CurrentViva HealthPolicy IC-0014

Bevacizumab and biosimilars (intravenous)

Clinical coverage and prior authorization criteria for bevacizumab and listed biosimilars for oncology indications for Viva Health members.

Policy Summary

PayerViva Health

PolicyBevacizumab and biosimilars (intravenous)

Policy CodePolicy IC-0014

Change TypeRoutine review — no material changes

Effective DateOct 17, 2008

Next Review DateDec 2, 2025

Key ActionRequest prior authorization and document prior intolerance, contraindication, or failure to Alymsys and Mvasi; include appropriate Appendix 1 ICD-10 diagnosis code and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30+indications enumerated

Multipleproducts covered

6 monthsinitial authorization length

12 weeksspecial CNS authorization

J9035 + Q-codesHCPCS codes listed

Coverage Criteria and Indication-Specific Rules

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Medicare / CMS applicability

Medicare / CMS applicability — The information below clarifies applicability of the coverage criteria to Medicare (Part B) beneficiaries and references to CMS policy.

The preceding Coverage Criteria and indication-specific rules are intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is governed by CMS policy and may differ from the rules shown above.

Medicare coverage determinations are found in the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 Drugs and Biologicals, and by National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs). Where an applicable NCD or LCD exists, that CMS policy must be followed for Medicare beneficiaries.

Local Coverage Articles (LCAs) may exist to clarify claims payment or Part B benefit eligibility for drugs that can be self-administered; these should be consulted when processing Medicare claims.

Users may search for NCD, LCD, or LCA documents at the CMS Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx.

Additional indications or the plan-specific Coverage Criteria above may be applied at the discretion of the health plan for non-Medicare members, but Medicare members must follow CMS (NCD/LCD/LCA) requirements where applicable.

Specific contractor guidance: see NCD/LCA/LCD document A52370 and contractor National Government Services, Inc. for Medicare Part B covered diagnosis codes and related claims instructions.

Regimens and Combination Therapy Specifications

Indication	Regimen / Combination	Coverage status
Cervical cancer (persistent, recurrent, or metastatic)
Bevacizumab in combination with paclitaxel AND either cisplatin, carboplatin, or topotecan; Bevacizumab may be continued as maintenance therapy.
When used with pembrolizumab: Bevacizumab + pembrolizumab + paclitaxel + either cisplatin or carboplatin when tumor PD-L1 CPS ≥1 (FDA-approved or CLIA-compliant test); Bevacizumab + atezolizumab + paclitaxel + either cisplatin or carboplatin is an alternative; single-agent bevacizumab allowed as subsequent therapy.

Indication	Regimen / Combination	Coverage status
Hepatocellular carcinoma (unresectable or metastatic)
Bevacizumab in combination with atezolizumab as first-line therapy; may be used as subsequent therapy following progression on or after systemic therapy provided patient has not previously received bevacizumab or a checkpoint inhibitor.

Indication	Regimen / Combination (examples by biomarker/status)	Coverage status
Non-squamous non-small cell lung cancer (recurrent, advanced, or metastatic)
Bevacizumab combined with carboplatin + paclitaxel; or pemetrexed + either carboplatin or cisplatin (in selected patients); or atezolizumab + carboplatin + paclitaxel; or bevacizumab + erlotinib for EGFR exon 19 deletion or L858R mutations. Selection depends on actionable biomarker status and prior therapies.
Continuation/maintenance: bevacizumab as single-agent maintenance if included in first-line, or in combination with pemetrexed or atezolizumab per prior regimen; use as subsequent therapy combinations described (see policy).

Indication	Regimen / Combination	Coverage status
Medulloblastoma (pediatric, age ≥3 and ≤21 years) — recurrent or progressive disease
Bevacizumab used as part of TEMR regimen (temozolomide, irinotecan, bevacizumab) or MEMMAT regimen (thalidomide, celecoxib, fenofibrate, etoposide, cyclophosphamide, bevacizumab).

Indication	Regimen / Combination	Coverage status
Pediatric diffuse high-grade glioma (recurrent or progressive; patient ≤21 years)
Bevacizumab used as single-agent palliation for recurrent/progressive disease.
Excludes oligodendroglioma IDH-mutant with 1p/19q co-deletion and astrocytoma IDH-mutant per policy definitions.

Indication	Regimen / Combination	Coverage status
Vaginal cancer (recurrent or metastatic)
Bevacizumab combined with paclitaxel AND either cisplatin, carboplatin, or topotecan as first-line or subsequent therapy; alternative regimen: bevacizumab + pembrolizumab + paclitaxel + cisplatin/carboplatin when tumor PD-L1 CPS ≥1; single-agent bevacizumab allowed as subsequent therapy.
Vulvar cancer (advanced, recurrent, or metastatic): bevacizumab in combination with paclitaxel + cisplatin/carboplatin, or with pembrolizumab + paclitaxel + cisplatin/carboplatin; bevacizumab (and pembrolizumab) may be continued as maintenance.

Billing Codes, Diagnosis Codes, and Dose Limits

HCPCS CodesHCPCS

J9035	Injection, bevacizumab, 10 mg; 1 billable unit = 10 mg
Q5107	Injection, bevacizumab-awwb, biosimilar (mvasi), 10 mg; 1 billable unit = 10 mg
Q5118	Injection, bevacizumab-bvzr, biosimilar (zirabev), 10 mg; 1 billable unit = 10 mg
Q5126	Injection, bevacizumab-maly, biosimilar (alymsys), 10 mg; 1 billable unit = 10 mg
Q5129	Injection, bevacizumab-adcd (vegzelma), biosimilar, 10 mg; 1 billable unit = 10 mg
Q5160	Injection, bevacizumab-nwgd (jobevne), biosimilar, 10 mg; 1 billable unit = 10 mg (Effective 01/01/2026)
J9999	Not otherwise classified, antineoplastic drugs (Avzivi and Jobevne only) (Discontinue use on 01/01/2026 for Jobevne only)

NDC CodesNDC

50242-0060-xx	Avastin single-dose vial, 100 mg/4 mL solution for injection
50242-0061-xx	Avastin single-dose vial, 400 mg/16 mL solution for injection
55513-0206-xx	Mvasi single-dose vial, 100 mg/4 mL solution for injection
55513-0207-xx	Mvasi single-dose vial, 400 mg/16 mL solution for injection
000690315-xx	Zirabev single-dose vial, 100 mg/4 mL solution for injection
00069-0342-xx	Zirabev single-dose vial, 400 mg/16 mL solution for injection
701211754-xx	Alymsys single-dose vial, 100 mg/4 mL solution for injection
701211755-xx	Alymsys single-dose vial, 400 mg/16 mL solution for injection
72606-0011-xx	Vegzelma single-dose vial, 100 mg/4 mL solution for injection
72606-0012-xx	Vegzelma single-dose vial, 400 mg/16 mL solution for injection

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Covered ICD-10 Diagnosis Codes (selected list)ICD-10Covered

C78.00	Secondary malignant neoplasm of unspecified lung
C78.01	Secondary malignant neoplasm of right lung
C78.02	Secondary malignant neoplasm of left lung
C78.6	Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7	Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.31	Secondary malignant neoplasm of brain
C83.30	Diffuse large B-cell lymphoma, unspecified site
C83.390	Primary central nervous system lymphoma
C83.398	Diffuse large B-cell lymphoma of other extranodal and solid organ sites
C83.59	Lymphoblastic (diffuse) lymphoma, extranodal and solid organ sites

1–10 of 16

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Covered ICD-10 Diagnosis Codes (benign, uncertain behavior, and other)ICD-10Covered

D10.5	Benign neoplasm of other parts of oropharynx
D10.6	Benign neoplasm of nasopharynx
D10.9	Benign neoplasm of pharynx, unspecified
D14.0	Benign neoplasm of middle ear, nasal cavity and accessory sinuses
D14.1	Benign neoplasm of larynx
D14.2	Benign neoplasm of trachea
D14.30	Benign neoplasm of unspecified bronchus and lung
D14.31	Benign neoplasm of right bronchus and lung
D14.32	Benign neoplasm of left bronchus and lung
D14.4	Benign neoplasm of respiratory system, unspecified

1–10 of 41

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Prior Authorization, Documentation, and Renewal Guidance

Prior Authorization

Prior authorization length

Prior authorization is required. Initial prior authorization is generally valid for 6 months; for Adult CNS symptom management the initial authorization is 12 weeks (and may not be renewed). Renewals are available every 6 months unless otherwise specified.

Prior Authorization

Renewal requirements

Renewal of prior authorization may be granted if the patient continues to meet the universal and indication-specific criteria, the original authorization duration has not been exceeded, disease response or stability is documented, and there is no unacceptable toxicity.

Note

Consider PA for select indications

Prior authorization should be considered for bevacizumab and its biosimilars when the indication and drug cost meet the plan's NQTL considerations (indication = yes; cost = yes), even though safety/efficacy was not judged to prioritize PA.

Note

Medicare/Appendix note

Appendix 2 notes that Medicare Part B coverage is governed by the Medicare Benefit Policy Manual and any applicable NCDs, LCDs, or LCAs; the plan may apply additional indications at its discretion.

Step Therapy

Step requirement: prior product trial

Step therapy requires documented contraindication, intolerance, or treatment failure to both Alymsys® and Mvasi® before another bevacizumab product will be considered for coverage.

Documentation Required

Concomitant therapy must be documented

For certain indications, authorization requires that bevacizumab be used following or in combination with specified chemotherapies or immunotherapies; authorization requests should reflect the required concomitant regimen when applicable.

Examples include combinations with paclitaxel + carboplatin, oxaliplatin + docetaxel, interferon alfa, everolimus, or atezolizumab where indicated.

Prior Authorization

Required information on PA request

Providers must request prior authorization and document prior use, intolerance, or contraindication to Alymsys® and Mvasi®, indicate patient age, and confirm the patient meets the universal safety criteria (e.g., no recent hemoptysis, no recent surgery/unhealed wound).

Documentation Required

Documentation required for renewal

For renewal requests, provide documentation that the patient continues to meet universal and indication‑specific criteria, including any required concomitant therapy, performance status, duration limits, evidence of disease response or stability, and absence of unacceptable toxicity.

Billing Rule

Submit a covered ICD‑10 diagnosis code

Claims and prior authorization submissions must include an appropriate covered ICD‑10 diagnosis code from Appendix 1 (see Appendix 1 lists of covered codes).

Documentation Required

Comply with CMS Medicare requirements

When Medicare rules apply, providers must comply with applicable CMS documents (Medicare Benefit Policy Manual, NCDs/LCDs/LCAs) and follow payment/coverage guidance referenced in Appendix 2.

Use the CMS Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx) to locate NCD/LCD/LCA guidance.

Denial Risk

Prior product failure must be documented

Prior authorization will require documented contraindication, intolerance, or failure to both Alymsys® and Mvasi® before another bevacizumab product is considered; lack of this documentation may result in denial.

Denial Risk

Renewal denial triggers

Renewal requests may be denied if the original authorization duration has been exceeded, the patient does not demonstrate disease response or stability, or the patient has unacceptable toxicity from the drug.

Examples of unacceptable toxicity include gastrointestinal perforation, hemorrhage, thromboembolic events, uncontrolled hypertension, nephrotic syndrome, severe infusion reactions, among others.

Note

PA considerations per NQTL checklist

Prior authorization may be applied to this drug group based on indication and cost considerations identified in the plan's NQTL checklist; safety/efficacy considerations did not independently drive PA placement.

Billing Rule

Use Appendix 1 diagnosis codes on claims

Ensure claims include one of the covered ICD‑10 diagnosis codes listed in Appendix 1; omission or use of a non‑listed code may affect payment or trigger denial.

Definitions and Biomarker Notes

Actionable biomarkers (selected)

EGFRListed as an actionable biomarker for NSCLC and regimen selection

KRASIncluded among molecular markers to guide therapy

ALKIncluded among molecular markers to guide therapy

ROS1Included among molecular markers to guide therapy

BRAFIncluded among molecular markers to guide therapy

NTRK1/2/3Included among molecular markers to guide therapy

MET / RET / NRG1 / ERBB2 (HER2)Included among actionable markers listed in policy

Epithelial subtypes

SerousListed epithelial ovarian/fallopian tube/primary peritoneal subtype

EndometrioidListed epithelial subtype

Carcinosarcoma (MMMT)Included as an epithelial subtype

Clear cellIncluded as an epithelial subtype

MucinousIncluded as an epithelial subtype

Borderline epithelial (LMP)Also known as low malignant potential tumors; explicitly listed

Compendia and guideline references (NCCN)

NCCN Guidelines referencedNCCN Clinical Practice Guidelines cited throughout as the supporting compendium for cancer-specific bevacizumab recommendations

Guideline versionsMultiple tumor-specific NCCN guideline versions (2025–2026) referenced in policy references

Use for regimen and testing guidanceNCCN guidance cited for CRC MMR/MSI testing and regimen selection, HCC, ovarian, and other cancers

Biomarker and Testing Requirements

PD-L1 (CPS) requirement

PD-L1 (CPS) thresholdCPS ≥1 required where specified (e.g., cervical cancer with pembrolizumab)

Test typeDetermined by an FDA-approved or CLIA-compliant test as specified in indication nodes

Indication examplesRequired for pembrolizumab combinations in cervical cancer and for pembrolizumab combinations in vaginal cancer where noted

Multiple actionable markers

Actionable marker listEGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, ERBB2 (HER2)

Use caseComplete biomarker testing recommended to guide NSCLC therapy selection (biopsy and/or plasma testing)

ImplicationIf a clinically actionable marker is found, it is reasonable to start therapy directed at that marker

MMR / MSI and TMB guidance

MMR/MSI thresholddMMR/MSI-H (or POLE/POLD1 ultrahypermutated phenotype) or TMB >50 mut/Mb suggests checkpoint inhibitor therapy

ContextNCCN recommends universal MMR/MSI testing in newly diagnosed CRC; results influence immunotherapy candidacy

Testing notePOLE/POLD1 mutations with ultrahypermutated phenotype noted alongside MSI/TMB considerations

Folate receptor-alpha requirement

Folate receptor-alpha threshold≥25% positive tumor cells required where specified (e.g., mirvetuximab combinations)

ApplicationUsed to determine eligibility for mirvetuximab soravtansine-containing regimens in ovarian cancer

Testing contextSpecified within ovarian regimen nodes where folate receptor-alpha expression is required

PD-L1 (CPS) — other indication contexts

PD-L1 (CPS) — duplicate contextsCPS ≥1 required for pembrolizumab-containing regimens where specified (e.g., cervical, vaginal cancers)

DeterminationMust be by an FDA-approved or CLIA-compliant test as noted in indication criteria

Indication examplesCervical cancer and vaginal cancer pembrolizumab combinations reference CPS ≥1

BRCA1/2 and homologous recombination (HR) deficiency

BRCA1/2 and HR deficiencyReferenced as biomarker considerations for ovarian and certain endometrioid/high-grade serous tumors to guide single-agent vs PARP combination use

Use caseBRCA1/2 mutation or HRD status informs eligibility for combination with olaparib or niraparib in specified histologies

Policy locationBRCA/HRD logic appears in epithelial gynecologic tumor and NSCLC/ovarian sections

OpenPayer

Bevacizumab and biosimilars (intravenous)

Coverage Criteria and Indication-Specific Rules

Regimens and Combination Therapy Specifications

Billing Codes, Diagnosis Codes, and Dose Limits

Prior Authorization, Documentation, and Renewal Guidance

Background and Rationale

Definitions and Biomarker Notes

Line of Therapy Designations

Biomarker and Testing Requirements

Policy Revision History