Print

Date Printed: June 25, 2017: 01:28 PM

Private Property of Blue Cross and Blue Shield of Florida.
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-J0000-86

Original Effective Date: 02/15/09

Reviewed: 03/08/17

Revised: 04/15/17

Subject: Trastuzumab (Herceptin®) 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

 

Previous Version

           

DESCRIPTION:

Trastuzumab (Herceptin) is a monoclonal antibody that antagonizes human epidermal growth factor 2 protein (HER2). Trastuzumab was initially granted US Food and Drug Administration (FDA) approval for the treatment of metastatic breast cancer in September 1998. In 2006, the FDA expanded the approval to include adjuvant treatment of early breast cancer and 2010 first-line treatment of HER2 positive metastatic gastric or gastroesophageal cancer in combination with cisplatin and fluorouracil or capecitabine.

HER2 overexpression is seen in 25-30% of breast cancers and 7-34% of gastric cancers; overexpression has been associated with aggressive disease and decreased overall survival. Current National Comprehensive Cancer Network (NCCN) Breast Cancer (Version 2.2016) guidelines support the use of trastuzumab for the treatment of invasive breast cancer in the following settings: as neo-adjuvant therapy, as adjuvant therapy, and metastatic disease therapy. Trastuzumab is commonly used in combination with other chemotherapies, including cytotoxic chemotherapy (e.g., docetaxel) and targeted chemotherapy (e.g., pertuzumab). NCCN Gastric Cancer guidelines support the use of trastuzumab as a first- or second-line therapy option in combination with cisplatin and capecitabine or cisplatin and fluorouracil.

POSITION STATEMENT:

Initiation of trastuzumab (Herceptin) meets the definition of medical necessity for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Breast Cancer

a. Member has HER2-positive disease as documented by ONE of the following – laboratory documentation must be provided:

i. Immunohistochemistry (IHC) is 3+

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

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

b. Trastuzumab therapy will be used for ANY of the following:

i. Neoadjuvant therapy

ii. Adjuvant therapy

iii. Metastatic disease therapy

c. Member is 18 years of age

d. Dose does not exceed:

i. Initial dose: 8 mg/kg x 1 dose

ii. Maintenance dose: 2 mg/kg weekly OR 6 mg/kg every 3 weeks

2. Gastric, Esophageal, or Esophagogastric Junction Adenocarinoma

a. Member has HER2-positive disease as documented by ONE of the following – laboratory documentation must be provided:

i. Immunohistochemistry (IHC) is 3+

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

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

b. Trastuzumab will be used in combination with EITHER of the following:

i. Cisplatin and capecitabine

ii. Cisplatin and fluorouracil

c. Member is 18 years of age

d. Dose does not exceed:

i. Initial dose: 8 mg/kg x 1 dose

ii. Maintenance dose: 6 mg/kg every 3 weeks

Approval duration: 6 months

Continuation of trastuzumab (Herceptin) 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, gastric, esophageal, or esophagogastric adenocarcinoma, or for a designated orphan indication, OR the member has previously met all indication-specific initiation criteria

2. Member meets one of the following:

a. If indication for use is adjuvant treatment of breast cancer, member has received fewer than 52 weeks of trastuzumab therapy

b. Member’s disease has not progressed during treatment with trastuzumab (excluding adjuvant treatment of breast cancer)

3. Dose does not exceed 2 mg/kg weekly OR 6 mg/kg every 3 weeks

Approval duration: 6 months

Trastuzumab meets the definition of medical necessity when used for the following designated Orphan Drug indication (http://www.fda.gov/orphan/designat/list.htm) when the dose does not exceed the maximum FDA-approved dose:

1. Treatment of members with pancreatic cancer that overexpress p185HER2 (i.e., HER-2 positive disease)

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: trastuzumab is indicated for the treatment of HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. Trastuzumab should be administered as an intravenous (IV) infusion and should not be administered as an IV push or bolus. The recommended dosage is outlined in Table 1.

Table 1

FDA recommended dosage

Indication

Dose

Adjuvant HER2-postive breast cancer

EITHER of the following

1. Initial dose of 4 mg/kg IV over 90 minutes, followed by 2 mg/kg IV over 30 minutes every week

2. Initial dose of 8 mg/kg IV over 90 minutes, followed by subsequent doses of 6 mg/kg IV over 30 minutes every 3 weeks

Metastatic HER2-positive breast cancer

Initial dose of 4 mg/kg IV over 90 minutes, followed by 2 mg/kg IV over 30 minutes every week

Metastatic HER2-positive Gastric cancer

Initial dose of 8 mg/kg IV over 90 minutes, followed by 6 mg/kg IV over 30-90 minutes every 3 weeks.

Drug Availability: trastuzumab is supplied as a multidose vial containing 440 mg of trastuzumab.

PRECAUTIONS:

BOXED WARNING

• Cardiomyopathy: trastuzumab therapy can result in sub-clinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab for cardiomyopathy.

• Infusion reactions, Pulmonary toxicity: Discontinue trastuzumab for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

• Embryo-Fetal Toxicity: Exposure to trastuzumab during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death.

WARNINGS/PRECAUTIONS

Chemotherapy-induced neutropenia: trastuzumab therapy may result in Grade 3-4 neutropenia. Monitor complete blood count.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J9355

Trastuzumab, 10 mg

ICD-10 Diagnoses Codes That Support Medical Necessity

C15.3 – C16.9

Malignant neoplasm of esophagus and stomach

C50.011 – C50.929

Malignant neoplasm of female and male breast

C79.32

Secondary malignant neoplasm of cerebral meninges

D37.1

Neoplasm of uncertain behavior of stomach

D37.8

Neoplasm of uncertain behavior of other specified digestive organs

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

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) was found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Trastuzumab (Herceptin), (L34026) located at fcso.com.

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.

Metastatic cancer: when cancer spreads from the primary site (place where it started) to other places in the body.

Neo-adjuvant treatment: Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy

RELATED GUIDELINES:

Carboplatin (Paraplatin®) IV, 09-J0000-93
Docetaxel (Taxotere®) IV, 09-J0000-95

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

Gemcitabine (Gemzar®), 09-J0000-96

Irinotecan HCl Camptosar®) IV, 09-J0000-99

Oxaliplatin (Eloxatin®) IV, 09-J1000-00

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

Pertuzumab (Perjeta™) IV, 09-J1000-75

OTHER:

None applicable.

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 2017 Jan 28]. Available from: http://www.thomsonhc.com/.
  5. Genetech, Inc Herceptin (trastuzumab) [package insert]
  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:

02/15/09

New Medical Coverage Guideline.

04/15/09

Revision; consisting of adding maximum dose and ICD-9 coding.

05/15/09

Revision; consisting of updating ICD-9 coding.

07/15/09

Revision; consisting of updating ICD-9 coding.

10/15/09

Revision; consisting of clarifying dosage, and adding new compendia supported indication and coding update.

04/15/10

Revision; consisting of updating coding.

08/01/10

Revision; consisting of updating coding.

01/15/11

Review and revision; consisting of updating coding, related guidelines and references.

01/15/12

Review and revision to guideline; consisting of updating description, dosage, precautions and reference sections.

04/15/12

Revision to guideline; consisting of adding requirement of HER2 testing for gastric and esophageal cancers.

11/15/12

Review and revision to guideline; consisting of reformatting position statement and modifying coverage criteria, updating precautions, exceptions and references.

04/15/13

Review and revision to guideline; consisting of updating position statement with orphan indications and reformatting. Update references.

04/15/14

Review and revision to guideline; consisting of revising position statement, dosage/administration, precautions/warnings, references, and description section; added definitions; updated program exceptions section.

10/15/14

Revision to guideline; consisting of revising position statement and updating references.

04/15/15

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

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

12/15/15

Revision consisting of updating dosing.

04/15/16

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

04/15/17

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

Date Printed: June 25, 2017: 01:28 PM