CurrentCareSourcePolicy N/A

Oncology (Injectable Programmed Death-Ligand 1) — Tecentriq Hybreza Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing, and authorized indications for Tecentriq Hybreza (subcutaneous atezolizumab + hyaluronidase) for CareSource members; applies to prescribing clinicians and prior authorization reviewers.

Policy Summary

PayerCareSource

PolicyTecentriq Hybreza (atezolizumab + hyaluronidase) coverage criteria

Policy CodePolicy N/A

Change TypeRevised indications and biomarker criteria

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure Tecentriq Hybreza is prescribed by or in consultation with a specialist.

SourceLink

POLICY UPDATE CHANGES

Hepatocellular carcinoma: duration of approval changed from 1 year to 'approve for the duration noted' and multiple prior requirements (Child-Pugh requirement, prior systemic therapy) removed; added adjuvant option with up to 1 year duration and first-line options for non-transplantable liver-confined disease.

Non-small cell lung cancer: multiple mutation and biomarker requirements were removed/added and criteria clarified (e.g., removed KRAS general listing, added NRG1 fusion, added first-line/continuation maintenance requirement and performance status allowance for squamous cell disease).

1,875 mgapproved subcutaneous dose per administration

q3wmaximum dosing frequency

1 yrtypical approval duration

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Recommended Authorization Criteria

Non-Small Cell Lung Cancer (FDA)

Non-Small Cell Lung Cancer (FDA) — Approve when the following criteria are met for the specified NSCLC subgroups. Consolidated and clarified from source indications.

ALL of the following

Patient is ≥ 18 years of age.
NSCLC subgroups (meet ONE of the following)
- Non-squamous NSCLC (first-line or continuation/maintenance)
  - Patient has recurrent, advanced, or metastatic non-squamous NSCLC (includes adenocarcinoma, large cell, or NSCLC not otherwise specified).
  - Tumor is negative for actionable driver mutations (examples include EGFR exon 19 deletion/exon 21 L858R, EGFR exon 20 insertions, ALK rearrangements, ROS1 rearrangements, RET rearrangements, NTRK fusions, MET exon 14 skipping, HER2 mutations, KRAS G12C) unless otherwise specified in another subgroup.
  - Medication is used as first-line therapy or as continuation/maintenance therapy as indicated.
- Squamous NSCLC (first-line or continuation/maintenance)
  - Patient has recurrent, advanced, or metastatic squamous cell NSCLC.
  - Tumor is negative for actionable driver mutations (as above).
  - Medication is used as first-line therapy or as continuation/maintenance therapy as indicated.
- PD-L1 high expression non-small cell NSCLC
  - Patient has recurrent, advanced, or metastatic NSCLC and tumor expresses PD-L1 ≥ 50% as determined by an FDA-approved test.
  - Tumor is negative for actionable driver mutations (EGFR, ALK, ROS1, RET, NTRK, MET exon 14 skipping) when required by the specific indication subgroup.
  - Medication may be used as first-line therapy when criteria met.
- EGFR/other mutation-positive NSCLC (specific combinations)
  - Tumor harbors a specified mutation for which the FDA indication supports use in combination with chemotherapy or after targeted therapy (examples from source: BRAF V600E mutation, NTRK1/2/3 fusion, MET exon 14 skipping, EGFR S768I/L861Q/G719X and others as indicated).
  - Patient has received appropriate targeted therapy for the specific mutation when required by the indication (examples: afatinib, osimertinib, erlotinib, gefitinib, dacomitinib) prior to use when the indication specifies prior targeted therapy.
  - Medication is used in combination with chemotherapy or as subsequent therapy as defined by the specific FDA indication.
- Subsequent therapy single-agent use
  - Patient has recurrent, advanced, or metastatic NSCLC and the medication is intended as subsequent therapy.
  - Medication will be used as a single agent.
- Resected/adjuvant disease
  - Patient has completed resected disease and is being considered for adjuvant therapy.
  - Patient's tumor expresses PD-L1 ≥ 1% as determined by an FDA-approved test, and the patient received previous adjuvant chemotherapy; and patient is negative for EGFR exon 19 deletion, exon 21 L858R mutations, and ALK rearrangements when required by the indication.
The medication is prescribed by or in consultation with an oncologist.
Dosing: Approve 1,875 mg of atezolizumab and 30,000 units of hyaluronidase (15 mL) administered subcutaneously no more frequently than once every 3 weeks.

Authorized Regimens and Dosing Context

Regimen	Indication	Line of therapy	Dose / frequency	Coverage
Atezolizumab + cobimetinib (Cotellic) + vemurafenib (Zelboraf)	Melanoma with BRAF V600 mutation-positive unresectable or metastatic disease	Subsequent therapy	Approve 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) subcutaneously no more frequently than once every 3 weeks	Covered

Regimen	Indication	Line of therapy	Dose / frequency	Coverage
Atezolizumab (Tecentriq Hybreza) in combination with carboplatin and etoposide	Extensive-stage small cell lung cancer	First-line	Approve 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) subcutaneously no more frequently than once every 3 weeks	Covered

Regimen / context	Indication	Eligibility details	Dose / frequency	Coverage
Atezolizumab per policy dosing; may be used with listed chemotherapy regimens (examples: cisplatin or carboplatin with etoposide)	Urothelial carcinoma	First-line if cisplatin-ineligible with PD-L1 immune cells covering ≥5% of tumor area, OR ineligible for any platinum regardless of PD-L1; or current benefit from Tecentriq as determined by prescriber	Approve 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) subcutaneously no more frequently than once every 3 weeks	Covered

PD-L1 and Genomic Biomarker Criteria

PD-L1 — Example thresholds

PD-L1 high threshold>= 50% PD-L1 staining of tumor cells (by an approved test)

Immune cell threshold (example)PD-L1 staining of tumor-infiltrating immune cells covering >= 10% of the tumor area

Urothelial first-line exceptionFirst-line urothelial eligibility when PD-L1 immune cells covering >= 5%

Usage contextThresholds applied to define first-line single-agent eligibility in select tumor types (e.g., NSCLC, urothelial carcinoma)

Genomic tumor aberrations used to guide eligibility

EGFREpidermal growth factor receptor — genomic aberrations noted as actionable mutations to guide eligibility or exclusion

Line of Therapy Specifications

first-line | second-line | salvage

Line of therapy determinations:

Line of therapy examples: Includes first‑line, subsequent therapy, adjuvant (HCC adjuvant up to 1 year), and continuation maintenance depending on the indication; the required line (first‑line vs subsequent) is specified per tumor type and subgroup in the criteria above

PD-L1 and Relevant Codes

PD-L1 expression — shorthand

Shorthand PD-L1 definition>= 50% of tumor cells OR tumor-infiltrating immune cells covering >= 10% of tumor area

Test requirementPD-L1 status must be determined by an approved test

Clinical applicationDefines eligibility for single-agent first-line therapy in selected indications (e.g., NSCLC)

Authorization, Prescriber Requirements, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior Authorization is required for medical benefit coverage of Tecentriq Hybreza. Approval is recommended when the patient meets the Recommended Authorization Criteria and dosing for the listed indications. All approvals are provided for the duration noted in the Criteria. Requests for doses, durations, or indications outside of those established in the Criteria may be denied. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Tecentriq Hybreza, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required for medical benefit coverage
Approvals provided only when Recommended Authorization Criteria and dosing are met
Requests outside established criteria (dose/duration/indication) may be denied
Must be prescribed by or in consultation with a specialist (oncologist as applicable)

Step Therapy

Prior Targeted Therapy Requirement (where specified)

Key Terms and Drug Identifier

Tecentriq Hybreza — drug identifier

Drug identityTecentriq Hybreza = atezolizumab and hyaluronidase-tqjs subcutaneous injection

FormulationFixed-dose subcutaneous combination product (atezolizumab + hyaluronidase)

Prescribing contextUsed across multiple FDA-approved tumor types as described in policy (see indications)

PD-L1 expression — definitions and use

PD-L1 thresholds used in select indications>= 50% tumor cells OR tumor-infiltrating immune cells covering >= 10% — used to define first-line single-agent eligibility

Urothelial carcinoma noteUrothelial first-line eligibility includes immune cell PD-L1 >= 5% in specified cisplatin-ineligible scenarios

Policy Background and Drug Description

Tecentriq Hybreza is a subcutaneous formulation that combines atezolizumab with hyaluronidase (atezolizumab and hyaluronidase‑tqjs) for use across multiple tumor types. The policy aligns coverage decisions with FDA‑approved indications and cited guidance, and specifies dosing and authorization criteria for use in conditions such as non‑small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, urothelial carcinoma, and certain sarcomas and other tumor types.

Document Changes and History

2025-01-22Early Annual RevisionLatest

Hepatocellular carcinoma criteria materially revised: duration of approval wording changed (from 1 year to 'approve for the duration noted'), prior Child-Pugh and prior systemic therapy requirements removed, adjuvant approval option added (up to 1 year), and first-line options for certain liver‑confined non‑transplantable disease added.

2024-09-25New Policy / Initial Review

Policy created and entered review on 09/25/2024 (New Policy).

2025-01-22Early Annual Revision