ModifiedCentenePolicy CP PHAR.93

Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev) - Coverage Criteria

Defines prior authorization, continuation, dosing, preferred biosimilar sequencing, exclusions, and administrative rules for bevacizumab (and listed biosimilars) for oncology and non‑ophthalmology uses for Centene members.

Policy Summary

PayerCentene

PolicyBevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev) - Coverage Criteria

Policy CodePolicy CP PHAR.93

Change TypeMaterial content revisions and biosimilar additions

Effective DateDec 1, 2011

Next Review Date

Key ActionSubmit prior authorization with the correct HCPCS/J/Q code and supporting ICD-10 diagnosis; use Mvasi or Zirabev first for non-ophthalmology uses unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Re-organized FDA-approved indications for improved clarity and revised multiple oncology and ophthalmology indications per NCCN updates.

Added multiple newly FDA-approved biosimilars (Avzivi, Jobevne, Mvasi, Zirabev, Vegzelma referenced) to the policy and aligned redirection preferences.

Aligned initial approval durations as 6 months and harmonized legacy line of business policies.

Updated Appendix E to include Oklahoma and Mississippi and revised language and exception for Tennessee.

6 monthsapproval duration

15 mg/kgmax dose

Mvasi, Zirabev

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

preferred biosimilars

100 mg / 400 mgvial sizes

Q51261, Q51291HCPCS codes added

multipleNCCN updates

Coverage Criteria for Bevacizumab and Biosimilars

inv-01: Continued Therapy — Covered for continuation when ALL of the following are met:

Covered for continuation when ALL of the following are met:

Continued therapy prerequisites: Member is currently receiving the requested bevacizumab product via the Centene benefit or has previously met initial approval criteria; the member may be enrolled in a state/product with continuity-of-care regulations (see state addendums); documentation shows the member is receiving Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, or Zirabev for a covered oncology indication and has received the medication for at least 30 days.

Continuation criteria from Section II and continuation subsections.

inv-02: Other diagnoses/indications — biosimilar preference and state exceptions

For Alymsys, Avastin, Avzivi, Jobevne, or Vegzelma requests for non‑ophthalmology uses, must meet 1 and either 2 or 3:

Primary requirement: Request is for a non-ophthalmology use and the requested product is Alymsys, Avastin, Avzivi, Jobevne, or Vegzelma.

See Other diagnoses/indications section.

Either of the following: (a) Member must use a preferred biosimilar (Mvasi or Zirabev) unless both are contraindicated or cause clinically significant adverse effects (prior authorization may be required for Mvasi or Zirabev); OR (b) The request is for treatment associated with cancer in a state with regulations against step therapy/redirection (see Appendix E).

Biosimilar sequencing and state exceptions per policy.

inv-03: Dose increase authorization — If request is for a dose increase, meet one of the following:

If request is for a dose increase, meet one of the following:

Dose increase authorization: (a) The new dose does not exceed the documented maximums (15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks); OR (b) The new dose is supported by practice guidelines or peer‑reviewed literature for the indication with prescriber documentation submitted.15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks

Dose maxima and rounding guidance (Appendix F) apply.

inv-04: General medical necessity — Covered when the requested bevacizumab or biosimilar is used for an FDA-approved or NCCN-supported indication with documented appropriate...

Covered when the requested bevacizumab or biosimilar is used for an FDA-approved or NCCN-supported indication with documented appropriate dosing and supporting diagnosis code from the policy list.

General coverage requirements: Request documents a covered indication (oncology or ophthalmology) AND provides an appropriate ICD-10 diagnosis code listed in the policy AND specifies a dosing regimen that matches the indication-specific dosing guidance in the policy.

Indication-specific dosing regimens and ICD-10 support codes are detailed in the dosing and coding sections.

inv-05: Oncology biosimilar selection — Oncology-specific criteria and redirection

Oncology-specific criteria and redirection

Oncology biosimilar redirection: When policy redirection applies, use the preferred biosimilar (e.g., Mvasi or Zirabev) unless a policy-allowed bypass is documented (such as state regulations prohibiting redirection or documented clinical contraindication/adverse effect to the preferred biosimilar).

Policy history documents redirection updates and allowed bypasses.

inv-06: General coverage posture and updates — Coverage follows FDA-approved indications and NCCN-recommended regimens; revisions updated specific qualifiers and combination allowances.

Coverage follows FDA-approved indications and NCCN-recommended regimens; revisions updated specific qualifiers and combination allowances.

General: Coverage aligns with FDA labeling and NCCN-recommended regimens; ophthalmology uses require an ophthalmologist prescriber; initial approvals have been standardized (e.g., aligned to 6 months in updates); biosimilars are included and redirection language has been updated per NCCN and state considerations.

Summary of policy posture and recent material revisions.

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy are excluded from authorization unless the provider submits sufficient documentation supporting off‑label use in accordance with the applicable off‑label policies (for example, CP.CPA.09 for commercial or HIM.PA.154 for health insurance marketplace).

Per the referenced NCCN updates incorporated into this policy, the breast cancer indication for bevacizumab has been removed and is no longer supported by the coverage criteria.

Policy updates have removed certain combination regimens and requalified others per NCCN guidance — examples include removal of the RCC combination with interferon alfa and simplification or qualification changes for ovarian cancer combination and maintenance options. Refer to the indication‑specific dosing and regimen sections for the current allowed combinations and qualifiers.

AIDS‑related Kaposi sarcoma has been removed from the list of supported off‑label uses and is no longer covered under this policy following NCCN guidance updates.

Coverage is constrained to FDA‑approved indications and NCCN‑specified regimens. Use of bevacizumab or a biosimilar outside those supported regimens, or use without required prescriber qualifications (for example, ophthalmology uses that require an ophthalmologist prescriber), may be considered not medically necessary and subject to denial unless adequate justification and documentation are provided.

Coding and Billing Codes

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required; Approval Duration

Prior authorization is required for bevacizumab and its biosimilars. Initial and renewal approval durations vary by line of business: Medicaid and HIM requests default to 6 months; Commercial requests are approved for up to 12 months or the duration of the request, whichever is less. Requests for continuation should document ongoing benefit and align with the approved duration.

Initial approval durations: Medicaid/HIM = 6 months; Commercial = 12 months or duration of request, whichever is less
Renewals: documentation of continued clinical benefit and adherence to dosing/regimen limits may be required

Billing Rule

Coding and Coverage Risk

Providers must include the specific HCPCS/HCPCS Q-code or J-code for the requested bevacizumab product on the authorization and claims. Inclusion or omission of codes in the policy does not guarantee coverage — professional coding guidance and up‑to‑date code sets must be used. Claims may be denied if coding is not aligned with current guidance.

Background and Scope

Bevacizumab and its biosimilars are anti‑VEGF monoclonal antibodies used across multiple oncology and ophthalmology indications. Intravenous oncology dosing varies by cancer type (common regimens include 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks), while intravitreal ophthalmology dosing is typically 1.25–2.5 mg every 4 weeks with a maximum intravitreal dose of 2.5 mg/dose. Safety considerations in oncology include known risks such as fatal pulmonary hemorrhage in patients with recent hemoptysis or squamous‑cell predominant NSCLC; product labeling and NCCN guidance should be consulted when assessing contraindications and appropriateness of therapy.

Definitions and Abbreviations

inv-31: Chemotherapy regimen abbreviations

FOLFOXFluorouracil, leucovorin, oxaliplatin (Appendix A abbreviation key).

FOLFIRIFluorouracil, leucovorin, irinotecan (Appendix A abbreviation key).

FOLFIRINOXFluorouracil, leucovorin, irinotecan, oxaliplatin (Appendix A abbreviation key).

CapeOXCapecitabine, oxaliplatin (Appendix A abbreviation key).

Other regimen abbreviationsAppendix A lists additional chemotherapy regimen abbreviations used in the policy.

inv-32: Biosimilar bevacizumab

FDA‑approved bevacizumab biosimilars referenced

Initial Therapy Criteria and Dosing

inv-35: Initial Therapy / Approval Duration — Approval duration and initial approval considerations

Approval duration and initial approval considerations

Initial approval duration: Initial approvals: Medicaid/health insurance marketplace (HIM) — 6 months; Commercial — 12 months or duration of request, whichever is less. Dose must be within FDA maximum limits for the indication or justified by practice guidelines/peer‑reviewed literature with prescriber evidence for off‑label use.

Approval duration and prescriber documentation requirements per initial therapy rules.

inv-36: Initial therapy dosing — Indication-specific initial dosing regimens

Indication-specific initial dosing regimens

NSCLC dosing: Non-squamous NSCLC: 15 mg/kg IV every 3 weeks with carboplatin/paclitaxel (maximum 15 mg/kg q3w or 10 mg/kg q2w).

See NSCLC dosing in Dosage and Administration.

Continuation Therapy Criteria

inv-38: Continuation Therapy — Continuation criteria for members already receiving therapy

Continuation criteria for members already receiving therapy

Continuation: Member is currently receiving the requested bevacizumab product via the Centene benefit or previously met initial approval criteria; continuity-of-care regulations apply where relevant; member has been on the medication at least 30 days and is responding to therapy or deriving clinical benefit as documented.

Continuation criteria reference Section II continuation subsections.

inv-39: Continuation therapy — Approval durations and continued therapy notes

Approval durations and continued therapy notes

Continued therapy duration: Continued therapy approvals align with revised approval durations (commercial: 12 months or duration of request; Medicaid/HIM: 6 months) and require documentation of ongoing clinical benefit and consistency with the original indication and dosing regimen.

Revised approval durations noted in policy history and redirection template updates.

Step Therapy and Biosimilar Sequencing

Step	Requirement	Exceptions / Notes
1	Preference for Mvasi or Zirabev before other bevacizumab products for non‑ophthalmology uses	Member must use Mvasi or Zirabev unless both are contraindicated or clinically significant adverse effects occur; prior authorization may be required for Mvasi and Zirabev

Step	Policy Action	Bypass / State Rules
1	Implements redirection to preferred biosimilars (e.g., Mvasi, Zirabev) as a step in prior authorization	Option to bypass redirection where state regulations prohibit redirection in certain oncology settings (see Appendix E); template updates allow generalized bypass language

Step	Clinical Requirement	Reference / Trigger
1	Use permitted after progression on prior specified systemic therapies in accordance with NCCN-recommended subsequent-line options	Progression on prior therapy as defined by NCCN for the indication (e.g., HCC subsequent-line therapy); follow indication-specific sequencing in policy

Quantity Limits and Vial Recommendations

inv-44: bevacizumab — vial quantity per Appendix F

Vial quantity guidance (Appendix F)Vial quantity recommendations by weight-based dose ranges are provided in Appendix F for bevacizumab (see table entries for 100 mg/4 mL and 400 mg/16 mL vial combinations).

Example low-range recommendation0–104.99 mg: recommend 1 vial of 100 mg/4 mL.

Example mid/high-range recommendationsRanges from 105 mg upward specify combinations of 100 mg and 400 mg vials (e.g., 315–419.99 mg = 1 vial of 400 mg/16 mL), per Appendix F.

inv-45: Bevacizumab (and biosimilars) — vial sizes and dosing limits

Available single‑use vial sizesBevacizumab and biosimilars are supplied as single‑use vials in 100 mg/4 mL and 400 mg/16 mL presentations.

Intravitreal dosing limit

Site of Care

Note

Typical administration settings — infusion center, hospital outpatient, office

Typical administration settings referenced include outpatient infusion centers, hospital outpatient departments, or physician offices for IV oncology infusions; intravitreal ophthalmology administrations occur in ophthalmology outpatient/office settings.

IV oncology: infusion center or hospital outpatient setting
Intravitreal ophthalmology: outpatient ophthalmology/office setting

Note

Administration settings by route — IV oncology vs intravitreal ophthalmology

IV oncology administrations are typically delivered in infusion centers or hospital outpatient departments; intravitreal (ophthalmology) administrations occur in outpatient office settings.

IV oncology dosing and administration described in oncology sections
Intravitreal injections for ophthalmology performed in outpatient/office ophthalmology settings

Biosimilar Products and Redirection

Billing Rule

Preferred biosimilars (Mvasi, Zirabev) required unless contraindicated

Members must use Mvasi or Zirabev as the preferred biosimilars unless both are contraindicated or cause clinically significant adverse effects; prior authorization may be required for Mvasi and Zirabev.

Preferred biosimilars: Mvasi and Zirabev
Provide clinical documentation if both preferred agents are contraindicated or produced adverse effects

Billing Rule

Bevacizumab (Avastin) redirected to preferred biosimilars — bypass per state rules

The policy redirects Avastin to preferred biosimilars and allows bypass of redirection where state regulations apply; redirection language and preferred agent alignment have been updated in recent policy revisions.

Redirection to preferred biosimilars may be applied to Avastin requests
Bypass redirection when state regulations prohibit step therapy or per documented exception

Revision History and Policy Changes

2023-01-06HCPCS update

Added HCPCS code Q51261 for a bevacizumab biosimilar and removed legacy C9142 in coding updates.

2023-04-17HCPCS update

Added HCPCS code Q51291 for a bevacizumab biosimilar.

2023-11-23clinical update

4Q 2023 annual review: per NCCN, clarified CRC as advanced/metastatic/unresectable, added single-agent option for cervical cancer, removed RCC combination with interferon alfa, and simplified ovarian cancer combination criteria; aligned initial approval durations to 6 months and harmonized redirection to Mvasi or Zirabev.

Policy Summary

PayerCentene

PolicyBevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev) - Coverage Criteria

Policy CodePolicy CP PHAR.93

Change TypeMaterial content revisions and biosimilar additions

Effective DateDec 1, 2011

Next Review Date

Key ActionSubmit prior authorization with the correct HCPCS/J/Q code and supporting ICD-10 diagnosis; use Mvasi or Zirabev first for non-ophthalmology uses unless contraindicated.

SourceLink

On This Page

Support authorization with the exact HCPCS/HCPCS Q-code or J-code for the product requested (e.g., J9035, Q5126*, Q5129*, Q51261, Q51291)
Policy code lists are informational only; verify current codes prior to claim submission

Denial Risk

Coverage Constrained to NCCN‑Specified Regimens

Coverage for oncology indications is constrained to FDA‑approved regimens and/or NCCN‑recommended regimens and classifications as specified in the policy. Deviations from NCCN‑aligned regimens (including unlisted combination regimens or single‑agent uses not supported by NCCN) may be considered not medically necessary.

Prescribed chemotherapy regimen must be FDA‑approved or recommended by NCCN where specified
Coverage limited to indications, disease stage, and combination regimens listed in the policy; see section I and NCCN‑aligned criteria

Documentation Required

Supporting Documentation for Non‑Standard Uses and Biosimilar Exceptions

Requests for non‑standard or off‑label uses, and requests seeking bypass of biosimilar redirection, must include sufficient supporting documentation. For biosimilar exceptions, documentation should demonstrate contraindication or clinically significant adverse effect to the preferred biosimilars (Mvasi or Zirabev), or that state regulations prohibit redirection/step therapy for the member's oncology setting (see Appendix E).

If requesting a non‑FDA indication not listed in this policy, follow off‑label use policies (CP.CPA.09, HIM.PA.154, CP PMN.53) and submit supporting peer‑reviewed evidence
To bypass biosimilar redirection, provide documentation of contraindication/adverse reaction to preferred biosimilars OR cite applicable state regulation from Appendix E that prohibits redirection for the member's diagnosis/state

Documentation Required

Clinical and Coding Documentation

Authorization requests must document the indication, relevant ICD‑10 diagnosis code(s), dosing regimen (including dose, frequency, and route), prior therapies, and evidence of response or ongoing clinical benefit where applicable. For members already receiving therapy, documentation that the member has received the specified bevacizumab product for at least 30 days may be required.

Include the supporting ICD‑10 diagnosis code(s) from the policy when submitting prior authorization
Document dosing regimen and whether the dose increase (if requested) is supported by guidelines or literature and does not exceed maximum dosing limits
For continuation: document positive response or clinical stability; new starts: document indication and planned regimen

Documentation Required

Prescriber Requirement for Ophthalmology Uses

Ophthalmology uses require the prescriber to be an ophthalmologist. Authorization for intravitreal uses must include indication, ophthalmic dosing, and ophthalmologist certification where applicable.

Ophthalmic indications (e.g., neovascular AMD, diabetic macular edema, retinal vein occlusion) require an ophthalmologist prescriber on the request
Include intravitreal dose and frequency (typical 1.25–2.5 mg every ~4 weeks) and supporting ocular diagnosis codes

Step Therapy

Biosimilar Redirection

The policy includes redirection to preferred biosimilars (e.g., Mvasi, Zirabev) for non‑ophthalmology oncology uses. Members must use Mvasi or Zirabev unless both are contraindicated or clinically significant adverse effects occur, or an applicable state regulation prevents redirection. Prior authorization may be required for the preferred biosimilars themselves.

Default redirection: requests for Avastin and certain biosimilars should be redirected to Mvasi or Zirabev when clinically appropriate
Bypass allowed with documentation of contraindication/adverse event or when Appendix E state rules prohibit redirection
Prior authorization may also be required for Mvasi and Zirabev

Step Therapy

NCCN‑Aligned Sequencing and State Step‑Therapy Exceptions

Sequencing and redirection decisions are aligned with NCCN guidance and state regulations. The policy references NCCN‑based sequencing which may impose step or sequencing requirements for specific indications; where state law (Appendix E) prohibits redirection in certain advanced/metastatic oncology settings, the policy allows bypass of redirection.

NCCN‑aligned sequencing may require use of specific agents or combinations before others for particular indications
If a state in Appendix E prohibits step therapy/redirection for the member's diagnosis, the sequencing/redirection requirement may be bypassed

Policy references multiple FDA‑approved biosimilars including Mvasi, Zirabev, Vegzelma, Alymsys, Avzivi, and Jobevne (added across template updates).

Redirection to preferred biosimilarsPolicy language directs redirection to preferred biosimilars (e.g., Mvasi or Zirabev) for many non‑ophthalmology uses unless contraindicated or state rules permit bypassing redirection.

HCPCS/Q-code additions for biosimilarsPolicy history shows addition of Vegzelma via C9142L and later Q‑codes (Q51261, Q51291) for biosimilars; these updates reflect inclusion of new FDA‑approved products.

inv-33: Dose rounding

Dose rounding guidance referencedPolicy references Appendix F dose rounding guidelines for biologic dose rounding and vial-sparing recommendations.

Use for vial-sparing and percent roundingAppendix F provides specific vial quantity recommendations by weight-based total dose ranges to support dose rounding and vial selection.

Operational applicationDose rounding per Appendix F should be applied when preparing single-use vials to minimize waste and align with quantity limit/vial recommendations.

inv-34: Ophthalmologist — Definition

Definition: Ophthalmologist prescriberPolicy requires ophthalmology uses to be prescribed by an ophthalmologist as specified in the ophthalmology updates (Appendix and coverage criteria).

Ophthalmology-specific requirementCertain retinal and intravitreal indications (e.g., neovascular AMD, DME, RVO, PDR) explicitly require an ophthalmologist prescriber per policy updates.

DocumentationAuthorization requests for ophthalmology indications must document the prescriber specialty to meet the policy's prescriber requirement.

Ovarian cancer dosing: Epithelial ovarian, fallopian tube, primary peritoneal cancer: 15 mg/kg IV q3w with carboplatin/paclitaxel for up to 6 cycles followed by maintenance 15 mg/kg q3w; platinum-resistant options include 10 mg/kg q2w with weekly chemo (maximums per policy).

See ovarian cancer dosing in Dosage and Administration.

HCC dosing: Hepatocellular carcinoma (HCC): 15 mg/kg IV every 3 weeks in combination with atezolizumab (Tecentriq) 1200 mg IV on the same day; follow NCCN and Child‑Pugh considerations noted in policy updates.

See HCC dosing in Dosage and Administration.

Ophthalmology intravitreal dosing: Neovascular AMD and other retinal indications: intravitreal 1.25–2.5 mg every 4 weeks (maximum 2.5 mg/dose); proliferative diabetic retinopathy dosing: 1.25 mg 5–20 days prior to vitrectomy.2.5 mg/dose maximum

Intravitreal dosing and maxima per dosing section.

inv-37: Initial therapy — Initial therapy criteria

Initial therapy criteria

Initial: Initiation follows FDA-approved and NCCN-recommended regimens with any indicated qualifiers (disease stage, mutation status, combination requirements). Initial approval duration has been standardized (aligned to 6 months in updates); prescriber must document indication, regimen, and supporting diagnosis code per policy.

High-level initial therapy criteria derived from updated policy language.

inv-40: Continuation therapy duration — Continuation/renewal approvals

Continuation/renewal approvals

Duration: Initial approvals were aligned to 6 months in updates; continuation or renewal is granted based on clinical response and ongoing alignment with NCCN/FDA-supported regimens.

Derived from alignment statement in policy history.

Intravitreal maximum dose specified as 2.5 mg per dose for retinal/ophthalmology indications.

IV oncology dosing limitsIV maximum dosing commonly referenced as 15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks depending on indication and regimen.

Appendix F vial mappingAppendix F maps weight-based total dose ranges to combinations of the 100 mg and 400 mg vials for vial-sparing selection.

Note

No explicit site‑of‑care limitations specified

The policy does not specify site‑of‑care restrictions that would prohibit administration in hospital outpatient settings; follow standard facility billing and site‑of‑care rules.

No site‑of‑care limitations specified in policy chunks
Follow applicable state Medicaid or payer site‑of‑care rules where they supersede this policy

Vegzelma added; redirection to preferred biosimilars applies

Vegzelma (HCPCS C9142L / Q5129 reference) was added to the policy; where redirection applies, Mvasi or Zirabev remain the preferred agents unless a bypass is documented.

Vegzelma added to policy via HCPCS C9142L (referenced) and Q5129 mapping
Use preferred biosimilars (Mvasi or Zirabev) per redirection rules unless exception applies

Billing Rule

Avzivi added as FDA‑approved biosimilar — follow redirection rules

Avzivi was added as a newly FDA‑approved bevacizumab biosimilar in the policy; treat Avzivi per the policy’s biosimilar redirection and authorization rules.

Avzivi included as a biosimilar option in policy updates
Authorization and redirection rules for biosimilars apply to Avzivi

Billing Rule

Jobevne added to policy — include updated coding in requests

Jobevne (RT4) was added to the criteria as a newly FDA‑approved biosimilar; include Jobevne on authorization and coding submissions per the updated HCPCS/Q‑code guidance.

Jobevne added to policy as newly FDA‑approved biosimilar
Use applicable HCPCS/Q codes per the policy’s updated coding section

2024-06-05Appendix update

Updated Appendix E to include Mississippi (state list for redirection/step therapy exceptions).

2024-08-12clinical update

4Q 2024 annual review: re-organized FDA-approved indications for clarity and revised multiple oncology and ophthalmology indications per NCCN, including NSCLC qualifiers and expanded ophthalmology indications; references reviewed and updated.

2025-05-05biosimilar addition & clinical updateLatest

RT4 updates added newly FDA-approved biosimilar Jobevne to criteria, updated cervical cancer combinations to include atezolizumab (Tecentriq) in some regimens, and adjusted HCC use pathways; Appendix E language and Tennessee exception revised on 2025-05-14.