BlueCross BlueShield of Tennessee Medical Policy Manual

Atezolizumab

NDC CODE(S)

50242-0917-XX Tecentriq 1200 MG/20ML SOLN (GENENTECH)

DESCRIPTION

Atezolizumab is a monoclonal antibody that binds to programmed death-ligand 1 (PD-L1), a transmembrane protein which may be expressed on tumor cells and/or tumor-infiltrating immune cells and are often increased.  By binding to the receptors on PD-L1, atezolizumab prevents its binding to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells.  This releases the PD-L1/PD-1 mediated inhibition of the immune response and activates the body’s own anti-tumor immune response, leading to decreased tumor growth.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications

1200 mg IV every 21 days

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 atezolizumab for the treatment of conditions or diseases.

SOURCES

Lexicomp Online. (2017, March). AHFS DI. Atezolizumab. Retrieved May 1, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, March). Atezolizumab. May 1, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Atezolizumab. Retrieved May 1, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, April). Center for Drug Evaluation and Research. Tecentriq® (atezolizumab) injection, for intravenous use.  Retrieved May 1, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/7/2016

MOST RECENT REVIEW DATE:  8/11/2017

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

Atezolizumab (Tecentriq ®)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #7

  1. Is the individual 18 years of age or older with a request for use as a single agent?

If yes, go to question #3

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

  1. Does the individual have a diagnosis of locally advanced/metastatic urothelial carcinoma with ANY ONE of the following?

If yes, go to question #6

If no, go to question #4

  1. Does the individual have a diagnosis of bladder cancer with histology of urothelial carcinoma for subsequent with a diagnosis of ANY ONE of the following?

If yes, go to question #6

If no, go to question #5

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

If yes, go to question #6

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

  1. Is the request for 120 billable units (10 mg = 1 billable units) or 1200 mg/20 mL (1 vial) every 21 days for six months with possible 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 initial approval criteria in questions 2 through 6?

If yes, go to question #8

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

  1. Is tumor response indicated with stabilization of disease or decrease in size of tumor or tumor spread?

If yes, go to question #9

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

  1. Is there absence of unacceptable toxicity from the drug (e.g., fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, constipation, 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.