ModifiedArizona Complete HealthPolicy CP.PHAR.93

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

Defines medical necessity, prior authorization, step therapy, and coverage criteria for bevacizumab and listed biosimilars across oncology and selected off-label ophthalmology and pediatric uses for Arizona Complete Health lines of business.

Policy Summary

PayerArizona Complete Health

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

Policy CodePolicy CP.PHAR.93

Change TypeMultiple material revisions (added biosimilar, indication updates, billing code, duration and step therapy changes)

Effective DateDec 1, 2011

Next Review DateN/A

Key ActionSubmit prior authorization with documentation demonstrating the listed indication, prescriber specialty, dosing, and biosimilar/step therapy status.

SourceLink

POLICY UPDATE CHANGES

Added newly FDA-approved biosimilar Jobevne to criteria.

Re-organized FDA-approved indications for clarity and updated multiple oncology and ophthalmology criteria per NCCN 4Q 2024 annual review.

Extended initial approval duration for Medicaid and HIM from 6 months to 12 months and added step therapy bypass for IL HIM per IL HB 5395 (4Q 2025 annual review).

Added newly FDA-approved biosimilar Jobevne to criteria.

Expanded oncology and ophthalmology indication pathways, including adjuvant therapy option for members at high risk of recurrence following resection or ablation.

HCPCS code Q5160 added for bevacizumab biosimilar billing.

Ophthalmology uses revised to allow choroidal neovascularization from any cause and expanded diabetic retinopathy language to allow any cause and stage.

12 monthstypical approval duration

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Coverage Criteria

Off‑label Oncology (Adult and Pediatric)

Off-label Oncology (Adult and Pediatric) — Non‑FDA‑Approved Oncology Indications (must meet ALL of the following):

ALL of the following

- Glioma of one of the following types: oligodendroglioma that is IDH‑mutant, 1p19q codeleted; IDH‑mutant astrocytoma; circumscribed glioma; pleomorphic xanthroastrocytoma; gliosarcoma; H3‑mutated high‑grade glioma; high‑grade astrocytoma with piloid features
- Ampullary adenocarcinoma - intestinal type
- Endometrial carcinoma
- Intracranial and spinal ependymoma
- Peritoneal mesothelioma
- Pleural mesothelioma
- Medulloblastoma
- Meningioma
- Metastatic spine tumors or brain metastases
- Primary central nervous system lymphoma
- Primary spinal cord tumors
- Small bowel adenocarcinoma
- Soft tissue sarcoma - solitary fibrous tumor or angiosarcoma
- Vulvar cancer - adenocarcinoma or squamous cell carcinoma
- Neurofibromatosis type 2 vestibular schwannomas with hearing loss
- Vaginal cancer
Prescribed by or in consultation with an oncologist
Age ≥ 18 years
For requests for Alymsys, Avastin, Avzivi, Jobevne, or Vegzelma, one of the following must be met: member must use Mvasi or Zirabev unless both are contraindicated or clinically significant adverse effects are experienced; OR the request is for treatment associated with cancer in a state with regulations that bypass redirection to a preferred agent (see Appendix E)
For ampullary adenocarcinoma, peritoneal mesothelioma, pleural mesothelioma, small bowel adenocarcinoma, or vulvar cancer: therapy must be prescribed as part of combination therapy
For neurofibromatosis type 2 vestibular schwannomas with hearing loss: therapy may be prescribed as a single agent
Dose must be within the FDA maximum limit for any FDA‑approved indication OR supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA‑approved or recommended by NCCN

type":"criteria_group

title":"Off‑label Oncology (Adult and Pediatric) — Non‑FDA‑Approved Oncology Indications (Adult)"}],

Initial Therapy Criteria

Initial therapy requirements

Initial therapy coverage requires meeting diagnosis‑specific and general criteria:

Initial therapy requirements: Diagnosis‑specific criteria, prescriber specialty, age requirements, regimen source (FDA or NCCN), dosing limits, and biosimilar/step therapy preference must be satisfied for initial therapy approvals.

Initial Therapy

Initial use of certain branded biosimilars is subject to biosimilar‑preference and state exceptions.

Biosimilar preference for initial therapy: For initial non‑ophthalmology therapy with branded bevacizumab products (Alymsys, Avastin, Avzivi, Jobevne, Vegzelma), member should start on a preferred biosimilar (Mvasi or Zirabev) unless both are contraindicated or cause clinically significant adverse effects; states listed in Appendix E may prohibit redirection for certain cancer settings; prior authorization may be required for Mvasi and Zirabev.

Initial Therapy

Continuation and Maintenance Criteria

Continuation

Continuation approvals require evidence of prior authorization or ongoing therapy and clinical benefit.

Continuation: Member currently receiving medication via the Centene benefit or previously met initial approval criteria OR member currently receiving medication and enrolled in a state/product with continuity‑of‑care regulations OR has received listed bevacizumab for a covered oncology indication for ≥30 days; member demonstrates clinical benefit or no unacceptable toxicity; biosimilar preference/step therapy rules apply as above; dose increases must be within specified limits or supported by guidelines/literature with prescriber evidence.

Continued therapy

Continued therapy requires documentation of ongoing benefit and alignment with disease‑specific criteria and regimen.

Continued therapy: Member documents ongoing clinical benefit from bevacizumab therapy and remains on an approved regimen per policy; approvals and duration vary by line of business and are consistent with policy thresholds.

Provider Actions and Requirements

Prior Authorization

Prior Authorization, Documentation, and Off‑Label Use

Prior authorization is required and approval is contingent on meeting the clinical criteria in this policy. Providers must submit documentation (such as office chart notes, laboratory results, treatment history, and other pertinent clinical information) demonstrating that the member meets all applicable approval criteria, including indication, dosing, prior therapies, and response to therapy.

Failure to submit required documentation may result in denial of the request or delay in processing.
Documentation that a member is currently receiving the medication for a covered oncology indication for at least 30 days, or evidence that the member previously met initial approval criteria, may support continuation requests.
For off‑label (non‑FDA) indications not specifically addressed in this policy, the prescriber must submit supporting peer‑reviewed literature or guideline evidence and follow applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), and CP.PMN.53 (Medicaid).

Coding and Dose Guidance

Drug HCPCS/Codes referencedHCPCS

C9257	Injection, bevacizumab, 0.25 mg
J9035	Injection, bevacizumab, 10 mg
J9999	Not otherwise classified, antineoplastic drugs
Q5107	Injection, bevacizumab-awwb, biosimilar, (Mvasi), 10 mg
Q5118	Injection, bevacizumab-bvcr, biosimilar, (Zirabev), 10 mg
Q5126	Injection, bevacizumab-maly, biosimilar, (Alymsys), 10 mg
Q5129	Injection, bevacizumab-adcd (Vegzelma), biosimilar, 10 mg
Q5160	Injection, bevacizumab-nwgd (jobevne), biosimilar, 10 mg

ICD-10 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
C33	Malignant neoplasm of trachea
C34.00-C34.92	Malignant neoplasm of bronchus and lung (various sites)
C48.0-C48.8	Malignant neoplasm of retroperitoneum and peritoneum
C49.0-C49.9	Malignant neoplasm of other connective and soft tissue
C50.01-C50.929	Malignant neoplasm of breast

1–10 of 15

1/2

Covered HCPCS CodesHCPCSCovered

Q5160

HCPCS code added (bevacizumab biosimilar)

Dosing limits

IV oncology dose limitsDose must not exceed 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks (unless supported by practice guidelines or peer‑reviewed literature).

Intravitreal ophthalmology dose limitIntravitreal bevacizumab requests limited to intravitreal formulation and dose must not exceed 2.5 mg per dose (or be supported by guidelines/literature).

Dose exceptionsDose above standard limits may be considered if supported by practice guidelines or peer‑reviewed literature; prescriber must submit supporting evidence.

Weight-based vial mapping (Appendix F)

≤ 104.99 mgUse 1 x 100 mg vial (100 mg/4 mL).

105 mg – 209.99 mg

Step Therapy Rules

Step	Requirement	Notes
1
Member must use Mvasi or Zirabev before other branded bevacizumab products (Alymsys, Avastin, Avzivi, Jobevne, Vegzelma)
Applies unless both preferred biosimilars are contraindicated or cause clinically significant adverse effects; prior authorization may be required

Step	Requirement	State/Exception Notes
1
For requests of Alymsys, Avastin, Avzivi, Jobevne, or Vegzelma for non-ophthalmology uses, member must use Mvasi or Zirabev first unless both are contraindicated or cause clinically significant adverse effects
States listed in Appendix E may prohibit redirection/step therapy for certain advanced/metastatic cancer settings; prior authorization may be required for Mvasi and Zirabev

Step	Bypass/Exception	Scope
1
Step therapy bypass added for Illinois Health Insurance Marketplace (HIM) per Illinois HB 5395
Bypass applies to IL HIM members for all indications as of 1/1/2026; otherwise general step therapy and redirection to preferred biosimilars remain in effect per policy

Step	Bypass	Effective/Notes
1
A step therapy bypass was added for Illinois Health Insurance Marketplace (HIM) per IL HB 5395
Implemented for all indications (effective 1/1/2026); other step therapy rules continue to apply for non-IL HIM lines of business

Quantity Limits and Vial Rounding

Bevacizumab — weight-based dosing & vial rounding

Quantity limits referenceBevacizumab quantity and vial rounding follow weight-based dosing and vial rounding guidance in Appendix F.

Dose examples in dosing sectionIV dosing regimens and maximum doses for oncology indications are specified in Dosage and Administration (e.g., 15 mg/kg q3w, 10 mg/kg q2w, 10 mg/kg q2w for recurrent glioblastoma).

Vial rounding policy locationAppendix F contains the weight-based dose range to vial quantity recommendations used for claim/quantity calculations.

Bevacizumab and biosimilars — coding & quantity references

HCPCS/J-code list for bevacizumab and biosimilarsCodes referenced include J9035 (bevacizumab 10 mg), C9257 (bevacizumab 0.25 mg), biosimilar Q-codes (Q5107, Q5118, Q5126, Q5129, Q5160), and J9999 for NOC antineoplastics.

New biosimilar billing code

Site of Care

Note

Biosimilar Preference and Handling

Note

Background

Bevacizumab and its biosimilars are vascular endothelial growth factor (VEGF)–specific angiogenesis inhibitors used across multiple malignancies and selected ophthalmologic conditions. This clinical policy uses FDA‑approved indications and NCCN‑supported regimens to determine coverage and also defines ophthalmology uses (intravitreal administration) and selected off‑label oncology and pediatric indications when supported by evidence. The policy is a guide to medical necessity and does not supersede state or plan coverage documents; providers must follow documentation and prescriber requirements when requesting authorization.

Definitions and Acronyms

Bevacizumab and biosimilars — definitions & references

Class definitionBevacizumab and biosimilars are vascular endothelial growth factor (VEGF)-specific angiogenesis inhibitors.

NCCN acronymNCCN = National Comprehensive Cancer Network (Appendix A).

Child‑Pugh class referenceChild‑Pugh class is referenced for HCC treatment qualifiers; policy historically referenced class A/B and updated language modifies requirements.

NCCN (definition)

NCCN acronymNCCN stands for National Comprehensive Cancer Network (listed in Appendix A).

Appendix locationDefinition appears in Appendix A: Abbreviation/Acronym Key.

Policy Summary

PayerArizona Complete Health

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

Policy CodePolicy CP.PHAR.93

Change TypeMultiple material revisions (added biosimilar, indication updates, billing code, duration and step therapy changes)

Effective DateDec 1, 2011

Next Review DateN/A

Key ActionSubmit prior authorization with documentation demonstrating the listed indication, prescriber specialty, dosing, and biosimilar/step therapy status.

SourceLink

On This Page

Billing Rule

Coding and Billing Risks

Providers should ensure that billed diagnosis and drug codes match the HCPCS/J‑codes and ICD‑10 codes referenced by this policy. Coding mismatches or use of unsupported codes may trigger claim denials or require claim adjustment.

Codes referenced for informational use include: J9035, C9257, Q5107, Q5118, Q5126, Q5129, Q5160, and J9999.
Inclusion or exclusion of codes in this policy does not guarantee coverage; providers must reference up‑to‑date professional coding guidance prior to claim submission.

Documentation Required

Coverage Document Compliance

Coverage decisions are guided by this clinical policy but remain subject to the member’s specific coverage documents and Health Plan administrative policies. Meeting clinical criteria does not guarantee payment; benefit limitations, exclusions, prior authorizations, and other plan terms apply.

Coverage determinations are subject to the terms, conditions, exclusions, and limitations of the member’s evidence of coverage, certificate of coverage, or contract.
State and federal statutory requirements and Health Plan‑level administrative policies and procedures may affect coverage; providers should consult member benefit documents and plan addenda (including state‑specific appendices) as needed.

Documentation Required

Required Documentation and Adherence

Providers must adhere to the requirements in this clinical policy when submitting prior authorization requests and supporting materials. Failure to comply with required documentation or to follow plan‑level administrative policies may result in denial, delay, or rescission of authorization.

Follow plan‑level administrative policies and any applicable state addendums (e.g., continuity of care provisions or state restrictions on step therapy described in Appendix E).
For requests involving dosing outside FDA limits, include supporting evidence from practice guidelines or peer‑reviewed literature as specified in the policy.