CurrentMass General Brigham Health PlanPolicy N/A

Recorlev (levoketoconazole) prior authorization

Defines prior authorization, specialty-fill, quantity limits, and medical necessity criteria for Recorlev (levoketoconazole) for adults with endogenous Cushing's syndrome for whom surgery is not an option or was not curative; applies to Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRecorlev (levoketoconazole) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation that surgery is not an option or was not curative, diagnosis of hypercortisolemia due to Cushing's disease, endocrinologist involvement, and for continuation, reduction in baseline 24-hour urinary free cortisol.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial approval duration

12 moReauthorization duration

240/30dQty limit (150 mg)

Specialty onlySpecialty fill

AdultsAge group

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Coverage and Medical Necessity Criteria

Initial therapy criteria

Authorization may be granted when ALL of the following are met; documentation must be provided:

Indication: Member has a diagnosis of hypercortisolemia secondary to Cushing's disease

Surgery status: Documentation that surgery (e.g., pituitary surgery, adrenal surgery) is not an option or has not been curative

Age: Member is >= 18 years old>=18

Prescriber: Prescribed by or in consultation with an endocrinologist

Continuation of therapy

Reauthorization criteria

Response: Physician attestation that member demonstrates a positive response to therapy

Biochemical improvement: Documentation of reduction in baseline 24-hour urinary free cortisol levelreduction from baseline

Required for continuation of therapy

This policy applies to adult members and identifies specialty pharmacy handling requirements. The plan designates Recorlev (levoketoconazole) as a specialty medication and it must be filled at a contracted specialty pharmacy. The policy scope is limited to adults (see coverage criteria requiring member age >= 18) and does not list additional patient population exclusions beyond the age restriction.

The document does not include explicit statements labeling any uses of Recorlev as not medically necessary. Coverage guidance and authorization criteria are presented without a separate 'not medically necessary' declaration in the policy text.

Product Coding and Clinical Measures

Quantity limits (NDC/product level)NDCCovered

Recorlev 150mg

Quantity limit: 240 tablets per 30 days

24-hour urinary free cortisol

ThresholdDocumentation of reduction from baseline 24-hour urinary free cortisol required for reauthorization

When requiredAt time of reauthorization/continuation of therapy

PurposeDemonstrates biochemical improvement on therapy

Provider Requirements, Prior Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization required. This medication is designated specialty and must be filled at a contracted specialty pharmacy. Initial approvals will be granted for 6 months; reauthorizations for 12 months.

Specialty fill required — use contracted specialty pharmacy
Initial approval: 6 months
Reauthorization: 12 months
Contact (All Plans specialty): Phone: 877-519-1908; Fax: 855-540-3693
Non-specialty contact: Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step therapy is not specified beyond the specialty designation and prior authorization requirements.

Clinical Response and Definitions

Positive response

DefinitionPhysician attestation that the member demonstrates a positive response to therapy

Supporting evidenceMust be supported by documentation of reduction in baseline 24-hour urinary free cortisol level

TimingRequired for reauthorization/continuation of therapy

Drug Background and Indication

Recorlev (levoketoconazole) is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative. The policy requires documentation that surgery (for example, pituitary or adrenal surgery) is not appropriate or was not curative when considering medical therapy. Monitoring for therapeutic response includes measurement of 24‑hour urinary free cortisol and physician assessment of clinical improvement.

Documentation Required

Required Documentation

Provide documentation of diagnosis of hypercortisolemia secondary to Cushing's disease; documentation that surgery (e.g., pituitary or adrenal surgery) is not an option or was not curative; patient age (must be ≥ 18 years); and that the drug is prescribed by or in consultation with an endocrinologist. For continuation, provide physician attestation of positive response and documentation of reduction in baseline 24-hour urinary free cortisol level.

Diagnosis: hypercortisolemia secondary to Cushing's disease
Documentation that surgery is not an option or was not curative (e.g., pituitary or adrenal surgery)
Patient age ≥ 18 years
Prescribed by or in consultation with an endocrinologist
For reauthorization: physician attestation of positive response and documented reduction in baseline 24-hour urinary free cortisol (24‑hour UFC)

Denial Risk

Triggers for Denial

Authorization may be denied for lack of required documentation (diagnosis, surgical history, endocrinology involvement), if patient is under 18 years of age, if surgery was curative or an option and not addressed, or if continuation criteria (positive response and reduction in 24‑hour urinary free cortisol) are not met.

Missing documentation of Cushing's-related hypercortisolemia
No documentation that surgery is not an option or was not curative
No documentation of endocrinology consult/prescriber
Patient age < 18 years
For continuation, no physician attestation of positive response or no documented reduction in baseline 24‑hour urinary free cortisol