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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum-based therapy. Patients with comorbidities (e.g., hearing loss, neuropathy, poor PS, renal insufficiency, etc.) may not be eligible for cisplatin. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.

RENEWAL CRITERIA

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

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

Refer to DOSAGE LIMITS below

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).

SOURCES

Lexi-Comp Online. (2019, February). AHFS DI. Avelumab. Retrieved April 25, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, April). Avelumab. Retrieved April 25, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drgs & Biologics Compendium®. Avelumab. Retrieved April 25, 2019 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2018, July). NCCN Clinical Practice Guidelines in Oncology®. Bladder Cancer, version 5.2018. Retrieved October 16, 2018 from National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, October). Center for Drug Evaluation and Research. Product Information. Bavencio® (avelumab). Retrieved April 25, 2019 from

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf.

ORIGINAL EFFECTIVE DATE: 4/28/2017

MOST RECENT REVIEW DATE:  6/11/2019

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.

This document has been classified as public information.

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg

DIAGNOSIS

 MAXIMUM UNITS

All indications

120 billable units every 14 days