CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Recorlev (levoketoconazole) prior authorization for Cushing syndrome

Defines medical necessity criteria, documentation, quantity limits, and authorization durations for Recorlev (levoketoconazole) for adult members with hypercortisolemia/Cushing syndrome under the payer's Medicaid scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRecorlev (levoketoconazole) prior authorization for Cushing syndrome

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of diagnosis, pretreatment biochemical testing, prior treatment history including failures, baseline QTc value, and clinician specialty for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

6 moContinuation authorization duration

8 tabs/150 mgQuantity limit

>=18Min age

<=470 msQTc requirement

Coverage and Medical Necessity Criteria

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRecorlev (levoketoconazole) prior authorization for Cushing syndrome

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of diagnosis, pretreatment biochemical testing, prior treatment history including failures, baseline QTc value, and clinician specialty for prior authorization.

SourceLink

On This Page

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Initial Therapy

Authorization of 6 months may be granted when ALL of the following are met:

Initial approval criteria: Patient is 18 years or older

Initial approval criteria: Documented diagnosis of hypercortisolemia with Cushing syndrome

Initial approval criteria: Medication prescribed by, or in consultation with, an endocrinologist

Pretreatment biochemical confirmation: Pretreatment biochemical testing with one of the following: 24-hour urine free cortisol (UFC) OR late-night salivary cortisol OR overnight 1 mg dexamethasone suppression test (DST) OR low‑dose DST (2 mg/day for 48 hours) when UFC is not appropriate (e.g., renal insufficiency)

Surgical status: Member has had noncurative surgery OR is not a candidate for surgery

Prior treatment requirement: Member has experienced failure, contraindication, or intolerance to ketoconazole and at least two alternative agents (e.g., cabergoline, pasireotide [Signifor LAR], mitotane [Lysodren])

Hepatic and biliary contraindications: No diagnosis of cirrhosis, acute liver disease, or poorly controlled chronic liver disease; no recurrent symptomatic cholelithiasis; no extensive metastatic liver disease

Cardiac safety: Baseline QTc-interval less than or equal to 470 milliseconds<= 470 milliseconds

Arrhythmia history: No history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome

Continuation Therapy

Authorization of 6 months may be granted for members currently receiving the medication who meet ONE of the following:

Continuation criteria: Documentation showing reduction in cortisol since treatment initiation as demonstrated by one of the following: reduction in 24-hour urine free cortisol from baseline OR reduction in late-night salivary cortisol OR improvement on an appropriate dexamethasone suppression test (e.g., overnight 1 mg DST or low‑dose 2 mg/day for 48 hours when UFC not appropriate)

Continuation criteria: Improvement in signs or symptoms of Cushing syndrome compared with baseline clinical status

Members with significant hepatic disease or gallstone-related complications are excluded from approval. Specifically, authorization is not appropriate for members with cirrhosis, acute liver disease, or poorly controlled chronic liver disease, or those with recurrent symptomatic cholelithiasis or extensive metastatic liver disease. These conditions are listed as contraindications in the approval criteria and will generally preclude coverage due to safety concerns related to hepatic metabolism and hepatobiliary complications. Documentation indicating the presence of any of these diagnoses may be a basis for denial.

Use is not recommended in patients with certain cardiac risk factors. The policy requires a baseline QTc-interval of less than or equal to 470 milliseconds for approval and explicitly excludes members with a history of ventricular arrhythmias. Specifically, therapy should not be used in members with a baseline QTc > 470 ms or a documented history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome, as these represent safety contraindications.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Duration

An authorization of 6 months may be granted when all approval criteria are met. Continuation authorizations may be granted for 6 months with documentation of ongoing benefit.

Initial and continuation authorization duration: 6 months when criteria are met.
Documentation required for continuation: evidence of lower cortisol levels or clinical improvement since therapy initiation.

Denial Risk

Denial Triggers

Denial may be issued if baseline testing or safety exclusions are missing or if contraindications are present. Ensure all required baseline tests and safety screenings are submitted.

Missing baseline tests: pretreatment 24-hour urine free cortisol (UFC), late-night salivary cortisol, or appropriate dexamethasone suppression test when UFC is not appropriate.
Safety exclusions: diagnosis of cirrhosis, acute or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, extensive metastatic liver disease.
Cardiac safety: absence of documentation showing baseline QTc ≤ 470 ms or history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or congenital prolonged QT syndrome.

Step Therapy

Step Therapy / Prior Treatment Requirement

Prior to approval, members must have experienced failure, contraindication, or intolerance to specified prior therapies; documentation should be provided.

Step therapy requirement: failure, contraindication, or intolerance to ketoconazole AND at least two alternative agents (examples include cabergoline, pasireotide [Signifor LAR], mitotane [Lysodren]).
Medication must be prescribed by or in consultation with an endocrinologist.
If UFC is not appropriate (e.g., renal insufficiency/failure, adrenal incidentaloma), provide alternative pretreatment testing (e.g., 1 mg overnight DST, low-dose 2 mg/day for 48 hours DST).

Clinical Background

Cushing syndrome is a disorder of chronic glucocorticoid excess caused by endogenous or exogenous sources. Diagnosis requires biochemical confirmation; the policy specifies pretreatment testing such as a 24-hour urine free cortisol (UFC) or late-night salivary cortisol, with an overnight 1 mg dexamethasone suppression test (DST) or a low-dose DST (2 mg/day for 48 hours) as alternatives when UFC is not appropriate (for example, in renal insufficiency). Levoketoconazole is used as a steroidogenesis inhibitor in patients with persistent disease after noncurative surgery or in those who are not surgical candidates.

OpenPayer

Recorlev (levoketoconazole) prior authorization for Cushing syndrome

Coverage and Medical Necessity Criteria

Key Coding & Safety Thresholds

Prior Authorization, Documentation, and Step Therapy

Pretreatment Biochemical Tests

Clinical Background