CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Recorlev (levoketoconazole) — Coverage Criteria for Cushing Syndrome

Policy governs medical necessity criteria, authorization, and continuation requirements for Recorlev (levoketoconazole) in adult members with hypercortisolemia/Cushing syndrome; applies to providers prescribing or consulting endocrinologists and to Neighborhood Health Plan of Rhode Island members subject to plan authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRecorlev (levoketoconazole) — Coverage Criteria for Cushing Syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 1, 2025

Key ActionObtain prior authorization with documentation of diagnosis, pretreatment cortisol testing, prior medication trials (ketoconazole and ≥2 alternatives), baseline QTc ≤470 ms, and endocrinology involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

6 monthsContinuation authorization duration

150 mgPer-tablet strength

8/dayQuantity limit

≥18Minimum age

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 is prescribed by, or in consultation with, an endocrinologist; documented diagnosis of hypercortisolemia with Cushing syndrome with available pretreatment testing: 24-hour urine free cortisol (UFC) OR if UFC is not appropriate (e.g., renal insufficiency/failure, adrenal incidentaloma) pretreatment late-night salivary cortisol OR pretreatment 1 mg overnight dexamethasone suppression test (DST) OR pretreatment low-dose DST (2 mg/day for 48 hours); patient has had surgery that was not curative OR is not a candidate for surgery; member has experienced failure, contraindication, or intolerance to ketoconazole and at least two alternatives (e.g., cabergoline, Signifor LAR, Lysodren); baseline QTc-interval ≤ 470 milliseconds; no diagnosis of cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, or extensive metastatic liver disease; no history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome.

Continuation Therapy

Covered when ANY of the following are met for members already receiving therapy

Continuation approval criteria:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRecorlev (levoketoconazole) — Coverage Criteria for Cushing Syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 1, 2025

SourceLink

On This Page

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Documentation showing a reduction in 24-hour urine free cortisol levels from baseline; OR documentation showing lower cortisol levels since the start of therapy by one of the following when UFC is not appropriate: late-night salivary cortisol, 1 mg overnight DST, or low-dose DST (2 mg/day for 48 hours); OR improvement in signs or symptoms of the disease.

The medication is not appropriate for members with significant hepatic or biliary disease. Specifically, therapy is excluded for members with a documented diagnosis of cirrhosis, acute liver disease, or poorly controlled chronic liver disease, as well as those with recurrent symptomatic cholelithiasis or extensive metastatic liver disease. Documentation of these conditions at baseline will preclude approval.

Use is considered not medically appropriate for patients with baseline cardiac conduction abnormalities or a history of serious ventricular arrhythmia. Specifically, therapy should not be initiated if the baseline corrected QT interval (QTc) is >470 milliseconds, or if there is a history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or diagnosed prolonged QT syndrome.

Key Coding and Baseline Thresholds

Baseline QTc-interval

Baseline QTc-interval≤ 470 milliseconds

ContextRequired documentation of baseline QTc ≤470 ms is a condition for initial authorization

Not approved ifBaseline QTc >470 ms or history of torsades/ventricular arrhythmia/prolonged QT syndrome

Prior Authorization, Documentation, and Step Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy; approvals are for 6 months.

Step Therapy

Required Prior Medication Trials

The member must have experienced failure, contraindication, or intolerance to ketoconazole and to at least two alternative therapies prior to approval. Examples of alternatives include cabergoline, Signifor LAR (pasireotide LAR), and mitotane (Lysodren).

Denial Risk

Missing Required Baseline Criteria — Denial Risk

Missing or incomplete baseline documentation may result in denial. Providers must submit complete baseline information with initial requests, including evidence of all applicable items below.

Patient age documented as ≥ 18 years
Evidence that medication is prescribed by or in consultation with an endocrinologist
Documented diagnosis of hypercortisolemia with Cushing syndrome
Pretreatment cortisol testing: 24-hour urine free cortisol (UFC) OR, if UFC is not appropriate (e.g., renal insufficiency/failure, adrenal incidentaloma), one of: late-night salivary cortisol; 1 mg overnight dexamethasone suppression test (DST); or low‑dose DST (2 mg/day for 48 hours)
Documentation of prior adrenal surgery that was not curative OR documentation that the member is not a candidate for surgery
Baseline QTc interval result ≤ 470 milliseconds
Documentation of prior medication trials as described above (ketoconazole + ≥2 alternatives)
Documentation excluding cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, or extensive metastatic liver disease
No history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or congenital prolonged QT syndrome

Background

Cushing syndrome is a state of pathologic hypercortisolemia that requires biochemical confirmation before initiating targeted medical therapy. Levoketoconazole (Recorlev) is indicated for adult patients (age ≥18) with Cushing syndrome when surgery was not curative or the patient is not a surgical candidate. Pretreatment biochemical testing must document elevated cortisol (preferably a 24‑hour urine free cortisol [UFC], or when UFC is not appropriate, a late‑night salivary cortisol, 1 mg overnight DST, or a low‑dose DST [2 mg/day for 48 hours]). Baseline cardiac and hepatic safety parameters must be documented prior to initiation, including a baseline QTc ≤ 470 milliseconds and absence of excluded liver disease or prior torsades/ventricular arrhythmia.

Definitions and Diagnostic Tests

24-hour urine free cortisol (UFC)

Primary biochemical testPretreatment 24-hour urine free cortisol (UFC)

PurposeDocument hypercortisolemia prior to initiating therapy

When requiredSubmit UFC result as part of initial authorization documentation

Alternative cortisol tests

Alternative testsLate-night salivary cortisol; 1 mg overnight dexamethasone suppression test (DST); low-dose DST (2 mg/day for 48 hours)

When to useWhen UFC is not appropriate (e.g., renal insufficiency/failure, adrenal incidentaloma)

DocumentationPretreatment results of one of these alternative tests must be submitted if UFC unavailable or inappropriate