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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAHCA Crenessity Prior Auth Coverage | OpenPayer
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    CurrentAgency for Health Care AdministrationPolicy N/A

    Crenessity (crinecerfont) Prior Authorization Criteria

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    This pharmacy policy governs prior authorization and continuation coverage for Crenessity (crinecerfont) in patients with classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency. It applies to providers requesting coverage through the Agency for Health Care Administration.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCrenessity (crinecerfont) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming the patient is at least 4 years old, meets diagnostic criteria, continues replacement-dose glucocorticoid therapy, and has specialist involvement.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 yearMaximum authorization length
    ≥4 yearsMinimum patient age
    4CAH confirmation pathways
    4Dosage forms and strengths

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Criteria

    Initial Therapy Criteria

    Covered when all of the following are met:

    Initial therapy criteria

    • Age: Patient is at least 4 years of age.≥ 4 years

    • Diagnosis confirmation

      • Infant screening: Positive infant screening with secondary-tier confirmatory testing.
      • 17-hydroxyprogesterone: Elevated serum 17-hydroxyprogesterone level above the upper limit of normal.> ULN
      • Cosyntropin stimulation: Cosyntropin (ACTH) stimulation test.
      • Genetic testing for a CYP21A2 gene mutation consistent with CAH.
    • Current glucocorticoid therapy: Patient is currently treated with glucocorticoid replacement therapy, such as hydrocortisone, prednisone, prednisolone, or dexamethasone.
    • Concurrent replacement therapy: Patient will continue glucocorticoid therapy at the dosage required for replacement therapy in combination with Crenessity.Replacement dosage
    • Specialist involvement: The prescriber is a specialist in the area of the patient's diagnosis, such as an endocrinologist or geneticist, or has consulted with such a specialist.

    Continuation Therapy Criteria

    Continuation is covered when all of the following are met:

    Continuation therapy criteria

    • Initial criteria met: Patient met the initial review criteria.
    • Positive clinical response: Documentation shows a positive clinical response.
    • No treatment-restricting adverse effects: Patient has not experienced any treatment-restricting adverse effects, such as clinically significant hypersensitivity reactions.
    • Appropriate dosing: Dosing is appropriate as per labeling or is supported by compendia.

    Prior Authorization and Provider Requirements

    Prior Authorization

    Initial Prior Authorization

    Prior authorization is required before initiating Crenessity. The patient must meet all initial review criteria, including age, diagnosis with qualifying confirmation, ongoing glucocorticoid replacement, combination treatment, and specialist involvement.

    • Patient is 4 years of age or older.
    • Patient has classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency, confirmed by one of the following: positive infant screening with secondary-tier 2 confirmatory testing; elevated serum 17-hydroxyprogesterone (17OHP) above the upper limit of normal; cosyntropin (ACTH) stimulation testing; or genetic testing showing a CYP21A2 mutation consistent with CAH.
    • Patient is currently receiving glucocorticoid replacement therapy, such as hydrocortisone, prednisone, prednisolone, or dexamethasone.
    • Patient will continue replacement-dose glucocorticoid therapy in combination with Crenessity.
    • Prescriber is a specialist in the patient’s diagnosis, such as an endocrinologist or geneticist, or has consulted with an appropriate specialist.
    Documentation Required

    Initial Authorization Documentation

    Submit documentation supporting every initial authorization criterion with the prior authorization request.

    • Patient date of birth or other documentation confirming age of at least 4 years.
    • Documentation of classic CAH due to 21-hydroxylase deficiency and one qualifying confirmation: positive infant screening with secondary-tier 2 confirmatory testing, elevated 17OHP above ULN, cosyntropin (ACTH) stimulation test, or CYP21A2 genetic testing consistent with CAH.
    • Current glucocorticoid replacement regimen and documentation that replacement-dose glucocorticoid therapy will continue with Crenessity.
    • Prescriber specialty or documentation of consultation with a specialist in the patient’s diagnosis.
    Documentation Required

    Continuation Documentation

    For continuation authorization, document that the patient met the initial review criteria and continues to benefit from and tolerate therapy. The requested dose must comply with labeling or be supported by compendia.

    • Documentation of the initial Crenessity approval.
    • Documentation of positive clinical response.
    • Confirmation that the patient has not experienced treatment-restricting adverse effects, including clinically significant hypersensitivity reactions.
    • Documentation that dosing is appropriate according to product labeling or supported by compendia.
    Denial Risk

    Failure to Meet Initial Criteria

    Initial therapy may be denied when the submitted documentation does not establish that all initial review criteria are met.

    • Patient is younger than 4 years of age.
    • Classic CAH due to 21-hydroxylase deficiency is not documented or lacks one of the specified qualifying diagnostic confirmations.
    • Patient is not currently receiving glucocorticoid replacement therapy.
    • Replacement-dose glucocorticoid therapy will not continue in combination with Crenessity.
    • Prescriber is neither an appropriately focused specialist nor documented as having consulted with one.
    Denial Risk

    Failure to Meet Continuation Criteria

    Continuation therapy may be denied when the patient does not satisfy all continuation requirements or when the record does not document ongoing clinical appropriateness.

    • Initial Crenessity review criteria were not met or initial approval is not documented.
    • Positive clinical response is not documented.
    • The patient has experienced a treatment-restricting adverse effect, such as a clinically significant hypersensitivity reaction.
    • Requested dosing is not consistent with labeling and is not supported by compendia.

    Qualifying Diagnosis

    Qualifying CAH diagnosis
    Infant screeningPositive infant screening with secondary-tier confirmatory testing
    17-hydroxyprogesteroneElevated serum 17-hydroxyprogesterone level above the upper limit of normal (ULN)
    Cosyntropin/ACTH testCosyntropin (adrenocorticotropic hormone [ACTH]) stimulation test
    Genetic testingGenetic testing for a CYP21A2 gene mutation consistent with congenital adrenal hyperplasia

    Initial Therapy

    Initial Therapy Criteria

    Initial coverage requires all listed clinical and authorization criteria:

    Initial therapy criteria

    • Age: Patient is at least 4 years of age.≥ 4 years

    • Diagnosis confirmation

      • Infant screening: Positive infant screening with secondary-tier confirmatory testing.
      • 17-hydroxyprogesterone: Elevated serum 17-hydroxyprogesterone level above the upper limit of normal.> ULN
      • Cosyntropin stimulation: Cosyntropin (ACTH) stimulation test.
      • Genetic testing for a CYP21A2 gene mutation consistent with CAH.
    • Current glucocorticoid therapy: Patient is currently treated with glucocorticoid replacement therapy, such as hydrocortisone, prednisone, prednisolone, or dexamethasone.
    • Concurrent replacement therapy: Patient will continue glucocorticoid therapy at the dosage required for replacement therapy in combination with Crenessity.Replacement dosage
    • Specialist involvement: The prescriber is a specialist in the area of the patient's diagnosis, such as an endocrinologist or geneticist, or has consulted with such a specialist.

    Continuation Therapy

    Continuation Therapy Criteria

    Continuation is covered when all of the following are met:

    Continuation therapy criteria

    • Initial criteria met: Patient met the initial review criteria.
    • Positive clinical response: Documentation shows a positive clinical response.
    • No treatment-restricting adverse effects: Patient has not experienced any treatment-restricting adverse effects, such as clinically significant hypersensitivity reactions.
    • Appropriate dosing: Dosing is appropriate as per labeling or is supported by compendia.
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCrenessity (crinecerfont) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming the patient is at least 4 years old, meets diagnostic criteria, continues replacement-dose glucocorticoid therapy, and has specialist involvement.
    SourceLink
    On This Page
    Coverage CriteriaPrior Authorization and Provider RequirementsQualifying DiagnosisInitial TherapyContinuation Therapy