ModifiedEmblemHealthPolicy N/A

Oncology (Injectable) - Bevacizumab Products Utilization Management Medical Policy

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Defines prior authorization recommendations, coverage criteria, and dosing for bevacizumab products (Avastin, Alymsys, Mvasi, Vegzelma, Zirabev) for non-ophthalmic indications in Medicare Advantage members across specified service areas.

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ModifiedEmblemHealthPolicy N/A

Oncology (Injectable) - Bevacizumab Products Utilization Management Medical Policy

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Policy Summary

PayerEmblemHealth

PolicyOncology (Injectable) - Bevacizumab Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMultiple material updates (criteria additions, mutation list changes, approval duration edits)

Effective DateN/A

Last ReviewSep 10, 2025

Next Review DateSep 10, 2025

Key ActionSubmit prior authorization with documentation showing indication-specific criteria, age, mutation status, and requested mg/kg dosing per indication.

SourceLink

POLICY UPDATE CHANGES

New actionable mutations (RET rearrangement positive, MET exon 14 skipping, NTRK gene fusion positive, BRAF V600E mutation positive) were added to the list of examples of actionable mutations.

Criteria referencing bevacizumab use with 'platinum therapies' was replaced with 'with other systemic therapies' and a Note with examples of systemic therapies was added.

Multiple indications and age requirements (≥18 years) were added or clarified across CNS tumors, NSCLC, colon/appendiceal cancers, hepatocellular carcinoma, ovarian/peritoneal cancer, renal cell carcinoma, mesothelioma, pediatric CNS tumors, and others.

Hepatocellular carcinoma criteria were modified repeatedly: Child-Pugh class specifications updated, approval durations changed, adjuvant and first-line options added, and prior systemic therapy requirements removed.

Coverage for Hereditary Hemorrhagic Telangiectasia (HHT) with arteriovenous malformations (AVMs) was added per LCD L33394.

KRAS G12C was removed from the list of actionable mutations for first-line use and was also noted as not considered actionable in a prior revision; NRG1 was added as actionable and as an option for first-line use.

9+distinct covered indications listed (adult oncology)

1 yrtypical approval duration for indications

updatedmolecular markers updated

addedHHT with AVMs included

NGS, J6, JKexplicit applicable jurisdictions

Recommended Authorization Criteria

Cervical Cancer (FDA-approved)

Approve for 1 year if ALL of the following are met

Cervical Cancer criteria: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of the following: (i) recurrent or metastatic cervical cancer; OR (ii) persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix.age >= 18

IC-COMP

Colon, Rectal, or Appendiceal Cancer (FDA-approved)

Approve for 1 year if ALL of the following are met

Colon/Rectal/Appendiceal criteria: A) Patient is ≥ 18 years of age; AND B) Patient has recurrent, advanced, or metastatic colon, rectal, or appendiceal cancer; AND C) Medication is used in combination with a chemotherapy regimen (examples include fluorouracil/leucovorin with or without oxaliplatin or irinotecan, capecitabine with or without oxaliplatin, irinotecan with or without oxaliplatin).age >= 18

IC-COMP

Central Nervous System Tumors (FDA-referenced)

Approve for 1 year if ALL of the following are met

CNS tumor criteria: A) Patient is ≥ 18 years of age; AND B) Patient has tried at least one previous therapy (examples include temozolomide, etoposide, carmustine, radiotherapy); AND C) Patient has ONE of the following: anaplastic gliomas; astrocytoma; glioblastoma; intracranial or spinal ependymoma (excluding subependymoma); meningiomas; oligodendroglioma; medulloblastoma; neurofibromatosis type 2 vestibular schwannomas; OR symptoms due to radiation necrosis, brain edema, or mass effect.age >= 18; prior therapy required

IC-COMP

Hepatocellular Carcinoma (in combination with atezolizumab)

Approve for 1 year if ALL of the following are met

HCC criteria: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of the following: (i) post-resection or ablation and is at high risk of recurrence (high-risk defined as size > 5 cm, > 3 tumors, macrovascular invasion, microvessel invasion on histology, or grade 3/4 histology) with medication used as adjuvant therapy; OR (ii) medication is used for first-line therapy and the patient has either (1) liver-confined, unresectable disease and is deemed ineligible for transplant; OR (2) extrahepatic/metastatic disease and is deemed ineligible for resection, transplant, or locoregional therapy; AND C) Medication is used in combination with atezolizumab (Tecentriq).age >= 18; high-risk defined as size>5 cm, >3 tumors, macrovascular invasion, microvessel invasion, or grade 3/4 histology

IC-COMP

Non-Small Cell Lung Cancer (non-squamous)

Approve for 1 year if ALL of the following are met

NSCLC criteria: A) Patient is ≥ 18 years of age; AND B) Patient does not have a history of recent hemoptysis; AND C) Patient has recurrent, advanced, or metastatic non-squamous NSCLC and meets ONE of multiple subcriteria relating to tumor mutation status and line of therapy (includes pathways for tumors negative/unknown for actionable mutations with use as initial therapy in combination, continuation maintenance, or subsequent therapy in combination; and mutation-specific branches for EGFR exon 19 deletion/L858R, EGFR exon 20, ERBB2 (HER2), NRG1, BRAF V600E, NTRK fusions, MET exon 14 skipping, ALK, ROS1, RET, and other listed mutations with specified combination/sequence rules).age >= 18; no recent hemoptysis

IC-COMP; includes mutation-specific branches and combination/sequence rules

Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Approve for 1 year if the following is met

Ovarian-type cancer criteria: Patient is ≥ 18 years of age.age >= 18

IC-COMP

Renal Cell Carcinoma (metastatic)

Approve for 1 year if ALL of the following are met

RCC criteria: A) Patient is ≥ 18 years of age; AND B) Patient has relapsed, metastatic, or Stage IV renal cell cancer.age >= 18

IC-COMP

Ampullary Adenocarcinoma

Approve for 1 year if ALL of the following are met

Ampullary adenocarcinoma criteria: A) Patient is ≥ 18 years of age; AND B) Patient has intestinal type disease; AND C) Medication is used in combination with chemotherapy (examples include FOLFOX, FOLFIRI, FOLFIRINOX, CapeOX).age >= 18

IC-COMP

Endometrial Carcinoma

Approve for 1 year if ALL of the following are met

Endometrial carcinoma criteria: A) Patient is ≥ 18 years of age; AND B) Patient has recurrent, advanced, or metastatic disease.age >= 18

IC-COMP

Ampullary Adenocarcinoma (duplicate inventory entry)

Approve for 1 year if ALL of the following are met:

Ampullary Adenocarcinoma criteria: A) Patient is ≥ 18 years of age; B) Patient has intestinal type disease; C) Medication is used in combination with chemotherapy.

Endometrial Carcinoma (duplicate inventory entry)

Approve for 1 year if ALL of the following are met:

Endometrial carcinoma criteria: A) Patient is ≥ 18 years of age; B) Patient has recurrent, advanced, or metastatic disease.

Mesothelioma

Approve for 1 year if ALL of the following are met:

Mesothelioma criteria: A) Patient is ≥ 18 years of age; B) Patient has pleural, peritoneal, pericardial, or tunica vaginalis testis mesothelioma; AND C) Patient meets ONE of: (i) bevacizumab used in combination with a chemotherapy regimen (examples include pemetrexed, cisplatin, carboplatin); OR (ii) bevacizumab used in combination with atezolizumab (Tecentriq).

Pediatric Central Nervous System Tumors

Approve for 1 year if ALL of the following are met:

Pediatric CNS tumor criteria: A) Patient is < 18 years of age; AND B) Patient has ONE of: pediatric-type diffuse high-grade glioma (examples include diffuse hemispheric glioma, infant-type hemispheric glioma, diffuse midline glioma) OR pediatric medulloblastoma; AND C) Patient has recurrent or progressive disease.

Small Bowel Adenocarcinoma

Approve for 1 year if ALL of the following are met:

Small bowel adenocarcinoma criteria: A) Patient is ≥ 18 years of age; AND B) Patient has advanced or metastatic disease; AND C) Medication is used in combination with chemotherapy (examples include FOLFOX, CapeOX, FOLFIRINOX).

Soft Tissue Sarcoma

Approve for 1 year if BOTH of the following are met:

Soft tissue sarcoma criteria: A) Patient is ≥ 18 years of age; AND B) Patient has angiosarcoma or solitary fibrous tumor.

Vaginal Cancer

Approve for 1 year if ALL of the following are met:

Vaginal cancer criteria: A) Patient is ≥ 18 years of age; AND B) Patient has advanced, recurrent, or metastatic disease.

Vulvar Cancer

Approve for 1 year if ALL of the following are met:

Vulvar cancer criteria: A) Patient is ≥ 18 years of age; AND B) Patient has advanced, recurrent, or metastatic disease.

Hereditary Hemorrhagic Telangiectasia with AVMs

Approve for 1 year:

HHT with AVMs: Policy states approval for 1 year; dosing: approve the requested dose.

Neovascular or Vascular Ophthalmic Conditions

Approve for 3 years if indication applies:

Ophthalmic conditions: Examples include diabetic macular edema (including diabetic retinopathy with DME), macular edema following retinal vein occlusion, myopic choroidal neovascularization, neovascular (wet) age-related macular degeneration, neovascular glaucoma, retinopathy of prematurity, sickle cell neovascularization, and other choroidal neovascular conditions.

Indication-specific medical necessity criteria (summary)

Coverage depends on indication-specific criteria including disease state, age (often 18), mutation status, combination with systemic therapies, prior therapies, and surgical/transplant candidacy.

NSCLC (non-squamous): Covered when the patient has recurrent, advanced, or metastatic non-squamous NSCLC AND tumor mutation status is documented (options include positive for listed actionable mutations OR negative/unknown for actionable mutations) AND bevacizumab is used in combination with other systemic therapies as specified; patient must be ≥18 years and not have recent hemoptysis.age >= 18; no recent hemoptysis

Actionable mutations examples include EGFR exon 19 deletion/L858R, EGFR exon 20, BRAF V600E, NTRK fusions, MET exon 14 skipping, RET rearrangement, NRG1; KRAS G12C handling was changed across revisions.

Hepatocellular Carcinoma (HCC): Covered for unresectable or metastatic HCC with criteria updated to include Child-Pugh Class A or B disease and options for approval as adjuvant (post-resection/ablation high-risk) for 1 year or for first-line therapy in liver-confined unresectable disease when ineligible for transplant; prior systemic therapy requirements were removed in later revisions.varies by option

Approval duration changed from 1 year to indication-specific durations in revisions.

Bevacizumab is not indicated for adjuvant treatment of colon cancer. This is a labeled limitation of use and requests for bevacizumab in the adjuvant colon cancer setting should be denied or not recommended unless new, validated evidence or regulatory labeling changes are provided to support such use.

Coverage is not recommended for circumstances that are not listed in the Recommended Authorization Criteria. Requests for indications or clinical scenarios outside the specific, enumerated criteria in this policy are subject to non-approval and should include supporting published evidence before they will be considered.

Use of bevacizumab for breast cancer has been removed from the policy’s section of 'Other Uses with Supportive Evidence' following the NCCN withdrawal of the recommendation. Historical references to bevacizumab for breast cancer have therefore been deleted and such use is no longer supported by this policy unless re-established by subsequent guideline or regulatory changes.

For certain non‑small cell lung cancer (NSCLC) first‑line criteria, the policy clarifies that KRAS G12C is not considered an actionable mutation. KRAS G12C should not be treated as an actionable marker that alone qualifies a patient for the mutation‑directed bevacizumab pathways described in the first‑line NSCLC criteria; other listed actionable mutations and the Note with examples should be used to determine eligibility.

Authorization, Documentation, and Sequencing Requirements

Prior Authorization

Prior authorization required for non‑ophthalmic bevacizumab

Prior authorization is recommended for medical benefit coverage of bevacizumab products for non-ophthalmic indications; approvals are recommended only for patients who meet the indication-specific Criteria and Dosing. All approvals are provided for the duration noted in the policy and may be extended if the patient continues to meet the Criteria and Dosing.

Prior Authorization

Prior authorization and approval periods

Prior authorization is required and approval durations are specified by indication — most non-ophthalmic oncology indications are recommended for 1‑year approvals; neovascular or vascular ophthalmic conditions are approved for 3 years.

Prior Authorization

Specify indication, mutation status, and therapy context

Products, Codes, and Dosing Information

Listed products (brand and biosimilars)mixed

Avastin	bevacizumab (Genentech) - intravenous infusion (brand name listed)
Alymsys	bevacizumab-maly (Amneal) - intravenous infusion (biosimilar listed)
Mvasi	bevacizumab-awwb (Amgen) - intravenous infusion (biosimilar listed)
Vegzelma	bevacizumab-adcd (Celltrion) - intravenous infusion (biosimilar listed)
Zirabev	bevacizumab-bvzr (Pfizer) - intravenous infusion (biosimilar listed)

Dosing regimens by indication

Cervical cancer dosing15 mg/kg IV every 3 weeks (approve dosing for cervical cancer)

Colon/rectal/appendiceal dosing options5 mg/kg IV every 2 weeks OR 10 mg/kg IV every 2 weeks OR 7.5 mg/kg IV every 3 weeks

Hepatocellular carcinoma dosing15 mg/kg IV every 3 weeks (in combination with atezolizumab)

Ovarian-type cancer dosingUp to 15 mg/kg IV every 3 weeks OR 10 mg/kg IV every 2 weeks

Renal cell carcinoma dosing10 mg/kg IV every 2 weeks

Ampullary and small bowel dosingAmpullary: 7.5 mg/kg IV every 3 weeks; Small bowel: up to 7.5 mg/kg IV every 2 weeks

Clinical Background and Scope

Bevacizumab is a recombinant humanized monoclonal antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF), a key mediator of angiogenesis. It has multiple labeled oncology indications, including use in combination with chemotherapy for cervical cancer and metastatic colorectal cancer, and other malignancies per labeling and referenced guidance; dosing and specific combination requirements vary by indication.

Policy Definitions and Terms

IC-COMP (Internal criteria supported by CMS compendia)

DefinitionIC-COMP: Internal criteria supported by CMS-approved compendia.

Usage in policyDenotes indications where internal criteria reference and are supported by CMS‑approved compendia to guide coverage decisions.

ScopeApplied across multiple oncology indications in this policy (e.g., cervical, colon, NSCLC, HCC).

IC-L (Internal criteria supported by the labeled indication)

DefinitionIC-L: Internal criteria supported by the labeled indication.

Usage in policyMarks indications where coverage criteria align with the FDA‑labeled indication and manufacturer labeling.

Policy Summary

PayerEmblemHealth

PolicyOncology (Injectable) - Bevacizumab Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMultiple material updates (criteria additions, mutation list changes, approval duration edits)

Effective DateN/A

Last ReviewSep 10, 2025

Next Review DateSep 10, 2025

Key ActionSubmit prior authorization with documentation showing indication-specific criteria, age, mutation status, and requested mg/kg dosing per indication.

SourceLink

On This Page

Pediatric central nervous system tumors: New pediatric CNS tumor indications added (e.g., medulloblastoma); separate pediatric criteria/Notes referenced; adult CNS tumor indications also refined with age >=18 for adult criteria.pediatric specific pathways follow a separate note

Pediatric medulloblastoma added; adult CNS age requirement added.

Other solid tumors: Coverage includes expanded or clarified indications: 'recurrent, advanced, or metastatic' descriptors added to many tumor types; appendiceal and ampullary cancers added; adult age requirement (≥18) added for many; combination therapy requirements adjusted per tumor type.age >= 18 for many indications

Specifics vary by tumor type and are enumerated in full policy.

Authorization requests must document the specific disease indication, relevant tumor mutation status (actionable mutation positive, negative, or unknown as applicable), and whether bevacizumab is being used in combination with other systemic therapies per the indication-specific criteria and policy Notes.

Step Therapy

Prior therapy required for CNS tumors

For adult central nervous system tumor indications, the patient must have tried at least one previous therapy before approval is recommended; examples of prior therapies are provided in the policy Notes.

Policy text: 'B) Patient has tried at least one previous therapy; Note: Examples are temozolomide capsules or injection, etoposide, carmustine, radiotherapy.'

Documentation Required

Pediatric CNS tumors: age, subtype, and recurrence requirement

Pediatric CNS tumor approvals apply only to patients <18 years and require specific tumor subtypes (pediatric‑type diffuse high‑grade glioma or pediatric medulloblastoma) and recurrent or progressive disease.

Policy text: 'A) Patient is < 18 years of age; B) Patient has ONE of the following... pediatric‑type diffuse high‑grade glioma OR pediatric medulloblastoma; C) Patient has recurrent or progressive disease.'

Step Therapy

Therapy sequencing considerations for NSCLC

Some NSCLC authorization pathways reference prior targeted therapy sequencing (for example, subsequent therapy following prior targeted therapy), so requesters must document prior targeted therapy and sequencing when applicable.

Policy notes that 'The medication is used as subsequent therapy following prior targeted therapy' and includes multiple mutation‑specific branches.

Documentation Required

Clinical documentation supporting authorization criteria

Providers must supply clinical documentation demonstrating the patient meets the indication‑specific criteria (age, diagnosis, prior therapies when required, combination with chemotherapy or other agents, and dosing) to support authorization.

Policy statement: 'The presence of a specific HCPCS or ICD-10 code in a chart ... is not by itself sufficient to approve coverage.'

Documentation Required

Required clinical documentation (age, histology, stage, combination therapy, dosing)

Required clinical documentation should include age eligibility, disease histology/subtype and stage (e.g., recurrent/advanced/metastatic), documentation of combination therapy or specific agents when required, and requested dosing (mg/kg and interval) consistent with the indication‑specific criteria.

Examples: dosing and interval are specified per indication (e.g., 10 mg/kg q2w for some CNS and pediatric CNS indications; 15 mg/kg q3w for multiple adult indications).

Documentation Required

HCC: prescriber attestation of non‑surgical/transplant candidacy may be required

For hepatocellular carcinoma, prescriber attestation regarding the patient’s surgical/transplant candidacy (e.g., patient is not a surgical or transplant candidate) may be required to support approval decisions.

HCC criteria include options for post‑resection/ablation adjuvant use or first‑line therapy when the patient is ineligible for resection/transplant; policy revisions note prescriber attestation options.

Denial Risk

PA recommended; HCPCS/ICD‑10 coding alone insufficient for approval

Prior authorization is recommended and coding alone (presence or absence of HCPCS/ICD‑10 codes) is not sufficient for approval; lack of prior authorization for non‑ophthalmic bevacizumab uses may lead to non‑approval.

Policy: 'The presence of a specific HCPCS or ICD-10 code in a chart ... is not by itself sufficient to approve coverage. Similarly, the absence of such a code does not necessarily mean ... excluded.'

Denial Risk

Non‑listed indications risk denial

Coverage is not recommended for uses outside the situations listed in the Recommended Authorization Criteria; requests for indications not listed in the criteria risk denial.

Policy: 'Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.'

Denial Risk

NSCLC: recent hemoptysis is a contraindication and can lead to non‑approval

A history of recent hemoptysis in a patient with NSCLC is a contraindicating factor; the policy requires no recent hemoptysis for NSCLC approvals and such history can lead to non‑approval.

NSCLC criteria: 'B) No history of recent hemoptysis;' and policy revision notes adding 'the patient does NOT have a history of recent hemoptysis.'

ExamplesUsed for specific FDA‑approved oncology indications referenced in the policy (see FDA‑Approved Indications).

IC-ISGP (Interpretive/supplemental internal criteria)

DefinitionIC-ISGP: Internal criteria intended to interpret or supplement general provisions outlined in applicable NCDs, LCDs, and/or LCAs.

PurposeUsed when policy needs to clarify or extend CMS NCD/LCD/LCA language to specific clinical scenarios.

ApplicationMay appear alongside other internal indicators when NCD/LCD guidance requires interpretation for coverage determinations.

IC-EC (Internal criteria expanding coverage)

DefinitionIC-EC: Internal criteria intended to expand coverage beyond applicable NCDs, LCDs, and/or LCAs.

PurposeDenotes policy-developed coverage that extends beyond CMS determinations for conditions not directly covered by NCDs/LCDs/LCAs.

NoteIndications marked with this may represent expanded, internally developed coverage pathways.

Combination with chemotherapy (examples)

Common regimen examplesFOLFOX (leucovorin, fluorouracil, oxaliplatin); FOLFIRI (leucovorin, fluorouracil, irinotecan); FOLFIRINOX (leucovorin, fluorouracil, oxaliplatin, irinotecan); CapeOX (capecitabine, oxaliplatin).

Other chemo agents citedPemetrexed, cisplatin, carboplatin, capecitabine referenced as examples in mesothelioma, NSCLC, and other indications.

ContextPolicy requires bevacizumab to be used in combination with a chemotherapy regimen for many indications (e.g., ampullary, small bowel, colon/rectal/appendiceal).

Actionable mutation (examples)

Examples of actionable mutationsRET rearrangement, MET exon 14 skipping, NTRK gene fusions, BRAF V600E, EGFR exon 19 deletion/L858R, NRG1 listed as examples influencing eligibility for targeted therapy combinations.

Policy noteActionable mutations are presented as examples in a policy Note and used to guide mutation‑specific coverage branches (especially in NSCLC).

Revision historyKRAS G12C was removed from being considered actionable for certain first‑line NSCLC criteria in recent revisions; NRG1 was added.

Child‑Pugh class (liver disease severity)

DefinitionChild‑Pugh class: Liver disease severity classification referenced in HCC criteria (Child‑Pugh A and B).

Policy applicationChild‑Pugh class is used to characterize hepatic function in hepatocellular carcinoma coverage determinations; criteria for Child‑Pugh A/B were referenced in revisions.

ContextHCC criteria include options for adjuvant and first‑line therapy in combination with atezolizumab; Child‑Pugh status historically influenced eligibility language in policy revisions.