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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-J2000-57

Original Effective Date: 03/15/16

Reviewed: 02/10/16

Revised: 01/01/17

Next Review: 08/09/17

Subject: Necitumumab (PortrazzaTM)

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:

Necitumumab (Portrazza), a recombinant human IgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR), was approved by the U.S. Food and Drug Administration (FDA) in November 2015 treatment of patients with ALK-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The efficacy and safety of necitumumab at the recommended dose were demonstrated in an open-label, global, multi-center, 2-arm, randomized trial in 1093 patients with squamous NSCLC (Trial JFCC [SQUIRE]). A 1.6-month improvement in median overall survival (OS) among patients in the gemcitabine/ cisplatin + necitumumab arm compared with those in the gemcitabine/cisplatin arm (HR = 0.842 [0.736, 0.962]; p=0.012) was demonstrated. Necitumumab was associated with a higher rate adverse events that were grade 3 or higher (72% vs 62%) and serious adverse events (48% versus 38%). Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with necitumumab.

National Comprehensive Cancer Network (NCCN) Guidelines for Non-Small Cell Lung Cancer (Version 4.2016) recommend (category 3) necitumumab for use in combination with cisplatin and gemcitabine for patients with a performance status of 0-2 as first line therapy, subsequent therapy in EGFR-positive tumors after failure of erlotinib, afatinib, or gefitinib, and subsequent therapy for ALK-positive tumors subsequent therapy after crizotinib for ALK-positive recurrent or metastatic disease.

POSITION STATEMENT:

Necitumumab (Portrazza) is associated with a clinically irrelevant benefit and an increased risk of serious adverse events. Use does not meet the definition of medical necessity for any indication, including non-small cell lung cancer (NCCN category 3).

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

Contraindications

Precautions/Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J9295

Injection, necitumumab, 1 mg

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: No National Coverage Determination (NCD) was found at the time of the last guideline review date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Label and Off-label Coverage of Outpatient Drugs and Biologicals, (L33915) located at fcso.com.

DEFINITIONS:

NCCN Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2015 [cited 2016-01-27]. Available from: http://www.clinicalpharmacology.com/.
  2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016-01-27]. Available from: http://clinicaltrials.gov/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016-01-27]. Available from: http://www.thomsonhc.com/.
  4. Eli Lilly. Necitumumab (Portrazza) solution. 2015 [cited 2016-01-27]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7/.
  5. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Non-small cell lung cancer, v. 4.2016 [cited 2016-01-27]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2015 [cited 2016-01-27]. 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; 2015 [cited 2016-01-27]. 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 02/10/16.

GUIDELINE UPDATE INFORMATION:

03/15/16

New Medical Coverage Guideline.

04/01/16

Revision to guideline consisting of adding code C9475.

05/15/16

Revision to program exceptions to add LCD L33915.

01/01/17

Revision: added HCPCS code J9295.

Date Printed: August 23, 2017: 01:19 PM