CurrentAvMedPolicy N/A

mifepristone (Korlym) prior authorization

Defines AvMed's prior authorization and step-edit requirements for mifepristone 300 mg (Korlym) for treatment of endogenous Cushing's syndrome and associated glycemic control; applies to providers prescribing this specialty pharmacy medication to AvMed members.

Policy Summary

PayerAvMed

Policymifepristone (Korlym) prior authorization

Policy CodePolicy N/A

Change TypeNon‑material revision/reformat (12/9/202112/23/202110/27/2023)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization with supporting labs (current HbA1c/OGTT), prescriber signature, and documentation of prior therapies to avoid denial.

SourceLink

POLICY UPDATE CHANGES

Policy was revised/reformatted/updated on 12/9/2021; 12/23/2021; 10/27/2023.

300 mgrequested drug strength

120quantity limit per 30 days

6 moinitial authorization duration

12 moreauthorization duration

Coverage Criteria for mifepristone (Korlym)

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization

Diagnosis-specific: Diagnosis of Type 2 Diabetes Mellitus OR glucose intolerance documented by oral glucose tolerance test OR Hemoglobin A1c (HbA1c)
Submit documentation (OGTT or HbA1c)
Surgical/medical candidacy: One of: prior surgery was non-curative OR member is not a candidate for surgery
Document past medical/surgical history
Prior medical therapy failure: Documentation of clinical failure to ketoconazole plus ONE of: an additional steroidogenesis inhibitor (e.g., metyrapone) OR mitotane OR a pituitary-directed therapy (e.g., cabergoline or pasireotide [Signifor LAR])

Policy Summary

PayerAvMed

Policymifepristone (Korlym) prior authorization

Policy CodePolicy N/A

Change TypeNon‑material revision/reformat (12/9/202112/23/202110/27/2023)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization with supporting labs (current HbA1c/OGTT), prescriber signature, and documentation of prior therapies to avoid denial.

SourceLink

On This Page

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Provide prior therapy documentation

Glycemic therapy failure: Documentation of clinical failure to control glucose with metformin AND TWO of: a GLP-1 receptor agonist, insulin, or a DPP-4 inhibitor

Specify agents tried

Drug interaction avoidance: Member is not taking and will not take strong CYP2A inhibitors (examples include simvastatin, lovastatin, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus)

Verify concomitant medications

Initial Authorization

Initial authorization criteria (all must be met):

Eligibility: Age >= 18 years; prescribing physician is an endocrinologist; diagnosis of endogenous Cushing's Syndrome

Documentation required

Continuation Therapy

Reauthorization covered when ALL of the following are met:

Reauthorization: Positive disease response has been achieved, demonstrated by improved glycemic control (decreased hemoglobin A1c)

Current HbA1c/lab results must be submitted

Reauthorization

Reauthorization requires documentation of response:

Response documentation: Positive disease response demonstrated by improved glycemic control (decreased HbA1c) with current lab results submitted

All documentation, including lab results, diagnostics, and chart notes, must be provided or request may be denied

Members who are taking or planning to take strong CYP2A inhibitors are excluded from approval. Examples listed in the policy include simvastatin, lovastatin, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. The prescribing clinician must verify concomitant medications and confirm the member will not take these strong inhibitors while on mifepristone 300 mg.

Use of drug samples to initiate mifepristone therapy does not meet step edit or preauthorization criteria and will not be accepted as evidence that prior therapies were tried. Prior therapies will be verified through pharmacy paid claims or submitted chart notes and documentation of required prior treatment failure must be provided with the prior authorization request.

Requested Drug and Dosing / Coding Details

Requested drugNDC | drug_description

mifepristone 300 mg

Drug requested (Korlym) strength as listed on form

Recommended maximum daily dose

Recommended maximum daily doseDaily dose will NOT exceed 20 mg/kg/day OR 1,200 mg once daily

Initiation and titrationInitiate therapy with 300 mg/day and titrate every 2-4 weeks based on tolerability and symptom control

Dose-related documentationPrescriber must document weight to support mg/kg dosing calculations

mifepristone 300 mg — quantity limit per 30 days

Quantity limit (30 days)120 tablets per 30 days

Drug strength referencedmifepristone 300 mg (Korlym)

Formulation noteQuantity limit applies to tablets as listed on the PA form

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for both initial and reauthorization requests. Initial authorization duration: 6 months. Reauthorization duration: 12 months. Ensure all required clinical criteria are met and documented for approval.

Initial Authorization: 6 months
Reauthorization: 12 months

Denial Risk

Samples Not Acceptable

Samples may not be used to satisfy preauthorization or step-edit requirements. Do not rely on sample supply to initiate therapy or fulfill prior-therapy requirements.

Use of samples does not meet step edit/preauthorization criteria

Documentation Required

Required Supporting Documentation

All documentation supporting clinical criteria must be submitted with the request. This includes relevant labs (e.g., HbA1c, oral glucose tolerance test), diagnostic test results, and chart notes demonstrating diagnosis, prior therapies, and treatment response. Failure to provide required supporting documentation may result in delay or denial of the request.

Submit recent lab results to document HbA1c or oral glucose tolerance testing
Provide diagnostics and chart notes that support Endogenous Cushing's Syndrome diagnosis and prior therapy failures
Include documentation of prior treatment attempts (e.g., ketoconazole, metyrapone, pasireotide) and outcomes

Documentation Required

Form Signatures and Contact Information

The prescribing physician must sign and clearly print their name on the prior authorization request form (preprinted stamps are not valid). Include prescriber demographic and contact information: office contact name, phone number, fax number, and DEA or NPI. Incomplete or missing prescriber signature or contact information may delay authorization.

Prescriber signature and printed name (no preprinted stamps)
Office contact name, phone and fax numbers
DEA or NPI number

Denial Risk

Form Completeness

Ensure the form is complete, legible, and correct. Incomplete, incorrect, or illegible forms (including missing signature or missing contact info) may delay processing or cause denial.

Incomplete/incorrect/illegible forms can delay or cause denial
Verify all required fields are filled before submission

Denial Risk

Missing Supporting Documentation

Failure to provide required labs, diagnostics, and chart notes to support each clinical criterion checked on the form may result in denial. If documentation is missing, the request may be returned or denied until complete records are received.

Missing supporting documentation may lead to denial
Provide current HbA1c and other requested lab results with reauthorization requests

Definitions

Endogenous Cushing's Syndrome — diagnosis required for coverage

Required diagnosis for coverageMember must have a documented diagnosis of Endogenous Cushing's Syndrome

Supporting evidenceDocumentation may include diagnosis statement and relevant chart notes

Associated clinical requirementsCoverage requires meeting additional criteria such as T2DM or glucose intolerance and prior therapy history as listed on the PA form

Background

Mifepristone 300 mg (Korlym) is indicated in this policy for patients with Endogenous Cushing's Syndrome to manage hyperglycemia and related metabolic issues when surgery is not curative or the patient is not a surgical candidate and prior medical therapies have failed. Coverage requires documentation of the diagnosis and supporting clinical details, evidence of prior steroidogenesis or pituitary-directed therapy failure, and documentation of glycemic status (e.g., HbA1c or oral glucose tolerance test). For females of reproductive potential, pregnancy must be excluded prior to initiation and contraception planned during treatment and for one month after stopping. Prior authorization is required and the medication is provided through specialty pharmacy.

Step Therapy Requirements

Requirement	Verification / Notes
Documentation of prior therapies required (clinical failure or intolerance as specified)	Provide chart notes or other clinical documentation showing failure/intolerance to ketoconazole plus an additional steroidogenesis inhibitor or pituitary‑directed therapy as listed; include documentation of failure to control glucose with metformin plus two other specified agents when applicable.
Previous therapies verified via pharmacy paid claims or submitted chart notes	Pharmacy claims history may be used to confirm prior medication trials; if not available, submit chart notes documenting prior therapy dates, doses, and reason for discontinuation or failure.
Use of samples to initiate therapy is not acceptable to meet step-edit or prior authorization requirements	Samples will not be accepted as evidence of a prior trial; submit paid-claim records or clinical chart documentation instead.
Reauthorization requires documentation of positive disease response	For reauthorization (12 months), submit current labs demonstrating improved glycemic control (decreased HbA1c) as evidence of response.

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization requires documentation of response (clinical and/or lab):

Lab-supported response: Improved glycemic control demonstrated by decreased Hemoglobin A1c compared to baseline

Current HbA1c must be submitted

Supplemental documentation: Supporting documentation may include clinic chart notes describing clinical improvement or diagnostics in addition to laboratory results

Provide relevant chart notes or diagnostics

Site of Care / Dispensing

Note

Specialty pharmacy dispensing required (Proprium Rx noted)

Medication must be dispensed through a Specialty Pharmacy; Proprium Rx is noted as the specialty provider on the form.

Policy Revision History

2023-10-27policy revisionLatest

Policy revised/reformatted/updated.

2021-12-23policy revision

Policy revised/reformatted/updated.

2021-12-09policy revision

Policy revised/reformatted/updated.