CurrentHealth NetPolicy CP PHAR.692

Crinecerfont (Crenessity) — Coverage Criteria

Defines medical necessity and prior authorization criteria for Crinecerfont (Crenessity) as adjunctive treatment to glucocorticoid replacement in adults and pediatric patients ≥4 years with classic congenital adrenal hyperplasia (CAH); applies to Health Net lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerHealth Net

PolicyCrinecerfont (Crenessity) — Coverage Criteria

Policy CodePolicy CP PHAR.692

Change TypeRevised age and dosing limits

Effective DateDec 13, 2024

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, etc.) showing the patient meets all approval criteria, including diagnostic confirmation of classic 21‑hydroxylase CAH.

SourceLink

POLICY UPDATE CHANGES

Revised minimum patient age from 2 years to 4 years and updated maximum dosing and quantity limits.

≥4minimum covered age

200 mg/daystandard adult max dose

400 mg/daymax w/ strong CYP3A4 inducer

300 mg/daymax w/ moderate CYP3A4 inducer

25/50/100 mg; 50 mg/mL

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial approval for Crinecerfont: 1) Diagnosis of classic congenital adrenal hyperplasia (CAH) due to 21‑hydroxylase deficiency; 2) Prescribed by or in consultation with an endocrinologist; 3) Member is currently receiving chronic glucocorticoid treatment for CAH (e.g., hydrocortisone, prednisone, prednisolone, methylprednisolone, dexamethasone); 4) Medically confirmed diagnosis by one of: elevated 17‑hydroxyprogesterone (17‑OHP), positive newborn screen with confirmatory second‑tier testing (e.g., LC‑MS/MS), confirmed CYP21A2 genotype, or cosyntropin stimulation test; 5) Crinecerfont is prescribed in combination with glucocorticoid treatment; 6) Requested dose does not exceed policy dosing limits including adjustments for concomitant CYP3A4 inducers as specified in the dosing appendix (standard adult: ≤200 mg/day; with strong CYP3A4 inducer: ≤400 mg/day; with moderate CYP3A4 inducer: ≤300 mg/day).see dosing thresholds

Provider must submit supporting documentation (office notes, lab results, etc.)

Continued Therapy

Continued use is covered when ONE of the following is met and the member is responding:

Continuation criteria: a) Member is currently receiving medication via the benefit or previously met initial approval criteria; OR b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.N/A

AND member is responding positively to therapy as evidenced by clinical benefit such as reduction in serum androstenedione, reduction in glucocorticoid dose, or other documented improvement; new/continued dose must not exceed current policy dosing limits including CYP3A4 inducer adjustments (standard adult: ≤200 mg/day; with strong CYP3A4 inducer: ≤400 mg/day; with moderate CYP3A4 inducer: ≤300 mg/day).

Requests for use of Crinecerfont (Crenessity) for non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, and CP.PMN.53 for Medicaid) or evidence of coverage documents.

Use of Crinecerfont for indications that are not supported by this policy or that lack sufficient evidence will be considered under the referenced formulary/off‑label pathways. Providers should follow the off‑label use processes and submit supporting clinical documentation as required by CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), or CP.PMN.53 (Medicaid) for review.

Product Coding & Dosing

Product strengths/formulationsmixed

25 mg	Capsule strength
50 mg	Capsule strength; oral solution 50 mg/mL
100 mg	Capsule strength

Adult maximum daily dose

Standard adult maximum daily dose200 mg/day

With strong CYP3A4 inducer400 mg/day (increase both morning and evening doses 2-fold)

With moderate CYP3A4 inducer300 mg/day (increase evening dose 2-fold)

Pediatric dosing by weight

Age range4–17 years

10–19 kg25 mg PO twice daily

20–54 kg50 mg PO twice daily

Provider Actions & Prior Authorization

Prior Authorization

Initial approval requirements

Prior Authorization Required: Initial approval for Crenessity (for classic CAH due to 21‑hydroxylase deficiency) requires documentation that the member has a medically confirmed diagnosis of classic CAH and that the drug is prescribed by or in consultation with an endocrinologist. Provider must submit office notes, lab results, or other clinical information supporting that the member meets all approval criteria.

Member has a medically confirmed diagnosis of classic 21‑hydroxylase deficiency CAH (documentation may include elevated 17‑OHP, positive newborn screening with confirmatory testing, CYP21A2 genotype, or cosyntropin stimulation test).
Prescribed by or in consultation with an endocrinologist.
Member is currently receiving chronic glucocorticoid therapy for CAH and Crenessity will be used in combination with glucocorticoids.
Dosing limits and adjustments apply (e.g., standard and maximum daily doses, and reduced maxima when co‑administered with strong/moderate CYP3A4 inducers) — see dosing section for specifics.

Note

Formulary / Off‑label pathway

Background

Crenessity 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. Clinical response is typically assessed by reduction in androgen markers or by glucocorticoid dose optimization; providers must document the underlying diagnosis and treatment context when requesting coverage.

Definitions

congenital adrenal hyperplasia

TermCongenital adrenal hyperplasia (CAH)

AbbreviationCAH

ContextListed in policy appendix as abbreviation for congenital adrenal hyperplasia

corticotropin‑releasing factor type 1

TermCorticotropin‑releasing factor type 1 (CRF1)

AbbreviationCRF1

ContextListed in policy appendix as abbreviation for corticotropin‑releasing factor type 1