00002-7716-XX Portrazza 800 MG/50ML SOLN (LILLY)
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.
Necitumumab for the treatment of non-small cell lung cancer (NSCLC) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Necitumumab for the treatment of other conditions/diseases is considered investigational.
Necitumumab is considered medically appropriate if ALL of the following criteria are met:
Diagnosis of non-small cell lung cancer (NSCLC) if ALL of the following:
Individual is 18 years of age or older
Disease is metastatic
Histology is squamous cell
Treatment is first-line therapy
Used in combination with gemcitabine AND cisplatin
Individual must have performance status of 0 to 2
Necitumumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug such as rash, hypomagnesemia, dermatologic toxicity, infusion reactions, venous and arterial thromboembolic events, etc.
DOSAGE & ADMINISTRATION
800 mg IV Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Click here to view DOSAGE LIMITS
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.
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.
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).
Lexi-Comp Online. (2018). AHFS DI. Necitumumab. Retrieved January 3, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, November). Necitumumab. Retrieved January 3, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. No longer recommended: necitumumab. Retrieved January 3, 2019 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 January 3, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2015
MOST RECENT REVIEW DATE: 2/12/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit