44087-3535-XX Bavencio 200 MG/10ML SOLN (SERONO)
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.
Avelumab is considered medically necessary for the treatment of the following if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Bladder cancer with histology of urothelial carcinoma /Urothelial carcinoma
Merkel cell carcinoma (MCC)
Avelumab for the treatment of other conditions/diseases is considered investigational.
Avelumab is considered medically appropriate if ALL of the following:
Used as a single agent
InIndividual has not received previous therapy with a programmed death ligand (PD-1/PD-L1) -directed therapy (e.g., nivolumab, pembrolizumab, atezolizumab, durvalumab) unless otherwise specified
Diagnosis of ANY ONE of the following:
Bladder cancer with histology of urothelial carcinoma/Urothelial Carcinoma if ALL of the following:
Individual is 18 years of age or older
As subsequent therapy after previous platinum treatment
Further diagnosis of ANY ONE of the following:
Locally advanced or metastatic Urothelial Carcinoma
Primary carcinoma of the urethra
Metastatic Upper Genitourinary Tract Tumors
Metastatic Urothelial Carcinoma of the Prostate
Recurrent or metastatic Primary Carcinoma of the Urethra, without recurrent stage T3-4 disease and without palpable inguinal lymph nodes
Merkel cell carcinoma (MCC) if ALL of the following:
Individual is 12 years of age or older
Disease is disseminated metastatic
*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.
Avelumab is considered medically appropriate for renewal if ALL of the following:
Individual continues to meet initial approval criteria
Tumor response is indicated by stabilization of disease or decrease in size of tumor or tumor spread
|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.
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. (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
ORIGINAL EFFECTIVE DATE: 4/28/2017
MOST RECENT REVIEW DATE: 6/11/2019
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg