Atezolizumab (Tecentriq, Tecentriq Hybreza) coverage criteria
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Clinical prior authorization and coverage criteria for Tecentriq (atezolizumab) and Tecentriq Hybreza across multiple oncology indications, specifying clinical scenarios, combinations, and restrictions for Anthem members.
Add Tecentriq Hybreza step therapy and new step therapy table.
Remove age criteria for alveolar soft part sarcoma (ASPS) and update wording/formatting.
Add FDA indication for combination use with Zepzelca (lurbinectedin) in extensive-stage small cell lung cancer.
Modified non-squamous NSCLC criteria to allow use in actionable molecular markers and PD-L1 expression and allowed subsequent line or maintenance therapy.
Removed requirement for platinum therapy and ECOG in certain NSCLC updates and added cervical cancer criteria.
Added new indication for alveolar soft part sarcoma and later clarified do not approve criteria.
Coverage Criteria and Approval Rules
Summary of revised coverage groups
Coverage criteria were revised across several tumor types; specifics appear in other sections of the policy not included in this part. Summaries of major changes are below.
See full criteria in main policy (document history entries 05/17/2024; 05/21/2021; 12/09/2019)
Added 12/12/2022; clarified 11/17/2023; see history 05/17/2024
Refer to 05/21/2021 document history and main policy text
Select review 02/23/2024
Tecentriq (atezolizumab) or Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) may not be approved when any of the following apply: the individual has documented disease progression while receiving another PD-1 or PD-L1 inhibitor; the individual is currently receiving therapy for an autoimmune disease or other chronic condition that requires treatment with a systemic immunosuppressant; or the request does not meet the applicable indication-specific criteria outlined elsewhere in this policy.
Several indication-specific changes were made to the policy following regulatory and guideline updates. Notable revisions include allowing non-squamous NSCLC use guided by actionable molecular markers and PD-L1 expression, expanding NSCLC to permit subsequent-line or maintenance therapy, adding mesothelioma criteria, and clarifying or adding explicit 'do not approve' criteria. Additionally, certain indications were removed or altered in response to prior FDA withdrawals (see urothelial-related changes). These documented changes are reflected in the policy history and coding updates.
Requests that do not meet the specific, indication-related clinical criteria described in this policy are considered not medically necessary. Approval decisions require the submitted clinical information to match the applicable coverage criteria for the requested diagnosis and regimen.
Use of Tecentriq as subsequent treatment following platinum therapy for urothelial carcinoma was removed from coverage per the FDA withdrawal and policy updates; such requests are considered not medically necessary under the current policy and will be denied when submitted for that indication.
Regimens and Combination Therapies
| Regimen | Indication / Key criteria | Coverage status |
|---|---|---|
| Atezolizumab in combination with nab-paclitaxel (albumin-bound paclitaxel) and carboplatin | First-line treatment of recurrent, advanced, or metastatic nonsquamous NSCLC; individual does not have presence of actionable molecular markers | Covered when criteria met |
| Regimen | Indication / Key criteria | Coverage status |
|---|---|---|
| Atezolizumab in combination with carboplatin, paclitaxel, and bevacizumab (or bevacizumab biosimilar) | First-line, subsequent-line, or maintenance treatment of recurrent, advanced, or metastatic NSCLC; used as combination regimen per label/NCCN | Covered when criteria met |
| Regimen | Indication / Key criteria | Coverage status |
|---|---|---|
| Atezolizumab with etoposide and carboplatin followed by maintenance atezolizumab monotherapy | First-line treatment of extensive-stage small cell lung cancer (ES-SCLC); induction with etoposide + carboplatin followed by maintenance atezolizumab | Covered when criteria met |
| Atezolizumab in combination with Zepzelca (lurbinectedin) | First-line treatment option for ES-SCLC per label/NCCN (combination with lurbinectedin) | Covered when criteria met |
| Regimen | Indication / Key criteria | Coverage status |
|---|---|---|
| Atezolizumab in combination with bevacizumab (or biosimilar) | First-line treatment of advanced, unresectable, or metastatic hepatocellular carcinoma (HCC); also adjuvant HCC at high risk of recurrence when used with bevacizumab | Covered when criteria met |
| Regimen | Indication / Key criteria | Coverage status |
|---|---|---|
| Atezolizumab in combination with carboplatin plus nab-paclitaxel | NSCLC combination regimens as described in IMpower studies; applicable for first-line or subsequent contexts per policy nodes | Covered when criteria met |
| Atezolizumab with other chemotherapy per IMpower studies | Use in NSCLC combinations supported by IMpower clinical trial references (see policy references) | Covered when criteria met |
| Regimen | Indication / Key criteria | Coverage status |
|---|---|---|
| Atezolizumab plus nab-paclitaxel (albumin-bound paclitaxel) | Treatment of PD-L1 selected advanced triple-negative breast cancer per referenced trials (clinical trial evidence cited: Adams et al., Emens et al.) | Covered when criteria met |
Line of Therapy Criteria
First-line
First‑line uses covered when ALL of the following indication‑specific conditions are met, as listed below.
Chunk 9.A; overview chunk 2
Chunk 9.C; historical addition chunk 20
Chunk 10.J; overview chunk 2
Second-line
Subsequent‑line (second‑line) coverage is met when ALL of the following are satisfied for the NSCLC subsequent‑use pathway:
Chunk 9.F and Chunk 10.G
First-line | Second-line | Maintenance
First‑line, second‑line, and maintenance contexts updated to allow overlap of uses in NSCLC and other tumor types; apply the indication‑specific nodes above.
Biomarkers and Testing Requirements
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 | ICD-10-CM codes added for mesothelioma (per coding review) |
| C53.0-C53.9 | ICD-10-CM codes for cervical cancer added |
| C68.0-C68.9 | ICD-10-CM codes added previously (urothelial related codes) |
| C22.0-C22.9 | ICD-10-CM codes for hepatocellular carcinoma added |
Provider Actions, Authorization, and Denial Risks
Medical necessity — meet indication‑specific criteria
Prior authorization may be approved when the patient meets any of the listed indication-specific clinical criteria (examples include first-line HCC in combination with bevacizumab, adjuvant high‑risk HCC with bevacizumab, specified first-line and subsequent NSCLC regimens, ES‑SCLC combinations, melanoma with BRAF V600 combination therapy, ASPS monotherapy, cervical cancer combinations, and mesothelioma subsequent therapy).
- Approval logic: Requests for Tecentriq or Tecentriq Hybreza may be approved if any of the indication-specific criteria in the COVERAGE CRITERIA are met (see chunks 8–11).
- Examples of covered scenarios are enumerated in chunk 9 (HCC, NSCLC, ES‑SCLC, etc.) and chunk 11 (mesothelioma).
Prior authorization implied; benefit tiering lists Tecentriq as preferred
Prior authorization is implied for medical benefit coverage and, effective 06/01/2026, Tecentriq is listed as the preferred agent and Tecentriq Hybreza as non‑preferred on the Commercial and Medicare medical benefit lists.
- Commercial Medical Benefit listing: Preferred Agents = Tecentriq; Non‑Preferred Agents = Tecentriq Hybreza (effective 06/01/2026).
- Medicare Medical Benefit listing: Preferred Agents = Tecentriq; Non‑Preferred Agents = Tecentriq Hybreza (effective 06/01/2026).
Tecentriq Hybreza step therapy — preferred agent(s) required
Tecentriq Hybreza is subject to a step therapy requirement: even if clinical criteria are met, the benefit plan may require use of a preferred agent(s) first; Tecentriq Hybreza may be approved when the individual is unable to receive intravenous Tecentriq due to no venous access.
- Benefit plans may require use of a preferred agent or agents when Tecentriq Hybreza is otherwise approvable (chunk 12).
- Specific approval condition: Tecentriq Hybreza requests may be approved if the individual is unable to use intravenous Tecentriq due to no venous access (chunk 13).
- A list of preferred products is referenced in the policy (chunk 13).
Step edits / quantity limits — none specified here; previous quantity limits retired
Quantity limits were retired (05/21/2021); the document does not specify step edits or ongoing quantity limits in this extract.
- Document history notes removal/retirement of quantity limits on 05/21/2021 (chunk 20).
- Current excerpt does not list explicit step edits or quantity limits (chunk 18).
Required molecular marker testing and measures before therapy
Actionable molecular marker testing (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) is recommended prior to initiating therapy; if insufficient tissue is available, repeat biopsy and/or plasma testing should be performed, and if not feasible patients may be treated as though driver oncogenes are absent.
- Markers to test: EGFR, ALK, ROS1, BRAF, NTRK, MET, RET (chunk 4).
- If testing not possible: repeat biopsy and/or plasma testing recommended; if infeasible, treat as though driver oncogenes are absent (chunk 4).
- ECOG performance status definitions are provided for contextual use (chunk 4).
Provide supporting clinical references (IMvigor210, IMpower trials, other citations)
References and clinical trial citations that support indication and medical necessity determinations (for example IMvigor210, IMpower trials, and trial reports of atezolizumab combinations) should be available on request.
- Examples of cited trials/publications include IMvigor210 and IMpower studies and specific trial reports listed in the References section (chunk 21).
- Providers should have these references available to support medical necessity decisions upon request (chunk 21).
Denial triggers — prior PD‑1/PD‑L1 progression or systemic immunosuppression
Requests may be denied if the individual has disease progression on another PD‑1 or PD‑L1 inhibitor, or if the individual is receiving systemic immunosuppressive therapy for an autoimmune or chronic condition; requests that do not meet the listed criteria will also be denied.
- Do not approve if disease progression occurred with another PD‑1 or PD‑L1 inhibitor (chunk 11).
- Do not approve if receiving systemic immunosuppressant therapy for autoimmune or chronic conditions (chunk 11).
- Requests not meeting the indication‑specific criteria are considered not medically necessary and may be denied (chunk 11).
Denial triggers — inconsistent with 'do not approve' or removed indications
Requests inconsistent with updated 'do not approve' criteria or for indications removed following FDA actions (for example removal of subsequent‑line urothelial indications following withdrawal) may be denied.
- Document history documents removal of urothelial subsequent‑line use per FDA withdrawal and addition of 'do not approve' criteria (chunks 18 and 20).
- Providers should confirm that the requested indication remains listed as approvable in the current policy before submission (chunk 18).
Definitions and Reference Terms
Background
Atezolizumab is an anti–PD-L1 immune checkpoint inhibitor indicated for multiple tumor types. It is used as monotherapy and in combination regimens across indications including non‑small cell lung cancer, extensive‑stage small cell lung cancer, hepatocellular carcinoma (commonly in combination with bevacizumab), unresectable or metastatic melanoma in BRAF V600–mutant disease (in combination with targeted agents), alveolar soft part sarcoma, cervical cancer, and mesothelioma. NCCN guidance and trial evidence (referenced in the policy) inform specific regimen selection, biomarker testing requirements, and line‑of‑therapy considerations.
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