Draftblue cross blue shield - tennesseePolicy N/A

Atezolizumab and Hyaluronidase-tqjs (Tecentriq Hybreza)

Defines covered indications, prior authorization documentation, exclusions, authorization durations, continuation/reauthorization rules, and medication quantity limits for Tecentriq Hybreza (subcutaneous atezolizumab-hyaluronidase). Applies to FDA-approved and compendial uses when approval criteria are met and member has no exclusions.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyAtezolizumab and Hyaluronidase-tqjs (Tecentriq Hybreza)

Policy CodePolicy N/A

Change TypeDraft Revision / Clarified (Do Not Implement)

Effective Date

Next Review Date

Key ActionSubmit required test result documentation (PD-L1, EGFR/ALK/RET/ROS1 status, BRAF V600, MSI-H/dMMR or POLE/POLD1 with TMB >50 mut/Mb) when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Policy document is labeled Draft Revision and 'Do Not Implement'; references a 2025 package insert and 2026 NCCN compendium.

MultipleCovered Indications (FDA & Compendia)

6 monthsTypical Authorization Duration

1875/30,000 q3wStandard SC Dosing Regimen

TMB >50Ultra-hypermutated Threshold

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This policy covers Tecentriq Hybreza (subcutaneous atezolizumab-hyaluronidase) for FDA-approved indications and compendial uses when all specified approval criteria are met and the member has no exclusions. The policy aligns with statutory requirements for Tennessee that mandate coverage of off-label uses recognized by standard compendia or peer-reviewed literature. Document status: DRAFT (Do Not Implement).

General Coverage Criteria / Indications

The FDA-approved indications and compendial uses are considered covered when ALL of the following are met:

ALL of the following

Indication is one of the listed FDA-approved indications or compendial uses (see list)
All approval criteria specific to the indication are met
Member has no exclusions to the prescribed therapy

Initial Therapy Criteria (by Indication)

Non-Small Cell Lung Cancer (NSCLC) Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis: recurrent, advanced or metastatic NSCLC OR stage IB to IIIB PD-L1 positive NSCLC for adjuvant therapy as specified
No EGFR exon 19 deletions or L858R mutations and no ALK, RET, or ROS1 gene fusions/rearrangements (unless testing not feasible due to insufficient tissue)
One of
- Requested medication used as continued maintenance therapy as a single agent or in combination with bevacizumab
- Requested medication used as first-line or subsequent therapy in combination with chemotherapy with or without bevacizumab
- Requested medication used as first-line or subsequent therapy as a single agent

Small Cell Lung Cancer (SCLC) Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis: extensive-stage SCLC
Requested medication will be used in combination with carboplatin and etoposide, followed by maintenance therapy as a single agent or with lurbinectedin

Hepatocellular Carcinoma (HCC) Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis: progressive, unresectable, or metastatic HCC
Requested medication used in combination with bevacizumab for first-line treatment or for adjuvant treatment following resection or ablation

Melanoma (BRAF V600 mutation-positive) Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis: BRAF V600 mutation-positive unresectable or metastatic melanoma
Tumor BRAF V600 mutation confirmed by an FDA-approved test (where applicable)
Requested medication will be used in combination with cobimetinib and vemurafenib

Alveolar Soft Part Sarcoma (ASPS) Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis: unresectable or metastatic ASPS
Use as a single agent

Mesothelioma Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis: peritoneal, pericardial, or tunica vaginalis testis mesothelioma
Requested medication used in combination with bevacizumab for subsequent treatment

Cervical Cancer Authorization Criteria

Authorization of 6 months may be granted when ONE of the following criteria is met:

ANY of the following

Member has recurrent or metastatic adenocarcinoma, adenosquamous, or squamous cell carcinoma and requested medication used in combination with bevacizumab, paclitaxel, and either cisplatin or carboplatin (may be used with bevacizumab for maintenance)
Member has persistent, recurrent or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) and requested medication used in combination with etoposide and either cisplatin or carboplatin (may be used followed by single agent for maintenance)

Colon Cancer (Adjuvant) Authorization Criteria

Authorization of 6 months may be granted for adjuvant treatment of stage III colon cancer when ALL of the following are met:

ALL of the following

Disease is confirmed deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) OR polymerase epsilon/delta (POLE/POLD1) mutation with ultra-hypermutated phenotype (TMB >50 mut/Mb)
Requested medication will be used in combination with FOLFOX or CAPEOX regimens (followed by single agent maintenance)

Thymic Carcinoma Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Requested for first-line or postoperative systemic therapy for thymic carcinoma
Used in combination with carboplatin and paclitaxel followed by single agent maintenance

Chronic Lymphocytic Leukemia (CLL) Authorization Criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis: CLL with Richter's transformation
Requested medication will be used in combination with venetoclax and obinutuzumab

Small Bowel Adenocarcinoma Authorization Criteria

Authorization of 6 months may be granted when disease is dMMR/MSI-H or POLE/POLD1 ultra-hypermutated (TMB >50 mut/Mb) and ONE of the following settings applies:

ANY of the following

As neoadjuvant therapy for resectable disease, when used as a single agent
As adjuvant therapy when used in combination with FOLFOX or CAPEOX regimens, followed by single agent maintenance
As treatment for locally unresectable, medically inoperable, advanced, or metastatic disease, when used as a single agent

Continuation / Reauthorization Criteria

Authorization of 6 months may be granted for continued treatment when ALL of the following apply (varies by indication):

ANY of the following

Adjuvant treatment of HCC, NSCLC, colon cancer, and small bowel adenocarcinoma: up to 12 months total if no disease recurrence or unacceptable toxicityup to 12 months total
Thymic carcinoma: up to 24 months total if no disease progression or unacceptable toxicityup to 24 months total
All other listed indications: reauthorization for 6 months if no evidence of unacceptable toxicity or disease progression while on current regimen6 months

Unproven / Exclusions

Exclusion (Not Covered) Criterion

Coverage will not be provided for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization review requires submission of the documentation listed in the policy (see documentation callout). When the approval criteria are met, authorization is typically granted for 6 months.

Documentation Required

Required test result documentation

Submit test results as part of the prior authorization: PD-L1 tumor expression (where applicable); absence of EGFR exon 19 deletion and L858R mutations and absence of ALK, RET, or ROS1 gene fusions/rearrangements (where applicable); BRAF V600 mutation status (where applicable); and results confirming MSI-H/dMMR or POLE/POLD1 with ultra-hypermutated tumor mutational burden (TMB >50 mut/Mb) (where applicable).

PD-L1 tumor expression (where applicable)
Absence of EGFR exon 19 deletion and L858R mutations (where applicable)
Absence of ALK, RET, or ROS1 gene fusions/rearrangements (where applicable)
BRAF V600 mutation (where applicable)
MSI-H/dMMR or POLE/POLD1 with ultra-hypermutated TMB >50 mut/Mb (where applicable)

Denial Risk

Denial for prior PD-1/PD-L1 progression

Claims will be denied / not covered for members who have experienced disease progression while on prior PD‑1 or PD‑L1 inhibitor therapy.

Billing Rule

Medication quantity limits / dosing frequency

Maximum dosing regimen for all listed diagnoses is subcutaneous 1875/30,000 mg‑units every 3 weeks. Report billing per applicable billing guidance.

Applicable Codes

NDC / ProductNDC

No codes listed

Clinical Evidence & Thresholds

Evidence includes the Tecentriq Hybreza package insert (Genentech, November 2025) and the NCCN Drugs & Biologics Compendium (2026). Policy coverage is aligned with FDA-approved indications and compendial uses.

Background

Tecentriq Hybreza is a subcutaneous formulation combining atezolizumab with hyaluronidase. The product is indicated across multiple tumor types per FDA labeling and recognized compendia; coverage in this policy follows those FDA indications and compendial uses. Note: Tennessee mandate requires consideration of compendia-supported off-label uses; this policy reflects that requirement. Document is labeled Draft — Do Not Implement.

Definitions:

PD-L1 TC/IC: PD-L1 expression on tumor cells (TC) and tumor-infiltrating immune cells (IC) as measured by FDA-approved tests; high expression is defined per indications (e.g., TC ≥50% or IC ≥10%) and other indication-specific thresholds.

Ultra-hypermutated TMB: Tumor mutational burden greater than 50 mutations per megabase (mut/Mb).

Revision History

2026draft_revisionLatest

Document labeled Draft Revision with 'Do Not Implement' notice; references Tecentriq Hybreza package insert (November 2025) and NCCN Drugs & Biologics Compendium (2026). No explicit clinical policy changes identified (marked as not material).

Policy Summary

Payerblue cross blue shield - tennessee

PolicyAtezolizumab and Hyaluronidase-tqjs (Tecentriq Hybreza)

Policy CodePolicy N/A

Change TypeDraft Revision / Clarified (Do Not Implement)

Effective Date

Next Review Date

Key ActionSubmit required test result documentation (PD-L1, EGFR/ALK/RET/ROS1 status, BRAF V600, MSI-H/dMMR or POLE/POLD1 with TMB >50 mut/Mb) when requesting prior authorization.

SourceLink

On This Page

OpenPayer

Atezolizumab and Hyaluronidase-tqjs (Tecentriq Hybreza)

Coverage Summary

Initial Therapy Criteria (by Indication)

Continuation / Reauthorization Criteria

Unproven / Exclusions

Provider Actions

Applicable Codes

Clinical Evidence & Thresholds

Background

Revision History