CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Recorlev (levoketoconazole) — Medical coverage criteria for Cushing syndrome

Medical coverage criteria for use of Recorlev (levoketoconazole) to treat hypercortisolemia/Cushing syndrome for Medicaid members; defines initial and continuation authorization requirements and limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRecorlev (levoketoconazole) — coverage criteria for Cushing syndrome

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for 6 months and submit documentation of diagnosis, required pretreatment biochemical testing, prior therapy failures, and baseline QTc ≤ 470 ms.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization

6 mocontinuation authorization

8max tablets/day

150 mgtablet strength

7/2025last review

Coverage Criteria for Recorlev (levoketoconazole)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: Patient is 18 years or older; medication prescribed by or in consultation with an endocrinologist; documented diagnosis of hypercortisolemia with Cushing syndrome with pretreatment 24-hour urine free cortisol OR, if UFC is not appropriate, pretreatment late-night salivary cortisol, 1 mg overnight dexamethasone suppression test, or longer low‑dose DST (2 mg/day for 48 hours); patient has had surgery that was not curative OR is not a candidate for surgery; patient has experienced failure, contraindication, or intolerance to ketoconazole and at least two alternatives (e.g., cabergoline, Signifor LAR, Lysodren); documentation of a baseline QTc-interval ≤ 470 milliseconds; patient does NOT have cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, or extensive metastatic liver disease; patient does NOT have a history of torsades de pointes, ventricular tachycardia/fibrillation, or congenital/other prolonged QT syndrome.

Authorization duration: 6 months.

Continuation Therapy

Authorization may be granted when ONE of the following is met for members already receiving therapy:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRecorlev (levoketoconazole) — coverage criteria for Cushing syndrome

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for 6 months and submit documentation of diagnosis, required pretreatment biochemical testing, prior therapy failures, and baseline QTc ≤ 470 ms.

SourceLink

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Requests without required pretreatment biochemical confirmation or other mandatory safety information are not medically appropriate for approval. Prior to initial authorization, documentation must include pretreatment confirmation of hypercortisolemia by 24‑hour urine free cortisol (UFC) or, if UFC is not appropriate, one of the listed alternatives (pretreatment late‑night salivary cortisol, 1 mg overnight dexamethasone suppression test, or a low‑dose DST of 2 mg/day for 48 hours). Additionally, the member must have documented failure, contraindication, or intolerance to ketoconazole and at least two alternatives. A baseline electrocardiographic QTc must be documented as ≤ 470 milliseconds. Presence of disqualifying conditions (disqualifying hepatic disease or a history of torsades/ventricular arrhythmia/prolonged QT) or failure to meet these pretreatment, prior‑therapy, or baseline QTc requirements may result in denial.

Provider Requirements and Authorization Details

Prior Authorization

Prior authorization duration

Prior authorization required. Initial and continuation authorizations are each limited to 6 months.

Initial authorization duration: 6 months
Continuation authorization duration: 6 months

Step Therapy

Step therapy / prior treatment requirement

Step therapy / prior treatment requirement: member must have experienced failure, contraindication, or intolerance to ketoconazole and at least two alternatives prior to approval.

Required prior treatments include ketoconazole plus ≥2 alternatives (examples: cabergoline, pasireotide [Signifor LAR], mitotane [Lysodren])

Documentation Required

Required documentation

Required documentation must be submitted to support diagnosis and treatment response, including pretreatment and follow-up biochemical testing and specialty consult notes.

Diagnostic confirmation of hypercortisolemia/Cushing syndrome
Pretreatment biochemical testing: 24-hour urine free cortisol (UFC) OR when UFC inappropriate: late‑night salivary cortisol, 1 mg overnight DST, or low‑dose (2 mg/day x48 hr) DST
Documentation of prior surgery status (noncurative) or reason patient is not a surgical candidate
Endocrinology prescribing or consult note
For continuation: documentation of reduced UFC or alternative cortisol test values from baseline, or documented clinical improvement
Baseline QTc-interval documentation ≤ 470 ms

Denial Risk

Triggers for denial

Denial may be triggered when required tests, specialty consultation, or safety assessments are missing, when age or comorbidity exclusions apply, or when prior treatment requirements are not met.

Missing pretreatment biochemical testing (UFC or acceptable alternative)
No endocrinology prescription or consult documented
Age under 18 years
Absence of documentation of failure/intolerance/contraindication to ketoconazole plus at least two alternatives
No baseline QTc documented or baseline QTc > 470 ms
Diagnosis of cirrhosis, acute liver disease, poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, or extensive metastatic liver disease
History of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or congenital/known prolonged QT syndrome
For continuation: lack of documentation showing biochemical improvement or clinical benefit

Definitions and Pretreatment Requirements

inv-11: Appropriate pretreatment biochemical tests

Primary testPretreatment 24-hour urine free cortisol (UFC) levels.

When UFC inappropriate - option 1Pretreatment late-night salivary cortisol.

When UFC inappropriate - option 2Pretreatment 1 mg overnight dexamethasone suppression test (DST).

When UFC inappropriate - option 3Pretreatment longer low-dose DST (2 mg per day for 48 hours).

inv-12: Baseline cardiac safety requirement

Required documentationDocumentation of a baseline QTc-interval ≤ 470 milliseconds must be submitted prior to authorization.

Source requirementBaseline QTc documentation is listed as a specific approval criterion in the initial authorization criteria.

Associated denial riskAbsence of baseline QTc ≤ 470 ms is identified as a trigger for denial or not medically necessary determination.

OpenPayer

Recorlev (levoketoconazole) — Medical coverage criteria for Cushing syndrome

Coverage Criteria for Recorlev (levoketoconazole)

Coding and Safety Thresholds

Provider Requirements and Authorization Details

Clinical Background

Definitions and Pretreatment Requirements