CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Bavencio (avelumab)

Defines accepted indications, continuation and exclusion criteria, and utilization management processes for coverage of avelumab (Bavencio) including FDA-approved and supported off-label uses for oncology indications (Merkel cell carcinoma, urothelial carcinoma, renal cell carcinoma notes).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Bavencio (avelumab)

Policy CodePolicy N/A

Change TypeClarified (committee review/approval dates listed)

Effective DateMay 31, 2024

Next Review Date

Key ActionSubmit medication requests to Evolent for prior authorization; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Policy lists committee review history through 05/08/24 and approval date in 08/2024 while indicating effective date 05/31/2024.

3Primary covered indications (MCC, urothelial carcinoma, continuation exemptions)

3Key exclusion criteria (prior PD-1/PD-L1 progression, >800 mg single dose, insufficient evidence/off-label investigational)

Coverage Summary & Indications

Coverage stance: mixed. Scope: Defines accepted indications, continuation and exclusion criteria, and utilization management processes for avelumab (Bavencio). Status: CURRENT. Effective date: 2024-05-31. Document notes committee review history through 05/08/24 and an approval date in 08/2024.

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 of 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 (including upper genitourinary tract and urethra) — Covered Indications

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

Continuation requests 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

Not Medically Necessary / Exclusions

Renal Cell Carcinoma (RCC) — Policy Note

Policy statement / limitation

ALL of the following

Bavencio (avelumab) + Inlyta (axitinib) is NOT supported by Evolent Policy for subsequent treatment of advanced or metastatic renal cell carcinoma (i.e., combination in subsequent-line setting is not supported)

Prior Authorization, Documentation & Billing

Prior Authorization

Prior authorization required via Evolent

Medication requests are processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Documentation of prior therapy response required for maintenance urothelial indication

For maintenance therapy after first-line platinum-containing chemotherapy, document that the member experienced a complete response, partial response, or stable disease after 4-6 cycles of platinum (cisplatin or carboplatin) chemotherapy.

Denial Risk

Use after progression on PD-1/PD-L1

Avelumab used after disease progression on prior PD-1 or PD-L1 inhibitor therapy is an exclusion and claims may be denied.

Billing Rule

Single-dose limit enforcement

Dosing that exceeds a single dose of avelumab 800 mg is excluded and may be denied; single dose must be ≤ 800 mg.

Background & Clinical Evidence

Policy defines accepted indications for Bavencio (avelumab) including FDA-approved indications and supported off-label indications. Use must be supported by one of: FDA approved product labeling, ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15. Evolent is responsible for processing all medication requests as the utilization management (UM) vendor.

Evidence cited in the policy includes:

- JAVELIN Bladder 100 trial (Powles et al., N Engl J Med 2020) supporting avelumab maintenance in urothelial carcinoma.

- Bavencio prescribing information / FDA product labeling (EMD Serono, Inc., 2024).

- Policy criteria referencing standards for sufficient peer-reviewed evidence and CMS compendia requirements (definitions of adequate study design, clinically meaningful outcomes per ASCO, and exclusions for case reports/abstract-only evidence).

Definitions & Thresholds

Key Thresholds and Continuation Exemption

Age for MCC>= 12 years

Maximum single dose<= 800 mg

Prior platinum chemotherapy cycles for maintenance4-6 cycles

Continuation request exemption (definition)Requests for continuation of a not-approvable medication are exempt if: the medication was used within the last year; the member has not experienced disease progression and/or no intolerance to the medication; and no additional medications are being added to the continuation request.