Centene Avelumab Coverage Prior Auth Update

Coverage Criteria for Avelumab (Bavencio)

Initial Therapy — Merkel Cell Carcinoma

Covered when ALL of the following are met

MCC initial criteria: 1) Diagnosis of metastatic or recurrent Merkel cell carcinoma; 2) Age >= 12 years; 3) Prescribed by or in consultation with an oncologist; 4) Request meets one of the following: a) dose does not exceed 800 mg every two weeks; OR b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).dose <= 800 mg q2w

Dose limit repeated in policy

Initial Therapy — Urothelial Carcinoma

Covered when ALL of the following are met

UC initial criteria: 1) Diagnosis of recurrent, locally advanced, or metastatic urothelial carcinoma; 2) Prescribed by or in consultation with an oncologist; 3) Age >= 18 years; 4) Prescribed as a single agent (maintenance indication noted separately); 5) Member has received prior platinum‑based chemotherapy (cisplatin or carboplatin) when used for treatment (not maintenance); 6) Request meets one of the following: a) dose does not exceed 800 mg every two weeks; OR b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 7) Prescribed regimen must be FDA‑approved or recommended by NCCN.prior platinum chemotherapy for treatment indication (except maintenance), dose <=800 mg q2w

Maintenance indication also listed in FDA approvals section

Initial Therapy — Renal Cell Carcinoma (first-line with axitinib)

Covered when ALL of the following are met

RCC initial criteria: 1) Diagnosis of advanced (stage IV) renal cell carcinoma with clear cell histology; 2) Age >= 18 years; 3) Prescribed by or in consultation with an oncologist; 4) Prescribed as first‑line therapy in combination with axitinib (Inlyta) OR use is supported by practice guidelines or peer‑reviewed literature for the relevant use (prescriber must submit supporting evidence); 5) Dose does not exceed 800 mg every two weeks; 6) Prescribed regimen must be FDA‑approved or recommended by NCCN.combined use with axitinib for first-line, dose<=800 mg q2w

Prior authorization may be required for axitinib (Inlyta)

Initial Therapy — NCCN-Recommended Off-Label Indications

Covered when ALL of the following are met (per individual off-label indication rules)

Off-label NCCN uses: 1) Diagnosis is one of the listed NCCN‑recommended tumor types (examples include: gestational trophoblastic neoplasia; endometrial carcinoma that is MSI‑H/dMMR and recurrent/metastatic; thymic carcinoma; salivary gland tumors including recurrent adenoid cystic carcinoma; extranodal NK/T‑cell lymphomas); 2) Age >= 18 years; 3) Prescribed by or in consultation with an oncologist; 4) Indication‑specific prior therapy requirements are met (e.g., for gestational trophoblastic neoplasia: prescribed as a single agent following failure of >= 2 systemic chemotherapeutic agents OR recurrent/progressive intermediate trophoblastic tumor after platinum‑based regimen, or high‑risk disease as specified in Appendix B); 5) Request meets one of the following: a) dose does not exceed 800 mg every two weeks; OR b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 6) Prescribed regimen must be FDA‑approved or recommended by NCCN.age>=18 for listed off-label uses, dose<=800 mg q2w unless supported

Specifics vary by tumor type; prescriber must supply supporting evidence for off‑label use

Continuation Therapy

Covered when ALL of the following are met

Continued therapy criteria: 1) Member is currently receiving Bavencio via the Centene benefit or documentation supports current receipt for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) New dose does not exceed 800 mg every two weeks; 4) If request is for a dose increase, the new dose must be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 5) Prescribed regimen must be FDA‑approved or recommended by NCCN.>=30 days on therapy prior to continuation request

Approval durations differ by line of business (Medicaid/HIM 12 months; Commercial 6 months or to member renewal)

Indication and criteria updates

Coverage is aligned with FDA labeling and NCCN recommendations; several indication-specific requirements were added in annual reviews.

indication_updates: Policy incorporates multiple indication‑specific coverage rules added or updated across annual reviews (examples: recurrent urothelial carcinoma and requirement for prior platinum exposure; gestational trophoblastic neoplasia with requirements for high‑risk disease or post‑platinum refractory/recurrent disease; requirement for clear cell histology in RCC; additions for salivary gland tumors, thymic carcinoma, and extranodal NK/T‑cell lymphomas).

See policy annual review notes for precise effective dates and P&T approval information.

Requests for indications that are not FDA‑approved and not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety per the applicable off‑label use policies or evidence of coverage documents.

Non‑FDA approved uses will only be considered when the request includes supporting documentation that meets the referenced off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or when authorization is consistent with the member’s evidence of coverage.

Use of avelumab for non‑FDA indications that are not listed in this policy and that lack adequate supporting evidence per the referenced off‑label policies or evidence of coverage is considered not authorized (not medically necessary).

Dosing, Regimens, and Supported Combinations

Regimen	Indication	Notes
Avelumab (Bavencio) in combination with axitinib (Inlyta)
First-line therapy for advanced (stage IV) renal cell carcinoma with clear cell histology
Prior authorization may be required for axitinib (Inlyta); regimen must be FDA‑approved or NCCN‑recommended

Regimen	Indication	Notes
Avelumab (Bavencio) as a single agent
Recurrent, locally advanced, or metastatic urothelial carcinoma; also FDA‑approved as maintenance therapy after non‑progression on first‑line platinum‑containing chemotherapy
Member must have received prior platinum‑based chemotherapy for the treatment indication (except maintenance); dose limit applies (800 mg every 2 weeks)

Dose and Schedule	Indications	Notes
800 mg IV infusion every 2 weeks until disease progression or unacceptable toxicity
Merkel cell carcinoma (MCC) and urothelial carcinoma (UC)
Maximum dose referenced in policy: 800 mg (4 vials) every 2 weeks

Dose and Schedule	Combination	Indication / Notes
800 mg IV every 2 weeks
Axitinib 5 mg PO twice daily (Inlyta)
Used in combination as first‑line therapy for advanced RCC (clear cell histology); prior authorization may be required for axitinib; maximum avelumab dose = 800 mg every 2 weeks

Prior Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior authorization required — include diagnosis, prescriber specialty, age, and prior therapy

Prior authorization is required. Requests must document the member's diagnosis, that the drug was prescribed by or in consultation with an oncologist, the member's age meeting the indication-specific minimum (e.g., ≥12 years for Merkel cell carcinoma; ≥18 years for most other indications), any required prior therapies (for example prior platinum‑based chemotherapy for urothelial carcinoma), and that the requested dose does not exceed 800 mg every two weeks unless supporting guideline or peer‑reviewed literature is provided.

Diagnosis of the covered tumor type must be documented.
Prescriber specialty documented (oncologist or consultation).
Age documented per indication (MCC ≥12 yrs; most others ≥18 yrs).
Prior therapy documented when required (e.g., platinum for UC).
Dose documented and ≤800 mg q2w unless supported by evidence.

Billing Codes and Coding Guidance

HCPCS Codes referencedHCPCS

J9023

HCPCS code referenced in this clinical policy

Indication-Specific Line of Therapy

first-line

first-line: Avelumab in combination with axitinib (Inlyta) as first‑line therapy for advanced renal cell carcinoma (clear cell histology).

second-line

second-line: Use in urothelial carcinoma for patients with disease progression during or following platinum‑containing chemotherapy; maintenance use after non‑progression on first‑line platinum‑containing chemotherapy is also FDA‑approved (see maintenance criteria).

first-line | second-line | salvage

line_of_therapy_notes: Annual reviews added and clarified line‑of‑therapy requirements for specific indications; consult the full policy for precise first‑line, second‑line, and salvage distinctions per indication (examples include recurrent disease additions for UC, prior platinum requirements, and RCC clear cell histology requirement).

Required Biomarkers and Definitions

MSI-H / dMMR — biomarker requirement key

BiomarkerMSI-H (microsatellite instability-high) or dMMR (deficient mismatch repair) required for recurrent/metastatic endometrial carcinoma

Testing requirementDisease must be MSI-H or dMMR as documented in pathology/genomic testing report

Therapeutic contextRequired when prescribing avelumab as single-agent second-line or subsequent therapy for endometrial carcinoma with MSI-H/dMMR

dMMR / MSI-H — biomarker requirement key (duplicate/alternate listing)

BiomarkerdMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high) required for recurrent/metastatic endometrial carcinoma

Role in criteriaMember disease must be documented as recurrent or metastatic and MSI-H/dMMR to meet this indication-specific requirement

Acronyms and Key Terms

dMMR definition

AbbreviationdMMR = deficient mismatch repair

ContextUsed in policy to identify tumors (e.g., endometrial carcinoma) eligible for avelumab when recurrent/metastatic and dMMR/MSI-H

Source appendixDefined in Appendix A: Abbreviation/Acronym Key

MSI-H definition

AbbreviationMSI-H = microsatellite instability-high

Clinical relevanceMSI-H status used with dMMR to identify endometrial carcinoma patients eligible for avelumab in recurrent/metastatic disease

Source appendix

Background on Avelumab (Bavencio)

Avelumab (Bavencio) is a programmed death‑ligand 1 (PD‑L1) blocking monoclonal antibody. It is FDA‑approved for metastatic or recurrent Merkel cell carcinoma (MCC) in patients aged ≥12 years, for treatment and maintenance indications in urothelial carcinoma (UC), and as first‑line therapy in combination with axitinib for advanced clear‑cell renal cell carcinoma (RCC). The standard dosing referenced in this policy for MCC and UC is 800 mg IV every 2 weeks, and the RCC regimen is avelumab 800 mg IV every 2 weeks in combination with axitinib per product labeling and NCCN recommendations.

OpenPayer

Clinical Policy: Avelumab (Bavencio)

Coverage Criteria for Avelumab (Bavencio)

Dosing, Regimens, and Supported Combinations

Prior Authorization, Documentation, and Billing Requirements

Billing Codes and Coding Guidance

Indication-Specific Line of Therapy

Required Biomarkers and Definitions

Acronyms and Key Terms

Background on Avelumab (Bavencio)