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Date Printed: October 20, 2017: 12:01 PM

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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-J1000-60

Original Effective Date: 01/01/12

Reviewed: 12/12/12

Revised: 11/01/15

Subject: Mitotane (Lysodren®) Tablets

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:

Mitotane can best be described as an adrenal cytotoxic agent, although it can cause adrenal inhibition, apparently without cellular destruction. Its biochemical mechanism of action is unknown. Data are available to suggest that the drug modifies the peripheral metabolism of steroids as well as directly suppressing the adrenal cortex. The administration of mitotane alters the extra-adrenal metabolism of cortisol in man; leading to a reduction in measurable 17-hydroxy corticosteroids, even though plasma levels of corticosteroids do not fall. The drug apparently causes increased formation of 6-β-hydroxyl cortisol.

POSITION STATEMENT:

Mitotane meets the definition of medical necessity when used to treat the following:

• Adrenal cortical carcinoma; AND

• Dose does not exceed 10 g/day.

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.

Adults

Adrenal cortical carcinoma: Maximum dose is 20 g/day. The maximum tolerated dose (MTD) will vary from 2 to 16 g/day, but has usually been 9 to 10 g/day.

Initial dosage: 2 to 6 g/day in divided doses, either 3 or 4 times a day.

Dosage titration: Doses are usually increased incrementally to 9 to 10 g/day. If severe adverse reactions appear, the dose should be reduced until the maximum tolerated dose is achieved. If the patient can tolerate higher doses and improved clinical response appears possible, the dose should be increased until adverse reactions interfere.

Maintenance dosage: 9 to 10 g/day or until maximum tolerated dose (MTD) is achieved.

General dosing considerations:

Treatment should be instituted in the hospital until a stable dosage regimen is achieved.

PRECAUTIONS:

Black Box Warning

Mitotane should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents. Mitotane should be temporarily discontinued immediately following shock or severe trauma since adrenal suppression is its prime action. Exogenous steroids should be administered in such circumstances, since the depressed adrenal may not immediately start to secrete steroids.

Adrenal insufficiency: Adrenal insufficiency may develop in patients treated with mitotane, and adrenal steroid replacement should be considered for these patients.

A substantial percentage of the patients treated show signs of adrenal insufficiency. It therefore appears necessary to watch for and institute steroid replacement in those patients. However, some investigators have recommended that steroid replacement therapy be administered concomitantly with mitotane. It has been shown that the metabolism of exogenous steroids is modified and consequently somewhat higher doses than normal replacement therapy may be required.

Liver function impairment: Mitotane should be administered with care to patients with liver disease other than metastatic lesions from the adrenal cortex, since the metabolism of mitotane may be interfered with and the drug may accumulate.

Hypersensitivity reactions: Mitotane should be temporarily discontinued immediately following shock or severe trauma, since adrenal suppression is its prime action. Exogenous steroids should be administered in such circumstances, since the depressed adrenal may not immediately start to secrete steroids.

Special risk patients: All possible tumor tissues should be surgically removed from large metastatic masses before mitotane administration is instituted. This is necessary to minimize the possibility of infarction and hemorrhage in the tumor due to a rapid cytotoxic effect of the drug.

Long-term continuous administration of high doses of mitotane may lead to brain damage and impairment of function. Behavioral and neurological assessments should be made at regular intervals when continuous mitotane treatment exceeds 2 years.

Hazardous tasks: Since sedation, lethargy, vertigo, and other CNS side effects can occur, ambulatory patients should be cautioned about driving, operating machinery, and other hazardous pursuits requiring mental and physical alertness.

Carcinogenesis: The carcinogenic potential of mitotane is unknown. However, the mechanism of action of this compound suggests that it probably has less carcinogenic potential than other cytotoxic chemotherapeutic drugs.

Mutagenesis: The mutagenic potential of mitotane is unknown.

Children: Safety and efficacy in children have not been established.

BILLING/CODING INFORMATION:

HCPCS Coding

J8999

Prescription drug, oral, chemotherapeutic, NOS

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

C74.90

Malignant neoplasm of unspecified part of unspecified adrenal gland

E24.0

E24.Ø Pituitary-dependent Cushing's disease

E24.2

Drug-induced Cushing's syndrome

E24.3

Ectopic ACTH syndrome

E24.8

Other Cushing's syndrome

E24.9

Cushing's syndrome, unspecified

E31.21

Multiple endocrine neoplasia [MEN] type I

Z85.858

Personal history of malignant neoplasm of other endocrine glands

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.

Medicare Part D:

Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Carboplatin (Paraplatin®) IV, 09-J0000-93
Erythropoiesis Stimulating Agents, 09-J0000-31

Gonadotropin Releasing Hormone Analogs and Antagonists, 09-J0000-48

Granulocyte Colony Stimulating Factors, 09-J0000-62

Interferon alfa-n3 (Alferon N Injection®), 09-J0000-33

Paclitaxel and Paclitaxel (protein-bound) IV, 09-J1000-05

Positron Emission Tomography (PET Scans) Oncologic Applications, 04-78000-17

Topotecan HCl (Hycamtin®) Injection or Oral, 09-J1000-02

Tumor Markers, 05-86000-22

OTHER:

None.

REFERENCES:

  1. Clinical Pharmacology. Copyright® 2011 Elsevier. Accessed 09/30/11.
  2. DRUGDEX®. Accessed 09/30/11.
  3. Facts & Comparisons® E Answers. Accessed 09/30/11.
  4. Ingenix HCPCS Level II, Expert 2011.
  5. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2011.
  6. NCCN Drugs & Biologics Compendium™. Accessed 09/30/11.
  7. Lysodren® Prescribing Information. Revised June 2010.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 12/12/12.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

01/15/13

No Longer Review

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: October 20, 2017: 12:01 PM