Atezolizumab (Tecentriq, Tecentriq Hybreza) Coverage Criteria
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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.
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.
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.
See full policy for exact AND/OR logic and testing requirements
Refer to full policy for Child-Pugh thresholds
See full policy sections
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):
(Label, NCCN 2A)
(Label, NCCN 2A)
(Label)
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.
Refer to full policy for PD-L1 thresholds and selection
Continuation and Maintenance Therapy
Continuation Maintenance
Continuation maintenance therapy rules for NSCLC:
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).
See full policy for duration and prior regimen requirements
Step Therapy and Preferred-Product Requirements
Denial for Not Meeting Indication Criteria
Denial: Requests that do not meet the clinical indication criteria in this policy should be denied.
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.
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":""} |
Billing and Diagnosis Codes
| 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 |
| 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 |
Provider Requirements, Documentation, and Denial Triggers
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 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.
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 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 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.
Administration Site and Formulation
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.
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).
- Administer per standard infusion center or office protocols depending on formulation and benefit coverage.
Quantity Limits and Formulary Designation
Definitions and Clinical Terms
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
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.
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