Bevacizumab (and listed biosimilars) — Intravenous oncology coverage and prior authorization criteria
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Clinical coverage and prior authorization criteria for bevacizumab and listed biosimilars for oncology indications for Viva Health members; defines authorization length, dosing unit limits, and indication-specific clinical criteria.
No material clinical or coverage changes in this revision.
Coverage Criteria and Indication-Specific Rules
inv-01: Universal Initial Criteria
Initial approval requires ALL of the following universal criteria:
inv-02: Ampullary Adenocarcinoma
Ampullary Adenocarcinoma — Covered when ALL of the following are met:
inv-03: Adult CNS Cancers (symptom management and other CNS uses)
Adult CNS Cancers — Covered when ANY of the following indication-specific conditions are met in addition to universal criteria:
inv-04: Cervical Cancer
Cervical Cancer — Covered when ALL of the following are met:
PDL1 testing must be FDA‑approved or CLIA‑compliant.
inv-05: Colorectal Cancer
Colorectal Cancer (CRC) — Covered when ALL of the following are met:
Refer to NCCN guidelines; universal MMR/MSI testing recommended and dMMR/MSI‑H or ultrahypermutated (TMB>50) tumors should be treated with checkpoint inhibitors when appropriate.
inv-06: Appendiceal Neoplasms and Cancers
Appendiceal Neoplasms and Cancers — Covered when ALL of the following are met:
Refer to NCCN guidance.
inv-07: Endometrial Carcinoma
Endometrial Carcinoma — Covered when ALL of the following are met:
inv-08: Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC) — Covered when ALL of the following are met:
inv-09: Peritoneal Mesothelioma
Peritoneal Mesothelioma — Covered when ALL of the following are met:
High‑risk features include Ki‑67 >9%, nodal metastasis, thrombocytosis, PS=2, PCI>17, cc>1, biphasic/sarcomatoid histology, or bicavitary disease.
inv-10: Pleural Mesothelioma
Pleural Mesothelioma — Covered when ALL of the following are met:
inv-11: Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Non‑Squamous Non‑Small Cell Lung Cancer (NSCLC) — Covered when specified biomarker and combination therapy conditions are met:
PD‑1/PD‑L1 contraindications may include active autoimmune disease or immunosuppression.
inv-12: Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Ovarian, Fallopian Tube, and Primary Peritoneal Cancer — Covered when specified histology, platinum‑sensitivity, biomarker, and combination regimen criteria are met:
BRCA1/2 and HR status considerations apply; refer to histology‑specific subclauses.
inv-13: Ovarian/Fallopian Tube/Primary Peritoneal Cancer
Ovarian/Fallopian Tube/Primary Peritoneal Cancer — covered when specific histology, setting, and biomarker criteria are met:
See histology and biomarker subclauses.
inv-14: Pediatric Central Nervous System (CNS) Cancers
Pediatric CNS Cancers — covered for specific tumor types, ages, and regimens:
Age and histology restrictions apply.
inv-15: Renal Cell Carcinoma (RCC)
Renal Cell Carcinoma (RCC) — Covered when indication‑specific criteria are met:
inv-16: Respiratory Papillomatosis
Respiratory Papillomatosis — Covered when indication‑specific criteria are met:
inv-17: Small Bowel Adenocarcinoma
Small Bowel Adenocarcinoma — Covered when ALL of the following are met:
inv-18: Soft Tissue Sarcoma (STS)
Soft Tissue Sarcoma (STS) — Covered when ALL of the following are met:
inv-19: Vaginal Cancer
Vaginal Cancer — Covered when ALL of the following are met:
PDL1 testing must be FDA‑approved or CLIA‑compliant.
inv-20: Vulvar Cancer
Vulvar Cancer — Covered when ALL of the following are met:
Will not be used as part of adjuvant treatment for colorectal cancer. For metastatic, unresectable, or advanced colorectal disease, bevacizumab is covered only in combination with a fluoropyrimidine-based regimen or with irinotecan-based therapy as specified in the colorectal coverage criteria and per NCCN guidance; adjuvant (post‑resection) use is excluded.
Will not be used for locoregional recurrence in endometrial carcinoma without prior radiation to the site of recurrence or after surgical exploration confined to the vagina or paravaginal soft tissue. Coverage for endometrial carcinoma is limited to recurrent disease and to the specific combination or single‑agent contexts described in the policy (for example, combination with carboplatin/paclitaxel with continuation as single‑agent maintenance, or single‑agent subsequent therapy after progression on cytotoxic chemotherapy).
Certain regimens explicitly exclude use in grade 1 endometrioid carcinoma and low grade serous carcinoma. Specifically, oxaliplatin/docetaxel combinations and adjuvant oxaliplatin/docetaxel are not allowed for these lower‑grade histologies as noted in the ovarian/fallopian tube/primary peritoneal cancer criteria and associated surgical/adjuvant clauses.
| Indication | Covered bevacizumab combination/regimen | Coverage status |
|---|---|---|
| Colorectal cancer (CRC) | ||
| Bevacizumab in combination with fluoropyrimidine-based regimens (e.g., FOLFOX, CapeOX, FOLFIRI) for metastatic/unresectable CRC; may be continued after progression per clinical context | ||
| Indication | Covered bevacizumab combination/regimen | Coverage status |
|---|---|---|
| Ovarian, fallopian tube, primary peritoneal cancer (gynecologic cancers) | ||
| Bevacizumab combined with paclitaxel + carboplatin; carboplatin + paclitaxel or docetaxel; oxaliplatin + docetaxel (with histology exclusions); used as maintenance or single agent in biomarker-specified contexts; may be combined with PARP inhibitors (olaparib or niraparib) when specified by BRCA/HR status | ||
| Indication | Covered bevacizumab combination/regimen | Coverage status |
|---|---|---|
| Pediatric central nervous system (CNS) tumors | ||
| Single-agent bevacizumab or in combination as part of TEMR (temozolomide, irinotecan, bevacizumab) or MEMMAT (thalidomide, celecoxib, fenofibrate, etoposide, cyclophosphamide, bevacizumab) regimens; also combined with standard therapies (e.g., irinotecan, carboplatin, vinblastine) depending on tumor type and age-specific criteria | ||
| Indication | Covered bevacizumab combination/regimen | Coverage status |
|---|---|---|
| Small bowel adenocarcinoma | ||
| Bevacizumab combined with a fluoropyrimidine-based regimen (e.g., 5-FU or capecitabine) for advanced/metastatic disease; used as initial therapy if tumor is pMMR/MSS or as subsequent therapy if not previously given | ||
| Reference | Regimen / finding cited | Notes |
|---|---|---|
| Hurwitz H et al. (Bevacizumab + irinotecan/5-FU/leucovorin) | ||
| Supports bevacizumab combined with irinotecan and fluorouracil/leucovorin in metastatic colorectal cancer (clinical trial evidence) | ||
Billing, Code Lists, and Unit Limits
| HCPCS units | Max billable units specified per indication groups (see policy) |
| 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) |
| 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 |
| 00069-0315-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 |
| 70121-1754-xx | Alymsys single-dose vial, 100 mg/4 mL solution for injection |
| 70121-1755-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 |
| C17.0 | Malignant neoplasm duodenum |
| C17.1 | Malignant neoplasm jejunum |
| C17.2 | Malignant neoplasm ileum |
| C17.3 | Meckel's diverticulum, malignant |
| C17.8 | Malignant neoplasm of overlapping sites of small intestines |
| C17.9 | Malignant neoplasm of small intestine, unspecified |
| C18.0 | Malignant neoplasm of cecum |
| C18.1 | Malignant neoplasm of appendix |
| C18.2 | Malignant neoplasm of ascending colon |
| C18.3 | Malignant neoplasm of hepatic flexure |
| C45.9 | Mesothelioma, unspecified |
| C48.0 | Malignant neoplasm of retroperitoneum |
| C48.1 | Malignant neoplasm of specified parts of peritoneum |
| C48.2 | Malignant neoplasm of peritoneum, unspecified |
| C48.8 | Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum |
| C49.0 | Malignant neoplasm of connective and soft tissue of head, face and neck |
| C49.10 | Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder |
| C49.11 | Malignant neoplasm of connective and soft tissue of right upper limb including shoulder |
| C49.12 | Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder |
| C49.20 | Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip |
Authorization, Documentation, and Denial Risk Guidance
Prior Authorization Required
Prior Authorization Required. Prior authorization is required and initial authorizations are generally valid for 6 months (except adult CNS symptom management which is valid for 12 weeks). Renewals may be requested every 6 months unless otherwise specified.
- Initial validity: 6 months (12 weeks for adult CNS symptom management).
- Renewal frequency: may be renewed every 6 months unless noted otherwise.
- Biosimilar step requirement: patient must have a contraindication, intolerance, or failure to Alymsys® AND Mvasi® prior to consideration of another bevacizumab product.
Renewal Authorization Requirements
Renewal authorizations require documentation that the member continues to meet both the universal criteria and the indication‑specific criteria (including any concomitant therapy requirements where applicable). Renewals will not be issued if the original duration limit has been exceeded.
- Renewal requires evidence the patient continues to meet universal and indication‑specific criteria including performance status and any required concomitant therapies.
- Confirm duration of authorization not exceeded (see Length of Authorization).
- Documentation must show disease response (stability or tumor decrease) unless the indication states otherwise.
- Document absence of unacceptable toxicity (examples include GI perforation/fistula, wound healing complications, necrotizing fasciitis, hemorrhage, ATE/VTE, uncontrolled hypertension, PRES, nephrotic syndrome/proteinuria, severe infusion reactions, ovarian failure, CHF).
Renewal Denial Triggers
Renewal requests may be denied for lack of disease response, unacceptable toxicity, or if the allowed duration of prior authorization has been exceeded.
- Denial triggers: no stabilization or tumor decrease as documented; evidence of unacceptable toxicity; authorization duration exceeded.
Therapy History and Testing Documentation
Therapy history and diagnostic testing must be documented when requesting initial or renewal authorization. Provide prior lines of therapy and relevant biomarker testing results per the indication.
- Example: CRC — document prior FOLFOX/CapeOX within 12 months when indicated and MMR/MSI testing per NCCN.
- Example: Ovarian — document BRCA1/2 status and homologous recombination deficiency testing when required; document prior use of bevacizumab if maintenance/continuation criteria apply.
- For vaginal/vulvar cancer, document PDL1 (CPS) status when pembrolizumab combinations are requested (use FDA‑approved or CLIA‑compliant assay).
Required Documentation for Renewal
Required documentation for renewal must demonstrate the member continues to meet universal and indication‑specific criteria, includes evidence of concomitant therapies where applicable, and supports clinical benefit and tolerability of continued therapy.
- Include clinical assessment showing disease response or stability per the indication.
- Include records of concomitant therapies (e.g., chemotherapy, PARP inhibitor, immunotherapy) when required by the indication.
- Include documentation of adverse events and rationale for continuing therapy if prior toxicity occurred.
Required Diagnosis Coding
Diagnosis coding: providers must submit an appropriate ICD‑10 diagnosis code from Appendix 1 that supports a covered indication when requesting prior authorization or submitting claims.
- Use one of the covered ICD‑10 codes listed in Appendix 1 (e.g., C18.*, C20, C34.*, C51-55 series, etc.).
- Submit the code that best reflects the treated primary site/indication and include supporting clinical documentation.
Medicare vs Non‑Medicare Guidance
Medicare vs Non‑Medicare Guidance. The preceding criteria are intended for non‑Medicare coverage determinations. Medicare Part B coverage follows CMS manuals and may be governed by National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs); compliance with applicable NCDs/LCDs/LCAs is required for Medicare claims.
- For Medicare Part B, refer to Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15, §50 and search the CMS coverage database for applicable NCDs/LCDs/LCAs.
- Local contractor guidance (e.g., NCD/LCA/LCD A52370; contractor examples) may apply—confirm the beneficiary’s jurisdiction and applicable documents before authorization.
- Non‑Medicare determinations should follow the policy criteria in this document.
Prior Authorization: Consider
Consideration for Prior Authorization. Per the NQTL Factor Checklist, indication and drug cost support applying prior authorization to this agent; safety/efficacy factors did not indicate PA as a priority alone. Prior authorization should be considered when the indication and cost factors apply.
- NQTL assessment: Indication = Yes (consider PA); Cost of drug = Yes (consider PA); Safety/efficacy = No (PA not a priority solely for these factors).
- Use clinical criteria and cost considerations when determining whether to require PA for a specific request.
Combination and Sequencing Notes
Combination and sequencing notes: many gynecologic and vulvovaginal indications specify bevacizumab in combination with particular chemotherapy agents or with PARP inhibitors/immunotherapy; sequencing and combination requirements are indication specific and must be followed.
- Examples: Ovarian cancer — bevacizumab is described in combination with carboplatin + paclitaxel (or docetaxel) and may be used with olaparib or niraparib for maintenance in specific biomarker contexts.
- Vaginal/vulvar cancers — bevacizumab may be used with paclitaxel plus cisplatin/carboplatin/topotecan or with pembrolizumab combinations when PDL1 CPS ≥1.
- Follow indication‑specific sequencing (neoadjuvant, adjuvant, maintenance, or subsequent therapy) as specified in Section III.
Line of Therapy and Sequencing Rules
inv-51: mixed
Mixed line‑of‑therapy rules across indications:
inv-52: first-line | subsequent
First‑line and subsequent therapy logic for various indications:
Biomarker and Molecular Testing Requirements
Examples of Covered Combination Regimens
| Example context (tumor type) | Example bevacizumab combination/regimen | Coverage status |
|---|---|---|
| Colorectal cancer / Appendiceal neoplasms | ||
| Bevacizumab with fluoropyrimidine-based regimens (FOLFOX, CapeOX, FOLFIRI); continuation after progression described in trial data | ||
| Gynecologic context | Bevacizumab combination/regimen | Coverage status |
|---|---|---|
| Ovarian maintenance/recurrence and other gynecologic uses | ||
| Bevacizumab with paclitaxel + carboplatin; carboplatin + paclitaxel or docetaxel; oxaliplatin + docetaxel (with exclusions); used as maintenance; combined with PARP inhibitors (olaparib or niraparib) when BRCA/HR criteria met | ||
| Pediatric CNS indication | Bevacizumab use/regimen | Coverage status |
|---|---|---|
| Diffuse high-grade glioma (≤21 years), medulloblastoma (3–21 years), optic pathway glioma (<18 years), NF2 vestibular schwannomas (≥6 years) | ||
| Single-agent bevacizumab for palliation; as part of TEMR or MEMMAT regimens; in combination with standard therapies for age- and tumor-specific indications | ||
| Small bowel adenocarcinoma context | Bevacizumab combination/regimen | Coverage status |
|---|---|---|
| Advanced or metastatic small bowel adenocarcinoma | ||
| Bevacizumab combined with a fluoropyrimidine-based regimen (e.g., 5-FU or capecitabine); used as initial therapy if pMMR/MSS | ||
| Study / reference | Regimen involving bevacizumab | Tumor type / relevance |
|---|---|---|
| Hurwitz H et al. (2004) | ||
| Bevacizumab plus irinotecan, fluorouracil, and leucovorin | ||
| Metastatic colorectal cancer (supports FOLFIRI + bevacizumab) |
Definitions and Clinical Terms
Background and Clinical Context
Bevacizumab and its listed biosimilars are monoclonal antibodies that inhibit vascular endothelial growth factor (VEGF) and are used to reduce tumor angiogenesis across multiple solid tumor types. In clinical practice and per this policy, bevacizumab is administered intravenously and is commonly given in combination with cytotoxic chemotherapy or immunotherapy regimens (e.g., fluoropyrimidine‑based regimens in colorectal and appendiceal cancers; carboplatin/paclitaxel in gynecologic cancers; atezolizumab plus bevacizumab in selected hepatocellular carcinoma regimens), and in selected settings may be used as single‑agent therapy for CNS symptomatic indications or maintenance after combination therapy. The policy also defines universal requirements (age, recent bleeding or surgical wound precautions, and biosimilar step requirements) and indication‑specific combinations, dosing ranges, and prior authorization expectations to guide appropriate use.
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