BlueCross BlueShield of Tennessee Medical Policy Manual
Avelumab (Bavencio®)
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PROCEDURE CODE(S) |
HCPCS |
J9023 |
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.
Maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
Treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
First-line treatment of patients with advanced renal cell carcinoma in combination with axitinib.
All other indications are considered experimental/investigational and not medically necessary.
Submission of the following information is necessary to initiate the prior authorization review:
Documentation of laboratory report confirming microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumor status, where applicable.
Coverage will not be provided for members who have experienced disease progression while on PD-1 or
PD-L1 inhibitor therapy.
Authorization of 6 months may be granted as a single agent for the treatment of Merkel cell carcinoma in members with locally advanced, recurrent, or metastatic disease.
Authorization of 6 months may be granted for treatment of bladder cancer as a single agent when either of the following criteria is met:
Authorization of 6 months may be granted for treatment of primary carcinoma of the urethra as a single agent when either of the following criteria is met:
Authorization of 6 months may be granted for the treatment of upper genitourinary (GU) tract tumors or urothelial carcinoma of the prostate as a single agent when either of the following criteria is met:
Authorization of 6 months may be granted for treatment of advanced, relapsed, or stage IV renal cell carcinoma with clear cell histology when given in combination with axitinib as first-line treatment for the disease.
Authorization of 6 months may be granted as a single agent for treatment of gestational trophoblastic neoplasia for multiagent chemotherapy-resistant disease when either of the following criteria is met:
1. Member has recurrent or progressive intermediate trophoblastic tumor (placental site trophoblastic tumor or epithelioid trophoblastic tumor).
2. Member has high-risk disease.
Authorization of 6 months may be granted as a single agent for subsequent treatment of recurrent or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
MEDICATION QUANITY LIMITS
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Drug Name |
Diagnosis |
Maximum Dosing Regimen |
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Avelumab (Bavencio) |
Endometrial Carcinoma |
Route of Administration: Intravenous 800mg every 2 weeks
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|
Avelumab (Bavencio) |
Gestational Trophoblastic Neoplasia |
Route of Administration: Intravenous 800mg every 2 weeks
|
|
Avelumab (Bavencio) |
Merkel Cell Carcinoma (MCC) |
Route of Administration: Intravenous 800mg every 2 weeks
|
|
Avelumab (Bavencio) |
Renal Cell Carcinoma (RCC) |
Route of Administration: Intravenous 800mg every 2 weeks
|
|
Avelumab (Bavencio) |
Urothelial Carcinoma |
Route of Administration: Intravenous 800mg 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.
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).
REFERENCES
ORIGINAL EFFECTIVE DATE: 4/28/2017
MOST RECENT REVIEW DATE: 3/4/2025
ID_CHS
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