BlueCross BlueShield of Tennessee Medical Policy Manual

Avelumab

NDC CODE(S)

44087-3535-XX Bavencio 200 MG/10ML SOLN (SERONO)

DESCRIPTION

Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody.  PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment.  By binding to receptors found on T cells and antigen presenting cells, PD-L1 suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine proliferation.  Avelumab binds to PD-L1 and its receptors and blocks its inhibitory effects on the immune response, including those on the anti-tumor immune responses.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*Compendia-based approval

**FDA-approved label-based approval

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications 10 mg/kg via intravenous infusion every 2 weeks

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 avelumab for the treatment or prevention of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2017, May). AHFS DI. Avelumab. Retrieved June 21, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, May). Avelumab. Retrieved June 21, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®.Trabectedin. Retrieved June 21, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Product Information. Bavencio® (avelumab). Retrieved June 21, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  4/28/2017

MOST RECENT REVIEW DATE:  9/12/2017

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

Avelumab (Bavencio®)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #6

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

If yes, go to question #5

If no, go to question #3

  1. Is the individual 12 years of age or older with a diagnosis of metastatic Merkel cell carcinoma (MCC)?

If yes, go to question #5

If no, go to question #4

  1. Is the individual 18 years of age or older with a diagnosis of urothelial carcinoma that is locally advanced or metastatic and ANY ONE of the following?

If yes, go to question #5

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

  1. Is the request for dosage of 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks for a period of 6 months?

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 continuer to meet initial approval criteria as in questions 2 through 5?

If yes, go to question #7

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

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

If yes, go to question #8

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

  1. Is the individual free from unacceptable infusion-related toxicities, e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis, renal dysfunction?

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.