CurrentallcareadvantagePolicy 111.1

Drug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

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Defines prior authorization, initial and renewal coverage criteria, and quantity/approval limits for levoketoconazole (Recorlev) for treatment of Cushing's syndrome in eligible members.

Policy Summary

Payerallcareadvantage

PolicyDrug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

Policy CodePolicy 111.1

Change TypeRoutine review — no material changes

Effective DateMay 23, 2022

Last ReviewJun 29, 2024

Next Review DateJun 29, 2024

Key ActionObtain prior authorization and document diagnosis, prior trials (or contraindications) to ketoconazole and pasireotide, and prescriber specialty or endocrinology consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age

6–12 moApproval length

8/dayDaily quantity limit

ketoconazole, pasireotideRequired prior trials

Policy Summary

Payerallcareadvantage

PolicyDrug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

Policy CodePolicy 111.1

Change TypeRoutine review — no material changes

Effective DateMay 23, 2022

Last ReviewJun 29, 2024

Next Review DateJun 29, 2024

Key ActionObtain prior authorization and document diagnosis, prior trials (or contraindications) to ketoconazole and pasireotide, and prescriber specialty or endocrinology consultation.

SourceLink

On This Page

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentallcareadvantagePolicy 111.1

Drug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

Customize your policy alerts

Sign up for allcareadvantage Policy 111.1 alerts

Get alerted when Policy 111.1 changes without checking for updates manually.

Monitor payer policy activity

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Defines prior authorization, initial and renewal coverage criteria, and quantity/approval limits for levoketoconazole (Recorlev) for treatment of Cushing's syndrome in eligible members.

Policy Summary

Payerallcareadvantage

PolicyDrug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

Policy CodePolicy 111.1

Change TypeRoutine review — no material changes

Effective DateMay 23, 2022

Last ReviewJun 29, 2024

Next Review DateJun 29, 2024

Key ActionObtain prior authorization and document diagnosis, prior trials (or contraindications) to ketoconazole and pasireotide, and prescriber specialty or endocrinology consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age

6–12 moApproval length

8/dayDaily quantity limit

ketoconazole, pasireotideRequired prior trials

Policy Summary

Payerallcareadvantage

PolicyDrug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

Policy CodePolicy 111.1

Change TypeRoutine review — no material changes

Effective DateMay 23, 2022

Last ReviewJun 29, 2024

Next Review DateJun 29, 2024

Key ActionObtain prior authorization and document diagnosis, prior trials (or contraindications) to ketoconazole and pasireotide, and prescriber specialty or endocrinology consultation.

SourceLink

On This Page

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization: Member is ≥18 years old.age >= 18 years

From policy Criteria #2: member must be >=18 years.

Initial Authorization: Documentation supports a diagnosis of Cushing's syndrome.

From policy Criteria #3: documentation of diagnosis required.

Initial Authorization: Medication is prescribed by or in consultation with an endocrinologist.

From policy Criteria #4: prescriber specialty or consultation required.

Initial Authorization: Member is not a candidate for surgery or surgery has not been curative.

From policy Criteria #5: surgery not an option or not curative.

Initial Authorization: Member has tried oral ketoconazole or has a documented contraindication to oral ketoconazole.

From policy Criteria #6: prior trial or contraindication to oral ketoconazole required.

Initial Authorization: Member has tried pasireotide or has a documented contraindication to pasireotide.

From policy Criteria #7: prior trial or contraindication to pasireotide required. If met, approve for up to 6 months with quantity limit.

Continuation / Renewal Therapy

Renewal covered when ALL of the following are met:

Renewal Authorization: Member previously met the initial prior authorization criteria (or is reviewed under initial criteria if not).

Renewal #1: member met initial PA criteria; if not, review under initial criteria.

Renewal Authorization: Documentation shows the member is tolerating treatment.

Renewal #2: documentation of tolerability required.

Renewal Authorization: Documentation demonstrates continued improvement of Cushing's syndrome (e.g., clinically meaningful reduction in 24-hour urinary free cortisol and/or improvements in signs and symptoms).

Renewal #3: if met, approve up to 12 months with quantity limit; if not met, do not approve.

Off-label indications: none listed. The policy specifies the FDA-approved indication only — treatment of Cushing's syndrome in patients for whom pituitary surgery is not an option or was not curative — and explicitly notes there are no off-label uses included in this document.

This therapy is not approved when any of the following apply: the member is under 18 years of age; documentation does not support a diagnosis of Cushing's syndrome; the medication is not prescribed by or in consultation with an endocrinologist; the member is a candidate for curative surgery or prior surgery was curative; or the member has not tried (or does not have a documented contraindication to) required prior therapies (oral ketoconazole and pasireotide).

Prior authorization is required and requests lacking the required specialty involvement, diagnostic documentation, or prior-therapy history should be denied per the criteria above.

Provider Actions and Requirements

Prior Authorization

Prior authorization required; initial and renewal approval durations

Prior authorization is required for levoketoconazole. For initial approvals, if the member meets all initial PA criteria approve for up to 6 months (policy notes approval length up to 6–12 months). For renewals, approval may be granted up to 12 months when renewal criteria are met (documentation of tolerability and continued clinical improvement).

Initial approval: approve x6 months when initial criteria met (policy indicates approval length up to 6–12 months).
Renewal approval: approve x12 months when renewal criteria met (documentation of tolerability and continued improvement).

Step Therapy

Required prior therapies (ketoconazole and pasireotide)

Before levoketoconazole is approved, the member must have tried oral ketoconazole and pasireotide unless there is a documented contraindication to either agent.

Member must have tried (or have a contraindication to) oral ketoconazole.
Member must have tried (or have a contraindication to) pasireotide.

Documentation Required

Required documentation to support PA and renewals

Include documentation that supports the diagnosis of Cushing's syndrome, the member is not a surgical candidate or surgery was not curative, the medication is prescribed by or in consultation with an endocrinologist, and prior therapy history; for renewals also provide evidence of tolerability and continued clinical improvement (for example, reduction in 24‑hour urinary free cortisol or improved signs/symptoms).

Diagnosis of Cushing's syndrome.
Evidence member is not a candidate for surgery or surgery was not curative.
Prescriber specialty: prescription by or consultation with an endocrinologist.
Prior trial of or documented contraindication to oral ketoconazole and pasireotide.
For renewal: documentation of tolerability and clinically meaningful improvement (e.g., reduction in 24‑hour urinary free cortisol or improvement in signs/symptoms).

Denial Risk

Triggers for denial (age, documentation, prescriber, prior therapies, surgical candidacy)

Requests will be denied if required criteria or documentation are missing, or if the member does not meet policy eligibility (including age and prescriber requirements).

Member under 18 years of age (minimum age ≥18) — do not approve.
No documentation supporting a diagnosis of Cushing's syndrome — do not approve.
Medication not prescribed by or in consultation with an endocrinologist — do not approve.
Member is a surgical candidate or surgery was curative — do not approve.
Required prior therapies (oral ketoconazole and pasireotide) not tried and no documented contraindication — do not approve.

Drug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

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Drug Specific: levoketoconazole (Recorlev) - Prior Authorization Criteria

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Coverage Criteria

Coding and Limits

Provider Actions and Requirements

Background

Definitions