Currentmoda_health_plan_incPolicy N/A

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Subcutaneous coverage criteria

Customize your policy alerts

Sign up for all moda_health_plan_inc policy alerts

Know when moda_health_plan_inc releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines prior authorization, dosing limits, and medical necessity criteria for coverage of Tecentriq Hybreza (subcutaneous atezolizumab and hyaluronidase-tqjs) across multiple oncology indications for Moda Health Plan Inc.

Policy Summary

Payermoda_health_plan_inc

PolicyTecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Subcutaneous coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date03/04/2025

Last ReviewJun 1, 2026

Next Review DateJun 1, 2026

Key ActionPrior authorization is required; initial authorization provided for 180 days (6 months) and may be renewed every 180 days with indication-specific maximums.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9024HCPCS billing code

375Max units / dose (q3w)

6mInitial PA validity

18 cyclesMax renewal (CLL/SLL)

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

Currentmoda_health_plan_incPolicy N/A

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Subcutaneous coverage criteria

Customize your policy alerts

Sign up for all moda_health_plan_inc policy alerts

Know when moda_health_plan_inc releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

Payermoda_health_plan_inc

PolicyTecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Subcutaneous coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date03/04/2025

Last ReviewJun 1, 2026

Next Review DateJun 1, 2026

Key ActionPrior authorization is required; initial authorization provided for 180 days (6 months) and may be renewed every 180 days with indication-specific maximums.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9024HCPCS billing code

375Max units / dose (q3w)

6mInitial PA validity

18 cyclesMax renewal (CLL/SLL)

24 monthsMax renewal (Thymic)

Coverage Criteria and Indication-Specific Rules

Universal Initial Criteria

Covered when ALL of the following are met:

Universal: Patient is at least 18 years of age (unless otherwise specified); AND patient has not received previous PD-1/PD-L1-directed therapy unless otherwise specified (note: not applicable when used as switch-therapy with IV atezolizumab); AND therapy will not be used concomitantly with intravenous atezolizumab; AND patient weighs at least 62 kg (patients <62 kg should use IV formulation) — does NOT apply to Alveolar Soft Part Sarcoma (ASPS).

Non-Small Cell Lung Cancer (NSCLC)

Covered when specific indication-dependent AND/OR criteria are met (organized by line of therapy, performance status, biomarkers, and combination regimens):

NSCLC general: Used for recurrent, advanced, or metastatic disease; AND can be used as first-line or subsequent therapy depending on branch; see children for detailed biomarker, performance status, and combination regimen rules.

First-line single-agent high PD-L1: First-line single-agent use for patients with performance status (PS) 0-2 whose tumors are negative for actionable biomarkers (may be KRAS G12C positive) AND tumor PD-L1 ≥50% (TC ≥50% or IC ≥10%) as determined by an FDA-approved or CLIA-compliant test; AND use restricted to patients with contraindication or intolerance to single-agent cemiplimab.PD-L1 ≥50%

Actionable biomarkers per policy (EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, ERBB2) — complete molecular testing expected.

Platinum-ineligible PS3 patients: Patients with PS 3 who have tumors negative for actionable biomarkers (may be KRAS G12C positive) AND are platinum-ineligible; OR patients with PS 3 who have tumors positive for listed biomarkers (EGFR exon 20, BRAF V600E, NTRK fusions, MET exon-14 skipping, ERBB2/HER2, NRG1 fusion) AND are platinum-ineligible; OR PS 3 patients positive for certain biomarkers with prior targeted therapy as specified — all subject to platinum-ineligible status.PS 3

Specific biomarker branches and prior targeted therapy exceptions are detailed in policy.

Combination regimens for non-squamous disease: Used in combination regimens for non-squamous NSCLC: carboplatin + paclitaxel + bevacizumab OR carboplatin + albumin-bound paclitaxel; AND used for non-squamous histology with biomarker-based eligibility (tumor negative or positive for specified biomarkers as described); AND certain uses restricted to patients with contraindication or intolerance to cemiplimab or specified cytotoxic agents when applicable.

Continuation/maintenance and post-first-line single-agent uses have additional PD-L1 or prior-therapy constraints per document.

Small Cell Lung Cancer (SCLC)

Covered when ALL of the following are met for SCLC:

SCLC criteria: Patient has extensive-stage small cell lung cancer (ES-SCLC); AND used as first-line therapy in combination with carboplatin and etoposide OR used as maintenance therapy if disease has not progressed following 4 cycles of first-line atezolizumab (IV or SC) with carboplatin and etoposide; OR used in subsequent or maintenance settings per specified sequences (including combination with lurbinectedin or single-agent use) after progression/relapse as allowed; AND patient has ECOG performance status 0-1; AND patient has no history of brain metastases.ECOG 0-1

Multiple sequence and combination options described in policy.

Hepatocellular Carcinoma (HCC)

Covered when ALL of the following are met:

HCC criteria: Used in combination with bevacizumab; AND patient does not have Child-Turcotte-Pugh (CTP) Class C liver disease; AND used as first-line therapy for unresectable or extrahepatic/metastatic disease in patients ineligible for resection/transplant/locoregional therapy OR used as subsequent-line therapy after prior systemic therapy; AND use is restricted to patients with contraindication or intolerance to durvalumab + tremelimumab-actl when applicable.No CTP Class C

Peritoneal Mesothelioma (PeM)

Covered when ALL of the following are met:

PeM criteria: Used as subsequent therapy in combination with bevacizumab; AND patient previously received platinum and pemetrexed unless contraindicated.

May also be used for pericardial mesothelioma and tunica vaginalis testis mesothelioma.

Cutaneous Melanoma

Covered when ALL of the following are met:

Melanoma criteria: Patient has BRAF V600 mutation–positive disease as detected by an FDA-approved or CLIA-compliant test; AND used in combination with cobimetinib and vemurafenib; AND patient has unresectable or metastatic disease; AND used as first-line therapy.BRAF V600 mutation positive

Alveolar Soft Part Sarcoma (ASPS)

Covered when ALL of the following are met:

ASPS criteria: Patient is at least 12 years of age AND weighs at least 40 kg; AND used as a single agent for unresectable or metastatic disease not curable by surgery.>=12 years; >=40 kg

ASPS is exempt from the ≥62 kg SC weight threshold noted in universal criteria.

Cervical Cancer

Covered when indication-specific combinations are met:

Cervical cancer branches: For small cell neuroendocrine carcinoma of the cervix: used as first-line therapy for persistent, recurrent, or metastatic disease in combination with etoposide and either cisplatin or carboplatin; OR used as single-agent maintenance after initial combination therapy. For adenocarcinoma, adenosquamous, or squamous histologies with recurrent/metastatic disease: used as first-line therapy in combination with bevacizumab, paclitaxel, and either cisplatin or carboplatin; OR used with bevacizumab as maintenance after initial atezolizumab-containing therapy.

Colon Cancer (adjuvant)

Covered when ALL of the following are met:

Colon cancer criteria: Patient has microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) disease per an FDA-approved or CLIA-compliant test; AND patient has stage III disease; AND used as adjuvant treatment in combination with FOLFOX or CAPEOX followed by single-agent maintenance therapy.Stage III; MSI-H/dMMR

Thymic Carcinoma

Covered when ALL of the following are met:

Thymic carcinoma criteria: Used in combination with carboplatin and paclitaxel; AND used as first-line therapy for recurrent, advanced, or metastatic thymic carcinoma.

Renewal may be provided for up to 24 months (730 days).

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - Richter transformation

Covered when ALL of the following are met:

CLL/SLL Richter uses: Used in combination with venetoclax and obinutuzumab for histologic transformation (Richter); AND may be used as additional therapy for partial response, refractory disease, or progression while on prior treatment; OR used as first-line treatment for Richter transformation if previously treated for CLL; OR used as continuation therapy for complete response until progression.

Prior authorization validity may be renewed for up to 18 cycles.

Thymic Carcinoma (compendia recommended)

Covered when ALL of the following are met for Thymic Carcinoma:

Thymic Carcinoma coverage: Used in combination with carboplatin and paclitaxel; AND used as first-line therapy for recurrent, advanced, or metastatic disease.

CLL/SLL (Richter transformation) coverage

Covered when ANY of the following are met for CLL/SLL (Richter transformation) in combination with venetoclax and obinutuzumab:

CLL/SLL Richter transformation coverage options: Used as additional therapy for partial response, refractory disease, or progression while on prior treatment; OR used as first-line treatment for Richter transformation if previously treated for CLL; OR used as continuation therapy for complete response until progression.

Prior treatment could have included PD-1/PD-L1-directed therapy.

Dosage, administration, and duration

Universal dosing/administration criteria:

Standard dosing: One 15 mL injection (1,875 mg atezolizumab + 30,000 units hyaluronidase) administered subcutaneously every 3 weeks until disease progression or unacceptable toxicity; administer subcutaneously in the thigh over approximately 7 minutes; pediatric dosing for patients ≥12 years who weigh <40 kg has not been established.

Billing: 1 billable unit = 5 mg (J9024); max 375 HCPCS units per dose.

Indication-specific duration limits: Adjuvant NSCLC: up to 12 months; Colon cancer (adjuvant): up to 12 months total; Thymic carcinoma: up to 24 months; CLL/SLL: up to 18 cycles.

Renewal Criteria

Renewal is allowed when ALL of the following are met:

Renewal criteria: Patient continues to meet universal and indication-specific criteria (including required concomitant therapies and performance status); AND duration of authorization has not been exceeded per Section I; AND there is documented disease response (stability or decrease in tumor size/spread) unless otherwise specified; AND absence of unacceptable toxicity from the drug.

Examples of unacceptable toxicity listed in policy (immune-mediated AEs, severe infusion reactions, HSCT complications, etc.).

Covered Diagnoses

Covered when the member has a diagnosis represented by one of the following ICD-10 codes (Appendix 1):

Appendix 1 ICD-10 match: Member diagnosis code matches one of the ICD-10 codes listed in Appendix 1.

Exact codes are enumerated in Appendix 1 (see coding module).

The subcutaneous formulation of Tecentriq Hybreza is not approved for use in patients who weigh less than 62 kg. For members under this weight threshold, the policy requires use of the intravenous formulation of atezolizumab except where explicitly noted for Alveolar Soft Part Sarcoma (ASPS), for which the 62 kg requirement does not apply.

Uses that are not specifically listed in this policy are considered to have inadequate evidence to support efficacy and are therefore excluded from the prior authorization coverage criteria. Providers should consider alternate options such as standard chemotherapy, radiation, surgery, clinical trials, or other appropriate treatments when an indication is not enumerated in the policy.

For Medicare Part B claims, applicable Centers for Medicare & Medicaid Services coverage determinations (including NCDs, LCDs, or LCAs) may apply and can take precedence over this policy. Providers submitting Part B claims should verify and comply with relevant CMS policies and local coverage determinations that govern outpatient drug administration and reimbursement.

Indications not included in this document are considered not medically supported by adequate data and are therefore excluded from authorization and coverage under this policy. Requests for therapies for non‑listed indications should be supported by clinical evidence or pursued under clinical trial, compassionate use, or other appropriate pathways.

Initial Therapy Requirements

Initial therapy

Initial authorization requirements:

Initial therapy general: Patient is age ≥18 (unless otherwise specified); AND universal criteria are met (no prior PD-1/PD-L1 therapy unless specified; not used concomitantly with IV atezolizumab; weight ≥62 kg except ASPS).

Specific indications may have their own age/weight exceptions.

Initial Therapy

Initial Therapy — rules and combinations as specified by indication:

Standard initial dosing and indication combos: Administer one 15 mL subcutaneous injection (1,875 mg) every 3 weeks until progression or unacceptable toxicity; for thymic carcinoma use in combination with carboplatin + paclitaxel as first-line for recurrent/advanced/metastatic disease; for CLL/SLL Richter transformation use in combination with venetoclax + obinutuzumab.

Refer to indication-specific criteria for biomarker and performance status requirements.

Continuation and Renewal

Continuation and renewal

Renewal and continuation provisions vary by indication.

General renewal: Prior authorization may be renewed every 6 months (180 days) unless otherwise specified; select indications have extended maximum renewal periods (NSCLC adjuvant and colon cancer up to 12 months; CLL/SLL up to 18 cycles; thymic carcinoma up to 24 months).

Refer to indication-specific sections for limits.

Continuation/Renewal

Continuation/renewal rules for therapy:

Continuation for CLL/SLL: Can be used as continuation therapy for complete response until progression for Richter transformation when used with venetoclax and obinutuzumab.

Prior treatment could have included PD-1/PD-L1-directed therapy.

General renewal guidance:

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior authorization required; initial 180 days and typical 180‑day renewals

Prior authorization is required. Initial authorization will be provided for 180 days (6 months) and may be renewed every 180 days thereafter; select indications have extended maximum renewal limits (e.g., CLL/SLL up to 18 cycles; thymic carcinoma up to 24 months; NSCLC adjuvant and colon cancer up to 12 months).

Initial: 180 days (6 months)
Renewal: may be renewed every 180 days unless specified
Extended maxima: CLL/SLL — up to 18 cycles; Thymic carcinoma — up to 24 months; NSCLC adjuvant/Colon cancer — up to 12 months

Prior Authorization

Renewal contingent on meeting criteria and duration limits

Prior authorization is required and renewals will only be granted if the member continues to meet the universal and indication‑specific criteria and duration limits described in the policy.

Renewal contingent on continued meeting of universal and indication‑specific criteria (including concomitant therapy requirements and performance status)

Billing Codes, Units, and Diagnosis Lists

Covered HCPCS unitsHCPCSCovered

HCPCS: units

Max 375 billable units every 21 days

HCPCS CodesHCPCSCovered

J9024

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

NDCsNDC

50242-0933-xx

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

Covered ICD-10 Diagnosis CodesICD-10Covered

C18.0	Malignant neoplasm of cecum
C18.2	Malignant neoplasm of ascending colon
C18.3	Malignant neoplasm of hepatic flexure
C18.4	Malignant neoplasm of transverse colon
C18.5	Malignant neoplasm of splenic flexure
C18.6	Malignant neoplasm of descending colon
C18.7	Malignant neoplasm of sigmoid colon
C18.8	Malignant neoplasm of overlapping sites of colon
C18.9	Malignant neoplasm of colon, unspecified
C22.0	Liver cell carcinoma

1–10 of 104

1/11

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

C49.9	Malignant neoplasm of connective and soft tissue, unspecified.
C53.0	Malignant neoplasm of endocervix.
C53.1	Malignant neoplasm of exocervix.
C53.8	Malignant neoplasm of overlapping sites of cervix uteri.
C53.9	Malignant neoplasm of cervix uteri, unspecified.
C7A.1	Malignant poorly differentiated neuroendocrine tumors.
C83.00	Small cell B-cell lymphoma, unspecified site.
C83.01	Small cell B-cell lymphoma, lymph nodes of head, face, and neck.
C83.02	Small cell B-cell lymphoma, intrathoracic lymph nodes.
C83.03	Small cell B-cell lymphoma, intra-abdominal lymph nodes.

1–10 of 35

1/4

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

Weight threshold

Weight threshold for subcutaneous formulation>= 62 kg — patients weighing less than 62 kg should use the intravenous (IV) formulation of Tecentriq (exception for Alveolar Soft Part Sarcoma).

Exception — Alveolar Soft Part Sarcoma (ASPS)The >=62 kg requirement does not apply to patients with ASPS; ASPS patients may use the subcutaneous formulation at the policy-specified ASPS criteria (e.g., >=12 years and >=40 kg).

Concomitant IV use prohibitionSubcutaneous Tecentriq Hybreza will not be used concomitantly with intravenous atezolizumab (IV formulation).

Relevance to site-of-care and formulation selectionWeight-based formulation selection differentiates subcutaneous from IV Tecentriq; providers should evaluate patient weight before selecting SC vs IV administration.

Quantity, Unit Definitions, and Dosing Limits

Quantity limit (HCPCS units)

ProductTecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)

Maximum HCPCS units per dose375 billable units every 21 days (maximum per dose and over time).

Billing unit basisHCPCS billing measured in 5 mg units (see J9024 for unit definition).

Dose and billing units

Single injection doseOne 15 mL subcutaneous injection containing 1,875 mg atezolizumab and 30,000 units hyaluronidase administered every 3 weeks.

Billing conversionHCPCS code J9024: Injection, atezolizumab, 5 mg and hyaluronidase-tqjs; 1 billable unit = 5 mg.

Administration Setting and Site-of-Care Rules

Note

Subcutaneous formulation differentiated from IV; IV may be used for certain patients

Subcutaneous formulation is distinct from IV; IV may be used for certain patients (e.g., those <62 kg). Tecentriq Hybreza must be administered by a healthcare professional and is for subcutaneous use in the thigh only.

Subcutaneous formulation has a weight threshold and is differentiated from IV; IV may be used when clinically indicated.
Must be administered by a healthcare professional; subcutaneous use in the thigh only.

Billing Rule

Administer only by HCP; subcutaneous use in thigh only; ~7 minute administration

Administration must be performed by a healthcare professional; subcutaneous injection is given in the thigh only and is administered over approximately 7 minutes.

Step Therapy and Required Prior Agents

Step	Requirement	Notes / Restriction
1
Atezolizumab (subcutaneous) may be used only when the patient has a documented contraindication or intolerance to cemiplimab
Applies to specified NSCLC regimens including first-line single‑agent high PD‑L1 and combination regimens (e.g., carboplatin + albumlet paclitaxel or carboplatin/paclitaxel/bevacizumab) per NSCLC criteria

Step	Required Combination	Allowed Uses / Notes
1
Atezolizumab must be used in combination with venetoclax and obinutuzumab
Indicated for CLL/SLL with histologic transformation (Richter): as additional therapy for partial response/refractory/progression, as first‑line for Richter if previously treated for CLL, or as continuation therapy for complete response until progression; prior PD‑1/PD‑L1 therapy does not preclude use

Background and Clinical Context

Atezolizumab is a programmed death‑ligand 1 (PD‑L1) immune checkpoint inhibitor used in multiple tumor types. The subcutaneous formulation, Tecentriq Hybreza (atezolizumab and hyaluronidase‑tqjs), combines atezolizumab with hyaluronidase to enable subcutaneous delivery as a single 15 mL (1,875 mg) injection administered in the thigh approximately every 3 weeks. The subcutaneous route is intended to facilitate outpatient administration while maintaining the same therapeutic intent as intravenous atezolizumab; the policy specifies administration details (thigh only, administration time ~7 minutes), dose limits (one 1,875 mg injection q3w; maximum billing of 375 HCPCS units per dose where 1 unit = 5 mg), and pediatric dosing considerations (dosage for patients <40 kg not established). Coverage is governed by indication‑specific efficacy, performance status, biomarker testing, concomitant therapy rules, and prior authorization requirements described elsewhere in the policy.

Definitions and Clinical Terms

Actionable biomarkers

Actionable biomarkers listEGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2).

Testing expectationComplete biomarker testing including molecular assessment (via biopsy and/or plasma testing) is expected where relevant.

Treatment guidanceIf a clinically actionable marker is found, it is reasonable to start therapy guided by the identified marker; if unknown, treat as though no driver oncogenes are present.

ECOG performance status

ECOG referencedECOG performance status is used in eligibility criteria for lung and SCLC indications (examples include ECOG 0-1 and 0-2 per indication-specific criteria).

SCLC requirement exampleFor extensive-stage SCLC, policy specifies an ECOG performance status of 0-1 for coverage in certain settings.

Operational Notes for Initial Authorization

Initial Therapy (operational — indication groupings)

Initial Therapy — rules and combinations as specified by indication (operational grouping separate from high-level initial criteria):

NSCLC operational initial rules: For NSCLC first-line high PD-L1 single-agent use: PS 0-2, PD-L1 ≥50%, actionable biomarkers negative; use restricted to patients with contraindication/intolerance to single-agent cemiplimab. For NSCLC combination regimens (non-squamous): use with carboplatin/paclitaxel/bevacizumab or carboplatin + albumin-bound paclitaxel with additional constraints per biomarker and prior therapy. Maintenance and adjuvant uses require PD-L1 ≥1% and stage-specific criteria per policy.

Complete biomarker testing expected as described in policy.

Operational Notes for Continuation and Renewal

Continuation/Renewal (operational)

Operational continuation/renewal rules, documentation, and limits:

Renewal documentation: Renewal requires documentation that the patient continues to meet universal and indication-specific criteria (including concomitant therapy requirements and performance status), duration limits have not been exceeded, disease response (stability or decrease in tumor size/spread) is documented, and there is absence of unacceptable toxicity.

Examples of unacceptable toxicity listed in policy.

Renewal limits: Prior authorization may be renewed every 6 months (180 days) unless otherwise specified; maximum renewal durations vary by indication (see Section I and V for specifics: colon cancer/NSCLC adjuvant up to 12 months, CLL/SLL up to 18 cycles, thymic carcinoma up to 24 months).

Policy Summary

Payermoda_health_plan_inc

PolicyTecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Subcutaneous coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date03/04/2025

Last ReviewJun 1, 2026

Next Review DateJun 1, 2026

Key ActionPrior authorization is required; initial authorization provided for 180 days (6 months) and may be renewed every 180 days with indication-specific maximums.

SourceLink

On This Page

Patients responding who relapse ≥6 months after discontinuation due to duration are eligible to re-initiate PD-directed therapy; patients who complete adjuvant therapy and progress ≥6 months after discontinuation are eligible to re-initiate for metastatic disease.

Case-by-case evaluation if actionable mutation status changes on re-biopsy.

Duration of authorization must not be exceeded (refer to Section I)

Documentation of disease response and absence of unacceptable toxicity may be required for renewal

Note

NQTL checklist emphasizes indication and cost when considering PA

The plan applies a Non‑Quantitative Treatment Limitation (NQTL) checklist when designing prior authorization; indication and drug cost were flagged as considerations for requiring prior authorization.

Factors considered include Indication, Safety/Efficacy, Potential for Misuse/Abuse, and Cost of drug
Indication and Cost of drug were specifically noted as reasons to consider PA

Documentation Required

Provide one of the Appendix 1 ICD‑10 diagnosis codes with the PA request

When requesting authorization, providers must supply a covered ICD‑10 diagnosis code from Appendix 1 that supports medical necessity; coverage is tied to the Appendix 1 diagnoses.

Provide one of the ICD‑10 codes listed in Appendix 1 with the PA request
Claims without an Appendix 1 code may be denied

Step Therapy

Atezolizumab restricted if cemiplimab available — document contraindication/intolerance

For certain NSCLC regimens, use of atezolizumab (subcutaneous) is restricted when cemiplimab is available; coverage requires that the patient have a contraindication or intolerance to single‑agent cemiplimab.

Restriction applies for single‑agent high PD‑L1 first‑line and specific combination regimens
Provider must document contraindication or intolerance to cemiplimab to qualify for atezolizumab coverage in these NSCLC scenarios

Step Therapy

CLL/SLL Richter transformation must be given with venetoclax + obinutuzumab

For Richter transformation of CLL/SLL, atezolizumab use is specified only in combination with venetoclax and obinutuzumab; coverage scenarios include additional therapy for partial response/refractory disease, first‑line for Richter if previously treated for CLL, or continuation therapy until progression.

Must be used in combination with venetoclax and obinutuzumab for Richter transformation
Document prior CLL treatment history when applicable (e.g., previously treated for CLL)

Billing Rule

No concomitant IV use; subcutaneous formulation limited to patients ≥62 kg (except ASPS)

Do not use the subcutaneous product concomitantly with intravenous atezolizumab; members weighing less than 62 kg should receive the IV formulation instead (this weight exception does not apply to Alveolar Soft Part Sarcoma).

Therapy will not be used concomitantly with IV atezolizumab
Patients <62 kg should use IV formulation (except ASPS)
Subcutaneous administration site and procedures are specified elsewhere (thigh only, ~7 minutes)

Denial Risk

Indications not listed in policy are excluded from authorization

Uses not listed in this policy are excluded from prior authorization validity because inadequate data support efficacy; alternative options (e.g., clinical trials, chemotherapy, radiation) may be appropriate.

Indications not enumerated in the policy are considered unsupported and excluded from authorization
Consider other treatment options or clinical trials where appropriate

Denial Risk

Claims lacking an Appendix 1 ICD‑10 code may be denied

Claims submitted without a covered diagnosis code from Appendix 1 risk denial; Appendix 1 enumerates the ICD‑10 codes that support medical necessity and coverage.

Appendix 1 contains the ICD‑10 codes considered covered
Providers should ensure the member diagnosis matches an Appendix 1 code on the PA and claim

Documentation Required

Document complete molecular biomarker testing results where relevant

Complete molecular biomarker testing is expected where relevant; providers should document results of actionable markers (e.g., EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET, NRG1, ERBB2/HER2) via biopsy and/or plasma testing as indicated by the disease-specific criteria.

Document complete biomarker assessment per policy (listed actionable markers)
If a clinically actionable marker is found, treatment may be guided by that marker

Documentation Required

Provide documentation of continued eligibility and disease response for renewals

Renewal requests must include documentation that the member continues to meet universal and indication‑specific criteria, that duration limits have not been exceeded, that disease response (stability or decrease in tumor burden) is present, and that unacceptable toxicity is absent.

Evidence of continued meeting of criteria (including concomitant therapy requirements and performance status)
Documentation of disease response (stabilization or tumor reduction)
Evidence that duration limits have not been exceeded and no unacceptable toxicity

Note

NQTL checklist documents factors considered when designing PA

The NQTL factor checklist used to design prior authorization documents the factors considered (Indication, Safety/Efficacy, Potential for Misuse/Abuse, Cost) and supports why PA may apply to this drug group.

Checklist notes Indication = Yes and Cost of drug = Yes as considerations for PA
NQTL checklist is part of the prior authorization design and should be referenced for PA rationale

Documentation Required

Include an Appendix 1 ICD‑10 code to support medical necessity

Appendix 1 lists the ICD‑10 diagnosis codes that support medical necessity for coverage; providers must include an appropriate Appendix 1 code with the authorization request to demonstrate a covered diagnosis.

Appendix 1 enumerates covered ICD‑10 codes used to support medical necessity
Include the matching Appendix 1 code on the PA request and associated claims

Pediatric weight consideration

Pediatric dosing not established under 40 kgThe recommended dosage for pediatric patients 12 years of age and older who weigh less than 40 kg has not been established.

Standard pediatric age referencePolicy dosage statement references pediatric patients aged 12 years and older for whom dosing guidance applies if weight criteria met.

Implication for authorization and prescribingFor patients ≥12 years who weigh <40 kg, avoid assuming the standard 1,875 mg (15 mL) subcutaneous dose — dosing has not been established and clinical justification/documentation will be needed for coverage decisions.

Administered q3w (every 3 weeks) until disease progression or unacceptable toxicity.

Dosage, administration, and duration (quantity limits)

Included here for quantity-limit context (dosing interval and max durations by indication):

Dosing interval and billing units: One 15 mL injection (1,875 mg) administered subcutaneously every 3 weeks; billing units: 1 billable unit = 5 mg (J9024); maximum 375 HCPCS units per dose (per policy).q3w; max 375 HCPCS units

Indication-specific maximum durations: Adjuvant NSCLC: up to 12 months; Colon cancer: up to 12 months total; Thymic carcinoma: up to 24 months; CLL/SLL: up to 18 cycles.

Note

Consult CMS policies for Medicare Part B coverage and site‑of‑care rules

Medicare Part B coverage determinations and site‑of‑care rules may apply for outpatient administration of this product; consult CMS NCDs/LCDs/LCAs as applicable for Medicare Part B claims.

Role in decision-makingPerformance status is evaluated alongside other indication-specific criteria (biomarkers, prior therapy, combinations).

EOV Program — redacted indications

EOV program usagePolicy uses Enhanced Oncology Value (EOV) Program listings to define covered indications; some indication details are redacted in the distributed document.

ImplicationUses not listed in the EOV/program or policy are considered to have inadequate data for prior authorization validity.

AlternativesOther options (radiation, surgery, chemotherapy, clinical trials, supportive care) may be appropriate when indications are not listed.

CMS coverage determinations

CMS coverage considerationsCenters for Medicare & Medicaid Services national or local coverage determinations (NCDs/LCDs/LCAs) may supersede or apply to Medicare Part B claims; providers must comply with applicable CMS policies.

Reference resourceCMS coverage database (https://www.cms.gov/medicare-coveragedatabase/search.aspx) may be used to locate relevant NCD/LCD/LCA documents.

ApplicabilityThe policy notes the preceding information is intended for non‑Medicare coverage determinations; Medicare rules may differ and take precedence where applicable.