CurrentmhnPolicy CP.PHAR.93

Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev)

Policy defines medical necessity criteria, authorized indications (FDA-approved and select off-label oncology, pediatric, and ophthalmology uses), dosing limits, step-therapy/redirection requirements among branded and biosimilar products, approval durations, and coding implications for bevacizumab and listed biosimilars across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyBevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev)

Policy CodePolicy CP.PHAR.93

Change TypeMultiple annual NCCN-driven updatesbiosimilars addedstep therapy/redirection revisions

Effective DateDec 1, 2011

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added Mvasi and Zirabev biosimilars and redirection language; step therapy bypass language for states with regulations.

Revised approval duration for Commercial line to 12 months or duration of request, whichever is less.

Added ophthalmology intravitreal indications and dose limits (off-label intravitreal use permitted up to 2.5 mg/dose).

Added NCCN-supported indications including ampullary adenocarcinoma, peritoneal mesothelioma, pediatric diffuse high-grade glioma (4Q2022).

Re-classified anaplastic gliomas to astrocytoma and oligodendroglioma per updated NCCN classification (4Q2022).

Removed breast cancer indication, WHO grade 2 glioma indication, and single-agent therapy option for cervical cancer per NCCN (4Q2022).

Added HCPCS code Q5126 and later Q5129; removed C9142 in multiple updates (2022-2023).

Added biosimilars (Vegzelma, Avzivi, Jobevne) to policy and aligned redirection to Mvasi or Zirabev in formulary redirection.

4Q2023 and 4Q2024: multiple NCCN-driven revisions for CRC, cervical cancer, RCC, ovarian cancers, HCC (including adjuvant and Child-Pugh language), ophthalmology expansion, and additional off-label uses.

4Q2025: added step therapy bypass for IL HIM per IL HB 5395 and extended initial approval duration for Medicaid/HIM from 6 to 12 months for maintenance medication.

Added multiple off-label uses supported by literature (e.g., pleomorphic xanthoastrocytoma, gliosarcoma, H3-mutated high-grade glioma, others) and requirement for combination use for certain rare malignancies.

Ophthalmology: prescriber specialty required; age restriction removed; choroidal neovascularization broadened to any cause.

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7Major FDA-approved indications listed

16Off-label adult oncology indications listed

2Off-label pediatric indications listed

9Key HCPCS/J-codes referenced

12moApproval Duration (Medicaid/HIM)

Coverage Summary

This policy covers bevacizumab (Avastin) and listed biosimilars aligning coverage to FDA-approved oncology indications and NCCN recommendations, and includes select off-label oncology, pediatric, and ophthalmology uses supported by guidance or literature. The policy recognizes bevacizumab and biosimilars as VEGF-specific angiogenesis inhibitors and lists the FDA oncology approvals (e.g., CRC, non‑squamous NSCLC, recurrent glioblastoma, RCC, cervical cancer, epithelial ovarian/fallopian tube/primary peritoneal cancer, and HCC with atezolizumab).

Biosimilar redirection and step-therapy rules require use of preferred biosimilars (e.g., Mvasi or Zirabev) for branded or nonpreferred biosimilar requests unless both are contraindicated or clinically significant adverse effects occur; state-specific exceptions apply (see Appendix E). For ophthalmology, intravitreal uses are permitted only for the intravitreal formulation—IV formulations for ophthalmologic indications will not be approved—and intravitreal dosing limits are specified separately.

Key thresholds & quick facts

Maximum oncology dose15 mg/kg IV every 3 weeks OR 10 mg/kg IV every 2 weeks

Ophthalmology intravitreal dose limitDose does not exceed 2.5 mg per dose (typical regimen 1.25 mg q4 weeks)

Pediatric ROP intravitreal dose0.2 mg per intravitreal injection (ROP dosing)

Initial approval duration (Medicaid/HIM)12 months (extended from 6 months for maintenance medication per 4Q2025)

Major covered indications (count)Multiple FDA-approved oncology indications (7 major listed) plus numerous NCCN-supported/off-label indications

Initial Therapy Criteria

Continuation Therapy Criteria

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Non-FDA approved indications not addressed in this policy are not covered unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

General Coverage Notes & Indication-Specific Updates

Applicable Codes

HCPCS / J-codes and related codes referencedHCPCS|mixedCovered

C9257	Injection, bevacizumab, 0.25 mg
J9035	Injection, bevacizumab, 10 mg
J9999	Not otherwise classified, antineoplastic drugs
Q5107	Injection, bevacizumab-awwb (Mvasi), biosimilar, 10 mg
Q5118	Injection, bevacizumab-bvcr (Zirabev), biosimilar, 10 mg
Q5126	Injection, bevacizumab-maly (Alymsys), biosimilar, 10 mg
Q5129	Injection, bevacizumab-adcd (Vegzelma), biosimilar, 10 mg

ICD-10 diagnosis codes that support coverageICD-10Covered

A18.53	Tuberculosis chorioretinitis
C17.0-C17.9	Malignant neoplasm of small intestine
C18.0-C18.9	Malignant neoplasm of colon
C19	Malignant neoplasm of rectosigmoid junction
C20	Malignant neoplasm of rectum
C21.8	Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C33	Malignant neoplasm of trachea
C34.00-C34.92	Malignant neoplasm of bronchus and lung (specific ranges listed)
C48.0-C48.8	Malignant neoplasm of retroperitoneum and peritoneum
C49.0-C49.9	Malignant neoplasm of other connective and soft tissue

1–10 of 28

1/3

HCPCS codes (added/updated in policy history)HCPCS

Q5126	HCPCS code added (replacement for previously added/removed codes)
Q5129	HCPCS code added 04.17.23

Provider Actions & Billing Rules

Documentation Required

Submit supporting documentation

Submit office chart notes, laboratory results, and any other clinical information that documents the member meets ALL approval criteria for the requested bevacizumab product and indication.

Prior Authorization

Prior authorization and product redirection

Prior authorization may be required. For requests for branded products (Alymsys, Avastin, Avzivi, Jobevne, Vegzelma), the member must use Mvasi or Zirabev unless both are contraindicated or clinically significant adverse effects occur. Exception: requests associated with cancer in states listed in Appendix E where redirection/step therapy is prohibited.

Prior Authorization

Intravitreal formulation restriction

Clinical Evidence & References

Primary references include the Avastin and listed biosimilar prescribing information (examples: Avastin prescribing information and specific biosimilar labels such as Mvasi and Zirabev) and multiple NCCN site‑specific guidelines and the NCCN Drugs & Biologics Compendium (references accessed in the 2024–2025 timeframe and cited in the policy).

Off‑label oncology and ophthalmology uses included in this policy rely on NCCN recommendations or peer‑reviewed literature and professional guidance (e.g., AAO guidance for retinal conditions, BEAT‑ROP/other ROP literature). When coverage or dosing for an off‑label indication or doses exceeding stated limits is requested, prescribers must submit supporting evidence (practice guidelines or peer‑reviewed literature) and documentation to demonstrate medical necessity.

Background

Background: Bevacizumab and its biosimilars are VEGF‑specific angiogenesis inhibitors used in oncology and off‑label ophthalmology settings. The policy enumerates FDA‑approved oncology indications (including CRC, non‑squamous NSCLC, recurrent glioblastoma, RCC, cervical cancer, epithelial ovarian/fallopian tube/primary peritoneal cancer, and HCC with atezolizumab) consistent with product labeling.

Policy alignment: Coverage and dosing follow FDA labeling and NCCN regimen recommendations, including explicit dose limits (general oncology maximums of 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks) and ophthalmology intravitreal dose limits (intravitreal bevacizumab ≤ 2.5 mg per dose, with typical 1.25 mg q4 weeks and pediatric ROP dosing noted). The policy implements biosimilar redirection to preferred agents (e.g., Mvasi or Zirabev) with state exceptions documented in Appendix E and allows prescriber‑submitted evidence to justify alternative products or off‑label dosing.

Definitions (quick reference)

RedirectionRequirement to use preferred biosimilar (Mvasi or Zirabev) instead of other branded/biosimilar products unless both are contraindicated or clinically significant adverse effects occur; state exceptions apply (see Appendix E)

NCCNNational Comprehensive Cancer Network; used as reference for regimen and recommendation support (policy requires prescribed regimen be FDA-approved or recommended by NCCN)

Health Plan

Revision History

4Q2021 (08.15.21 / 11.21 RT4)added

Added Mvasi and Zirabev biosimilars and redirection language; step therapy bypass option for states with regulations against redirection.

01.20.22 / 05.22 (Commercial approval duration revision)revised

Revised approval duration for Commercial line to 12 months or duration of request, whichever is less.

05.04.22 / 04.2022added

Added newly FDA‑approved biosimilar Alymsys and generalized oncology redirection bypass language.

Policy Summary

Payermhn

PolicyBevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev)

Policy CodePolicy CP.PHAR.93

Change TypeMultiple annual NCCN-driven updatesbiosimilars addedstep therapy/redirection revisions

Effective DateDec 1, 2011

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Intravitreal bevacizumab solution requests for ophthalmology indications are allowable. Intravenous (IV) formulations of Avastin or any bevacizumab biosimilar for ophthalmology uses will not be approved.

Billing Rule

Dose rounding guidance

Follow Appendix F vial quantity recommendations for weight-based dose rounding and select vial combinations for billing and preparation.

Documentation Required

Off-label evidence requirement

For off-label uses or requests with doses exceeding policy limits, the prescriber must submit supporting evidence from practice guidelines or peer‑reviewed literature demonstrating the rationale for the use or dose.

Documentation Required

Continued therapy documentation

For continued therapy, submit documentation showing the member is responding positively to therapy and meets continuity criteria: currently receiving the medication via the Health Plan, previously met initial approval criteria, is enrolled in a state/product with continuity rules, or has received the medication for at least 30 days for a covered oncology indication.

Prior Authorization

Prior authorization required per Health Plan clinical policy

Coverage decisions follow this clinical policy. Prior authorization may be required by line of business and approvals are subject to the policy's indication-specific criteria and stated initial approval durations.

Documentation Required

Ophthalmology prescriber requirement

Ophthalmology uses require that the prescriber be an ophthalmologist.

Step Therapy

Step therapy bypass for IL HIM

Illinois HIM members have a step therapy bypass per IL HB 5395; follow state-specific step therapy exceptions for HIM members as outlined in the policy.

Billing Rule

Biosimilar redirection

Providers should follow formulary and biosimilar redirection to preferred agents (Mvasi or Zirabev). Recognized biosimilars referenced in the policy include Mvasi and Zirabev and additional biosimilars added over time (Avzivi, Vegzelma, Jobevne); use of non-preferred branded/biosimilar products requires meeting the redirection exception criteria.

Preferred biosimilars: Mvasi, Zirabev
Additional biosimilars referenced: Avzivi, Vegzelma, Jobevne

A health plan that has adopted this clinical policy and is operated or administered, in whole or in part, by Centene Management Company, LLC, or affiliates

4Q2022 (10.24.22 / 11.22)added

Added ophthalmology intravitreal indications and dose limits (off‑label intravitreal use permitted up to 2.5 mg/dose); added additional NCCN‑supported indications including ampullary adenocarcinoma, peritoneal mesothelioma, pediatric diffuse high‑grade glioma; re‑classified glioma subtypes; removed certain indications per NCCN.

4Q2022 (HCPCS updates through 01.06.23 and 04.17.23)added

Policy HCPCS code list updated: removed C9142 and added Q5126, later added Q5129.

RT4 updates 12.14.23 and 4Q2023 (08.19.23 / 11.23)added

Added biosimilar Avzivi; multiple NCCN‑driven revisions for CRC, cervical cancer, RCC, ovarian cancers, and HCC (including Child‑Pugh language added then adjusted in later reviews).

4Q2024 (08.12.24 / 11.24)revised

Re‑organized FDA‑approved indications and applied multiple NCCN‑driven revisions across oncology (CRC, NSCLC, RCC, ovarian, HCC) and ophthalmology (broadened choroidal neovascularization, added radiation retinopathy and ROP, removed ophthalmology age restriction, required ophthalmologist prescriber).

RT4 / 05.05.25 and 4Q2025 (07.30.25 / 11.25)addedLatest

Added biosimilar Jobevne and Vegzelma; added multiple off‑label uses supported by literature; added IL HIM step therapy bypass per IL HB 5395 and extended initial approval duration for Medicaid/HIM maintenance medication from 6 to 12 months.