Mifepristone (Korlym) Form

Mifepristone (Korlym®) is a cortisol receptor blocker. FDA Approved Indication(s) Korlym is 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.
Limitation(s) of use: Do not use for the treatment of type 2 diabetes mellitus unrelated to endogenous Cushing's syndrome. Policy/Criteria Provider must submit documentation (including such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Korlym is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Cushing’s Syndrome (must meet all):

1. Diagnosis of uncontrolled hyperglycemia secondary to endogenous Cushing’s syndrome;
2. 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;
3. Prescribed by or in consultation with an endocrinologist;
   4. Age ≥ 18 years;
   5. Surgery to treat Cushing’s syndrome was insufficient or member is not a candidate for surgery;

4. At the time of request, member does not have any of the following contraindications (a and b): a. 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); b. Concurrent long-term corticosteroid use; Page 1 of 6

   CLINICAL POLICY
   Mifepristone

5. Dose does not exceed both of the following (a and b):
   a. 1,200 mg per day; b. 4 tablets per day.
   Approval duration:
   Medicaid/HIM - 6 months Commercial – 12 months or duration of request, whichever is less
   B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Cushing’s Syndrome (must meet all):
8. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. 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);

9. 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;

   3. If request is for a dose increase, new dose does not exceed both of the following (a and b):
      a. 1,200 mg per day; b. 4 tablets per day.
      Approval duration:
      Medicaid/HIM - 12 months Commercial – 12 months or duration of request, whichever is less Page 2 of 6

   CLINICAL POLICY
   Mifepristone B. Other diagnoses/indications (must meet 1 or 2):

10. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

11. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    Not applicable
    Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
    o Pregnancy; o 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); o Concurrent systemic corticosteroids for lifesaving purposes (e.g., immunosuppression after organ transplantation); o Women with history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; o Known hypersensitivity to mifepristone; • Boxed warning(s): termination of pregnancy Page 3 of 6

    CLINICAL POLICY
    Mifepristone V. Dosage and Administration
    Indication Cushing’s syndrome VI. Product Availability
    Tablet: 300 mg Dosing Regimen Starting dose is 300 mg PO QD. May increase in 300 mg increments (dose increase once every 2 to 4 weeks). Maximum Dose 1,200 mg/day VII.