CurrentmhnPolicy CP.PHAR.101

Clinical Policy: Mifepristone (Korlym)

Defines medical necessity criteria, prescribing and dosing limits, contraindications, and authorization durations for mifepristone (Korlym) for adults with endogenous Cushing's syndrome causing hyperglycemia; applies to members under the payer's commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Mifepristone (Korlym)

Policy CodePolicy CP.PHAR.101

Change TypeMaterial updates and clarifications

Effective Date05.01.12

Next Review Date

Key ActionSubmit prior authorization showing member meets all initial or continued therapy criteria, including diagnosis, endocrinology involvement, age ≥18, absence of contraindications, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Redirect requests for brand Korlym to use generic mifepristone 300 mg tablet unless contraindicated or adverse effects are experienced.

Initial approval duration extended from 6 to 12 months for this maintenance medication.

Diagnosis requirement clarified by separating into two separate requirements during prior review.

300 mgtablet strength available

1,200 mg/daymaximum daily dose

12 monthsapproval duration

Adults ≥18age requirement

Coverage Criteria

Initial Approval Criteria

Initial Approval — Cushing's Syndrome: Covered when ALL of the following are met.

ALL of the following

Diagnosis of uncontrolled hyperglycemia secondary to endogenous Cushing's syndrome.
Member has type 2 diabetes mellitus, impaired glucose tolerance or pre-diabetes as evidenced by a fasting blood glucose, oral glucose tolerance test, or hemoglobin A1c.
Prescribed by or in consultation with an endocrinologist.
Age ≥ 18 years.

Policy Summary

Payermhn

PolicyClinical Policy: Mifepristone (Korlym)

Policy CodePolicy CP.PHAR.101

Change TypeMaterial updates and clarifications

Effective Date05.01.12

Next Review Date

SourceLink

On This Page

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Surgery to treat Cushing's syndrome was insufficient or member is not a candidate for surgery.

If request is for brand Korlym, member must use generic mifepristone 300 mg tablet, unless contraindicated or clinically significant adverse effects are experienced. Prior authorization may be required for generic mifepristone.

Operational: document contraindication or adverse effects if brand requested.

Contraindications (must NOT have any):

Concurrent use of drugs metabolized by CYP3A (e.g., simvastatin, lovastatin), or CYP3A substrates with narrow therapeutic ranges (e.g., cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
Concurrent long-term corticosteroid use.

Dose limits (must not exceed):

1,200 mg per day.<= 1200 mg/day
4 tablets per day.

Continued Therapy

Continued Therapy — Cushing's Syndrome: Continued coverage when ALL of the following are met.

ALL of the following

Member eligibility (one of):
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B).
Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: improved fasting blood glucose, oral glucose tolerance test, or hemoglobin A1c since initiation of therapy.
Member must use generic mifepristone 300 mg tablet, unless contraindicated or clinically significant adverse effects are experienced. Prior authorization may be required for generic mifepristone.
If request is for a dose increase, new dose must not exceed:
- 1,200 mg per day.<= 1200 mg/day
- 4 tablets per day.

Coding and Dosing Limits

inv-05: Maximum daily dose

Maximum daily dose1,200 mg per day

Tablet limitNo more than 4 tablets per day

Starting doseStarting dose 300 mg PO once daily; may increase by 300 mg increments every 2–4 weeks

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must demonstrate the member meets all initial or continued therapy criteria, including diagnosis and supporting clinical evidence.

Prior authorization required for mifepristone 300 mg and Korlym per policy criteria
Provider must document diagnosis of uncontrolled hyperglycemia secondary to endogenous Cushing's syndrome and related laboratory evidence (fasting blood glucose, OGTT, or HbA1c)
Requests for brand Korlym will be redirected to generic mifepristone 300 mg tablet unless contraindicated or clinically significant adverse effects are experienced

Documentation Required

Required Documentation

Provider must submit documentation supporting that the member has met all approval criteria, such as office chart notes, lab results, or other clinical information.

Include relevant office notes, laboratory results (fasting glucose, OGTT, HbA1c), and consultation notes (endocrinologist) as applicable
If request is for dose increase or continuation, include evidence of positive clinical response (improvement in glucose parameters)

Billing Rule

Brand-to-Generic Redirection

Requests for brand Korlym should be redirected to generic mifepristone 300 mg unless there is a documented contraindication or clinically significant adverse event to the generic.

Prior authorization may be required for generic mifepristone
Document reason for brand use (contraindication or adverse reaction to generic) when submitting request

Denial Risk

Contraindications Trigger Denial

Presence of any contraindication listed below will trigger denial of the request.

Pregnancy (boxed warning: termination of pregnancy) — deny
Concurrent use of drugs metabolized by CYP3A or CYP3A substrates with narrow therapeutic ranges (e.g., simvastatin, lovastatin, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus) — deny
Concurrent long-term or systemic corticosteroid use for lifesaving purposes (e.g., immunosuppression after organ transplantation) — deny
Women with history of unexplained vaginal bleeding, endometrial hyperplasia with atypia, or endometrial carcinoma — deny
Known hypersensitivity to mifepristone — deny

Definitions

inv-11: Korlym / mifepristone — definition and indication summary

Generic/brand nameMifepristone (Korlym) — cortisol (glucocorticoid) receptor blocker

FDA indicationIndicated to control hyperglycemia secondary to hypercortisolism (endogenous Cushing's syndrome) in adults with type 2 diabetes mellitus or glucose intolerance who have failed surgery or are not candidates for surgery

Limitation of useNot for treatment of type 2 diabetes mellitus unrelated to endogenous Cushing's syndrome

Prescribing considerationsShould be prescribed by or in consultation with an endocrinologist per coverage criteria

Background

Mifepristone (Korlym) is a glucocorticoid (cortisol) receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and who have failed surgery or are not candidates for surgery. It works by antagonizing the glucocorticoid receptor to reduce the metabolic effects of excess cortisol and improve glycemic control in this specific population.