CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Bavencio (avelumab)

Defines accepted indications, continuation and exclusion criteria, and approval authority for Bavencio (avelumab) for cancer treatment including FDA-approved and supported off-label uses; includes specific indications for Merkel cell carcinoma, renal cell carcinoma guidance, and urothelial carcinoma (including maintenance).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBavencio (avelumab)

Policy CodePolicy N/A

Change TypeRevised approval/committee dates

Effective DateMay 31, 2024

Next Review Date

Key ActionProviders must support Bavencio use with FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

SourceLink

POLICY UPDATE CHANGES

Approval date and committee review history updated through May 08, 2024 with effective date May 31, 2024.

3Covered Indications (MCC, RCC guidance, Urothelial carcinoma)

1Hard Exclusion: prior PD-1/PD-L1 progression

800Single dose maximum (mg)

Coverage Summary

Scope: Defines accepted indications, continuation and exclusion criteria, and approval authority for Bavencio (avelumab) for cancer treatment including FDA-approved and supported off-label uses; includes specific indications for Merkel cell carcinoma, renal cell carcinoma guidance, and urothelial carcinoma (including maintenance). Coverage stance: covered_with_criteria — use of Bavencio must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements. Continuation requests are exempt when the requested medication was used within the last year, the member has not experienced disease progression or intolerance, and no additional medications are being added. Exclusion criteria and single-dose maximums are enforced by Evolent Utilization Management and final approval resides with the Utilization Management Committee.

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Key thresholds & quick facts

Age for MCC indication>= 12 years

Single dose maximum800 mg

Response requirement for maintenance urothelial indicationComplete or partial response, or stable disease after 4-6 cycles of first-line platinum (cisplatin/carboplatin) chemotherapy

General Coverage Requirements / Purpose

Covered when ALL of the following are met:

ALL of the following

Indication: Renal Cell Carcinoma (RCC)
- Member has a diagnosis of advanced or metastatic renal cell carcinoma (RCC).
- Therapy is being requested for initial or subsequent systemic treatment of advanced/metastatic RCC, excluding adjuvant or localized disease settings.
- Bavencio (avelumab) is being considered in combination with axitinib (Inlyta) only when the use is consistent with Evolent/plan-approved first-line combination regimens; note: Bavencio + Inlyta is not supported by Evolent policy for subsequent-line treatment of advanced or metastatic RCC due to lack of Level 1 evidence demonstrating superior outcomes compared to recommended alternatives.
- Request is not for use after disease progression on the same regimen or after progression on a prior PD-1 or PD-L1 inhibitor (e.g., nivolumab, pembrolizumab).
  Per exclusion criteria: prior PD-1/PD-L1 progression is not eligible.
- Dosing requested does not exceed the single dose limit of 800 mg.
Continuation exemption
- The requested medication was used within the last year.
- The member has not experienced disease progression and/or has not experienced intolerance to the requested medication.
- No additional medication(s) are being added to the continuation request.

Initial Therapy Criteria — Merkel Cell Carcinoma (MCC)

Indication: Merkel Cell Carcinoma (MCC)

Covered when ALL of the following are met:

Member is adult or pediatric >= 12 years>= 12 years

Diagnosis: metastatic, recurrent, or inoperable Merkel Cell Carcinoma

Avelumab will be used as a single agent, with or without surgery and/or radiation therapy

Indication Guidance — Renal Cell Carcinoma (RCC)

Policy note: Bavencio (avelumab) + Inlyta (axitinib) is NOT supported by Evolent Policy for subsequent treatment of advanced or metastatic renal cell carcinoma. Rationale: lack of Level 1 evidence (randomized trials and/or meta-analyses) demonstrating superior outcomes with this combination in the subsequent-line setting compared to Evolent-recommended alternative agents/regimens.

Indication — Urothelial Carcinoma (including upper genitourinary tract & urethra)

Indication: Urothelial Carcinoma (including upper genitourinary tract & urethra)

Covered when ANY of the following scenarios are met:

ANY of the following

Avelumab used as a single agent as second-line/subsequent therapy following prior platinum-based chemotherapy in a member with locally advanced or metastatic urothelial carcinoma (including upper genitourinary tract/urethra)
Avelumab used as a single-agent maintenance therapy when member has locally advanced or metastatic urothelial carcinoma and has experienced complete/partial response or stable disease after 4-6 cycles of first-line platinum (cisplatin or carboplatin)-containing chemotherapyComplete/partial response or stable disease after 4-6 cycles
Supported by JAVELIN Bladder 100 trial reference

Key clinical evidence: The JAVELIN Bladder 100 trial (Powles et al., NEJM 2020) supports avelumab maintenance therapy in advanced/metastatic urothelial carcinoma and is cited by this policy as foundational evidence for the maintenance urothelial indication.

Exclusion Criteria / Not Medically Necessary

Avelumab is NOT covered when ANY of the following exclusion criteria apply:

Use after disease progression with the same regimen or disease progression on prior PD-1 or PD-L1 inhibitor therapy (e.g., nivolumab, pembrolizumab)

Dosing exceeds single dose limit of Bavencio (avelumab) 800 mg>800 mg single dose

Claims with doses >800 mg single dose are excluded

Evidence insufficiency criteria (examples)

Clinical characteristics of patient and cancer not adequately represented in published evidence
Administered regimen not adequately represented in published evidence
Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions; e.g., HR >= 0.80 or survival benefit <3 months not clinically meaningful)
Experimental design inappropriate to address investigative question
Case reports or meeting abstracts without full peer-reviewed articles are insufficient

Exclusions and claims limits: Claims with single doses > 800 mg are excluded. The policy also excludes use of Bavencio after disease progression on prior PD-1 or PD-L1 inhibitor therapy (for example, nivolumab or pembrolizumab).

Provider Actions & Prior Authorization

Prior Authorization

Utilization management review required

Evolent's Utilization Management (UM) department processes all medication requests for Bavencio (avelumab). Medications that are not authorized by Evolent UM may be deemed not approvable and not reimbursable; prior authorization/UM review is required for coverage determination.

Documentation Required

Support therapy with accepted sources

Use of Bavencio must be supported by one of the following: FDA-approved product labeling, CMS-approved compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Continuation exemption requirements

Continuation requests are exempt from policy review only when ALL three conditions below are met; failure to meet these conditions may result in denial.

Requested medication was used within the last year
Member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Denial Risk

Dose limit enforcement

Claims will be excluded if dosing exceeds a single dose limit of Bavencio (avelumab) 800 mg.

Denial Risk

Prior PD-1/PD-L1 progression exclusion

Requests for Bavencio after disease progression on prior PD-1 or PD-L1 inhibitor therapy are excluded from coverage and may be denied.

Applicable Codes

No specific CPT/HCPCS/ICD-10 codes listedmixed

No codes listed

Clinical Evidence

Evidence summary: The policy references JAVELIN Bladder 100 (Powles et al., NEJM 2020) and the Bavencio prescribing information (EMD Serono, 2024). These references are used to support the avelumab maintenance indication in urothelial carcinoma and to document FDA-approved uses and off-label uses supported by compendia and guidelines.

Background

Background: This policy outlines accepted indications for avelumab including FDA-approved and supported off-label uses based on compendia, guidelines, and the literature. Evolent processes medication requests via the Utilization Management department and enforces continuation and exclusion criteria; trial evidence (e.g., JAVELIN Bladder 100) and prescribing information are referenced to support covered indications and management.

Definitions

Definitions: Continuation request exemption: Requests for ongoing therapy are exempt from policy review if medication used within last year, no disease progression/intolerance, and no additional medications are added to the request.

Revision History

2024-05-08approval

Approval date and committee review history updated through May 08, 2024 with effective date May 31, 2024.

2024-05-31effectiveLatest

Approval date and committee review history updated through May 08, 2024 with effective date May 31, 2024.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBavencio (avelumab)

Policy CodePolicy N/A

Change TypeRevised approval/committee dates

Effective DateMay 31, 2024

Next Review Date

Key ActionProviders must support Bavencio use with FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

SourceLink

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