CurrentViva Health PlanPolicy IC-0295

Bavencio (avelumab) (Intravenous) Coverage Criteria

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This policy governs prior authorization, dosing, initial approval, and renewal requirements for intravenous Bavencio (avelumab) for adult and specified pediatric members with eligible malignancies. Coverage requires indication-specific clinical criteria, and renewal requires ongoing benefit without unacceptable toxicity.

Policy Summary

PayerViva Health Plan

PolicyBavencio (avelumab) (Intravenous) Coverage Criteria

Policy CodePolicy IC-0295

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests and document that all applicable clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsAuthorization validity

800 mg/14 daysMaximum dose

10Covered indications

RequiredRenewal response

Not allowed

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CurrentViva Health PlanPolicy IC-0295

Bavencio (avelumab) (Intravenous) Coverage Criteria

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0295 alerts

Get alerted when Policy IC-0295 changes without checking for updates manually.

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Policy Summary

PayerViva Health Plan

PolicyBavencio (avelumab) (Intravenous) Coverage Criteria

Policy CodePolicy IC-0295

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests and document that all applicable clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsAuthorization validity

800 mg/14 daysMaximum dose

10Covered indications

RequiredRenewal response

Not allowed

Unacceptable toxicity

IV every 14 daysStandard administration

Coverage Criteria

Universal Initial Criteria

Initial approval requires all universal criteria, followed by all applicable indication-specific criteria.

Universal initial criteria

Member is at least 18 years of age unless otherwise indicated.Age >=18 years unless an indication-specific exception applies
Member has not received previous PD-1/PD-L1-directed therapy unless otherwise specified.

Merkel Cell Carcinoma

Covered for Merkel cell carcinoma when all applicable criteria are met.

Merkel cell carcinoma

Member is at least 12 years of age.Age >=12 years
Bavencio is used as single-agent therapy.
Eligible disease presentation
- Primary locally advanced disease for which both curative surgery and curative radiation therapy are not feasible.
- Recurrent locally advanced disease for which both curative surgery and curative radiation therapy are not feasible.
- Recurrent locally advanced disease with progression on neoadjuvant nivolumab therapy.
- In-transit N+ regional disease.
- Metastatic disease.
- Primary or recurrent regional disease for which both curative surgery and curative radiation therapy are not feasible.

Urothelial Carcinoma

Covered for urothelial carcinoma when all applicable criteria are met.

Urothelial carcinoma

Bavencio is used as single-agent therapy.
Treatment setting
- Locally advanced or metastatic urothelial carcinoma, including bladder, upper genitourinary tract, urethra, and/or prostate cancer, with disease progression during or following platinum-containing chemotherapy.
- First-line maintenance treatment for locally advanced or metastatic urothelial carcinoma, including bladder, upper genitourinary tract, urethra, and/or prostate cancer, when disease has not progressed with first-line platinum-containing chemotherapy.

Renal Cell Carcinoma

Covered for renal cell carcinoma when all criteria are met.

Renal cell carcinoma

Bavencio is used in combination with axitinib as first-line therapy for advanced, relapsed, or stage IV disease with clear cell histology.
Stage or disease setting
- Advanced disease.
- Relapsed disease.
- Stage IV disease; when used as first-line therapy for stage IV disease, the disease must be M1 or unresectable T4, M0.

Endometrial Carcinoma

Covered for endometrial carcinoma as subsequent therapy for recurrent disease when all criteria are met.

Endometrial carcinoma

Bavencio is used as subsequent therapy for recurrent disease.
The treatment is not used for locoregional recurrence when there has been no prior radiation therapy to the recurrence site or only previous vaginal brachytherapy.
The treatment is not used after surgical exploration for locoregional recurrence when disease is confined to the vagina or paravaginal soft tissue.
Molecularly appropriate regimen
- Single-agent therapy for MSI-H or dMMR tumors.

Extranodal NK/T-Cell Lymphomas

Covered for extranodal NK/T-cell lymphoma when all criteria are met.

Extranodal NK/T-cell lymphoma

Bavencio is used as single-agent therapy.
Disease is relapsed or refractory following additional therapy with an alternate asparaginase-based combination chemotherapy regimen not previously used.
Participation in a clinical trial is unavailable.

Thymic Carcinoma

Covered for thymic carcinoma when all applicable criteria are met.

Thymic carcinoma

Bavencio is used in combination with axitinib.
Eligible treatment setting
- Member is unable to tolerate first-line combination regimens and Bavencio is used as postoperative systemic therapy after R1 (microscopic residual tumor) or R2 (macroscopic residual tumor) resection.
- Member is unable to tolerate first-line combination regimens and Bavencio is used as first-line therapy for recurrent, advanced, or metastatic disease.
- Bavencio is used as subsequent therapy for unresectable or metastatic disease.

Colon Cancer

Covered for colon cancer when all criteria are met.

Colon cancer

Qualifying tumor biomarker or molecular finding
- MSI-H/dMMR disease confirmed by an FDA-approved or CLIA-compliant test.
- POLE/POLD1 mutation with an ultra-hypermutated phenotype confirmed by an FDA-approved or CLIA-compliant test.Example ultra-hypermutated phenotype: TMB >50 mut/Mb
Bavencio is used as single-agent therapy for locally unresectable, medically inoperable, advanced, or metastatic disease.

Rectal Cancer

Covered for rectal cancer when all criteria are met.

Rectal cancer

Qualifying tumor biomarker or molecular finding
- MSI-H/dMMR disease confirmed by an FDA-approved or CLIA-compliant test.
- POLE/POLD1 mutation with an ultra-hypermutated phenotype confirmed by an FDA-approved or CLIA-compliant test.Example ultra-hypermutated phenotype: TMB >50 mut/Mb
Bavencio is used as single-agent therapy for locally unresectable, medically inoperable, advanced, or metastatic disease.

Small Bowel Adenocarcinoma

Covered for small bowel adenocarcinoma when all criteria are met.

Small bowel adenocarcinoma

Qualifying tumor biomarker or molecular finding
- MSI-H/dMMR disease confirmed by an FDA-approved or CLIA-compliant test.
- POLE/POLD1 mutation with an ultra-hypermutated phenotype confirmed by an FDA-approved or CLIA-compliant test.Example ultra-hypermutated phenotype: TMB >50 mut/Mb
Bavencio is used as single-agent treatment.
Disease setting
- Advanced or metastatic disease.

Continuation and Renewal Therapy

Renewal requires all renewal criteria.

Renewal criteria

Member continues to meet the universal and relevant indication-specific criteria.
Disease response is demonstrated by stabilization of disease or a decrease in tumor size or tumor spread.
There is no unacceptable toxicity from Bavencio.

Endometrial carcinoma exclusion: Bavencio is not covered for locoregional recurrence when the member has had no prior radiation therapy to the recurrence site or has received previous vaginal brachytherapy only. It is also excluded after surgical exploration when the recurrent disease is confined to the vagina or paravaginal soft tissue.

Extranodal NK/T-cell lymphoma exclusion: Coverage is not available under this criterion when participation in a clinical trial is available. Covered use otherwise requires single-agent treatment for relapsed or refractory disease following additional therapy with an alternate asparaginase-based combination chemotherapy regimen not previously used.

Coding and Quantity Parameters

Covered HCPCS CodesHCPCSCovered

J9023

Injection, avelumab, 10 mg; 1 billable unit = 10 mg

Covered NDC CodesNDCCovered

44087-3535-xx

Bavencio 200 mg/10 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

C17.0	Malignant neoplasm of duodenum
C17.1	Malignant neoplasm of jejunum
C17.2	Malignant neoplasm of ileum
C17.3	Meckel's diverticulum, malignant
C17.8	Malignant neoplasm of overlapping sites of small intestine
C17.9	Malignant neoplasm of small intestine, unspecified
C18.0	Malignant neoplasm of cecum
C18.2	Malignant neoplasm of ascending colon
C18.3	Malignant neoplasm of hepatic flexure
C18.4	Malignant neoplasm of transverse colon

1–10 of 110

1/11

Covered Diagnosis CodesICD-10Covered

C7B.1	Secondary malignant neoplasm of liver and intrahepatic bile duct
C84.90	Mature T/NK-cell lymphomas, unspecified, unspecified site
C84.91	Mature T/NK-cell lymphomas, unspecified, lymph nodes of head, face, and neck
C84.92	Mature T/NK-cell lymphomas, unspecified, intrathoracic lymph nodes
C84.93	Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes
C84.94	Mature T/NK-cell lymphomas, unspecified, lymph nodes of axilla and upper limb
C84.95	Mature T/NK-cell lymphomas, unspecified, lymph nodes of inguinal region and lower limb
C84.96	Mature T/NK-cell lymphomas, unspecified, intrapelvic lymph nodes
C84.97	Mature T/NK-cell lymphomas, unspecified, spleen
C84.98	Mature T/NK-cell lymphomas, unspecified, lymph nodes of multiple sites

1–10 of 33

1/4

Bavencio HCPCS Dosing Limit

Quantity limit80 billable units

Dose equivalent800 mg

Dosing intervalEvery 14 days

Cisplatin-Ineligible Renal Function

Cisplatin-ineligible renal functionCrCl < 60 mL/min

CrClCreatinine clearance

Clinical context

Provider Actions and Authorization Risks

Prior Authorization

Six-Month Prior Authorization

Submit the initial prior authorization request for a 6-month (180-day) authorization period. Renewal authorization may be requested every 6 months (180 days), provided the renewal criteria are documented.

Initial authorization validity: 6 months (180 days).
Renewal authorization validity: every 6 months (180 days) thereafter.

Prior Authorization

Prior Authorization Required

Prior authorization applies because Bavencio is subject to review based on the requested indication and the cost of the drug. Document the applicable covered indication and supporting clinical information with the request.

PA consideration: indication.
PA consideration: cost of drug.

Unsupported block type: documentation

Background

Bavencio (avelumab) is an intravenous PD-L1-directed immunotherapy used under this policy for selected solid tumors, hematologic malignancies, and gestational trophoblastic neoplasia. Coverage depends on the malignancy, disease extent, biomarker status, prior treatment, and whether Bavencio is used alone or with another agent such as axitinib.

For most indications, the policy specifies 800 mg intravenously every 14 days until disease progression or unacceptable toxicity. When actual body weight is 66 kg or less, the applicable dose is 600 mg (10 mg/kg) intravenously every 2 weeks.

Definitions

MSI-H/dMMR

AbbreviationMSI-H/dMMR

MeaningMicrosatellite instability-high or mismatch repair deficient tumor status

Policy useQualifying tumor status for single-agent therapy in small bowel adenocarcinoma

pMMR

AbbreviationpMMR

MeaningMismatch repair proficient tumor status

Policy useFor endometrial carcinoma, therapy may be used in combination with axitinib

Initial Therapy

Initial approval requires the age requirement, all universal criteria, and all applicable indication-specific criteria.

Initial Bavencio therapy

Member meets the applicable age requirement.Age >=18 years unless otherwise indicated; Merkel cell carcinoma age >=12 years
Member has not received prior PD-1/PD-L1-directed therapy unless an exception applies.
Member meets all coverage criteria for the requested malignancy indication.
Indication-specific requirements may include disease extent, biomarker or molecular status, prior treatment, regimen, and clinical-trial availability.

Continuation and Re-initiation

Continuation Therapy

Renewal may be authorized every 6 months when all continuation criteria are met.

Bavencio continuation

Member continues to meet the universal and relevant indication-specific criteria.
Disease is stable or has decreased in size or spread.
There is no unacceptable toxicity from Bavencio.

Re-initiation after Re-biopsy

Case-by-case consideration may apply after tumor re-biopsy.

Re-initiation after changed actionable mutation

Quantity Limits

Bavencio Quantity Limit

DrugBavencio (avelumab)

Quantity limit80 billable units

Dose equivalent800 mg every 14 days

Administration Site and Schedule

Billing Rule

Administer on the required infusion schedule

Administer Bavencio intravenously in an infusion center every 14 days or every 2 weeks, using the applicable dose based on the indication and actual body weight.

Use 800 mg IV every 14 days for all indications unless the weight-based rule applies.
For actual body weight ≤ 66 kg, use 600 mg (10 mg/kg) IV every 2 weeks.

Policy Summary

PayerViva Health Plan

PolicyBavencio (avelumab) (Intravenous) Coverage Criteria

Policy CodePolicy IC-0295

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests and document that all applicable clinical criteria are met.

SourceLink

On This Page

Therapy in combination with axitinib for pMMR tumors.

Locally unresectable or medically inoperable disease, with Bavencio used as primary treatment.

Cisplatin-ineligible comorbidity

Cisplatin-Ineligible Performance Status

ECOG thresholdECOG PS ≥ 2

KPS thresholdKPS < 70%

Clinical contextCisplatin-ineligible comorbidity

Cisplatin-Ineligible Hearing Loss

Hearing-loss threshold≥ 25 decibels (dB)

Frequency requirementAt two contiguous frequencies

Clinical contextCisplatin-ineligible comorbidity

Cisplatin-Ineligible Neuropathy

Neuropathy thresholdGrade ≥ 2

ConditionPeripheral neuropathy

Clinical contextCisplatin-ineligible comorbidity

Cisplatin-Ineligible Heart Failure

Heart-failure thresholdNYHA Heart Failure class ≥ 3

Classification systemNYHA Heart Failure class

Clinical contextCisplatin-ineligible comorbidity

Platinum-Ineligible Renal Function

Platinum-ineligible renal functionCrCl < 30 mL/min

CrClCreatinine clearance

Clinical contextPlatinum-ineligible comorbidity

Platinum-Ineligible Performance Status

Performance-status thresholdECOG PS ≥ 3

Performance measureECOG performance status

Clinical contextPlatinum-ineligible comorbidity

High-Risk Gestational Trophoblastic Neoplasia

Prognostic-score threshold≥ 7

FIGO-stage thresholdStage IV disease

Disease categoryHigh-risk gestational trophoblastic neoplasia

Ultra-Hypermutated Phenotype

Tumor mutational burden> 50 mut/Mb

PhenotypeUltra-hypermutated

Molecular associationPOLE/POLD1 mutation

Actual Body Weight

Weight threshold≤ 66 kg

Applicable dose600 mg (10 mg/kg) IV

Dosing intervalEvery 2 weeks

Documentation Required

Platinum Treatment History and Eligibility

For urothelial carcinoma, document the platinum-containing chemotherapy history, treatment response or progression status, and whether the member remains eligible for platinum retreatment or is cisplatin- or platinum-ineligible.

For treatment after platinum therapy, document disease progression during or following platinum-containing chemotherapy.
For first-line maintenance, document locally advanced or metastatic disease and no progression on first-line platinum-containing chemotherapy.
If progression-free for more than 12 months after platinum therapy, consider platinum-based retreatment when the member remains platinum eligible.
Cisplatin-ineligible factors may include CrCl < 60 mL/min, ECOG performance status >= 2 or KPS < 70%, hearing loss >= 25 dB at two contiguous frequencies, grade >= 2 peripheral neuropathy, or NYHA heart failure class >= 3.
Platinum-ineligible factors may include CrCl < 30 mL/min, ECOG performance status >= 3, grade >= 2 peripheral neuropathy, or NYHA heart failure class > 3. Carboplatin may substitute for cisplatin in the metastatic setting when appropriate.

Documentation Required

Renewal Clinical Response and Safety

For renewal, document that the member continues to meet the universal and applicable indication-specific criteria, has clinical benefit, and is tolerating treatment without unacceptable toxicity.

Disease response must be shown by stabilization of disease or a decrease in tumor size or tumor spread.
Document absence of unacceptable toxicity, including severe or life-threatening infusion-related reactions; severe immune-mediated adverse reactions such as pneumonitis, hepatotoxicity or hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, or severe dermatologic reactions; major adverse cardiovascular events; or complications of allogeneic HSCT.
Renewal may be denied when applicable criteria are no longer met, disease progresses or fails to stabilize or decrease, or toxicity is unacceptable.

Denial Risk

Indication-Specific Criteria Not Met

Authorization may be denied when the requested use does not satisfy the applicable age, disease, biomarker, treatment-line, combination, disease-status, or clinical-trial criteria.

Merkel cell carcinoma: deny when the member does not meet the applicable age requirement, single-agent requirement, or qualifying locally advanced, recurrent, in-transit N+, metastatic, or otherwise specified disease and treatment-feasibility criteria.
Urothelial carcinoma: deny when single-agent use, locally advanced or metastatic disease, platinum-progression history, or first-line maintenance requirements are not met.
Renal cell carcinoma: deny when combination therapy with axitinib, first-line use, advanced/relapsed/stage IV clear-cell disease, or the required M1 or unresectable T4 M0 status is not documented.
Gestational trophoblastic neoplasia: deny when single-agent treatment for multiagent chemotherapy-resistant disease, qualifying PSTT/ETT disease, recurrent or progressive disease, or high-risk disease is not documented.
Endometrial carcinoma: deny when subsequent therapy for recurrent disease, required exclusions for locoregional recurrence, or the applicable MSI-H/dMMR single-agent or pMMR axitinib-combination criteria are not met.
Extranodal NK/T-cell lymphoma: deny when single-agent treatment, relapsed or refractory disease after an alternate asparaginase-based regimen, or unavailable clinical-trial participation is not documented.
Thymic carcinoma: deny when axitinib combination therapy, inability to tolerate first-line combination regimens, qualifying postoperative or first-line recurrent/advanced/metastatic use, or unresectable/metastatic subsequent-therapy criteria are not met.
Colon, rectal, or small bowel adenocarcinoma: deny when the required MSI-H/dMMR or POLE/POLD1 ultra-hypermutated phenotype, qualifying unresectable/medically inoperable or advanced/metastatic disease, or required single-agent treatment is not documented.

Denial Risk

Prior PD-Directed Therapy

Prior PD-1/PD-L1-directed therapy generally does not satisfy the universal criteria for Bavencio authorization unless the policy specifies an exception. Document the prior therapy and the applicable exception when requesting treatment.

Authorization may be denied when the member has received previous PD-1/PD-L1-directed therapy without a policy-supported exception.
A specified MCC pathway includes disease progression on neoadjuvant nivolumab.

Denial Risk

Dosing Limit Exceeded

Do not submit claims or requests that exceed the policy dosing limit or schedule. Bavencio is administered at 800 mg intravenously every 14 days, until disease progression or unacceptable toxicity.

Maximum: 80 billable HCPCS units (800 mg) every 14 days.
Dosing should be calculated using actual body weight rather than flat dosing, as applicable.

Denial Risk

Renewal Response or Safety Failure

Renewal may be denied when the member no longer meets universal or indication-specific criteria, lacks documented disease stabilization or tumor decrease, or develops unacceptable toxicity.

Document continued treatment benefit as stabilization of disease or decrease in tumor size or tumor spread.
Unacceptable toxicity may include severe or life-threatening infusion reactions, severe immune-mediated adverse reactions, major adverse cardiovascular events, or complications of allogeneic HSCT.
Do not request renewal when disease has progressed, response is inadequate, criteria are unmet, or treatment cannot be tolerated safely.

Billing Rule

Medicare Coverage Policy Compliance

For Medicare members, apply the applicable Medicare coverage requirements for outpatient Part B drugs. Claims and coverage determinations must comply with relevant NCDs, LCDs, and LCAs where applicable.

The policy's preceding criteria are intended for non-Medicare coverage determinations.
Review the Medicare Benefit Policy Manual, Pub. 100-2, Chapter 15, Section 50, and applicable CMS coverage policies and articles.

CrCl

AbbreviationCrCl

MeaningCreatinine clearance

Cisplatin-ineligible thresholdCrCl < 60 mL/min

ECOG PS

AbbreviationECOG PS

MeaningEastern Cooperative Oncology Group performance status

Referenced thresholdECOG PS ≥ 2 for cisplatin-ineligible status; ≥ 3 for platinum-ineligible status

KPS

AbbreviationKPS

MeaningKarnofsky performance status

Referenced thresholdKPS < 70% for cisplatin-ineligible status

Tumor re-biopsy demonstrates a change in actionable mutation.

An example is an MSS initial biopsy followed by an MSI-H subsequent biopsy.

Eligibility for re-initiation of PD-directed therapy is evaluated on a case-by-case basis.