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Date Printed: August 23, 2017: 06:10 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-69

Original Effective Date: 06/15/12

Reviewed: 07/13/16

Revised: 08/15/16

Subject: Mifepristone (Korlym™) Oral

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Cushing’s syndrome results from prolonged exposure to excessive concentrations of glucocorticoids; it is associated with significant morbidity and mortality with 75% of individuals with uncontrolled disease also have metabolic syndrome, characterized by glucose intolerance, obesity, hypertension, and dyslipidemia.1 Individuals with Cushing’s syndrome produce excess glucocorticoids in response to overproduction of adrenocorticotropin hormone (ACTH; ACTH-dependent) or due to abnormal adrenocortical tissues (ACTH-independent).1 The treatment of choice for both ACTH-dependent and ACTH-independent Cushing's syndrome is surgical resection of any offending tumors. However, several secondary pharmacologic treatment plans are available, depending on the etiology of the disease.1

Mifepristone (Korlym), a selective and potent antagonist of glucocorticoid receptors, was approved by the Food and Drug Administration (FDA) to control hyperglycemia secondary to endogenous Cushing’s syndrome in adults with type 2 diabetes mellitus or glucose intolerance who are not candidates for surgery or have failed surgery.2,3 The clinical data supporting the FDA approval of mifepristone resulted from an uncontrolled, open-label, multicenter, 24-week, phase three study of 50 patients with endogenous Cushing's syndrome, who were either not eligible for surgery or whose condition had relapsed after surgery. Study participants exhibited either glucose intolerance (29 patients) or hypertension (21 patients).3 Within the glucose-intolerant group, 60% of patients experienced a greater than 25% reduction from baseline in the oral glucose tolerance test. In this group, the mean hemoglobin A1C (HbA1C) value was reduced from 7.4% to 6.3%. All 14 patients with above-normal HbA1C levels at baseline experienced reductions. Eight of these patients experienced normalization of their HbA1C levels. Antidiabetic medications were reduced in 7 of the 15 patients with type 2 diabetes, and remained constant in the others.3

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Mifepristone (Korlym™) meets the definition of medical necessity to treat hyperglycemia in members meeting ALL of the following criteria:

Duration of approval: 6 months

Mifepristone (Korlym™) meets the definition of medical necessity when used to treat the following designated Orphan Drug indication (http://www.fda.gov/orpha/desinat/list.htm):

1. Ovarian Cancer

Duration of approval: 1 year

Continuation of mifepristone (Korlym™) meets the definition of medical necessity for endogenous Cushings syndrome when the following criteria are met:

A. The member has been previously approved by Florida Blue or another health plan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage

B. Member has a beneficial response to therapy (improved glucose tolerance)

C. The total daily dose does not exceed 1200 mg

Duration of approval: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA Approved

Dose adjustments:

Drug Availability

PRECAUTIONS:

Boxed Warning

Termination of pregnancy – pregnancy must be excluded before the ignition of treatment or if treatment is interrupted for more than 14 days in females

Contraindications

Precautions/Warnings

BILLING/CODING INFORMATION:

HCPCS Coding:

J8499

Prescription drug, oral, non-chemotherapeutic, NOS

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C56.1 – C56.9

Malignant neoplasm of ovary

E24.0

Pituitary dependent Cushing's disease

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Cushing’s syndrome: is a hormone disorder caused by high levels of cortisol in the blood. This can be caused by taking glucocorticoid drugs, or by tumors that produce cortisol or adrenocorticotropic hormone (ACTH) or CRH.

RELATED GUIDELINES:

H.P. Acthar® Gel, 09-J1000-15
Mitotane (Lysodren®) Tablets, 09-J1000-60

OTHER:

None applicable.

REFERENCES:

  1. Clinical Pharmacology [Internet Database]. Gold Standard, Inc., 2016 [cited 2016 June 18]. Available from: http://www.clinicalpharmacology-ip.com/.
  2. Ingenix HCPCS Level II, Expert 2012.
  3. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2012.
  4. KORLYM (mifepristone) tablet. Menlo Park (CA): Corcept, Inc; 2016 June. Package insert
  5. Micromedex ® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 6/18/16.
  6. Mifepristone. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 June 16 ].
  7. Smith SM. Chapter 85. Adrenal Gland Disorders. In: Talbert RL, DiPiro JT, Matzke GR, Posey LM, Wells BG, Yee GC, eds. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York: McGraw-Hill; 2011. http://www.accesspharmacy.com.lp.hscl.ufl.edu/content.aspx?aID=7992321. Accessed April 15, 2013.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 07/13/16.

GUIDELINE UPDATE INFORMATION:

06/15/12

New Medical Coverage Guideline.

06/15/13

Review and revision to guideline; consisting of description, position statement, dosage/administration, precautions, program exceptions, references; Review status changed to no longer reviewed.

11/01/15

Revision: ICD-9 Codes deleted.

08/15/16

Review and revision to guideline; including update to position statement, coding and references.

Date Printed: August 23, 2017: 06:10 AM