Pharmacy Prior Authorization Criteria

Korlym (mifepristone)

Indications for Prior Authorization

Korlym (mifepristone)

• For diagnosis of Hyperglycemia in Patients with Endogenous Cushing’s Syndrome and Type 2 Diabetes Mellitus
  Indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

  Limitations of use: Korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome.

Criteria

Brand Korlym, Generic mifepristone 300mg

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of endogenous Cushing’s syndrome (i.e., hypercortisolism is not a result of chronic administration of high dose glucocorticoids) [A]
AND
• One of the following:
• Diagnosis of type 2 diabetes mellitus
• Diagnosis of glucose intolerance
AND
• Patient has hyperglycemia that is secondary to hypercortisolism
AND
• One of the following: [1,2]
• Patient has failed surgery
• Patient is not a candidate for surgery
AND
• Trial or intolerance to generic mifepristone 300 mg (applies to Brand Korlym only)
AND
• Prescribed by or in consultation with an endocrinologist
AND
• Patient is not pregnant [1]

Brand Korlym, Generic mifepristone 300mg

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

• Documentation of one of the following:
• Patient has improved glucose tolerance while on therapy
• Patient has stable glucose tolerance while on therapy
AND
• Trial or intolerance to generic mifepristone 300 mg (applies to Brand Korlym only)

P & T Revisions

2024-09-04, 2024-03-06, 2023-08-28, 2022-09-14, 2021-09-07, 2021-05-19, 2020-08-27, 2019-08-15

References

1. Korlym prescribing information. Corcept Therapeutics Inc. Menlo Park, CA. November 2019.
2. Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831.
3. Mifepristone prescribing information. Actavis Pharma, Inc. May 2024.

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End Notes

1. Korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome. [1]

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Revision History

• 2024-09-04: Annual review: Updated criteria to apply to Brand Korlym to require trial of its AB-rated generic ( generic mifepristone). Updated references.
• 2024-03-06: Added generic mifepristone as target to guideline.
• 2023-08-28: 2023 Annual Review
• 2022-09-14: Annual Review
• 2021-09-07: Annual Review
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2020-08-27: Annual Review: removed drug name from reauth and updated references
• 2019-08-15: Annual review: no changes.

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