnnual review / clarified criteria

Effective Date

Next Review DateNov 20, 2025

Key ActionPrior authorization is recommended; approve only patients who meet the policy's documented criteria and durations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified; policy shows annual review and last revised date 11/20/2025 with recommended authorization criteria for initial and continuing therapy.

1Covered Indication (CAH)

4Diagnostic confirmation options required

6 moInitial approval duration

1 yrExtended approval duration

Coverage Summary

Background: Crenessity (crinecerfont) is a CRF1 receptor antagonist indicated as adjunctive treatment to glucocorticoid replacement to control androgens in classic congenital adrenal hyperplasia (CAH) for adults and pediatric patients ≥ 4 years of age. Initial prescribing by or in consultation with a specialist is required due to the specialized evaluation and monitoring needed.

Coverage stance: covered_with_criteria. Initial approval duration: 6 months. Continuation/extended approval duration: 1 year. Initial prescribing must be by or in consultation with an endocrinologist, urologist, or a physician who specializes in the treatment of adrenal hyperplasia.

Key thresholds and approval durations for Crenessity

Age requirementPatient must be ≥ 4 years of age

Diagnostic threshold — 17‑hydroxyprogesterone (baseline)Elevated 17‑hydroxyprogesterone > 3,000 ng/dL

Diagnostic threshold — cosyntropin stimulationCosyntropin‑stimulated 17OHP level > 10,000 ng/dL

Initial approval durationApprove for 6 months for initial therapy when criteria met

Extended approval durationApprove for 1 year for patients currently receiving Crenessity with documented positive response

Recommended Authorization Criteria

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of Crenessity. Approval is recommended only for patients who meet the policy's specified coverage criteria and the durations noted for initial or extended therapy.

Documentation Required

Specialist prescription requirement

Initial prescribing (or prescribing in consultation) must be by a specialist due to the specialized evaluation and monitoring required. The medication must be prescribed by or in consultation with an endocrinologist, urologist, or a physician who specializes in the treatment of adrenal hyperplasia.

Documentation Required

Confirmatory diagnostic documentation

For initial therapy, submit documentation confirming 21-hydroxylase deficiency CAH by ONE of the following diagnostic methods:

Elevated 17-hydroxyprogesterone (17OHP) level > 3,000 ng/dL
Confirmed cytochrome (CYP)21A2 genotype
Positive newborn screening with confirmatory second-tier testing
Diagnostic results after cosyntropin stimulation: 17OHP level > 10,000 ng/dL

Documentation Required

Oral suspension justification

If requesting the Crenessity oral suspension, document that the patient is unable to ingest a solid dosage form or requires a feeding tube for medication administration.

Inability to ingest a solid dosage form (e.g., due to age, oral-motor difficulties, or dysphagia)
Use of a feeding tube for medication administration

Documentation Required

Response documentation for continuation

For continuation (extended approval), provide evidence of a positive clinical response to Crenessity and documentation that the patient will continue to receive concomitant glucocorticoid replacement.

Evidence of positive clinical response (laboratory or clinical improvements such as reduced androstenedione or 17OHP, reduction in glucocorticoid dose, or improved/stabilized clinical signs/symptoms)
Ongoing concomitant systemic glucocorticoid replacement

Denial Risk

Coverage denial risk for non-listed uses

Requests for uses not listed in the Recommended Authorization Criteria may be denied; coverage is not recommended for circumstances not listed and such requests will be reviewed case-by-case for medical necessity or investigational status.

Applicable Codes

Drug / productNDC

No codes listed

Clinical Evidence & References

Evidence: Key supporting sources include the prescribing information (Neurocrine Biosciences, December 2024) and the pivotal Phase 3 trials published in the New England Journal of Medicine: the adult Phase 3 trial (NEJM 2024;391(6):504-514) and the pediatric Phase 3 trial (NEJM 2024;391(6):493-503).

Note: These cited trials and the prescribing information are the primary references supporting the effectiveness and regulatory information for Crenessity.

Background & Definitions

Crenessity is indicated as adjunctive therapy to glucocorticoid replacement to control androgens in classic CAH for adults and pediatric patients aged ≥ 4 years. Initial prescribing by or in consultation with a specialist (endocrinologist, urologist, or clinician specializing in adrenal hyperplasia) is required.

Scope summary: This policy defines prior-authorization–recommended coverage criteria, initial and continuation approval durations, prescribing specialist requirements, documentation expectations, and conditions not recommended for approval for Crenessity (crinecerfont) for treatment of classic CAH in patients ≥ 4 years.

Definitions:

Positive clinical response: Examples include reduced androstenedione levels, decreased 17-hydroxyprogesterone levels, reduction in glucocorticoid dose from baseline, or improved/stabilized clinical signs/symptoms (e.g., decreased BMI SDS, improved insulin resistance, reduction of hirsutism, or improvement in androstenedione-to-testosterone ratio).

Revision History

2025-11-20policy_reviewLatest

Annual review completed; policy last revised 11/20/2025 and reflects recommended authorization criteria for initial and continuing therapy (initial approval 6 months; extended approval 1 year). Marked as non-material clarification of policy text.

2024-12evidence_update

References updated to include prescribing information (Neurocrine Biosciences, December 2024) and Phase 3 trials in adults and pediatrics supporting indication and criteria.

Policy Summary

Payermedical mutual - ohio

PolicyCrenessity

Policy CodePolicy N/A

Change TypeAnnual review / clarified criteria

Effective Date

Next Review DateNov 20, 2025

Key ActionPrior authorization is recommended; approve only patients who meet the policy's documented criteria and durations.

SourceLink

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