Coverage Policies

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Effective Date: 09/01/2017 Title: Bavencio (Avelumab)
Revision Date: 12/01/2020 Document: BI555:00
CPT Code(s): J9023
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Bavencio (avelumab) requires prior authorization.

2)    Bavencio is used to treat Merkel Cell Carcinoma (MCC), advanced bladder cancer,advanced renal cell carcinoma, and gestational trophoblastic neoplasia.

Medical Statement

Bavencio (avelumab) is considered medically necessary for members meeting the following criteria:

Merkel Cell Carcinoma

1)    Diagnosis of metastatic, Stage IV Merkel Cell Carcinoma (MCC) AND

2)    Refractory to chemotherapy.

Bladder Cancer

1)    Diagnosis of local advanced or metastatic urothelial carcinoma AND

2)    Disease progression during or following platinum-containing chemotherapy OR

3)    Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Renal Cell Carcinoma

1)    Diagnosis of advanced RCC (e.g. relapse or stage IV disease) AND

2)    Age > 18 years AND

3)    Prescribed as first-line therapy with Inlyta


Gestational Trophoblastic Neoplasia

1)    Diagnosis of gestational trophoblastic neoplasia; AND

2)    Patient is 18 years of age or older; AND

3)    Prescribed as first-line therapy in combination with Inlyta

Codes Used In This BI:

J9023    Injection, avelumab, 10 mg


1)    Bavencio Prescribing Information. EMD Seronoa, Inc. Rockland, MA.  June 2020

2)    Clinical Pharmacology.  Accessed October 2020

3)    NCCN Drugs & Biological Compendium. Accessed October 2021.




1)    Effective 10/01/2017: Added new HCPCS code (C9491) to policy.

2)    Effective 1/1/2018: 2018 Code Updates. Updated Codes Used in This BI section to reflect new/deleted CPT/HCPCS codes. The following code was deleted 1/1/18: C9491. This code was replaced with the following new code effective 1/1/18: J9023.

3)    Effective 12/01/2020: Updated to include coverage criteria for Renal Cell Carcinoma.

4)    Effective 12/01/2021: Added coverage criteria for gestational trophoblastic neoplasia.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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