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Date Printed: June 23, 2017: 11:44 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-J1000-76

Original Effective Date: 12/15/12

Reviewed: 03/08/17

Revised: 04/15/17

Subject: Eribulin Mesylate (Halaven®) Injection

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.

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

DESCRIPTION:

Eribulin mesylate (Halaven) is a non-taxane microtubule dynamics inhibitor. Although eribulin is characterized in the group of antitubulin drugs, including vinblastine and paclitaxel, it exerts its inhibition of microtubule dynamics via a novel mechanism of action, which is thought to involve binding to a unique site on tubulin. Ultimately, eribulin causes irreversible mitotic block and apoptosis. Due to its novel mechanism of action, it has been hypothesized that eribulin may have efficacy in individuals with malignancies that are resistant to other tubulin-targeted agents as well as a more favorable tolerability profile.

Eribulin was approved by the Food and Drug administration (FDA) on November 15, 2010, for the treatment of individuals with metastatic breast cancer who have previously received an anthracycline and a taxane in either the adjuvant or metastatic setting, and at least two chemotherapeutic regimens for the treatment of metastatic disease. In 2016, eribulin was approved by the FDA for unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimenThe current indication for eribulin is based principally on the results of the EMBRACE trial, which compared eribulin monotherapy to any single-agent treatment of the physician’s choice, which served as a control designed to represent actual clinical options available for the management of metastatic breast cancer. Key inclusion criteria included previous therapy with 2 to 5 chemotherapy regimens, including an anthracycline- and a taxane-based regimen for adjuvant or metastatic disease. The one-year overall survival (OS) was 53.9% in the eribulin arm and 43.7% in the control arm and the median OS was 13.12 versus 10.65 months, representing a 19% statistically significant risk reduction (p=0.041).

Eribulin is included in National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines (version 2.2016) and Soft Tissue Sarcoma Guidelines (version 2.2017).

POSITION STATEMENT:

Initiation of eribulin mesylate (Halaven) meets the definition of medical necessity for the following indications when ALL indication-specific criteria are met:

1. Breast cancer

a. Member’s disease is recurrent or metastatic

b. Member meets one of the following:

i Eribulin is prescribed as a single agent

ii Eribulin is prescribed in combination with trastuzumab AND member has HER2-positive disease as documented by ONE of the following – laboratory documentation must be provided:

• Immunohistochemistry (IHC) is 3+

• Fluorescent in situ hybridization (FISH) HER2 gene copy is greater than 6

• FISH ratio of HER2 gene/chromosome 17 ratio is greater than or equal to 2.0

c. Dose does not exceed 2.8 mg/m2 every 21 days

d. Member is 18 years of age or older

2. Soft Tissue Sarcoma

a. Member’s disease is unresectable or metastatic

b. Eribulin is prescribed as a single agent for palliative therapy

c. Dose does not exceed 2.8 mg/m2 every 21 days

d. Member is 18 years of age or older

Approval duration: 1 year

Continuation of eribulin mesylate (Halaven) meets the definition of medical necessity when ALL of the following criteria are met:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years for treatment of breast cancer or soft tissue sarcoma, OR the member has previously met all indication-specific initiation criteria

2. Dose does not exceed 2.8 mg/m2 every 21 days

Approval duration: 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:

• Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle

Dosage Adjustments

• Members should be assessed for peripheral neuropathy and a complete blood count (CBC) should be obtained prior to each dose.

• Once the dose is reduced, do not re-escalate.

• Refer to prescribing information for detailed dose adjustments

Drug Availability

• Injection: 1 mg per 2 mL (0.5 mg per mL)

PRECAUTIONS:

Contraindications:

• None

WARNINGS

• Neutropenia: Monitor peripheral blood counts and adjust dose as appropriate.

• Peripheral neuropathy: Monitor for signs of neuropathy; manage with dose delay and adjustment

• QT Prolongation: Monitor for prolonged QT intervals in members with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in members with congenital long QT syndrome.

• Pregnancy and lactation:

o Eribulin is classified as Pregnancy Category D. There are no adequate and well-controlled studies of eribulin in pregnant women; however, eribulin was embryotoxic, fetotoxic, and teratogenic in rats that received half of the recommended human eribulin dose.

o There were no human or animal studies conducted to determine if eribulin is excreted into breast milk. Avoidance in nursing women is recommended.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J9179

Injection, eribulin mesylate, 0.1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity

C48.0

Malignant neoplasm of retroperitoneum

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C49.0

Malignant neoplasm of connective and soft tissue of head, face and neck

C49.10

Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder

C49.11

Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder

C49.12

Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder

C49.20

Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip

C49.21

Malignant neoplasm of connective and soft tissue of right lower limb, including hip

C49.22

Malignant neoplasm of connective and soft tissue of left lower limb, including hip

C49.3

Malignant neoplasm of connective and soft tissue of thorax

C49.4

Malignant neoplasm of connective and soft tissue of abdomen

C49.5

Malignant neoplasm of connective and soft tissue of pelvis

C49.6

Malignant neoplasm of connective and soft tissue of trunk, unspecified

C49.8

Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

C49.A0 - C49.A9

Gastrointestinal stromal tumor

C50.011

Malignant neoplasm of nipple and areola, right female breast

C50.012

Malignant neoplasm of nipple and areola, left female breast

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right male breast

C50.022

Malignant neoplasm of nipple and areola, left male breast

C50.029

Malignant neoplasm of nipple and areola, unspecified male breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

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

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:

Adjuvant Treatment: Additional cancer treatment given after the primary treatment to lower the risk that the cancer will return. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biologic therapy. Adjuvant therapy can be used after or in combination with another form of cancer therapy and is commonly used following removal of a cancerous tumor to further help in treatment.

RELATED GUIDELINES:

Capecitabine (Xeloda®) Tablets 09-J1000-42
Docetaxel (Taxotere®) IV 09-J0000-95

Doxorubicin HCl Liposome (Doxil®) IV 09-J0000-91

Gemcitabine (Gemzar®) IV 09-J0000-96

Paclitaxel and Nab-Paclitaxel IV 09-J1000-05

Vinorelbine tartrate (Navelbine®) IV 09-J1000-03

OTHER:

Table 3: Common Terminology Criteria for Adverse Events v4.0 (CTCAE)

Grade

Description

1

Mild; asymptomatic or mild symptoms; clinical diagnostic observations only; intervention not indicated

2

Moderate; minimal, local or noninvasive intervention indicated; limited age-appropriate instrumental activities of daily living

3

Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living

4

Life-threatening consequences; urgent intervention indicated

5

Death related to adverse event

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2015 [cited 2015 Jan 28]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017 Jan 28]. Available from: http://www.clinicalpharmacology.com/.
  3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2017 Jan 28]. Available from: http://clinicaltrials.gov/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017Jan 28]. Available from: http://www.thomsonhc.com/.
  5. Halaven (eribulin mesylate) [package insert]. Woodcliff Lake (NJ): September 2013
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017 Jan 28]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017 Jan 28]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 03/08/17.

GUIDELINE UPDATE INFORMATION:

12/15/12

New Medical Coverage Guideline.

04/01/13

Revision to guideline; consisting of adding quantity limit.

10/15/13

Review and revision to guideline; consisting of reformatting the position statement; updating references, coding, and program exceptions.

04/15/14

Review and revision to guideline; consisting of reformatting position statement and updating references.

04/15/15

Review and revision to guideline; consisting of program exceptions, references.

10/01/15

Revision to guideline; consisting of coding update.

11/01/15

Revision: ICD-9 Codes deleted.

01/15/16

Revision; ICD10 codes added.

03/15/16

Revision; consisting of position statement.

04/15/16

Review and revision; description , coding, dosage/administration, precautions/warning, position statement, references.

07/15/16

Revision to guideline; consisting of updating position statement.

10/01/16

Revision to guideline; consisting of ICD10 codes

04/15/17

Review and revision; description, coding, position statement, references.

Date Printed: June 23, 2017: 11:44 AM