Crenessity (crinecerfont) — Coverage Criteria for Classic Congenital Adrenal Hyperplasia
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Policy governing coverage and prior authorization requirements for Crenessity as adjunctive therapy to glucocorticoid replacement in adults and pediatric patients (≥4 years) with classic congenital adrenal hyperplasia (CAH) for Neighborhood Health Plan of Rhode Island (Medicaid scope).
No material clinical or coverage changes in this revision.
Coverage Criteria for Crenessity (crinecerfont)
Initial Therapy
Covered when ALL of the following are met
supported by dosing guidance
Patient must be stable on glucocorticoid therapy for at least 1 month
Also exclude non-21-hydroxylase CAH variants per policy
Continuation / Reauthorization (6 months)
Covered for reauthorization when ALL of the following are met
Coverage is limited to patients with classic congenital adrenal hyperplasia (CAH) due to 21‑hydroxylase deficiency. Requests will be denied for patients with a history of bilateral adrenalectomy, hypopituitarism, or other conditions requiring chronic glucocorticoid therapy, and for patients with a diagnosis of other known CAH variants (for example, 11‑beta‑hydroxylase or 17‑alpha‑hydroxylase deficiency).
Patients must be aged ≥ 4 years and have diagnostic confirmation by either genetic testing showing pathogenic CYP21A2 variants or biochemical criteria: baseline morning 17‑hydroxyprogesterone (17‑OHP) > 3,000 ng/dL (LC‑MS/MS) or cosyntropin stimulation 17‑OHP > 10,000 ng/dL.
Crenessity is authorized only as adjunctive therapy and must be prescribed in combination with chronic glucocorticoid treatment. Documentation must show the patient requires a supraphysiologic glucocorticoid regimen (pediatrics 4–17 years: ≥ 12 mg/m2/day hydrocortisone‑equivalent; adults ≥18 years: > 13 mg/m2/day hydrocortisone‑equivalent) and that the patient has been clinically stable on glucocorticoid therapy for at least 1 month.
If the diagnostic criteria or required documentation are not provided, coverage is considered not medically necessary. Required documentation includes chart notes confirming diagnosis (genetic or biochemical), prescriber specialty (prescribed by or in consultation with an endocrinologist), current glucocorticoid regimen and evidence of stability for ≥ 1 month, and patient weight with dosing consistent with FDA‑approved guidance.
Providers must also document that Crenessity will not be taken concomitantly with a strong or moderate CYP3A4 inducer, or provide a rationale why an appropriate alternative is not available. For requests for the oral solution in patients weighing ≥ 20 kg, a medical rationale documenting inability to swallow the capsule whole is required.
Coding, Age, and Dosing Information
| Crenessity 100 mg capsules | Crenessity 100 mg capsules — quantity limits described in policy |
| Crenessity 50 mg/ml oral solution | Crenessity 50 mg/ml oral solution — quantity limits described in policy |
| Capsules — standard limit | 2 capsules per day (with exceptions allowing up to 3 or 4 caps/day in specified circumstances) |
| Oral solution — standard limit | 2 mL per 50 mg per day (with exceptions allowing up to 3 or 4 mL/day in specified circumstances) |
Prescriber Requirements, Documentation, and Denial Risks
Prior Authorization Required
Prior authorization required for initial therapy and reauthorization. Authorizations may be granted for up to 6 months when all applicable clinical and documentation criteria are met.
- Initial and reauthorization requests: up to 6 months
- Prescriber requirement: must be prescribed by or in consultation with an endocrinologist
Prescribe with Glucocorticoid Therapy; Document Stability
Crenessity must be prescribed as adjunctive therapy in combination with chronic glucocorticoid treatment. Provider must document current glucocorticoid therapy, dose (converted to hydrocortisone equivalents), and stability on that regimen for at least 1 month.
- Medication must be prescribed in combination with glucocorticoid treatment (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone).
- Document baseline and ongoing glucocorticoid dose; for continuation, document clinical response such as reduction in total daily glucocorticoid dose or stabilization/decrease in androstenedione (A4) levels.
Document Diagnosis and Diagnostic Evidence in Chart
Chart notes or medical record must confirm diagnosis of classic congenital adrenal hyperplasia (classic CAH) and provide objective diagnostic evidence and genetic/laboratory confirmation as applicable.
- Acceptable diagnostic documentation: pathogenic CYP21A2 variants on genetic testing, or biochemical confirmation of 21-hydroxylase deficiency.
- Laboratory thresholds: baseline morning 17-hydroxyprogesterone (17-OHP) > 3,000 ng/dL by LC-MS/MS, or ACTH (cosyntropin) stimulation resulting in 17-OHP > 10,000 ng/dL.
- Age-specific glucocorticoid dosing documentation: for patients 4–17 years old, glucocorticoid (GC) dose ≧12 mg/m2/day hydrocortisone equivalent; for adults (≧18 years) GC dose >13 mg/m2/day hydrocortisone equivalent when qualifying as supraphysiologic.
Oral Solution Requests — Medical Rationale Required for ≥20 kg
For oral solution requests in patients weighing ≥20 kg, the provider must document a medical rationale demonstrating inability to swallow the oral capsule whole.
- Include explanation in chart notes why capsule cannot be swallowed and why alternative formulations or compounding are not appropriate.
Denial Risks — Other CAH Forms and Chronic GC-Requiring Conditions
Coverage will be denied for patients with other known forms of CAH or for those with conditions requiring chronic glucocorticoid therapy independent of classic CAH.
- Diagnosis of other known forms of CAH (e.g., 11-beta-hydroxylase deficiency, 17-alpha-hydroxylase deficiency) is not eligible for coverage.
- History of bilateral adrenalectomy, hypopituitarism, or other conditions that require chronic glucocorticoid therapy are exclusions and will result in denial.
Definitions and Clinical Thresholds
Background and Clinical Context
Classic CAH from 21‑hydroxylase deficiency leads to androgen excess that is typically managed with glucocorticoid replacement. Crenessity is indicated as adjunctive therapy to glucocorticoids in patients aged ≥ 4 years to help control excess androgen production when patients require chronic supraphysiologic glucocorticoid dosing.
Use of Crenessity must be combined with ongoing glucocorticoid therapy and appropriate endocrine oversight; prior authorization for an initial or reauthorization period of 6 months may be granted when the diagnostic, dosing, and documentation criteria described in policy are met.
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