BlueCross BlueShield of Tennessee Medical Policy Manual

Necitumumab

NDC CODE(S)

00002-7716-01 - Portrazza 800 mg/50 mL (Eli Lilly)

DESCRIPTION

Necitumumab is a recombinant monoclonal antibody which binds to the human epidermal growth factor receptor (EGFR) and blocks it binding to its ligands.  It is considered to be an epidermal growth factor receptor (EGFR) antagonist, causing the eventual destruction of cells upon whose growth and proliferation depend on the activity of EGFR, such as those in the progression of lung cancer.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Squamous NSCLC

800 mg IV Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of necitumumab for the treatment of other diseases or conditions.

SOURCES

Lexi-Comp Online. (2016, October). AHFS DI. Necitumumab. Retrieved November 11, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, October). Necitumumab. Retrieved November 11, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Necitumumab. Retrieved November 11, 2016 from National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, November). Center for Drug Evaluation and Research. Portrazza (necitumumab) injection, for intravenous use. Retrieved November 11, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2015

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Necitumumab (Portrazza ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #4

  1. Does the individual have a diagnosis of non-small cell lung cancer (NSCLC) with ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 800 billable units day 1 and 8 every 21 days for dosage of 800 mg on days 1 and 8 of each 3 week cycle prior to gemcitabine and cisplatin infusion for an authorization period of 6 months with a possibility of renewal?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 and 3?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread with absence of unacceptable toxicity from the drug such as rash, hypomagnesemia, dermatologic toxicity, infusion reactions, venous and arterial thromboembolic events, etc.?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.