CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Recorlev (levoketoconazole) for Endogenous Cushing's Syndrome

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Georgia Medicaid pharmacy prior authorization coverage for Recorlev in adults with endogenous Cushing's syndrome when surgery is not an option or has not been curative, including initial authorization, quantity, monitoring, and reauthorization requirements.

Policy Summary

PayerCareSource Georgia

PolicyRecorlev (levoketoconazole) for Endogenous Cushing's Syndrome

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateMarch 1, 2026

Next Review DateNot specified

Key ActionBefore initial treatment, attest that liver enzymes, ECG, potassium, and magnesium have been or will be assessed.

SourceLink

POLICY UPDATE CHANGES

Ketoconazole trial requirement changed from three months to at least two months at the maximum tolerated dose.

Provider attestation for liver enzymes, ECG, potassium, and magnesium assessment was added to the authorization criteria.

Improved signs and symptoms were removed from the reauthorization criteria; documentation of decreased urinary free cortisol compared with baseline is required.

Exclusions were removed from the authorization criteria.

Pharmacy PA requiredBenefit status

6 monthsInitial approval

12 months

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CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Recorlev (levoketoconazole) for Endogenous Cushing's Syndrome

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Policy Summary

PayerCareSource Georgia

PolicyRecorlev (levoketoconazole) for Endogenous Cushing's Syndrome

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateMarch 1, 2026

Next Review DateNot specified

Key ActionBefore initial treatment, attest that liver enzymes, ECG, potassium, and magnesium have been or will be assessed.

SourceLink

POLICY UPDATE CHANGES

Ketoconazole trial requirement changed from three months to at least two months at the maximum tolerated dose.

Provider attestation for liver enzymes, ECG, potassium, and magnesium assessment was added to the authorization criteria.

Improved signs and symptoms were removed from the reauthorization criteria; documentation of decreased urinary free cortisol compared with baseline is required.

Exclusions were removed from the authorization criteria.

Pharmacy PA requiredBenefit status

6 monthsInitial approval

12 months

240 tablets/30 daysQuantity limit

600 mg twice dailyMaximum dose

Coverage Criteria

Initial Therapy

Covered for initial authorization when ALL of the following criteria are met. If all requirements are met, authorization will be approved for 6 months.

ALL of the following

Member is at least 18 years of age.
Medication is prescribed by or in consultation with an endocrinologist.
Member has a diagnosis of endogenous Cushing's syndrome (e.g., pituitary adenoma).
Chart notes document elevated baseline urinary free cortisol (UFC).
Documentation confirms that pituitary surgery was not curative or that surgery is not an option.
Member has had a trial and failure of ketoconazole for at least 2 months at the maximum tolerated dose.
Provider attests that ALL of the following have been or will be assessed prior to treatment
- Liver enzymes.
- ECG.
- Potassium and magnesium.
Dosage and quantity limits are followed: initiate at 150 mg orally twice daily; titrate according to the package insert up to a maximum dose of 600 mg orally twice daily; quantity limit is 240 tablets per 30 days.

Continuation Therapy

Covered for continuation therapy when the following criterion is met. If the requirement is met, authorization will be approved for an additional 12 months.

The following is required

Chart notes document a decrease in urinary free cortisol (UFC) compared to baseline.

Conditions or indications not listed in this policy are excluded from medical necessity consideration. For any other indication, refer to the Off-Label policy.

Recorlev (levoketoconazole) is not medically necessary for the treatment of conditions that are not listed in this policy.

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Recorlev (levoketoconazole). For initial authorization, all clinical criteria must be met; approval is granted for 6 months when requirements are satisfied.

Member is at least 18 years of age.
Prescribed by or in consultation with an endocrinologist.
Diagnosis of endogenous Cushing's syndrome, such as from a pituitary adenoma.
Chart documentation of elevated baseline urinary free cortisol (UFC).
Documentation that pituitary surgery was not curative or that surgery is not an option.
Trial and failure of ketoconazole for at least 2 months at the maximum tolerated dose.
Provider attestation that required baseline monitoring has been or will be completed before treatment.
Initiate at 150 mg orally twice daily and titrate according to the package insert up to a maximum of 600 mg orally twice daily; quantity limit is 240 tablets per 30 days.

Clinical Background

Cushing's syndrome is a disorder caused by excess cortisol. It may be exogenous, such as from glucocorticoid use, or endogenous, resulting from the body's own cortisol production. Endogenous Cushing's syndrome is rare; Cushing's disease, caused by an adrenocorticotropic hormone-secreting pituitary adenoma, is the most common endogenous type described in this policy.

Recorlev (levoketoconazole) is a cortisol synthesis inhibitor indicated for adults with endogenous hypercortisolemia when surgery is not an option or has not been curative. Treatment carries boxed warnings for hepatotoxicity and QT prolongation.

Key Definitions

Cushing's syndrome

DefinitionA disorder of excess cortisol.

Exogenous causeMay result from taking glucocorticoids.

Endogenous causeMay result from excess cortisol produced within the body.

Cushing's disease

DefinitionA form of endogenous Cushing's syndrome.

Underlying causeCaused by a pituitary adenoma.

Hormonal effectThe adenoma secretes excess adrenocorticotropic hormone (ACTH), which is responsible for cortisol production.

Initial Authorization Criteria

Initial Therapy Criteria

Covered for initial authorization when ALL of the following are met:

Initial Recorlev authorization

Member is at least 18 years of age.At least 18 years old
Medication must be prescribed by or in consultation with an endocrinologist.
Member has a diagnosis of endogenous Cushing's syndrome, such as from a pituitary adenoma.
Chart notes must include documentation of elevated baseline urinary free cortisol (UFC).

Reauthorization Criteria

Continuation Criteria

Covered for reauthorization when the following criterion is met:

Continuation criterion

Chart notes must document a decrease in urinary free cortisol (UFC) compared with baseline.Decrease in UFC compared with baseline

Prerequisite Therapy

Step	Required prerequisite	Duration and dose requirement	Authorization stage
1	Trial and failure of ketoconazole	At least 2 months at the maximum tolerated dose	Before initial Recorlev authorization

Quantity and Dose Limits

Quantity limits

Quantity limit240 tablets per 30 days.

Initiation dose150 mg orally twice daily.

Maximum dose600 mg orally twice daily, titrated according to the package insert.

Policy Summary

PayerCareSource Georgia

PolicyRecorlev (levoketoconazole) for Endogenous Cushing's Syndrome

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateMarch 1, 2026

Next Review DateNot specified

Key ActionBefore initial treatment, attest that liver enzymes, ECG, potassium, and magnesium have been or will be assessed.

SourceLink

On This Page

Documentation Required

Reauthorization

Reauthorization requires the specified clinical documentation. When the requirement is met, coverage may be approved for an additional 12 months.

Chart notes must document a decrease in urinary free cortisol (UFC) compared with baseline.

Step Therapy

Ketoconazole Trial Required

Before initial authorization, document that the member has had a trial and failure of ketoconazole for at least 2 months at the maximum tolerated dose.

The ketoconazole prerequisite applies to initial Recorlev authorization.

Documentation Required

Initial Clinical Documentation

For initial authorization, chart notes must support the diagnosis and treatment history, including elevated baseline urinary free cortisol and the status of pituitary surgery.

Document endogenous Cushing's syndrome, such as a pituitary adenoma.
Document elevated baseline urinary free cortisol (UFC).
Document that pituitary surgery was not curative or that surgery is not an option.

Documentation Required

Baseline Monitoring Attestation

The provider must attest that all required baseline safety assessments have been or will be completed before treatment begins.

Liver enzymes
ECG
Potassium and magnesium

Documentation Required

Reauthorization Documentation

For reauthorization, submit chart notes documenting a decrease in urinary free cortisol compared with the member's baseline value.

The decrease in UFC must be documented in the clinical record.

Denial Risk

Failure to Meet Authorization Criteria

Authorization may be denied when the member does not meet the initial authorization requirements or the required documentation is not submitted.

Member is younger than 18 years of age.
Medication is not prescribed by or in consultation with an endocrinologist.
Member does not have endogenous Cushing's syndrome.
Baseline urinary free cortisol is not elevated or is not documented.
Pituitary surgery was curative, or documentation does not show that surgery was not an option.
Ketoconazole was not tried and failed for at least 2 months at the maximum tolerated dose.
Required baseline liver enzyme, ECG, potassium, and magnesium assessments are not completed or attested to.
Requested dose or quantity exceeds the policy limits.

Denial Risk

Unlisted or Off-Label Indication

Recorlev is not medically necessary for conditions or indications not listed in this policy. For any other indication, refer to the Off-Label policy.

Unlisted or off-label indications are not covered under this policy.

Recorlev (levoketoconazole)

Drug identityRecorlev (levoketoconazole).

Chemical originAn enantiomer derived from racemic ketoconazole.

MechanismInhibits cortisol synthesis.

Documentation confirms that pituitary surgery was not curative or that surgery is not an option.

Member has had a trial and failure of ketoconazole at the maximum tolerated dose.At least 2 months

Provider attestation that ALL of the following have been or will be assessed prior to treatment

Liver enzymes.
ECG.
Potassium and magnesium.