ModifiedAnthemPolicy CC-0128

Atezolizumab (Tecentriq, Tecentriq Hybreza) Coverage Criteria

Clinical medical policy governing medical-benefit coverage and prior authorization criteria for atezolizumab products (Tecentriq and Tecentriq Hybreza) for oncology indications, applicable to Anthem members.

Policy Summary

PayerAnthem

PolicyAtezolizumab (Tecentriq, Tecentriq Hybreza) Coverage Criteria

Policy CodePolicy CC-0128

Change TypeMaterial revisions — step therapy, indication updates, coding edits

Effective DateMar 26, 2026

Next Review DateDec 8, 2025

Key ActionObtain prior authorization and document indication, staging, PD-L1/molecular test results and prior therapies to support approval.

SourceLink

POLICY UPDATE CHANGES

Added Tecentriq Hybreza step therapy and step therapy table.

Removed age criteria for alveolar soft part sarcoma (ASPS) and combined Tecentriq and Tecentriq Hybreza criteria.

Step therapy table updates.

Modified non-squamous NSCLC criteria to allow use for actionable molecular markers and PD-L1 expression and to permit subsequent line or maintenance therapy; added mesothelioma criteria and updated do not approve criteria.

Updated hepatocellular carcinoma Child-Pugh scoring language and added indications for alveolar soft part sarcoma and mesothelioma; retired certain quantity limits.

Clarified NSCLC staging and removed platinum and ECOG requirements for some NSCLC indications; added stage IIIB inclusion.

Multiple (~15)Indications listed

Tecentriq

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Coverage Criteria and Indications

Coverage criteria by indication (summary)

Policy covers atezolizumab when indication-specific criteria are met (see individual indication sections in full policy). Recent revisions updated NSCLC, added mesothelioma, updated alveolar soft part sarcoma, and modified urothelial/other indication statements.

NSCLC updates: Non-squamous NSCLC criteria modified to allow use for actionable molecular markers and PD-L1 expression; subsequent line or maintenance therapy allowed; stage IIIB added; removed platinum requirement and ECOG in some contexts.per indication

See full policy for exact AND/OR logic and testing requirements

HCC updates: Policy updated Child-Pugh score language for hepatocellular carcinoma eligibility.per indication

Refer to full policy for Child-Pugh thresholds

Alveolar soft part sarcoma and mesothelioma: Alveolar soft part sarcoma indication added previously and updated for all stages; mesothelioma criteria added.per indication

See full policy sections

Urothelial carcinoma: Urothelial indications modified historically including removal for some platinum-following uses; current policy includes PD-L1 testing notes for cisplatin-ineligible contexts per prior edits.per indication

Refer to full policy for current stance

Tecentriq or Tecentriq Hybreza may not be approved when the individual has documented disease progression while receiving another PD‑1 or PD‑L1 inhibitor, or when the individual is receiving therapy for an autoimmune disease or chronic condition that requires treatment with a systemic immunosuppressant. Additionally, requests that do not meet the specific indication criteria in this policy are not approvable under this coverage rule.

The policy language includes updated do not approve statements that were added or revised for certain indications during recent reviews; these specific exclusion statements are called out within the individual indication sections of the full policy and must be satisfied for an approval to be considered.

Use of atezolizumab is not approved when the documented clinical criteria for the listed indication are not met or when the request is for an indication not listed in this policy. In particular, the policy specifies that therapy is not approvable after progression on another PD‑1/PD‑L1 agent or when systemic immunosuppressive therapy is required for an autoimmune or chronic condition.

Certain prior uses that were historically considered have been removed and are currently inapplicable for approval. Notably, the policy was revised to remove some urothelial subsequent‑therapy uses following changes in regulatory status and guideline recommendations; those previously listed non‑approved uses remain inapplicable under the current coverage criteria.

Initial Therapy — Indication-specific Requirements

Initial therapy requirements

Indication-specific initial therapy requirements (selections shown):

HCC combination: First-line or adjuvant HCC therapy must be used in combination with bevacizumab (or bevacizumab biosimilar)

(Label, NCCN 2A)

NSCLC nab-paclitaxel regimen: First-line treatment of nonsquamous NSCLC when used with nab-paclitaxel (paclitaxel, protein-bound) and carboplatin; absence of actionable molecular markers required

(Label, NCCN 2A)

Melanoma BRAF combo: Treatment of unresectable or metastatic melanoma requires combination with cobimetinib and vemurafenib for BRAF V600 mutation–positive disease

(Label)

Continuation and Maintenance Therapy

Continuation Maintenance

Continuation maintenance therapy rules for NSCLC:

NSCLC continuation maintenance: Individual is using atezolizumab with or without bevacizumab (or biosimilar) and has tumor response or stable disease following initial cytotoxic therapy (first-line therapy included atezolizumab)

Continuation maintenance allowed per label/NCCN

Continuation/Maintenance therapy

Continuation and maintenance therapy uses updated for NSCLC (allows maintenance or subsequent line use in certain scenarios).

NSCLC maintenance/subsequent use: Allowed after stable disease following certain first-line regimens (for example, atezolizumab with carboplatin and nab-paclitaxel) per update notes; see full policy for duration and prior regimen requirements.per indication

See full policy for duration and prior regimen requirements

Step Therapy and Preferred-Product Requirements

Denial Risk

Denial for Not Meeting Indication Criteria

Denial: Requests that do not meet the clinical indication criteria in this policy should be denied.

Step Therapy

Step Therapy and Preferred-Product Requirement

When Tecentriq Hybreza (atezolizumab) is otherwise approvable per clinical criteria, the member's benefit plan may require step therapy by using a preferred agent first. Providers should document trial and failure, intolerance, contraindication, or inability to receive the preferred product(s) before approval of Tecentriq Hybreza is considered.

Preferred-product requirement: the benefit plan may mandate use of a preferred alternative prior to approval of Tecentriq Hybreza.
Operational exception: Tecentriq Hybreza may be approved when the individual cannot use IV Tecentriq (atezolizumab) due to no venous access.

Billing and Diagnosis Codes

HCPCSHCPCS

J9022	Injection, atezolizumab, 10 mg [Tecentriq]
J9024	Injection, atezolizumab, 5 mg and hyaluronidase-tqjs [Tecentriq Hybreza]

ICD-10 DiagnosisICD-10

C22.0	Liver cell carcinoma
C22.8	Malignant neoplasm of liver, primary, unspecified as to type
C22.9	Malignant neoplasm of liver, not specified as primary or secondary
C33	Malignant neoplasm of trachea
C34.00-C34.92	Malignant neoplasm of bronchus and lung
C43.0-C43.9	Malignant melanoma of skin
C45.0-C45.9	Mesothelioma
C49.0-C49.9	Malignant neoplasm of other connective and soft tissue
C53.0-C53.9	Malignant neoplasm of cervix uteri
Z85.118	Personal history of other malignant neoplasm of bronchus and lung

Referenced ICD-10-CM codesICD-10

C45.0-C45.9	Mesothelioma ICD-10-CM range added
C53.0-C53.9	Cervical cancer ICD-10-CM range added
C49.9	Soft tissue sarcoma related code added
C22.0-C22.9	Hepatocellular carcinoma ICD-10-CM range added
C68.0-C68.9	Urothelial/related ICD-10-CM range referenced (added in 2021)
C43.0-C43.9	Melanoma of skin ICD-10-CM range added

PDL1 expression threshold for adjuvant NSCLC

PD-L1 threshold (adjuvant NSCLC)Tumor cell (TC) PD-L1 expression ≥ 1% required for Stage IB–IIIB adjuvant NSCLC use

Applicable stageStage IB to IIIB NSCLC (adjuvant)

ContextAdjuvant treatment for patients at high risk of recurrence per NCCN guidance referenced in policy

Child-Pugh score (HCC)

PurposeUsed to determine hepatic function suitability for hepatocellular carcinoma (HCC) eligibility

Policy update noteChild-Pugh scoring language updated in policy revisions (see HCC indication-specific section for thresholds)

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Authorization contingent on meeting indication-specific clinical criteria

Prior authorization may be approved only when the individual meets the specified clinical criteria for an approved indication (e.g., the indication- and regimen-specific requirements listed in the policy such as HCC with bevacizumab, NSCLC regimens, or mesothelioma combinations).

Approval requires meeting the indication-specific regimen and testing/staging conditions described in the policy.
Any one of the policy’s indication groups must be satisfied for approval.

Prior Authorization

Prior authorization required per policy CC-0128

Use of atezolizumab (Tecentriq or Tecentriq Hybreza) requires prior authorization per Anthem medical policy CC-0128 with criteria defined by indication, staging, molecular markers, and prior therapy history.

Submit a prior authorization request referencing policy CC-0128 and include documentation supporting the requested indication and regimen.
HCPCS codes J9022 and J9024 apply per coding guidance.

Administration Site and Formulation

Note

Subcutaneous option when IV access unavailable (Tecentriq Hybreza)

Tecentriq Hybreza provides a subcutaneous option when intravenous administration is not possible due to lack of venous access; document inability to use IV Tecentriq to support use of Hybreza.

Indicate ‘no venous access’ status in clinical notes or prior authorization documentation when requesting Tecentriq Hybreza.
Tecentriq Hybreza approval under step therapy is contingent on inability to receive IV Tecentriq.

Billing Rule

Site-of-care and preferred agent listing vary by benefit

Atezolizumab is administered under the medical benefit at standard sites of care; formulary designation differs by benefit with Tecentriq listed as preferred and Tecentriq Hybreza as non‑preferred in payer listings.

Commercial, Medicaid, and Medicare medical benefit lists show Tecentriq as preferred and Tecentriq Hybreza as non-preferred effective June 2026 (varies by state/plan).

Quantity Limits and Formulary Designation

Atezolizumab (Tecentriq) — Quantity limits

StatusQuantity limits for Atezolizumab (Tecentriq) were retired per the 05/21/2021 update

Effective changePolicy revision notes indicate ‘Retire quantity limits’ as part of updates

Operational implicationPrior authorization remains required with indication-specific clinical criteria, but pre-set quantity caps are no longer applied

Definitions and Clinical Terms

ECOG Performance Status (0-5)

DefinitionECOG Performance Status: 0 (fully active) to 5 (dead) scale describing functional status used to guide cancer treatment

Common useHelps determine an individual’s fitness for systemic cancer therapy and eligibility per indication-specific criteria

Scale examples0=fully active; 1=restricted in strenuous activity; 2=ambulatory but unable to work; 3=limited self-care; 4=totally disabled; 5=dead

Actionable molecular markers

Included markersEGFR, ALK, ROS1, BRAF, NTRK, MET, RET

Testing recommendationNCCN panel recommends testing these actionable molecular markers prior to initiating therapy to guide treatment

Background

Atezolizumab (Tecentriq) is an anti‑PD‑L1 monoclonal antibody indicated across multiple tumor types, including non‑small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma (in select BRAF V600 combination regimens), alveolar soft part sarcoma, mesothelioma, and certain cervical cancers. NCCN guidance and the drug label inform indication‑specific combinations, dosing contexts, and substitution of the subcutaneous formulation (Tecentriq Hybreza) where applicable.

Biosimilar and Combination Considerations

Billing Rule

Bevacizumab biosimilar may be used in combination regimens

Policy language incorporates bevacizumab biosimilar consideration when atezolizumab is used in combination regimens (for example in HCC, NSCLC, and mesothelioma combinations).

When the regimen requires bevacizumab, a bevacizumab biosimilar is acceptable per the policy wording.
Ensure combination regimen documentation specifies use of bevacizumab or an identified biosimilar where required.

Policy Summary

PayerAnthem

PolicyAtezolizumab (Tecentriq, Tecentriq Hybreza) Coverage Criteria

Policy CodePolicy CC-0128

Change TypeMaterial revisions — step therapy, indication updates, coding edits

Effective DateMar 26, 2026

Next Review DateDec 8, 2025

Key ActionObtain prior authorization and document indication, staging, PD-L1/molecular test results and prior therapies to support approval.

SourceLink

On This Page

Initial therapy criteria (summary)

Initial therapy contexts updated historically to add first-line uses in NSCLC and HCC and to define use in cisplatin-ineligible urothelial disease.

First-line NSCLC: First-line monotherapy and combination uses in NSCLC have been added historically; PD-L1 selection criteria and use with actionable molecular marker testing have been revised over time per IMpower trials and NCCN guidance.per indication

Refer to full policy for PD-L1 thresholds and selection

Note

Step/Sequence Therapy Considerations

Prior-line therapy and sequencing affect approval decisions. Document prior therapies, reason for discontinuation (progression, intolerance, contraindication), and dates. For subsequent-line approvals, ensure required prior targeted therapy or specific prior regimens are met per the clinical criteria (for example, prior targeted agent failure when listed in indication criteria). Note any prior anti–PD-1/PD-L1 exposure as this may influence appropriateness depending on the indication.

Document prior-line therapies, dates, and reasons for discontinuation.
If policy requires failure of a specific prior targeted regimen, include regimen name and evidence of progression or intolerance.
Prior anti–PD-1 or anti–PD-L1 use should be reported — it may preclude or modify approval depending on the indication.

Step	Requirement / Operational Note
{"text":"Preferred-product step","status":""},{"text":"Member must have trial and failure, contraindication, or intolerance to the plan-preferred agent(s), or documentation that the preferred agent is not available.","status":""}
{"text":"IV Tecentriq exception","status":""},{"text":"Tecentriq Hybreza may be approved if the individual cannot receive IV Tecentriq due to no venous access; document reason and supporting evidence.","status":""}

Operational Requirement	Documentation Needed
{"text":"Prior targeted therapy failure requirement","status":""},{"text":"Name of prior targeted agent(s), treatment dates, and objective evidence of progression or intolerance (e.g., radiology report, clinical notes).","status":""}
{"text":"Specific prior regimen required","status":""},{"text":"Regimen details (agents, dosing), treatment duration, and reason for discontinuation. If the policy permits substitution, document clinical rationale. ","status":""}

Reference guidancePolicy references NCCN and label updates when applying Child-Pugh for HCC determinations

Documentation Required

Required clinical documentation to support the request

Clinical documentation must support the oncologic indication, stage, molecular marker or PD‑L1 testing results, prior therapies (including platinum eligibility/inaeligibility), and Child‑Pugh score for HCC when applicable.

Provide pathology/diagnosis and staging details relevant to the requested indication.
Include results of actionable molecular marker testing (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) or PD‑L1 testing and documentation if tissue is insufficient.
Document prior systemic therapies and rationale for subsequent-line use (e.g., progression after targeted agents).
For HCC, include Child‑Pugh scoring as referenced by the policy.

Denial Risk

Denial triggers: prior PD‑1/PD‑L1 progression and systemic immunosuppression

Requests may be denied if the individual has disease progression while receiving another PD‑1 or PD‑L1 inhibitor or is receiving systemic immunosuppressive therapy for an autoimmune or chronic condition.

Evidence of progression on a different PD‑1/PD‑L1 inhibitor should be documented — such cases may be non-approvable per policy.
Concurrent systemic immunosuppressant therapy for autoimmune or chronic conditions is a denial trigger.

Denial Risk

Denial risk for failure to meet updated indication criteria

Requests that do not meet the policy’s updated indication‑specific criteria may be denied; the policy includes new or revised 'do not approve' statements for certain indications.

Check the indication-specific sections for updated inclusion/exclusion language (e.g., NSCLC, urothelial, mesothelioma).
If the submitted clinical scenario does not match the required regimen, staging, or testing thresholds, expect a denial.

Administer per standard infusion center or office protocols depending on formulation and benefit coverage.

If insufficient tissueRepeat biopsy and/or plasma testing should be done; if not feasible, treat as though driver oncogenes are absent

Immune checkpoint inhibitor

DefinitionImmune checkpoint inhibitor: drug class that blocks checkpoint proteins (eg, PD-1, PD-L1) to release immune 'brakes' and enhance T-cell killing of cancer cells

Examples of targetsProgrammed death (PD)-1 and PD-L1, CTLA-4/B7 family proteins

Atezolizumab classAtezolizumab (Tecentriq) is an anti–PD-L1 monoclonal antibody—an immune checkpoint inhibitor

Actionable molecular markers / PD-L1 (NSCLC)

Policy allowancePolicy updates permit use in NSCLC when either actionable molecular markers are present/assessed or PD-L1 expression meets indication-specific thresholds

Testing guidanceActionable molecular marker testing (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) is recommended prior to initiating therapy; insufficient tissue prompts repeat biopsy/plasma testing

NSCLC specificsSome NSCLC indications require absence of actionable markers for certain combination regimens (eg, nab‑paclitaxel + carboplatin) or PD-L1 thresholds for adjuvant use

Child-Pugh score (HCC — referenced use)

RoleChild‑Pugh score is referenced to determine hepatic function suitability for hepatocellular carcinoma (HCC) indications

Policy revisionChild‑Pugh scoring language was updated in policy revisions (see HCC indication section for application)

DocumentationClinical documentation should include Child‑Pugh score when submitting requests for HCC indications per policy guidance