CurrentAvMedPolicy N/A

Crenessity (crinecerfont) prior authorization

Prior authorization and step-edit requirements for Crenessity (crinecerfont) tablets and oral solution for AvMed members; applies to prescribers seeking coverage for this specialty medication.

Policy Summary

PayerAvMed

PolicyCrenessity (crinecerfont) prior authorization

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (labs, cosyntropin 17OHP or genetic testing, chart notes verifying glucocorticoid dosing) to obtain initial 6‑month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

12 monthsReauthorization duration

2Max capsules/day

120 mLMax solution/30d

Coverage Criteria for Crenessity (crinecerfont)

Initial Therapy

Covered when ALL of the following are met for initial authorization (6 months):

Specialist involvement: Medication must be prescribed by or in consultation with an endocrinologist, geneticist, or other physician who specializes in the treatment of congenital adrenal hyperplasia.

Confirmed diagnosis: Member has a confirmed diagnosis of 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH) as documented by cosyntropin stimulation 17OHP level > 10,000 ng/dL or genetic test results confirming a CYP21A2 variant.

Documentation required (stim test or genetic test)

Concomitant therapy: Medication will be taken in combination with a systemic glucocorticoid (hydrocortisone, prednisone, prednisolone, or dexamethasone).

Verified by chart notes and/or pharmacy paid claims

Policy Summary

PayerAvMed

PolicyCrenessity (crinecerfont) prior authorization

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (labs, cosyntropin 17OHP or genetic testing, chart notes verifying glucocorticoid dosing) to obtain initial 6‑month approval.

SourceLink

On This Page

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Reauthorization/Continuation

Covered when ALL of the following are met for reauthorization (12 months):

Toxicity assessment: Provider attests to absence of unacceptable toxicity from the drug (e.g., hypersensitivity reactions, recurrent adrenal insufficiency or adrenal crisis events).

Continued concomitant glucocorticoid: Medication will continue to be taken in combination with a systemic glucocorticoid (hydrocortisone, prednisone, prednisolone, or dexamethasone).

Verified by chart notes and/or pharmacy paid claims

Evidence of response: Member has experienced positive disease response indicated by at least ONE of: decreased androstenedione, decreased 17-hydroxyprogesterone, or a reduction in glucocorticoid dose from baseline while maintaining or improving biochemical markers.

Results must be submitted to document improvement

Initial Authorization Criteria (6 months)

Initial

Initial authorization (6 months) criteria:

Prescriber Specialty: Prescribed by or in consultation with a specialist in CAH (endocrinologist, geneticist, or other).

Diagnostic confirmation: Documentation of cosyntropin stimulation 17OHP > 10,000 ng/dL or genetic test confirming a pathogenic CYP21A2 variant.

Concomitant glucocorticoid: Taken in combination with a systemic glucocorticoid; evidence must be provided via chart notes or pharmacy paid claims.

Glucocorticoid dosing/stability: Meets age-based glucocorticoid dosing thresholds OR has been on a stable glucocorticoid regimen for ≥30 days: (age 4–17 with >12 mg/m2/day hydrocortisone equivalent; age ≥18 with >13 mg/m2/day hydrocortisone equivalent; OR stable regimen ≥30 days).

Verified by chart notes and/or pharmacy paid claims

Biochemical failure on therapy: Elevated androstenedione and 17-hydroxyprogesterone despite maximally tolerated glucocorticoid therapy (submit current labs).

Reauthorization / Continuation Criteria (12 months)

Reauthorization

Reauthorization conditions for continuation therapy (12 months):

Toxicity: Provider attests to absence of unacceptable toxicity from the drug.

Concomitant glucocorticoid: Continued use with a systemic glucocorticoid is required (verification via chart notes or pharmacy paid claims).

Clinical response: At least one indicator of positive disease response: decreased androstenedione, decreased 17-hydroxyprogesterone, or reduction in glucocorticoid dose from baseline while maintaining biochemical control.

Submit results to document improvement

Clinical Thresholds and Diagnostic Criteria

inv-04: Cosyntropin stimulation 17OHP — > 10,000 ng/dL

Cosyntropin stimulation 17OHP threshold> 10,000 ng/dL

Documentation acceptedCosyntropin stimulation test result must be submitted as documentation of confirmed 21-hydroxylase deficiency CAH

Alternative confirmationGenetic test results confirming a CYP21A2 variant may be used instead of stimulation test

inv-05: Age/weight dosing thresholds — Children ≥4 years with weight bands: 10–<20 kg, 20–<55 kg, ≥55 kg

Age and weight eligibilityChildren ≥4 years

Weight band 1 (pediatric dosing)10–<20 kg: 25 mg orally twice daily

Weight band 2 (pediatric dosing)20–<55 kg: 50 mg orally twice daily

Weight band 3 (adolescent/large child)≥55 kg: 100 mg orally twice daily

inv-06: Glucocorticoid dose threshold (children 4–17) — > 12 mg/m2/day hydrocortisone equivalent

Pediatric glucocorticoid threshold (age 4–17)> 12 mg/m2/day hydrocortisone equivalent

VerificationMust be verified by chart notes and/or pharmacy paid claims

Alternate qualifying criterionOr member has been on a stable glucocorticoid regimen for ≥30 days

inv-07: Glucocorticoid dose threshold (adults ≥18) — > 13 mg/m2/day hydrocortisone equivalent

Adult glucocorticoid threshold (≥18 years)> 13 mg/m2/day hydrocortisone equivalent

VerificationMust be verified by chart notes and/or pharmacy paid claims

Alternate qualifying criterionOr member has been on a stable glucocorticoid regimen for ≥30 days

Provider Requirements and Submission Guidance

Prior Authorization

Prior Authorization Duration & Clinical Criteria Not Met

Prior authorization required. Initial approval is for 6 months; reauthorization may be granted for 12 months when all reauthorization clinical criteria are met. Failure to meet all listed clinical criteria for initial authorization or reauthorization (including required lab results, stimulation testing, documentation of glucocorticoid use/dose, and demonstration of treatment response or absence of unacceptable toxicity) may result in denial.

Initial authorization: 6 months; Reauthorization: 12 months (contingent on meeting all clinical criteria).
All required supporting documentation must be submitted (see clinical criteria): cosyntropin stimulation 17OHP level > 10,000 ng/dL or genetic test confirming CYP21A2 variant, current androstenedione and 17‑hydroxyprogesterone lab results, documentation of glucocorticoid regimen and doses, chart notes or pharmacy claims verifying prior therapies and stability for at least 30 days, documentation of intolerance to capsules if liquid formulation requested for specified patients, and documentation of CYP3A4 inducer use for adult doses above quantity limits.

Documentation Required

Samples and Prior Therapy Verification

Use of samples to initiate therapy does not satisfy step-edit/preauthorization requirements. Previous therapies will be verified via pharmacy paid claims or submitted chart notes; absence of verification may delay or prevent approval.

Samples cannot be used to meet prior authorization or step-therapy requirements.
Pharmacy paid claims and chart notes will be reviewed to verify prior therapy and stable glucocorticoid use.

Documentation Required

Form Fields Required and Documentation Completeness

Ensure the prior authorization request form is complete, legible, and includes original prescriber signature (preprinted stamps not valid). Missing or incorrect form fields may delay processing or lead to denial. Required fields include member identifiers (AvMed member number, date of birth), prescriber name and NPI, prescriber signature and date, office contact phone and fax, drug name/form/strength, dosing schedule, length of therapy, diagnosis and ICD code, weight (if applicable) and date weight obtained, and documentation supporting each checked clinical criterion (labs, stimulation test results, genetic test results, chart notes, and pharmacy claims).

Prescriber signature must be original (no preprinted stamps).
Member AvMed number and date of birth required.
Prescriber NPI required.
Diagnosis and ICD code required.
Weight and date weight obtained required when applicable.
Attach supporting documentation for each checked clinical criterion: lab results (androstenedione, 17‑hydroxyprogesterone), cosyntropin stimulation 17OHP level or genetic testing, chart notes or pharmacy claims verifying glucocorticoid regimen and prior therapies, and documentation for capsule intolerance or CYP3A4 inducer use when applicable.

Step	Requirement
1
Use of samples to initiate therapy does not satisfy step-edit / preauthorization requirements; previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Quantity Limits and Dose Overrides

inv-20: Crenessity capsules (25, 50 & 100 mg) — Maximum of 2 capsules per day

Capsule strength limitsCrenessity capsules: 25 mg, 50 mg, 100 mg

Daily quantity limitMaximum of 2 capsules per day

Unit of measureLimit applies to capsules per day

inv-21: Crenessity oral solution (50 mg/mL) — Maximum of 120 mL per 30 days

Oral solution concentration50 mg/mL

Quantity limitMaximum of 120 mL per 30 days

Time periodLimit measured per 30-day supply

inv-22: Adult dose above quantity limit — Requests above 200 mg daily require documentation of moderate or strong CYP3A4 inducer

Requests above quantity limitAdult requests above 200 mg daily require documentation of use of a moderate or strong CYP3A4 inducer

Documentation requirementSubmit evidence of concomitant moderate/strong CYP3A4 inducer to approve doses >200 mg/day

Applies toAdult patients requesting doses above the stated quantity limit

Definitions and Response Criteria

inv-15: Confirmed 21-hydroxylase deficiency CAH — Confirmed diagnosis of 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH) — documented by cosyntropin stimulation 17OHP level...

Definition of confirmed diagnosisConfirmed 21-hydroxylase deficiency CAH documented by cosyntropin stimulation 17OHP level > 10,000 ng/dL or genetic test confirming CYP21A2 variant

Documentation to submitSubmit cosyntropin stimulation 17OHP result or CYP21A2 genetic test results with prior authorization request

ContextRequired for initial authorization under coverage criteria

inv-16: Response criteria — Positive disease response — decreased androstenedione and/or decreased 17-hydroxyprogesterone levels, or reduction in glucocorticoid dose...

Markers of positive disease responseDecreased androstenedione and/or decreased 17-hydroxyprogesterone levels

Alternative response indicatorReduction in glucocorticoid dose from baseline while maintaining or improving biochemical markers

DocumentationSubmit lab results or other records demonstrating decreased androstenedione/17OHP or steroid dose reduction for reauthorization

OpenPayer

Crenessity (crinecerfont) prior authorization

Coverage Criteria for Crenessity (crinecerfont)

Initial Authorization Criteria (6 months)

Reauthorization / Continuation Criteria (12 months)

Clinical Thresholds and Diagnostic Criteria

Provider Requirements and Submission Guidance

Step-Edit and Sample Use

Quantity Limits and Dose Overrides

Dispensing Site

Background

Definitions and Response Criteria