CurrentCignaPolicy N/A

Cushing's - Recorlev Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Recorlev (levoketoconazole) for adults with endogenous Cushing's syndrome; applies to prescriptions under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCushing's - Recorlev Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision (some editorial and added criteria)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization showing patient meets criteria including age ≥18, hypercortisolemia, prior ketoconazole trial, and prescribing by or in consultation with an endocrinologist.

SourceLink

POLICY UPDATE CHANGES

Criteria for patients awaiting surgery or awaiting therapeutic response after radiotherapy for endogenous Cushing's syndrome were added to the policy.

Annual revision entries indicate review dates and note 'No criteria changes' for some revisions.

1 yearapproval duration

≥18minimum age

ketoconazoletrial requirement

specialist requiredprescriber

Coverage Criteria for Recorlev (levoketoconazole)

Initial approval criteria (FDA-approved indication)

Covered when ALL of the following are met for FDA-approved indication (approve for 1 year):

FDA-Approved Indication: Endogenous Cushing's Syndrome: Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E)

A: Patient is >= 18 years of age

chunk 7

B: Patient has hypercortisolemia

chunk 7

Policy Summary

PayerCigna

PolicyCushing's - Recorlev Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision (some editorial and added criteria)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization showing patient meets criteria including age ≥18, hypercortisolemia, prior ketoconazole trial, and prescribing by or in consultation with an endocrinologist.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Billing, Codes, and Approval Details

No specific CPT/HCPCS/ICD-10 codes listed in policymixed

No codes listed

inv-05: Approval duration — 1 year

Approval durationApprove for 1 year for the FDA‑approved indication (Endogenous Cushing's Syndrome)

Approval units definitionWhen approval is authorized in months, 1 month = 30 days

Prior authorization requiredPrior authorization is recommended for prescription benefit coverage of Recorlev; approvals provided for the durations noted

inv-06: Minimum patient age for coverage — >= 18 years

Minimum patient agePatient must be ≥ 18 years of age

Population scopeApplies to adults with endogenous Cushing's syndrome for FDA‑approved indication

Prescriber requirementMedication must be prescribed by or in consultation with an endocrinologist or Cushing's specialist

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Recorlev. Approvals are provided for the durations noted in the policy (when authorized in months, 1 month = 30 days). Recorlev must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., an endocrinologist).

Prior authorization required for Recorlev (levoketoconazole tablets - Xeris).
Approvals provided for specified durations; 1 month = 30 days when applicable.
Prescriber requirement: prescribed by or in consultation with an endocrinologist or physician who specializes in endogenous Cushing's syndrome.

Step Therapy

Medication Trial Required

Patient must have previously tried ketoconazole tablets before Recorlev will be approved.

Medication trial requirement: prior trial of ketoconazole tablets is required.

Documentation Required

Documentation Required for Prior Authorization

Documentation submitted with the prior authorization must demonstrate the patient meets all policy criteria for the requested indication, including age, evidence of hypercortisolemia, surgical candidacy or status (not a candidate, awaiting surgery, or awaiting radiotherapy response), prior trial of ketoconazole, and that the medication is prescribed by or in consultation with an endocrinologist or specialist.

Required documentation: clinical records or notes confirming patient is ≥ 18 years of age.
Evidence of hypercortisolemia (laboratory results or other diagnostic documentation).
Documentation of surgical status: not a candidate for surgery, surgery not curative, awaiting surgery, or awaiting therapeutic response after radiotherapy.
Evidence of prior trial of ketoconazole tablets (dates, dosing, and response/intolerance).
Prescriber documentation: note that an endocrinologist or specialist prescribed or was consulted for treatment.

Denial Risk

Billing and Coverage Denial Risk

Claims submitted without covered diagnosis/procedure codes or not following the policy criteria will be denied per billing rules. Providers must bill using the most appropriate codes as of the date of service.

Billing/coverage denial risk: claims lacking covered diagnosis or procedure codes under this policy will be denied.
Use the most appropriate diagnosis and procedure codes current on the date of service.

Key Definitions

inv-12: Definition — Endogenous Cushing's Syndrome (hypercortisolemia from internal sources)

DefinitionEndogenous Cushing's Syndrome: hypercortisolism originating from internal sources such as pituitary adenomas, adrenal tumors, or ectopic ACTH production

Clinical characterizationCushing's syndrome denotes excessive cortisol levels (hypercortisolism) in the blood

Common formCushing's disease (ACTH‑dependent from pituitary adenomas) is the most common type

inv-13: Definition — Recorlev (levoketoconazole) description (2S,4R enantiomer of ketoconazole; 505(b)(2) approval)

Recorlev active ingredientRecorlev contains levoketoconazole, the 2S,4R enantiomer derived from racemic ketoconazole

Mechanism/indication summaryRecorlev is a cortisol synthesis inhibitor indicated for treatment of endogenous hypercortisolemia in adults when surgery is not an option or not curative

Regulatory pathwayApproved via the 505(b)(2) pathway relying on existing safety and efficacy information for ketoconazole tablets

OpenPayer

Cushing's - Recorlev Prior Authorization Policy

Coverage Criteria for Recorlev (levoketoconazole)

Billing, Codes, and Approval Details

Prior Authorization and Documentation Requirements

Background

Key Definitions