Currentmoda_health_plan_incPolicy N/A

Atezolizumab (Tecentriq) — Intravenous therapy coverage

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Defines prior authorization, dosing limits, and medical necessity criteria for intravenous atezolizumab (Tecentriq) across multiple cancer indications for Moda Health Plan members and providers requesting coverage.

Policy Summary

Payermoda_health_plan_inc

PolicyAtezolizumab (Tecentriq) — Intravenous therapy coverage

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective Date

Last ReviewJun 1, 2025

Next Review DateJun 1, 2026

Key ActionObtain prior authorization for initial treatment and document required biomarkers and indication-specific criteria; initial approvals are valid for 6 months with renewals every 6 months when criteria and response are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior auth validity

504 units / 84dmax units (most indications)

120 units / 21dmax units (mesothelioma/thymic/CLL)

J9022HCPCS code

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Currentmoda_health_plan_incPolicy N/A

Atezolizumab (Tecentriq) — Intravenous therapy coverage

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Policy Summary

Payermoda_health_plan_inc

PolicyAtezolizumab (Tecentriq) — Intravenous therapy coverage

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective Date

Last ReviewJun 1, 2025

Next Review DateJun 1, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior auth validity

504 units / 84dmax units (most indications)

120 units / 21dmax units (mesothelioma/thymic/CLL)

J9022HCPCS code

1200/840/1680 mglisted IV dosing

18+distinct indications

Medical Necessity & Indication Criteria

Universal Initial Approval Criteria

Covered when ALL of the following are met (universal criteria).

Universal criteria: Member is at least 18 years of age (unless otherwise specified); member has not received previous therapy with a PD-1/PD-L1-directed therapy unless otherwise specified; therapy will not be used concomitantly with subcutaneous atezolizumab.

See indication-specific exceptions in subsequent criteria.

Non-Small Cell Lung Cancer (NSCLC)

NSCLC criteria (distinct pathways for first-line, combination regimens, maintenance, adjuvant):

First-line single-agent: Used for recurrent, advanced, or metastatic disease as first-line single-agent therapy for members with ECOG performance status 0-2 whose tumors are negative for actionable biomarkers (may be KRAS G12C positive) AND have PD-L1 ≥50% (TC ≥50% or IC ≥10%) as determined by an FDA-approved or CLIA-compliant test; use restricted to members with contraindication or intolerance to single-agent cemiplimab.PD-L1 ≥50% (TC) or IC ≥10%

Applicable performance status and biomarker testing required.

First-line platinum-ineligible PS3 single-agent: Members with PS 3 who are platinum-ineligible and have tumors negative for actionable biomarkers (may be KRAS G12C positive) regardless of PD-L1 status; OR members with PS 3 who are platinum-ineligible and whose tumors are positive for EGFR exon 20, BRAF V600E, NTRK1/2/3 fusion, MET exon-14 skipping, ERBB2 (HER2), or NRG1 fusion.

Platinum-ineligible requirement applies.

Combination non-squamous first-line: Used in combination with carboplatin + paclitaxel + bevacizumab OR carboplatin + albumin-bound paclitaxel for non-squamous disease; eligible when tumor is negative for actionable biomarkers or positive for select biomarkers (EGFR exon 20, BRAF V600E, NTRK fusions, MET exon-14 skipping, ERBB2, NRG1), and use may be restricted to members with contraindication/intolerance to cemiplimab or specified chemotherapy alternatives per regimen notes.

Combination regimens limited to non-squamous histology per policy.

Subsequent single-agent: Used as subsequent therapy as a single agent for members with PS 0-2; OR members with PS 3 who are platinum-ineligible and positive for specified biomarkers (BRAF V600E, NTRK fusions, MET exon-14 skipping) or who previously received targeted therapy for certain biomarkers (EGFR exon 19del/L858R, S768I, L861Q, G719X; RET, ALK, ROS1 fusions); use may be restricted to those with contraindication/intolerance to cemiplimab when specified.

Performance status and prior targeted therapy considerations apply.

Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer (SCLC):

SCLC criteria: Member has extensive-stage disease (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 therapy with atezolizumab (IV or subcutaneous) plus carboplatin and etoposide; OR used as subsequent therapy or maintenance in combination with or following carboplatin/etoposide (including single-agent or in combination with lurbinectedin per policy).ECOG 0-1 required for certain subsequent/maintenance uses

Member must have at least stable disease following 4 cycles for specific maintenance/subsequent indications and no history of brain metastases for ECOG 0-1 requirement.

Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma (HCC):

HCC criteria: Used in combination with bevacizumab; member does not have Child-Turcotte-Pugh (CTP) Class C liver disease; AND used as first-line therapy for unresectable disease OR for extrahepatic/metastatic disease deemed ineligible for resection, transplant, or locoregional therapy; OR used as subsequent-line therapy after progression on or after systemic therapy; use may be restricted to members with contraindication or intolerance to durvalumab/tremelimumab for some uses.No CTP Class C

Combination with bevacizumab required per policy.

Peritoneal Mesothelioma

Peritoneal mesothelioma (PeM) and related mesotheliomas:

Peritoneal mesothelioma: Used as subsequent therapy in combination with bevacizumab; AND member received prior treatment with platinum and pemetrexed unless contraindicated.

Policy notes applicability to pericardial and tunica vaginalis testis mesothelioma.

Cutaneous Melanoma

Cutaneous melanoma (BRAF V600 mutant):

Cutaneous melanoma: Member has BRAF V600 mutation–positive disease as detected by an FDA-approved or CLIA-compliant test; AND used in combination with cobimetinib and vemurafenib for unresectable or metastatic disease; OR used as re-induction in members who previously achieved disease control with the cobimetinib/vemurafenib + atezolizumab combination and subsequently progressed > 3 months after discontinuation.BRAF V600 mutation (FDA/CLIA test)

Re-induction requires prior disease control and an interval > 3 months since discontinuation.

Alveolar Soft Part Sarcoma (ASPS)

Alveolar Soft Part Sarcoma (ASPS):

ASPS: Member is at least 2 years of age; AND used as a single agent for unresectable or metastatic disease not curable by surgery.Age ≥2 years

Cervical Cancer

Cervical cancer:

NECC pathway: Member has small cell neuroendocrine carcinoma of the cervix (NECC) and 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 atezolizumab + etoposide + cisplatin/carboplatin therapy.

Squamous/adenocarcinoma pathway: Member has adenocarcinoma, adenosquamous, or squamous cell carcinoma of the cervix with recurrent or metastatic disease and used as first-line therapy in combination with bevacizumab, paclitaxel, and either cisplatin or carboplatin; OR used in combination with bevacizumab as maintenance after initial atezolizumab + bevacizumab + paclitaxel + cisplatin/carboplatin therapy.

Distinct regimens specified by histology.

Colon, Rectal, and Small Bowel Cancer — biomarker-driven uses

MSI-H/dMMR and POLE/POLD1 biomarker-driven GI cancers (Colon, Rectal, Small Bowel):

Colon cancer (MSI-H/dMMR or POLE/POLD1): Member has MSI-H/dMMR disease by FDA-approved or CLIA-compliant test and used as adjuvant therapy with FOLFOX or CAPEOX followed by single-agent maintenance for stage IIC, stage III, or metastatic disease; OR used as single-agent for locally unresectable, medically inoperable, advanced or metastatic disease as initial or subsequent therapy. Alternatively, member has POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) and used as single agent for advanced/metastatic disease as subsequent therapy.MSI-H/dMMR positive OR POLE/POLD1 with TMB > 50 mut/Mb

Use may be restricted to members with contraindication or intolerance to durvalumab in some scenarios.

Rectal cancer (MSI-H/dMMR or POLE/POLD1): Member has MSI-H/dMMR disease by FDA-approved or CLIA-compliant test and used as single agent for locally unresectable, medically inoperable, advanced or metastatic disease as subsequent therapy; OR member has POLE/POLD1 ultra-hypermutated mutation and used as single agent for locally unresectable/advanced disease as subsequent therapy.MSI-H/dMMR OR POLE/POLD1 with TMB > 50 mut/Mb

Thymic Carcinoma

Thymic carcinoma:

Thymic carcinoma: Used in combination with carboplatin and paclitaxel as first-line therapy for recurrent, advanced, or metastatic disease.

Dosing and maximum duration specified in Dosage/Administration.

Indication-specific medical necessity

Covered when the following indication-specific criteria are met:

Small Bowel Adenocarcinoma - Adjuvant: Member has MSI-H/dMMR disease as determined by an FDA-approved or CLIA-compliant test; AND used as adjuvant therapy in combination with FOLFOX or CAPEOX followed by single-agent maintenance; AND member has T4,N0,M0 or T any,N1-2 disease.

Adjuvant dosing and duration specified in Dosage/Administration.

Small Bowel Adenocarcinoma - Single Agent: Used as a single agent for advanced or metastatic disease as initial or subsequent therapy; AND use may be restricted to members with contraindication or intolerance to durvalumab.

Single-agent dosing continued until progression or unacceptable toxicity.

Small Bowel Adenocarcinoma - Unresectable: Member has locally unresectable or medically inoperable disease and used as primary treatment.

May be used when POLE/POLD1 ultra-hypermutated as subsequent therapy.

Renewal Criteria

Prior authorization renewal can be granted when ALL of the following are met:

Renewal Criteria: Member continues to meet universal and indication-specific criteria (including concomitant therapy requirements and performance status); AND duration of authorization has not been exceeded; AND disease response defined as stabilization or decrease in tumor size or spread (unless otherwise specified); AND absence of unacceptable toxicity from the drug.

Examples of unacceptable toxicity listed include immune-mediated adverse reactions, severe infusion-related reactions, and complications of HSCT.

Per the universal coverage criteria, intravenous atezolizumab (Tecentriq) must not be used concomitantly with subcutaneous atezolizumab. This restriction is part of the member-level eligibility requirements and is intended to prevent overlapping formulations being administered at the same time.

Uses of intravenous atezolizumab that are not explicitly listed in this policy extract are considered to have inadequate data to support efficacy for prior authorization purposes and therefore are excluded from prior authorization validity. Alternative options (e.g., surgery, radiation, chemotherapy, clinical trials, supportive care) may be appropriate where the requested use is not covered.

Medicare Part B covered diagnosis codes are not applicable (N/A) in this policy extract; no Medicare Part B-specific diagnosis listings are provided in the included pages.

Regimens and Combination Therapies

Indication	Regimen	Coverage
Non‑Small Cell Lung Cancer (non‑squamous) — first‑line	Atezolizumab in combination with carboplatin, paclitaxel, and bevacizumab OR carboplatin and albumin‑bound paclitaxel	Covered when used for non‑squamous disease per policy pathways (see NSCLC criteria), with regimen and biomarker‑specific restrictions as specified in the policy.

Indication	Regimen	Coverage
Small Cell Lung Cancer (extensive‑stage) — first‑line	Atezolizumab in combination with carboplatin and etoposide	Covered as first‑line therapy for ES‑SCLC; maintenance and subsequent‑line uses described separately with ECOG and response criteria per policy.

Indication	Regimen	Coverage
Hepatocellular Carcinoma — first‑line	Atezolizumab in combination with bevacizumab	Covered as first‑line therapy for unresectable or extrahepatic/metastatic HCC in patients without Child‑Turcotte‑Pugh Class C disease; use may be restricted to members with contraindication or intolerance to durvalumab/tremelimumab per policy.

Indication	Regimen	Coverage
Cutaneous melanoma (BRAF V600 mutant) — unresectable or metastatic	Atezolizumab in combination with cobimetinib and vemurafenib	Covered for BRAF V600 mutation–positive disease (confirmed by FDA‑approved or CLIA‑compliant test) as first‑line or re‑induction after prior disease control with the same combination per policy criteria.

Indication	Regimen	Coverage
Peritoneal mesothelioma — subsequent therapy	Atezolizumab in combination with bevacizumab after prior platinum + pemetrexed	Covered as subsequent therapy when the member received prior platinum and pemetrexed unless contraindicated; policy notes applicability to pericardial and tunica vaginalis testis mesothelioma.

Indication	Regimen	Coverage
Thymic carcinoma — first‑line for recurrent/advanced/metastatic disease	Atezolizumab in combination with carboplatin and paclitaxel	Covered as first‑line therapy in combination with carboplatin and paclitaxel per policy; dosing and duration guidance provided in Dosage/Administration section.

Indication	Regimen	Coverage
Richter transformation (CLL/SLL)	Atezolizumab in combination with venetoclax and obinutuzumab	Covered for histologic transformation (Richter) in combination with venetoclax and obinutuzumab for the specified indications (additional therapy, first‑line for Richter if previously treated for CLL, or continuation therapy) with cycle limits as noted in policy.

Indication	Regimen / Dosing (selected)	Coverage
Small bowel adenocarcinoma — adjuvant	Atezolizumab with FOLFOX or CAPEOX followed by single‑agent maintenance (examples: 840 mg IV every 2 weeks for FOLFOX pathway; 1200 mg IV every 3 weeks for CAPEOX pathway, then maintenance per schedule)	Covered as adjuvant therapy in MSI‑H/dMMR disease per policy when given with FOLFOX or CAPEOX followed by single‑agent maintenance; specific cycle and duration schedules are provided in Dosage/Administration.
Small bowel adenocarcinoma — single‑agent for advanced/metastatic disease	Single‑agent atezolizumab until progression or unacceptable toxicity: examples include 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks	Covered as single‑agent initial or subsequent therapy for advanced/metastatic disease (MSI‑H/dMMR or POLE/POLD1 ultra‑hypermutated where indicated); use may be restricted to members with contraindication/intolerance to durvalumab per policy.

Combination / Trial Context	Examples of Regimens	Notes / Coverage relevance
Atezolizumab + bevacizumab — multiple tumor types	Atezolizumab plus bevacizumab (referenced for HCC, peritoneal mesothelioma, and other contexts)	Referenced in clinical literature and NCCN guidance; used as a covered regimen in specified indications (e.g., HCC, mesothelioma) per policy.
Atezolizumab + chemotherapy regimens	Atezolizumab combined with platinum‑based chemotherapy (e.g., carboplatin/paclitaxel) in NSCLC and other trials)	Multiple trials and references cited supporting first‑line combination uses; coverage limited to indications and regimens specified in the policy.
Atezolizumab + vemurafenib + cobimetinib (BRAF‑mutant melanoma)	Atezolizumab with vemurafenib + cobimetinib (IMspire150 and related studies)	Referenced randomized and phase III trial evidence supports the combination for BRAF V600 mutant melanoma; policy covers this combination when criteria are met.

Context	Examples of Monotherapy / Combination Regimens in Trials	Policy relevance
Monotherapy and combination trial references	Atezolizumab monotherapy and combinations cited (e.g., mFOLFOX6/bevacizumab/atezolizumab in COMMIT and other studies; basket trials addressing TMB‑high/MSI‑H tumors)	These trials are cited in the references section; policy coverage is applied to regimens and indications explicitly listed in the medical necessity criteria and dosing sections.

Billing Codes, Units, and Diagnosis Codes

Dosing unit limits (HCPCS units)HCPCS

HCPCS unit limits

Mesotheliomas/Thymic Carcinoma/CLL-SLL: 120 billable units every 21 days; All other indications: 504 billable units every 84 days

HCPCS CodesHCPCSCovered

J9022

Injection, atezolizumab, 10 mg; 1 billable unit = 10 mg

NDCNDC

50242-0917-xx	Tecentriq 1200 mg/20 mL solution for injection single-dose vial
50242-0918-xx	Tecentriq 840 mg/14 mL solution for injection single-dose vial

Covered ICD-10 Diagnosis CodesICD-10Covered

C17.0	Malignant neoplasm of duodenum
C17.1	Malignant neoplasm of jejunum
C17.2	Malignant neoplasm of ileum
C17.3	Meckel's diverticulum, malignant
C17.8	Malignant neoplasm of overlapping sites of small intestine
C17.9	Malignant neoplasm of small intestine, unspecified
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

1–10 of 119

1/12

Initial prior authorization duration

Initial prior authorization duration180 days (initial authorization provided for 6 months)

Renewal frequencyRenewals may be granted every 6 months (180 days) unless otherwise specified

Adjuvant colon/small bowel/NSCLC renewal capRenewal up to a maximum of 12 months for colon cancer adjuvant, small bowel adjuvant, and NSCLC adjuvant uses

Thymic carcinoma renewal capRenewal up to a maximum of 24 months for thymic carcinoma

CLL/SLL renewal capRenewal limited to a maximum of 18 cycles for CLL/SLL (Richter transformation)

Prior Authorization, Documentation, and Operational Notes

Prior Authorization

Obtain prior authorization; initial = 180 days, renewals every 180 days

Prior authorization is required for intravenous atezolizumab. Initial authorization is provided for 6 months (180 days); renewals may be granted every 6 months thereafter. Certain indications have specified maximum renewal durations (e.g., colon and small bowel adjuvant up to 12 months, NSCLC adjuvant up to 12 months, thymic carcinoma up to 24 months, CLL/SLL up to 18 cycles).

Initial prior authorization duration = 180 days; renewals every 180 days.
Indication-specific maximum renewal limits: colon/small bowel/NSCLC adjuvant = up to 12 months; thymic carcinoma = up to 24 months; CLL/SLL = up to 18 cycles.

Prior Authorization

Renewals require continued eligibility, response, and no unacceptable toxicity

Prior authorization may be renewed only if the member continues to meet the universal and indication-specific criteria, duration limits have not been exceeded, there is disease response (stability or decrease in tumor burden), and unacceptable toxicity is absent.

Allowed Lines of Therapy

First-line | second-line | maintenance | adjuvant | subsequent

Top-level lines of therapy captured in this policy (first-line, subsequent, maintenance, adjuvant) describe allowed placements by indication and regimen.

Lines of therapy captured: First-line, subsequent, maintenance, adjuvant, and re-induction settings are described depending on cancer type and regimen; specific indications list whether atezolizumab is used as first-line combination or single-agent, as maintenance after combination chemotherapy, as adjuvant following definitive resection with chemotherapy, or as subsequent/re-induction therapy.

Refer to each indication section for the permitted line(s) of therapy.

first-line

Specific first-line allowances referenced in the NSCLC and combination-regimen sections.

NSCLC first-line summaries: First-line single-agent for PD-L1 high expressive tumors (PD-L1 ≥50% TC or IC ≥10%) when tumors lack actionable biomarkers; OR first-line in combination with platinum-based chemotherapy regimens for non-squamous disease (carboplatin + paclitaxel + bevacizumab OR carboplatin + albumin-bound paclitaxel) per indication.

Testing & Biomarker Documentation

PD-L1 thresholds

PD-L1 threshold for first-line single-agent NSCLC>=50% tumor cells (TC) OR immune cells (IC) >=10% for selected first-line single-agent NSCLC without actionable biomarkers

PD-L1 threshold for adjuvant NSCLC>=1% for some adjuvant NSCLC uses after resection and adjuvant platinum-based chemotherapy

Actionable biomarker considerationIf a clinically actionable driver oncogene is found (e.g., EGFR, ALK, etc.), therapy is guided by that marker rather than PD-L1 alone

MSI-H/dMMR

MSI-H/dMMR test requirementPositive MSI-H/dMMR must be determined by an FDA‑approved or CLIA‑compliant test

Clinical uses requiring MSI-H/dMMRRequired for colon adjuvant or single-agent advanced/metastatic colon, rectal, and small bowel disease per indication-specific criteria

Terms & Abbreviations

Atezolizumab (Tecentriq) is an anti–PD-L1 immunotherapy administered intravenously and used as monotherapy or in combination with chemotherapy or targeted agents across multiple solid tumors and select hematologic malignancies. The policy identifies indication-specific medical necessity criteria, biomarker requirements (e.g., PD-L1, MSI‑H/dMMR, POLE/POLD1 where applicable), performance-status considerations, and formulation restrictions such as prior PD‑1/PD‑L1 therapy and the prohibition on concomitant use with subcutaneous atezolizumab.

Actionable biomarkers

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

Testing expectationComplete molecular assessment (biopsy and/or plasma) is expected to determine actionable markers prior to selecting therapy

Impact on treatment selectionIf a clinically actionable marker is found, treatment is guided by that marker rather than PD-L1 or other biomarkers alone

ES-SCLC (definition and policy relevance)

Policy Summary

Payermoda_health_plan_inc

PolicyAtezolizumab (Tecentriq) — Intravenous therapy coverage

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective Date

Last ReviewJun 1, 2025

Next Review DateJun 1, 2026

SourceLink

On This Page

Small bowel adenocarcinoma (MSI-H/dMMR or POLE/POLD1): Member has MSI-H/dMMR disease by FDA-approved or CLIA-compliant test and used as adjuvant therapy with FOLFOX or CAPEOX followed by single-agent maintenance for T4,N0,M0 or T any,N1-2 disease; OR used as single agent for advanced or metastatic disease as initial or subsequent therapy (use may be restricted to members with contraindication/intolerance to durvalumab). Members with POLE/POLD1 ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) may receive single-agent atezolizumab for advanced/metastatic disease as subsequent therapy.MSI-H/dMMR OR POLE/POLD1 with TMB > 50 mut/Mb

Adjuvant staging criteria apply for small bowel adenocarcinoma.

POLE/POLD1 ultra-hypermutated: Member has POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) as determined by an FDA-approved or CLIA-compliant test; AND used as a single agent for advanced or metastatic disease as subsequent therapy.TMB > 50 mut/Mb

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

Dosing up to 24 months as specified.

CLL/SLL (Richter transformation): Used in combination with venetoclax and obinutuzumab for histologic transformation (Richter); AND 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.

Administration schedule limited to up to 18 cycles.

Member must continue to meet universal and indication-specific criteria (including concomitant therapy and performance status).

Disease response defined as stabilization or decrease in tumor size/spread; no unacceptable toxicity (examples listed in policy).

Note

References support criteria (no new PA rules in references section)

The references section supplies the literature and compendia citations that support the coverage criteria but does not itself change prior authorization requirements.

References list clinical trials and compendia used to justify criteria (e.g., Fornasiero, Raghav et al.).

Prior Authorization

PA considered due to NQTL (cost and indication management)

Prior authorization is considered appropriate for this drug group based on the NQTL assessment that cited drug cost and indication-specific management as factors influencing utilization management.

Appendix A NQTL checklist indicates 'Cost of drug' as a factor prompting consideration for prior authorization.

Step Therapy

Restrict use to members intolerant/contraindicated to specified alternatives

Atezolizumab use is frequently restricted to members with contraindication or intolerance to specified alternative immunotherapies; the policy explicitly restricts use to members with contraindication/intolerance to alternative agents in multiple indications.

NSCLC: restricted to members with contraindication/intolerance to single‑agent cemiplimab in certain pathways.
HCC, colon, small bowel, and other indications: use may be restricted to members with contraindication/intolerance to durvalumab (or durvalumab/tremelimumab) where specified.

Step Therapy

Small bowel adenocarcinoma: require durvalumab contraindication/intolerance where noted

For small bowel adenocarcinoma, single-agent or adjuvant use of atezolizumab may be limited to members with a contraindication or intolerance to durvalumab where specified in the criteria.

Small bowel adenocarcinoma: adjuvant or single-agent advanced/metastatic use notes restriction to durvalumab contraindication/intolerance.
Colon indications also note restriction to durvalumab intolerance for some single‑agent uses.

Step Therapy

No step therapy rules described in this excerpt

No step therapy sequencing rules (mandatory prior trial of another agent before coverage) are described in these reference lists.

Policy states that no step therapy rules are described in the provided reference sections.

Note

No explicit provider action in this excerpt

(No provider action explicitly stated in this placeholder inventory item in the excerpt.)

Documentation Required

Document complete biomarker testing (EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET, NRG1, ERBB2)

Complete biomarker testing is expected to document actionable markers prior to certain uses: molecular assessment should include EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2) via biopsy and/or plasma testing.

Actionable biomarkers list: EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, ERBB2 (HER2).
Testing may be by FDA-approved or CLIA-compliant assays and guides therapy decisions if a marker is found.

Documentation Required

Document MSI‑H/dMMR or POLE/POLD1 results (or durvalumab contraindication/intolerance)

When coverage is contingent on MSI‑H/dMMR or POLE/POLD1 status (or when durvalumab intolerance is required), document test results from an FDA‑approved or CLIA‑compliant assay or documentation of contraindication/intolerance to durvalumab as specified by the indication.

MSI‑H/dMMR must be determined by an FDA‑approved or CLIA‑compliant test for colon, rectal, and small bowel indications.
POLE/POLD1 ultra‑hypermutated (e.g., TMB > 50 mut/Mb) requires documentation by FDA‑approved or CLIA‑compliant testing; where criteria restrict to durvalumab intolerance, document that contraindication/intolerance.

Note

References support medical necessity; no provider documentation templates provided here

The references list clinical trials and compendia that support medical necessity criteria; the excerpt does not provide specific templated provider documentation forms.

References and compendia are cited to justify criteria (e.g., phase II/III trials listed in references).
No direct provider documentation templates are provided in this excerpt.

Documentation Required

NQTL factors documented in Appendix A (support PA design/application)

Appendix A lists Non‑Quantitative Treatment Limitation (NQTL) factors considered when designing and applying prior authorization for this drug, which should be available as supporting documentation for utilization management decisions.

Appendix A enumerates factors considered (e.g., indication, safety/efficacy, potential for misuse, cost).
NQTL assessment identifies cost as a reason to consider PA.

Denial Risk

Document prior PD‑1/PD‑L1 therapy and avoid concomitant subcutaneous atezolizumab

Prior therapy with a PD‑1/PD‑L1–directed agent (unless the policy specifies otherwise) or concurrent use with subcutaneous atezolizumab may affect authorization; ensure prior PD‑1/PD‑L1 therapy history and formulation use are documented per the universal criteria.

Universal criteria state member must not have received prior PD‑1/PD‑L1 therapy unless otherwise specified; exceptions exist for switch‑therapy with subcutaneous atezolizumab.
Therapy must not be used concomitantly with subcutaneous atezolizumab.

Denial Risk

Only request authorization for listed indications; unlisted uses are excluded

Coverage is limited to the indications listed in the policy; uses not listed have inadequate evidence and are excluded from prior authorization validity.

Policy states uses not listed have inadequate data to support efficacy and are excluded from PA validity.
Consider alternative therapies or clinical trials for unlisted uses.

Note

References provide evidence support; no extra provider tasks specified here

This excerpt's references section contains supporting literature but does not state additional provider requirements beyond those already listed in the criteria and documentation sections.

References are provided to support medical necessity decisions; no new provider actions are specified in this excerpt.

Prior Authorization

PA may be applied due to cost and NQTL considerations—expect utilization management scrutiny

Prior authorization may be applied because of drug cost and other utilization management considerations identified in the NQTL assessment; be prepared to supply documentation that addresses indication, safety/efficacy, and cost‑related questions during PA review.

Appendix A indicates 'Cost of drug' as a factor to consider for PA.
Providers may be asked to justify indication and safety/efficacy consistent with criteria during review.

PD-L1 ≥50% (TC) or IC ≥10%

Performance status and contraindication/intolerance to alternatives modify eligibility.

initial | subsequent

Criteria addressing initial versus subsequent therapy in biomarker-driven small bowel adenocarcinoma contexts.

Small bowel initial vs subsequent: Atezolizumab may be used as adjuvant therapy in MSI-H/dMMR small bowel adenocarcinoma following FOLFOX/CAPEOX then maintenance; OR used as single-agent initial or subsequent therapy for advanced/metastatic disease; use may be restricted to durvalumab contraindication/intolerance in some single-agent uses.

Adjuvant staging criteria apply (T4,N0,M0 or T any,N1-2).

additional | first-line | continuation

Additional line-of-therapy nodes address Richter transformation (CLL/SLL) contexts.

CLL/SLL Richter transformation lines: Used as additional therapy for partial response, refractory disease, or progression while on prior treatment; OR used as first-line for Richter transformation if previously treated for CLL; OR used as continuation therapy for complete response until progression.Up to 18 cycles for administration in this indication

Prior treatment for CLL may have included immune checkpoint inhibitor therapy.

first-line | second-line (various depending on referenced study)

Line-of-therapy placement varies by referenced study and indication; examples follow.

Study-dependent placements: Clinical trials and guideline references place atezolizumab in first-line combinations (e.g., NSCLC combination regimens, HCC bevacizumab combination) and in later-line single-agent uses for biomarker-defined populations (e.g., dMMR/MSI-H, POLE/POLD1), reflecting that line-of-therapy is indication- and evidence-dependent.

Refer to indication sections for exact permitted lines.

Documentation expectationTest results should be provided when MSI-H/dMMR status is required by the indication

POLE/POLD1 (ultra-hypermutated)

POLE/POLD1 ultra-hypermutated definition exampleUltra-hypermutated phenotype exemplified by tumor mutational burden (TMB) > 50 mutations per megabase (mut/Mb)

Test requirementPOLE/POLD1 mutation with ultra-hypermutated phenotype must be determined by an FDA‑approved or CLIA‑compliant test when required

Indication-specific useSupports single-agent use for locally unresectable, advanced or metastatic colon, rectal, and small bowel cancers as specified

MSI-H/dMMR (placeholder)

MSI-H/dMMR (placeholder)Policy references MSI-H/dMMR testing by FDA‑approved or CLIA‑compliant methods for biomarker-driven indications

Common applicable tumor typesColon, rectal, and small bowel cancers have MSI-H/dMMR-specific pathways in the policy

Use constraintUse may be restricted to members with contraindication or intolerance to durvalumab in some scenarios

POLE/POLD1 (ultra-hypermutated) (duplicate)

POLE/POLD1 (duplicate entry)Ultra-hypermutated POLE/POLD1 phenotype exemplified by TMB > 50 mut/Mb for select single-agent advanced/metastatic uses

Test requirementDetermination must be by an FDA‑approved or CLIA‑compliant test when indicated

Clinical contextSupports subsequent single-agent therapy in advanced/metastatic small bowel, colon, and rectal cancers per criteria

dMMR / MSI-H (inventory reference)

dMMR / MSI-H inventory referencePolicy lists dMMR/MSI-H among biomarkers used to determine eligibility for specific GI and other indications

Testing standardMSI-H/dMMR status referenced should be from FDA‑approved or CLIA‑compliant assays

Associated indicationsIncluded in colon, rectal, and small bowel adjuvant and advanced disease pathways

Tumor mutational burden (TMB), MSI-H/dMMR, POLE mutations

Biomarker list: TMB, MSI-H/dMMR, POLE mutationsTumor mutational burden (TMB), MSI-H/dMMR, and POLE mutations are listed as biomarkers referenced in the policy for eligibility decisions

Example threshold for TMB/POLEExample threshold cited: TMB > 50 mut/Mb for POLE/POLD1 ultra-hypermutated tumors

ApplicationThese biomarkers inform single-agent use for advanced/metastatic GI tumors and other biomarker-driven indications

Extensive-stage SCLC (ES-SCLC) is disease beyond a single hemithorax; policy requires ES-SCLC for certain atezolizumab indications

Policy relevanceAtezolizumab is covered as first-line combination with carboplatin and etoposide, maintenance, or subsequent therapy for ES-SCLC per criteria

Performance status requirementFor certain maintenance/subsequent uses, member must have ECOG performance status 0-1 and no history of brain metastases

MSI-H/dMMR definition

MSI-H/dMMR definitionMicrosatellite instability-high or mismatch repair deficient disease as determined by an FDA‑approved or CLIA‑compliant test

Use casesDefined MSI-H/dMMR status is required for multiple colon, rectal, and small bowel indication pathways

Testing standardResults must come from FDA‑approved or CLIA‑compliant assays when indicated by the policy

POLE/POLD1 ultra-hypermutated

POLE/POLD1 ultra-hypermutated definitionPresence of POLE or POLD1 mutation with an ultra-hypermutated phenotype (example: TMB > 50 mut/Mb) as determined by an FDA‑approved or CLIA‑compliant test

Example thresholdExample numeric threshold: TMB > 50 mutations per megabase (mut/Mb)

Clinical implicationSupports eligibility for single-agent atezolizumab in advanced/metastatic colon, rectal, and small bowel cancers per indication-specific criteria