CurrentCignaPolicy N/A

Bevacizumab and biosimilars prior authorization (Mvasi, Zirabev, Vegzelma) coverage criteria

Form and prior authorization checklist governing requests for bevacizumab and its biosimilars for oncology indications submitted to Cigna; affects prescribers and infusion providers requesting coverage.

Policy Summary

PayerCigna

PolicyBevacizumab and biosimilars prior authorization (Mvasi, Zirabev, Vegzelma) coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form including diagnosis, prior therapies, intended regimen, and required identifiers to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3product options

~15listed indications

5 business daysresponse time

Coverage criteria and diagnosis-specific rules

Diagnosis- and regimen-specific coverage criteria

Coverage depends on the diagnosis selected on the form and completion of the branching clinical questions for that diagnosis, including disease stage, combination regimen, prior therapies, and relevant biomarker testing when applicable.

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Diagnosis selection: Patient has one of the listed diagnoses (e.g., ampullary adenocarcinoma; anaplastic glioma; cervical cancer; CNS brain metastases; colorectal cancer; endometrial cancer; ependymoma (excludes subependymoma); epithelial ovarian cancer; fallopian tube cancer; glioblastoma; granulosa cell ovarian cancer; hepatocellular carcinoma; medulloblastoma; non-small cell lung cancer; pleural mesothelioma; primary peritoneal cancer; radiation necrosis and uncontrolled cerebral edema; renal cell cancer; small bowel adenocarcinoma; solitary fibrous tumor/hemangiopericytoma; spine tumors; vulvar squamous cell carcinoma; or other specified oncology uses).

See form list for full diagnostic options.

Regimen and disease stage-specific requirements: For the selected diagnosis, the provider must complete branching questions addressing metastatic/advanced status, whether the drug is single-agent or used in combination, the specific combination agents (e.g., carboplatin + paclitaxel; paclitaxel + cisplatin/carboplatin; pemetrexed + cisplatin/carboplatin; atezolizumab for HCC; capecitabine or 5-FU regimens for small bowel adenocarcinoma; temozolomide for solitary fibrous tumor), prior lines of therapy, platinum-sensitivity for ovarian cancers, prior bevacizumab exposure and response, and any required biomarker testing (e.g., HRD/BRCA, RAS) where applicable.

Providers must answer all applicable branching questions on the form for the chosen diagnosis.

Biosimilar substitution / step therapy: When requesting a specific biosimilar (e.g., Vegzelma), document prior trials of covered biosimilars (Mvasi, Zirabev) or provide justification including documentation if an adverse reaction to an alternative was related to formulation differences.

Supports step-therapy and interchangeability documentation requirements on the form.

Diagnosis	Allowed combination regimens / required combination partners
{"text":"Cervical cancer","status":""},{"text":"Paclitaxel combined with either cisplatin or carboplatin; alternatively paclitaxel combined with topotecan (Hycamtin)","status":""}
{"text":"Colorectal cancer (CRC)","status":""},{"text":"Combination with fluorouracil (5-FU)–based chemotherapy; fluoropyrimidine–irinotecan or fluoropyrimidine–oxaliplatin regimens; trifluridine/tipiracil (Lonsurf) in appropriate second‑line setting (with prior anti‑VEGF and if RAS wild‑type, prior anti‑EGFR when indicated)","status":""}
{"text":"Endometrial cancer","status":""},{"text":"When advanced or recurrent, may be combined with carboplatin and paclitaxel","status":""}
{"text":"Epithelial ovarian, fallopian tube, or primary peritoneal cancer","status":""},{"text":"For advanced disease: may be used in combination with olaparib (Lynparza) for first‑line maintenance after response to platinum‑based chemotherapy; when used with cytotoxic therapy: carboplatin plus paclitaxel (including regimens followed by single‑agent bevacizumab)","status":""}
{"text":"Pleural mesothelioma","status":""},{"text":"In combination with pemetrexed (Alimta) and either cisplatin or carboplatin","status":""}
{"text":"Renal cell carcinoma (RCC)","status":""},{"text":"Depending on histology and setting: combinations may include everolimus or erlotinib for advanced papillary RCC; first‑line or other regimens per form branching (e.g., with Intron‑A for first‑line if indicated)","status":""}
{"text":"Vulvar squamous cell carcinoma","status":""},{"text":"In combination with paclitaxel and either cisplatin or carboplatin","status":""}
{"text":"Hepatocellular carcinoma (HCC)","status":""},{"text":"May be used in combination with atezolizumab (Tecentriq) for unresectable or metastatic disease","status":""}
{"text":"Small bowel adenocarcinoma","status":""},{"text":"In combination with capecitabine (Xeloda) or a 5‑fluorouracil (5‑FU) regimen","status":""}
{"text":"Solitary fibrous tumor / hemangiopericytoma","status":""},{"text":"May be used in combination with temozolomide (Temodar) when specified","status":""}
{"text":"Spine tumors / CNS brain metastases","status":""},{"text":"Form asks whether used as single‑agent to control symptoms or in combination per diagnosis‑specific branching","status":""}
{"text":"Gliomas / anaplastic glioma / medulloblastoma / ependymoma","status":""},{"text":"Form includes single‑agent use options for specific CNS tumors; combinations depend on diagnosis and prior therapy per branching questions","status":""}

Line of therapy requirements

Line of therapy — first-line vs subsequent

Coverage considerations differ for initial (first-line) therapy versus subsequent-line therapy; the form captures the line of therapy and related requirements.

First-line use: Form asks if the requested bevacizumab (or biosimilar) is being given as first-line therapy for the diagnosis (examples: first-line NSCLC regimens; first-line use in other specified cancers). If first-line and combination therapy is indicated, the provider must indicate the specific companion agents (e.g., carboplatin + paclitaxel).

Complete first-line branching questions on the form.

Subsequent-line use: For subsequent-line therapy the form requires documentation of prior therapies, prior bevacizumab-containing regimens and whether progression occurred on those regimens, and details such as prior exposure to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (and, if RAS wild-type, prior anti-EGFR therapy) when relevant (e.g., trifluridine/tipiracil combinations for CRC).

Providers must complete the prior-therapy and progression questions relevant to subsequent-line use.

Biomarker and genomic testing requirements

RAS — RAS wild-type requirement

BiomarkerRAS wild-type

Required contextUsed to qualify for trifluridine/tipiracil (Lonsurf) combination scenario in metastatic colorectal cancer

Form question locationCRC section asks if RAS wild-type for use with Lonsurf combination

BRCA / HRD — genomic instability and/or deleterious or suspected deleterious BRCA mutation

BiomarkerGenomic instability and/or deleterious or suspected deleterious BRCA mutation

Required contextNeeded when HRD-positive status is asserted for first-line maintenance with olaparib in epithelial ovarian, fallopian tube, or primary peritoneal cancer

Form question locationEpithelial ovarian/fallopian tube/primary peritoneal section asks whether gene testing showed genomic instability and/or a deleterious or suspected deleterious BRCA mutation

Provider submission, documentation, and prior authorization actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for bevacizumab products (including biosimilars). Complete the prior authorization form fully to avoid delays; all asterisked (*) patient and provider identifiers must be provided.

Complete all required patient identifiers: patient name, Cigna ID, date of birth, address, and phone.
Provide prescribing physician identifiers: physician name, specialty, DEA, NPI or TIN, office contact, phone, fax, and office address.
Specify medication requested (select exact product and strength), dose, frequency, duration, and patient weight.
Indicate new start vs continuation of therapy and provide treatment start dates if continuation.
Include facility/infusion site details, tax ID, and answer questions about lowest-cost medically appropriate setting.

Step Therapy

Biosimilar Step and Substitution Documentation

When requesting Vegzelma (a biosimilar), document trials of covered alternatives and the outcomes. Provide full details for each alternative tried to demonstrate step completion or contraindication.

List each covered alternative tried: Mvasi (bevacizumab-awwb) and Zirabev (bevacizumab-bvzr) including medication name and strength.
Provide dates of therapy and duration for each alternative (start and stop dates, total time on therapy).
Describe outcomes for each alternative: lack of efficacy, intolerances, adverse reactions, or other reasons for discontinuation.
If allergic or adverse reaction is claimed, document whether reaction is due to formulation differences in inactive ingredients between the requested product and the alternative (e.g., dyes, fillers, preservatives) and include supporting details.
If the member has not tried a covered alternative, indicate that explicitly and provide rationale for bypassing step if applicable.

Documentation Required

Required Submission Information

Provide the required submission information on the form so the review can be completed: include complete patient and provider identifiers, requested product/dose, weight, and supporting clinical/treatment information.

Patient identifiers: patient name, Cigna ID, date of birth, patient address, patient phone.
Prescriber identifiers: physician name, specialty, DEA, NPI or TIN, office contact, office phone and fax, office address.
Requested product: select exact medication and strength (Mvasi, Zirabev, Vegzelma), dose, frequency, and duration of therapy.
Clinical/treatment details: diagnosis, pertinent clinical information (disease stage, prior therapies, performance status), concurrent agents and schedules, and whether therapy is new or continuation (with start dates if continuation).
Weight: current patient weight for dose calculations.
Facility information: infusion/dispensing facility name, tax ID, address, and whether infusion is in a hospital outpatient setting.

Denial Risk

Infusion Setting Requirement

Per some Cigna plans, infusion MUST occur in the lowest cost, medically appropriate setting. If infusion will occur outside that setting, provide medical necessity rationale to justify the site of care.

Answer whether infusion is occurring in a hospital outpatient facility; if yes, indicate whether the patient can be redirected to an alternate lower-cost setting (AIS, MDO, home) with case manager assistance.
If not redirectable, include documentation and medical rationale explaining why the lower-cost setting is not medically appropriate (risk factors, monitoring needs, comorbidities).
Failure to document site-of-care justification may result in denial or re-direction of the claim.

Specific covered combination regimens

Specific combination regimen	Example indication(s) / form branch reference
{"text":"Carboplatin + paclitaxel","status":""},{"text":"Epithelial ovarian (including use followed by single‑agent bevacizumab), endometrial when advanced/recurrent, vulvar squamous cell carcinoma, pleural mesothelioma (with pemetrexed and cisplatin or carboplatin)","status":""}
{"text":"Paclitaxel + cisplatin or carboplatin","status":""},{"text":"Cervical cancer (paclitaxel with cisplatin or carboplatin) and vulvar squamous cell carcinoma","status":""}
{"text":"Paclitaxel + topotecan (Hycamtin)","status":""},{"text":"Alternative combination for cervical cancer as listed on the form","status":""}
{"text":"Pemetrexed (Alimta) + cisplatin or carboplatin","status":""},{"text":"Pleural mesothelioma (with pemetrexed plus either cisplatin or carboplatin)","status":""}
{"text":"Fluorouracil (5‑FU)–based chemotherapy regimens","status":""},{"text":"Colorectal cancer when used in combination with 5‑FU–based regimens","status":""}
{"text":"Fluoropyrimidine–irinotecan or fluoropyrimidine–oxaliplatin regimens","status":""},{"text":"Colorectal cancer combination options (including scenarios addressing progression on first‑line bevacizumab‑containing regimens)","status":""}
{"text":"Trifluridine + tipiracil (Lonsurf)","status":""},{"text":"CRC second‑line setting in patients meeting prior‑therapy and biomarker requirements (prior anti‑VEGF and, if RAS wild‑type, anti‑EGFR therapy)","status":""}
{"text":"Bevacizumab + atezolizumab (Tecentriq)","status":""},{"text":"Hepatocellular carcinoma (HCC) unresectable or metastatic disease branch","status":""}
{"text":"Bevacizumab + olaparib (Lynparza)","status":""},{"text":"Epithelial ovarian/fallopian tube/primary peritoneal for first‑line maintenance when criteria met (after response to platinum‑based chemo)","status":""}
{"text":"Bevacizumab + temozolomide (Temodar)","status":""},{"text":"Solitary fibrous tumor / hemangiopericytoma combination per form branch","status":""}

Background

This prior authorization form covers requests for bevacizumab and its listed biosimilars (Mvasi, Zirabev, Vegzelma) across multiple solid tumor types and related oncology indications. It captures the diagnosis, disease stage, prior lines of therapy, and intended combination regimens needed to determine medical necessity, and it requires documentation of prior bevacizumab or biosimilar use when applicable.

When requesting a biosimilar, the form requires providers to specify the requested product and—for certain products such as Vegzelma—document trials of covered alternatives (Mvasi and Zirabev) including medication name, strength, dates, duration, and outcomes or adverse reactions. Complete patient and prescriber identifiers, the requested product and dose, treatment intent (new start vs continuation), and supporting clinical details on the form to facilitate prior authorization review.