Viva Health Tecentriq Hybreza Coverage Update

Coverage and Medical Necessity Criteria

Initial Therapy — Indication-specific criteria

Covered when ALL of the following are met (universal criteria plus indication-specific criteria):

Universal eligibility: Patient is >= 18 years of age; patient has not received prior PD-1/PD-L1 therapy unless otherwise specified (exceptions for switch-therapy with intravenous atezolizumab); therapy will not be used concomitantly with intravenous atezolizumab; patient weight >= 62 kg (patients <62 kg should use IV Tecentriq).

Indication: Non-Small Cell Lung Cancer (NSCLC): Used for recurrent, advanced, or metastatic disease (excluding locoregional recurrence without disseminated disease) OR as adjuvant single-agent following resection and prior adjuvant platinum chemotherapy for eligible stages. First-line single-agent use: PS 0-2, tumors negative for actionable molecular markers and PD-L1 >= 50% (TC >=50% or IC >=10%), or specified PS 3 scenarios; first-line combination regimens for non-squamous disease with carboplatin/paclitaxel/bevacizumab or carboplatin + albumin-bound paclitaxel for PD-L1 <1% or >=1% as detailed; adjuvant use requires PD-L1 >=1% and absence of EGFR exon 19/21 or ALK rearrangements. Refer to molecular biomarker specifications for additional eligibility.

See chunks 5-8 for full molecular and PD-L1 detail.

Indication: Small Cell Lung Cancer (SCLC): Patient has extensive-stage SCLC and therapy is used as first-line in combination with carboplatin and etoposide; OR used as maintenance therapy if disease has not progressed following first-line atezolizumab (IV or SC) with carboplatin and etoposide (maintenance options include single-agent atezolizumab or combination with lurbinectedin); OR used as subsequent therapy for relapse/progression as specified. For certain maintenance/subsequent uses, patient must have at least stable disease after 4 cycles, ECOG 0-1, and no history of brain metastases.

Indication: Hepatocellular Carcinoma (HCC): Used in combination with bevacizumab as first-line therapy for unresectable or metastatic HCC; OR used as adjuvant therapy following resection or ablation for patients at high risk of recurrence (defined as size > 5 cm, > 3 tumors, macrovascular invasion or microvessel invasion on histology, or grade 3/4 histology).

Other covered indications: Peritoneal (and related) mesothelioma: used as subsequent therapy in combination with bevacizumab; Cutaneous melanoma: BRAF V600 mutation–positive disease used with cobimetinib and vemurafenib for unresectable/metastatic disease (first-line or subsequent/re-induction as specified); Alveolar soft part sarcoma (ASPS): single-agent use; Cervical cancer: specified histologies and combination or maintenance regimens as detailed.

Renewal Therapy

Renewal criteria (authorization continuation):

Renewal requirements: Patient continues to meet universal and indication-specific criteria (including concomitant therapy requirements and performance status); duration of authorization has not been exceeded; disease response is demonstrated (stable disease or tumor decrease); and there is absence of unacceptable toxicity (examples include immune-mediated adverse reactions, severe infusion-related reactions, complications of allogeneic HSCT, etc.).

Examples of unacceptable toxicity include immune-mediated adverse reactions, severe infusion reactions, complications of allogeneic HSCT, etc.

Subcutaneous Tecentriq Hybreza is approved as a distinct formulation with a fixed per-dose volume of 15 mL (1,875 mg) administered subcutaneously every 3 weeks; it has different dosing and administration than intravenous atezolizumab and must be given in the thigh by a healthcare professional. The policy requires that patients be at least 62 kg to receive the subcutaneous formulation; patients who weigh less than 62 kg should receive the intravenous formulation instead. Requests may be denied if the member’s weight is below this threshold or if the dosing/administration does not match the specified subcutaneous regimen.

Appendix material in this policy is intended for non‑Medicare coverage determinations. Medicare Part B coverage is governed separately by CMS guidance (Medicare Benefit Policy Manual, Chapter 15 §50) and by applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs); providers should follow those Medicare authorities when billing Medicare and consult the CMS Medicare Coverage Database for any applicable NCD/LCD/LCA.

Prior therapy with a programmed death (PD‑1/PD‑L1) directed agent generally makes subcutaneous Tecentriq Hybreza not covered unless a specific exception applies. One documented exception is permitted switching between intravenous atezolizumab and subcutaneous Tecentriq Hybreza at the next scheduled dose; however, concomitant use of subcutaneous and intravenous atezolizumab is not allowed. Ensure documentation clearly shows the clinical rationale for any switch and that universal criteria are met before authorization is approved.

Indication-Specific Regimens and Trial-Based Combinations

Indication	Regimen	Coverage status / Notes
Non‑small cell lung cancer (non‑squamous), first‑line
Atezolizumab Hybreza (subcutaneous atezolizumab + hyaluronidase‑tqjs) administered in combination with carboplatin, paclitaxel, and bevacizumab
Covered when used for non‑squamous disease as first‑line therapy per universal criteria (patient ≥18, weight ≥62 kg, negative for actionable molecular markers as specified); applicable PD‑L1 and performance‑status requirements per document

Indication	Regimen	Coverage status / Notes
Small cell lung cancer (extensive‑stage) — first‑line
Atezolizumab Hybreza in combination with carboplatin and etoposide
Covered as first‑line for extensive‑stage SCLC; maintenance options include single‑agent atezolizumab (intravenous or subcutaneous) or atezolizumab in combination with lurbinectedin per criteria (ECOG 0‑1 and no brain metastases for some maintenance/subsequent uses)

Indication	Regimen	Coverage status / Notes
Hepatocellular carcinoma (unresectable or metastatic) and adjuvant high‑risk patients
Atezolizumab Hybreza in combination with bevacizumab
Covered as first‑line for unresectable/metastatic HCC and as adjuvant therapy following resection/ablation for patients at high risk of recurrence (size >5 cm, >3 tumors, macrovascular invasion or high‑grade histology)

Indication	Regimen	Coverage status / Notes
Cutaneous melanoma — BRAF V600 mutation‑positive, unresectable or metastatic
Atezolizumab Hybreza combined with cobimetinib and vemurafenib
Covered for BRAF V600 mutation‑positive disease when used in combination with cobimetinib and vemurafenib as first‑line or subsequent therapy per criteria; BRAF mutation must be documented by FDA‑approved or CLIA‑compliant test

Indication	Regimen	Coverage status / Notes
Alveolar soft part sarcoma (ASPS)
Atezolizumab Hybreza as a single agent
Covered as single‑agent therapy for ASPS per document references

Context	Regimens / Evidence	Coverage status / Notes
IMbrave150 / IMbrave050 evidence
Atezolizumab + bevacizumab (IMbrave150 showed benefit in unresectable HCC; IMbrave050 evaluated adjuvant atezolizumab + bevacizumab)
These combinations are cited as the evidentiary basis for atezolizumab + bevacizumab coverage in HCC indications; other combination regimens (e.g., with nab‑paclitaxel, carboplatin, vemurafenib/cobimetinib) are referenced in trial citations and compendia

Billing Codes, Units, and Diagnosis Lists

Covered HCPCS CodesHCPCSCovered

J9024

Injection, atezolizumab, 5 mg and hyaluronidase-tqjs; 1 billable unit = 5 mg

NDCNDC

50242-0933-xx

NDC for Tecentriq 1,875 mg and 30,000 units/15 mL in a single-dose vial

Alternate Covered HCPCS CodesHCPCSCovered

J9024

Injection, atezolizumab, 5 mg and hyaluronidase-tqjs; 1 billable unit = 5 mg

NDC(s)NDC

50242-0933-xx

Tecentriq 1,875 mg and 30,000 units/15 mL in a single-dose vial (NDC)

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

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	Malignant neoplasm of unspecified main bronchus
C34.01	Malignant neoplasm of right main bronchus
C34.02	Malignant neoplasm of left main bronchus
C34.10	Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11	Malignant neoplasm of upper lobe, right bronchus or lung
C34.12	Malignant neoplasm of upper lobe, left bronchus or lung

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Medicare Part B Covered Diagnosis CodesICD-10

N/A	Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA)

Per-dose units and dosing frequency — billing units and mg/mL per administration

Billable units per administration375 billable HCPCS units every 21 days (per policy Max Units: 375 units/21 days)

Per-dose active drug volume and amountOne 15 mL subcutaneous injection contains 1,875 mg atezolizumab and 30,000 units hyaluronidase

HCPCS unit definition1 billable HCPCS unit = 5 mg of atezolizumab (J9024) — 375 units = 1,875 mg

Dose frequencyAdministration every 3 weeks (every 21 days)

Minimum patient weight required for subcutaneous formulation

Biomarker and Testing Requirements

PD-L1 thresholds for select first-line and adjuvant uses

First-line single-agent NSCLC PD-L1 thresholdPD-L1 ≥ 50% (TC ≥ 50% or IC ≥ 10%) required for some first-line single-agent uses

Adjuvant NSCLC PD-L1 thresholdPD-L1 ≥ 1% required for adjuvant single-agent use following resection and prior adjuvant platinum chemotherapy

Testing standardPD-L1 status determined by an FDA‑approved test or CLIA‑compliant test

Required genomic biomarker testing list

Required genomic biomarkersEGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, ERBB2 (HER2)

Testing requirementComplete genotyping via biopsy and/or plasma testing; use FDA‑approved or CLIA‑compliant tests where required by indication

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorization considered (cost-driven)

Prior authorization may be required for this drug primarily as a utilization management tool driven by cost considerations. Providers should obtain prior authorization before initiating therapy when required by the plan. Initial approvals are generally granted for 6 months; renewals may be requested every 6 months thereafter, with some adjuvant indications (NSCLC and HCC) eligible for renewal up to a maximum of 12 months of therapy. Document clinical rationale and expected duration when requesting authorization.

Initial prior authorization length: 6 months.
Renewal interval: every 6 months; adjuvant NSCLC/HCC may be renewed up to 12 months total.
Prior authorization applied as an NQTL; cost of drug was a factor in considering PA.

Prior Authorization

Medicare prior authorization considerations

For Medicare Part B members, providers must follow applicable Medicare rules and any relevant NCDs, LCDs, LCAs, and CMS manuals. Medicare coverage determinations govern Part B drugs; when Medicare policy exists it supersedes the plan’s non‑Medicare information. Use the CMS Coverage Database to check for applicable determinations before submitting claims or requesting prior authorization for Medicare members.

Permitted Line(s) of Therapy and Treatment Setting

first-line | subsequent/maintenance

First-line use supported for multiple cancers including NSCLC (single-agent or in combination depending on PD-L1 and histology), SCLC with carboplatin+etoposide, and HCC with bevacizumab; also first-line BRAF V600 mutant melanoma in combination with cobimetinib+vemurafenib as specified.

Subsequent/maintenance: Subsequent therapy and maintenance settings described for NSCLC, SCLC, cervical cancer, and mesothelioma with specified combination partners and requirements for response/stability (e.g., continuation maintenance after response or stable disease following first-line regimens).

first-line | second-line | salvage

Permitted lines of therapy: Atezolizumab is cited in trials and guidance across first-line, second-line, and salvage/post-platinum settings depending on indication and prior therapies; specific trial contexts and compendia references support use in these lines for select tumor types.

Clinical Background and Drug Overview

Atezolizumab is a monoclonal antibody that binds programmed death‑ligand 1 (PD‑L1) to block its interaction with PD‑1 and B7.1, thereby restoring anti‑tumor T‑cell activity. Tecentriq Hybreza is a subcutaneous co‑formulation of atezolizumab with hyaluronidase administered in the thigh approximately every 3 weeks; it delivers 1,875 mg per 15 mL dose and has distinct dosing and administration compared with intravenous atezolizumab. Clinically, atezolizumab is used across multiple tumor types as single‑agent therapy or in combination regimens (for example, with chemotherapy or bevacizumab) depending on indication, PD‑L1 status, and presence of actionable genomic biomarkers.

Key Terms and Billing Definitions

HCPCS and billing unit definition (J9024: injection; 5 mg per billable unit)

HCPCS code and descriptionJ9024 — Injection, atezolizumab, 5 mg and hyaluronidase‑tqjs

Billable unit definition1 billable unit = 5 mg of atezolizumab (per J9024 description)

Per‑dose equivalence375 billable units correspond to 1,875 mg (one 15 mL vial) administered every 21 days

NCD / LCD / LCA definitions and applicability

NCD / LCD / LCA definitionNational Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) are CMS instruments that define Medicare Part B coverage parameters for services and drugs; compliance with applicable NCDs/LCDs/LCAs is required when billing Medicare

Applicability note

Policy Revision History

2024-10-03policy_created

Policy created for Tecentriq Hybreza (subcutaneous atezolizumab with hyaluronidase-tqjs) establishing indication- and formulation-specific coverage and prior authorization criteria, including dosing and HCPCS/J-code details.

2025-02review

Policy reviewed (periodic review entry listed among Dates Reviewed).

2025-11-04review_and_updateLatest

OpenPayer

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — subcutaneous