CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Um Onc_1306 Bavencio Avelumab_05312024

Defines accepted indications, continuation and exclusion criteria, and approval authority for Bavencio (avelumab) for members (including pediatric ≥12) per FDA labeling and recognized compendia/guidelines. Includes specific guidance for Merkel cell carcinoma, renal cell carcinoma, and urothelial carcinoma, plus investigational/exclusion rules and dosing limit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1306 Bavencio Avelumab_05312024

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 31, 2024

Next Review Date

Key ActionUsage 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.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3Primary covered tumor types (MCC, RCC note, Urothelial)

800Single dose maximum (mg)

12Minimum age for MCC (years)

Coverage Summary

Scope: This policy defines accepted indications, continuation rules, and exclusion criteria for Bavencio (avelumab) for members (including pediatric patients age >= 12 years) and requires support by FDA labeling or recognized compendia/guidelines. Evolent (UM) processes medication requests and enforces evidence-based criteria for authorization.

Coverage stance: Bavencio (avelumab) is covered with criteria. FDA-approved and compendia-supported off-label uses are accepted when documentation meets policy requirements. The policy explicitly covers Merkel cell carcinoma (MCC) for adults and pediatric members >= 12 years, maintenance therapy in urothelial carcinoma following first-line platinum chemotherapy (after 4-6 cycles with response or stable disease), and includes a policy note on renal cell carcinoma (RCC) that Bavencio + Inlyta (axitinib) is not supported

Initial Therapy Criteria

Merkel Cell Carcinoma (MCC) - Covered Indication

Covered when ALL of the following are met:

ALL of the following

Member is an adult or pediatric member 12 years and older>= 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

Urothelial Carcinoma - Covered Indications

Covered when ANY of the following scenarios apply:

ANY of the following

Bavencio (avelumab) may be 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 the upper genitourinary tract/urethra
Maintenance therapy following first-line platinum
- Member has locally advanced or metastatic urothelial carcinoma including upper genitourinary tract/urethra
- Member experienced complete response, partial response, or stable disease after 4-6 cycles of first-line platinum-containing chemotherapy (cisplatin or carboplatin)4-6 cycles
- Bavencio (avelumab) is being used as a single agent for maintenance therapy following the above first-line platinum-containing chemotherapy

Continuation Therapy Criteria

Continuation request exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The 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

Exclusion Criteria (Not Medically Necessary / Not Covered)

Exclusion Criteria (Not Medically Necessary / Not Covered)

Bavencio is not approved when ANY of the following apply:

ANY of the following

Use after disease progression with the same regimen
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
Claims exceeding single dose limit are excluded
Investigational/off-label insufficient evidence
- Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
- Regimen not adequately represented in published evidence
- Reported study outcomes do not represent clinically meaningful outcomes per ASCO definitions (e.g., HR >= 0.80 or survival benefit < 3 months)HR >= 0.80; survival benefit < 3 months
- Inappropriate experimental design for question (e.g., unacceptable study methods)
- Case reports and meeting abstracts without full peer-reviewed articles generally insufficient

Renal Cell Carcinoma (RCC) - Policy Note

Policy position (NOT supported):

ALL of the following

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 showing superior outcomes in the subsequent line setting compared to Evolent recommended alternatives/regimens

Provider Actions & Authorization

Prior Authorization
Authorization required by Evolent
Evolent processes all medication requests. Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Documentation Required
Support with recognized evidence
Usage must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.
CMS-recognized compendia (e.g., Drugs and Biologics Compendium referenced in policy)
NCCN/ASCO clinical guidelines

Denial Risk
Denial if prior PD-1/PD-L1 progression
Requests for avelumab after disease progression on prior PD-1 or PD-L1 inhibitor therapy may be denied.

Billing Rule
Dose limit enforcement
Dosing that exceeds a single dose of Bavencio (avelumab) 800 mg is an exclusion and may be denied or rejected for reimbursement.
Single dose limit: <= 800 mg
Claims exceeding this single dose are excluded and may be denied/rejected

Clinical Evidence & References

Key evidence: The JAVELIN Bladder 100 trial (Powles et al., NEJM 2020) is cited as the pivotal trial supporting use of maintenance avelumab in advanced or metastatic urothelial carcinoma.

Additional supporting reference: Bavencio prescribing information (EMD Serono, Inc., 2024) is listed as the product labeling reference for dosing and approved indications.

Evidence standards: Off-label uses must be supported by CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements; insufficient evidence (per policy definitions) or investigational off-label uses may be excluded.

Continuation/real-world considerations: Continuation requests for ongoing therapy may be exempt if the medication was used within the last year, there is no disease progression or intolerance, and no additional drugs are being added to the regimen.

Evidence highlights

Key TrialJAVELIN Bladder 100 (Powles et al., NEJM 2020)

Prescribing informationBavencio prescribing information, EMD Serono, Inc., 2024

Background & Definitions

Background: This policy governs accepted indications for Bavencio (avelumab), including FDA-approved uses and off-label indications when supported by recognized compendia/guidelines or acceptable peer-reviewed literature. Evolent is responsible for processing medication requests and may deem medications not authorized as not approvable and not reimbursable.

Authorization and enforcement: The Utilization Management Department reviews requests and the Utilization Management Committee provides final approval; requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Chapter 15 standards.

Term	Definition
Sufficient evidence	Evidence supported by CMS-recognized compendia or acceptable peer-reviewed literature that adequately represents patient characteristics, regimens, outcomes (clinically meaningful), and study design.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1306 Bavencio Avelumab_05312024

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 31, 2024

Next Review Date

Key ActionUsage 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.

SourceLink

On This Page

Bavencio	avelumab (drug name referenced; policy governs its use)
Inlyta	axitinib (named as combination not supported for subsequent RCC)
Opdivo	nivolumab (example prior PD-1 inhibitor)
Keytruda	pembrolizumab (example prior PD-1 inhibitor)

OpenPayer

Um Onc_1306 Bavencio Avelumab_05312024

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Exclusion Criteria (Not Medically Necessary / Not Covered)

Provider Actions & Authorization

Applicable Codes & Referenced Drugs

Clinical Evidence & References

Background & Definitions

Revision History