Korlym – NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Korlym® (mifepristone) 

FDA Approved Use

• Treatment of 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. 

Criteria for Approval of Restricted Product(s)

Initial Coverage

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of endogenous Cushing’s syndrome (medical record documentation required); AND 
3. The provider has submitted documentation demonstrating one of the following (medical record documentation required): 
   1. Mean of at least two 24-hour urine free cortisol (UFC) levels greater than upper limit of normal for reference range; OR 
   2. Late night salivary cortisol (two measurements) greater than upper limit of normal for reference range; OR 
   3. 1 mg overnight dexamethasone suppression test (DST) > 1.8 mcg/dL; AND 
4. The patient has a diagnosis of type 2 diabetes or glucose intolerance secondary to hypercortisolism (medical record documentation required); AND 
5. The patient has failed surgery or is not a candidate for surgery (medical record documentation required); AND 
6. Hypercortisolism is not due to use of corticosteroids; AND 
7. The requested medication will NOT be used for the sole purpose of weight loss; AND 
8. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., endocrinologist); AND 
9. The provider has submitted patient’s current weight; AND 
10. The patient has poorly controlled diabetes mellitus (HgA1c > 8%) and glucose elevation is being treated with anti-diabetic medications (i.e., metformin, sulfonylurea, DPP-4 inhibitor, basal insulin, bolus insulin, etc.) (medical record documentation required); AND 
11. The patient has been titrated to maximally tolerated FDA dosing of antidiabetic medications and will continue on antidiabetic medications while using the requested agent; AND 
12. Both of the following baseline testing have been completed before initiation of treatment 
    1. Negative pregnancy test in women of childbearing potential, if treatment with Korlym is interrupted for more than 14 days another negative pregnancy test is needed; AND 
    2. Serum potassium to correct any hypokalemia prior to initiation of treatment; AND
13. If the request is for brand Korlym; 
    1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic mifepristone (medical record documentation required); AND 
14. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 90 days (3 months)

Continuation Coverage

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. There is documentation that the patient has shown improvement of hyperglycemia with the requested medication as indicated with a decrease in HgA1c (medical record documentation required); AND 
3. The requested medication will NOT be used for the sole purpose of weight loss; AND 
4. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., endocrinologist); AND 
5. The provider has submitted patient’s current weight; AND 
6. The patient has been titrated to max tolerated FDA dosing of antidiabetic medications and will continue antidiabetic medications while using the requested agent; AND 
7. If the request is for brand Korlym; 
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic mifepristone (medical record documentation required); AND 
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year) 

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. If the requested dose is for 4 tablets per day the patient’s weight is 45 kg or greater; AND 
4. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
5. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

February 2024: Criteria change: Updated policy to add newly launched generic with preference before brand medication and added P&T statement.

July 2022: Criteria change: Added documentation of approved testing for Cushing’s diagnosis in initial and continuation criteria. Added medication cannot be used for weight loss. Clarified endocrinologist must be involved in therapy. Require current weight of patient. Require use and titration of antidiabetic medications. Updated baseline testing. Added continuation criteria. Changed QL to 3 tablets unless documented weight above 45 kg.

January 2022: Criteria change: Medical record documentation required. Decreased duration of approval to 365 days. Addition of quantity limit.

October 2019: Reformatted criteria; changed duration of approval to 3 years.

September 2017: Original utilization management criteria issued.