CurrentCignaPolicy IP0092

Mifepristone

Defines prior authorization and medical necessity criteria for coverage of mifepristone (Korlym and generic) to control hyperglycemia secondary to endogenous Cushing's syndrome in adults with type 2 diabetes or glucose intolerance; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyMifepristone

Policy CodePolicy IP0092

Change TypeCoverage additions and criteria revisions

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and ensure patient meets all listed medical necessity criteria (including specialist consultation and required prior trials) before initiating mifepristone.

SourceLink

POLICY UPDATE CHANGES

Mifepristone tablets added to the policy.

Added a standard of care prerequisite step for endogenous Cushing's syndrome.

Added preferred product prerequisite (formulary-preference) for Korlym on Employer and IFP formularies.

Decreased initial authorization duration from 6 to 4 months for patients awaiting surgery or awaiting response after radiotherapy (now addressed under general Endogenous Cushing's Syndrome criteria).

1 yearstandard approval duration

≥18minimum age

Korlym+genericproducts included

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prior Authrequirement

Preferred productformulary trial

Coverage Criteria for Mifepristone (Korlym)

FDA‑Approved Indication — Endogenous Cushing's Syndrome

Approve for 1 year if the patient meets ALL of the following (A–F):

FDA-Approved Indication Criteria: A) Patient is ≥ 18 years of age;

FDA-Approved Indication Criteria: B) Mifepristone is being used to control hyperglycemia secondary to hypercortisolism in patients who have type 2 diabetes mellitus or glucose intolerance;

C) Surgical candidacy or timing

ONE of: i. According to the prescriber, the patient is not a candidate for surgery or surgery has not been curative;
ONE of: ii. Patient is awaiting surgery for endogenous Cushing's syndrome;
ONE of: iii. Patient is awaiting therapeutic response after radiotherapy for endogenous Cushing's syndrome;

D) Prior therapies or current treatment

ONE of: i. Patient has tried one of ketoconazole tablets, Metopirone (metyrapone capsules), Lysodren (mitotane tablets), Signifor (pasireotide subcutaneous injection), or Signifor LAR (pasireotide intramuscular injection) for the treatment of endogenous Cushing's syndrome;
ONE of: ii. Patient is currently receiving mifepristone;

E) Prescriber specialty: The medication is prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of Cushing's syndrome;

F) Formulary/preferred product: Preferred product criteria is met for the product(s) as listed in the policy tables;

See policy for specific formulary preference and exceptions (e.g., formulation allergy).

Coverage of mifepristone (Korlym and bioequivalent generic) is limited to use for control of hyperglycemia secondary to endogenous Cushing's syndrome in adults with type 2 diabetes mellitus or glucose intolerance who meet the policy's FDA‑approved indication criteria. Prior authorization is required; when the FDA‑approved indication criteria are met, approvals are typically granted for 1 year. Medication must be prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of Cushing's syndrome. Employer and Individual/Family Plan formularies may require a trial of the bioequivalent generic before Korlym except when the patient cannot take the generic due to an inactive‑ingredient allergy or serious adverse reaction.

Use of mifepristone for indications outside of the FDA‑approved context described in this policy is considered not medically necessary. Specifically, mifepristone should not be used for treatment of type 2 diabetes mellitus that is not associated with endogenous Cushing's syndrome. Additionally, use of mifepristone for treatment of psychotic features of psychotic depression is considered not medically necessary due to inconclusive and variable trial data.

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for mifepristone (Korlym) for covered indications. Approvals are provided per criteria and, when approved for an FDA‑approved indication, are typically granted for 1 year (when approval duration is specified in months, 1 month = 30 days).

Documentation Required

Specialist Prescribing Requirement

Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with mifepristone, the medication must be prescribed by or in consultation with a specialist. Specifically, for endogenous Cushing's syndrome the prescriber must be an endocrinologist or a physician who specializes in the treatment of Cushing's syndrome.

Step Therapy

Preferred Product and Prior Trial Requirements

Covered Codes and Billing

Covered Codesmixed

No codes listed

Definitions

Mifepristone (Korlym) — drug identifier

Drug name (brand)Korlym

Generic nameMifepristone

Mechanism / classCortisol receptor blocker

Indication (policy)To control hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance

Coverage actionPrior authorization required; approvals typically granted per criteria for 1 year when FDA‑approved indication criteria are met

Cushing's syndrome (hypercortisolism) — definition

Definition

Background

Cushing's syndrome is a state of hypercortisolism that may be endogenous (for example, due to a pituitary adenoma) or exogenous. First‑line therapy for endogenous causes is tumor resection when feasible. Mifepristone is a cortisol receptor blocker indicated to control hyperglycemia secondary to endogenous Cushing's syndrome in adults with type 2 diabetes or glucose intolerance who have failed surgery or are not candidates for surgery. Mifepristone is not intended as first‑line therapy for tumor management but as a medical treatment to manage hyperglycemia related to hypercortisolism when surgical options are not appropriate or have been unsuccessful.

Policy Summary

PayerCigna

PolicyMifepristone

Policy CodePolicy IP0092

Change TypeCoverage additions and criteria revisions

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and ensure patient meets all listed medical necessity criteria (including specialist consultation and required prior trials) before initiating mifepristone.

SourceLink

On This Page

Employer and Individual & Family (IFP) formularies prefer the bioequivalent generic mifepristone product. Coverage for Korlym (mifepristone) requires a trial of the bioequivalent generic formulation unless the member cannot take the generic due to a formulation difference in inactive ingredient(s) that would cause a significant allergy or serious adverse reaction. For IFP, prior authorization is required for formulary exceptions.

Employer plan requirement: trial of bioequivalent generic mifepristone unless contraindicated by inactive-ingredient allergy or serious adverse reaction.
Individual & Family plan requirement: trial of bioequivalent generic mifepristone (prior authorization required) unless contraindicated by inactive-ingredient allergy or serious adverse reaction.

Denial Risk

Billing and Coding Guidance — Coverage Risk

Claims submitted with diagnosis or procedure codes not covered under this policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service; receipt of sample product does not satisfy prior trial requirements.

Cushing's syndrome (hypercortisolism) — a state of excessive cortisol in the blood which may be endogenous (e.g., pituitary adenoma) or exogenous; Cushing's disease is ACTH‑dependent form due to pituitary adenomas

Clinical goalNormalization of cortisol excess, long‑term disease control, avoidance of recurrence, and reversal of clinical features

Relevant to policyMifepristone is indicated for control of hyperglycemia secondary to endogenous Cushing's syndrome in adults with type 2 diabetes or glucose intolerance who failed or are not candidates for surgery

Treatment contextFirst‑line therapy is tumor resection when possible; treatment is multimodal