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Korlym (mifepristone) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1054
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
04-01-2024 |
10-01-2012 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Korlym® (mifepristone) Tablet* |
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: Should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome |
* - generic available |
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Cushing's Syndrome |
Cushing's syndrome denotes pathologic hypercortisolism as a result of excessive adrenocorticotropic hormone (ACTH) production or autonomous adrenal production of cortisol. This potentially lethal disorder is associated with significant comorbidities including hypertension, diabetes, coagulopathy, cardiovascular disease, infections, and fractures. As a result, even after cure of hypercortisolism, mortality rates may be increased. Because of this it is important to make the diagnosis as early in the disease course as possible to prevent additional morbidity and residual disease. Signs and symptoms of Cushing’s syndrome are broad and often common among the general population such as obesity, depression, diabetes, hypertension, or menstrual irregularities. Some features are more discriminatory and unique to Cushing’s syndrome such as reddish-purple striae, plethora, proximal muscle weakness, bruising with no obvious trauma, and unexplained osteoporosis.(5) Guidelines recommend a multidisciplinary team, including an endocrinologist, providing education and treatment options to the patient. Goals of treatment in Cushing’s syndrome include reversal of clinical features, normalization of biochemical changes with minimal morbidity, and long-term control without recurrence. Surgical resection of the causal lesion(s) is the first-line approach. When surgery is delayed, contraindicated, or unsuccessful, second-line treatments, including medical therapy, bilateral adrenalectomy, and radiation therapy, must be considered. Glucocorticoid antagonists, such as mifepristone, are suggested in patients with diabetes or glucose intolerance who are not surgical candidates or who have persistent disease after surgery.(2) The American Diabetes Association defines impaired glucose tolerance (glucose intolerance) in prediabetes as plasma glucose of 140 mg/dL to 199 mg/dL (7.8 mmol/L to less than 11.1 mmol/L), and in diabetes as plasma glucose of greater than or equal to 200 mg/dL (11.1 mmol), after the oral glucose tolerance test (OGTT). The OGTT is a two-hour test that checks plasma glucose levels before and 2 hours after drinking a glucose-containing drink.(4) |
Efficacy (1) |
The safety and efficacy of Korlym in the treatment of endogenous Cushing’s syndrome was evaluated in an uncontrolled, open-label, 24-week, multicenter clinical study. The study enrolled 50 subjects with clinical and biochemical evidence of hypercortisolemia despite prior surgical treatment and radiotherapy. The reasons for medical treatment were failed surgery, recurrence of disease, and poor medical candidate for surgery. Patients belonged to one of two cohorts: a diabetes cohort or a hypertension cohort. While results in the hypertension cohort showed no changes in mean systolic and diastolic blood pressures at the end of the trial, the diabetes cohort showed improvements in glucose response [defined as a greater than or equal to 25% reduction from baseline in glucose area under the curve (AUC) in standard oral glucose tolerance test] in 60% of patients, and reduction in glycated hemoglobin (HbA1c) in all patients.
|
Safety (1) |
Mifepristone has a boxed warning for pregnancy termination. Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with mifepristone, or if the treatment is interrupted for more than 14 days in females of reproductive potential.
Mifepristone is contraindicated in:
|
REFERENCES
Number |
Reference |
1 |
Korlym prescribing information. Corcept Therapeutics Inc. November 2019. |
2 |
Nieman L, Biller B, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2015;100:2807–2831. |
3 |
|
4 |
American Diabetes Association Professional Practice Committee. “Classification and Diagnosis of Diabetes: Standards of Medical care in Diabetes-2023.” Diabetes Care 2023; 46(Supplement_1): S19-S40. Available at: https://diabetesjournals.org/care/issue/46/Supplement_1 |
5 |
Endocrine Society. Cushing’s disease. Accessed at: https://www.hormone.org/diseases-and-conditions/cushings-disease |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Korlym |
mifepristone tab |
300 MG |
M ; N ; O ; Y |
O ; Y |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Korlym |
mifepristone tab |
300 MG |
120 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Korlym |
mifepristone tab |
300 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Korlym |
mifepristone tab |
300 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent will be approved when ALL of the following are met:
Length of Approval: 6 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Initial: 6 months; Renewal: 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Korlym_PAQL _ProgSum_ 04-01-2024