Draftblue cross blue shield - tennesseePolicy N/A

Tecentriq (atezolizumab) — coverage criteria for oncology indications

Policy governs coverage and prior authorization criteria for Tecentriq (atezolizumab) for approved and compendial oncology indications for Blue Cross Blue Shield - Tennessee members.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyTecentriq (atezolizumab) — coverage criteria for oncology indications

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJun 30, 202618d

Next Review DateN/A

Key ActionObtain prior authorization and submit relevant diagnostic and biomarker documentation (PD-L1, MSI/dMMR or POLE/POLD1 TMB, EGFR/ALK status) to support a 6-month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical auth dur

≥1% / ≥50%PD-L1 thresholds

TMB >50 mut/Mbultra-hypermutated TMB

up to 12 monthsadjuvant max dur

up to 24 monthsthymic max dur

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Coverage criteria by cancer type and use case

NSCLC — covered scenarios

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

NSCLC adjuvant or metastatic single-agent or combination use: Tumor PD-L1 expression meets indicated threshold when required; no EGFR exon 19 deletions or L858R mutations or ALK rearrangements unless testing not feasible; use consistent with FDA‑approved single‑agent or combination indications (adjuvant, first‑line, or subsequent therapy).PD-L1 >=1% for adjuvant; PD-L1 >=50% (TC) or IC >=10% for frontline single-agent metastatic

Authorization of 6 months may be granted; see documentation requirements for molecular testing.

SCLC — covered scenarios

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

SCLC first-line extensive-stage: Requested medication will be used in combination with etoposide and carboplatin for first‑line treatment of extensive‑stage disease, followed by maintenance single‑agent therapy or maintenance with lurbinectedin.

Authorization of 6 months may be granted.

Hepatocellular carcinoma — covered scenarios

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

HCC first-line or adjuvant with bevacizumab: Tecentriq will be used in combination with bevacizumab for first‑line treatment of unresectable or metastatic HCC or as adjuvant therapy following resection or ablation.

Authorization of 6 months may be granted.

Melanoma — covered scenarios

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

BRAF V600 mutation-positive melanoma: Requested medication will be used in combination with cobimetinib and vemurafenib for unresectable or metastatic BRAF V600 mutation‑positive melanoma; documentation of a BRAF V600 mutation is required.

Authorization of 6 months may be granted; submit BRAF V600 test results.

Alveolar soft part sarcoma — covered scenarios

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

ASPS unresectable or metastatic: Tecentriq used as a single agent for unresectable or metastatic alveolar soft part sarcoma in adult or pediatric patients (≥2 years).

Authorization of 6 months may be granted.

Cervical cancer — covered scenarios

Authorization of 6 months may be granted for cervical cancer when ANY of the following are met:

Cervical cancer combination regimens: Member has recurrent or metastatic adenocarcinoma, adenosquamous, or squamous cell carcinoma and Tecentriq will be used with bevacizumab, paclitaxel, and cisplatin or carboplatin (bevacizumab may be used for maintenance); OR member has persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix and Tecentriq will be used with etoposide and cisplatin or carboplatin followed by single‑agent maintenance.

Authorization of 6 months may be granted.

Colon cancer — covered scenarios

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

Stage III colon cancer with hypermutated phenotype: Member's disease is confirmed dMMR/MSI‑H or POLE/POLD1 mutation with ultra‑hypermutated phenotype (TMB >50 mut/Mb) AND Tecentriq will be used in combination with FOLFOX or CAPEOX regimens followed by single‑agent maintenance.TMB >50 mut/Mb

Authorization of 6 months may be granted; requests not meeting biomarker and regimen criteria are excluded.

Mesothelioma — covered scenarios

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

Peritoneal/pericardial/tunica vaginalis mesothelioma: Tecentriq used as subsequent treatment in combination with bevacizumab followed by single‑agent maintenance for peritoneal, pericardial, or tunica vaginalis testis mesothelioma.

Authorization of 6 months may be granted.

Thymic carcinoma — covered scenarios

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

Thymic carcinoma first-line or postoperative systemic therapy: Tecentriq used in combination with carboplatin and paclitaxel followed by single‑agent maintenance for first‑line or postoperative systemic therapy.

Authorization of 6 months may be granted.

Adjuvant stage III colon cancer

Adjuvant treatment of stage III colon cancer — Covered when ALL of the following are met:

Colon adjuvant criteria: 1) Disease confirmed dMMR/MSI‑H or POLE/POLD1 mutation with ultra‑hypermutated phenotype (TMB >50 mut/Mb); 2) Tecentriq will be used in combination with FOLFOX or CAPEOX regimens followed by single‑agent maintenance.

Authorization of 6 months may be granted.

Thymic carcinoma — initial

Thymic carcinoma — Covered when ALL of the following are met:

Thymic carcinoma initial therapy: Requested for first‑line or postoperative systemic therapy in combination with carboplatin and paclitaxel followed by single‑agent maintenance.

Authorization of 6 months may be granted.

Thymic carcinoma — reauthorization

Thymic carcinoma — Reauthorization:

Thymic carcinoma reauthorization: Member has not experienced disease progression or unacceptable toxicity while on the current regimen.

Authorization of 6 months may be granted (up to 24 months total).

CLL with Richter's transformation

Chronic lymphocytic leukemia (CLL) with Richter's transformation — Covered when ALL of the following are met:

CLL (Richter's) criteria: Requested medication will be used in combination with venetoclax and obinutuzumab.

Authorization of 6 months may be granted.

Adjuvant HCC, NSCLC, colon — reauthorization

Adjuvant treatment reauthorization for HCC, NSCLC, and colon cancer — Covered when ALL of the following are met:

Adjuvant reauthorization: Member requesting reauthorization has not experienced disease recurrence or an unacceptable toxicity while on adjuvant therapy.

Authorization of 6 months may be granted (up to 12 months total).

Other indications — reauthorization

Reauthorization for other listed indications — Covered when ALL of the following are met:

General reauthorization: No evidence of unacceptable toxicity or disease progression while on the current regimen.

Authorization of 6 months may be granted.

All indications for Tecentriq (atezolizumab) not specifically listed in the Coverage Criteria section — i.e., uses outside the FDA‑approved indications and the compendial uses enumerated in this policy — are considered experimental/investigational and are not medically necessary for purposes of coverage.

Requests for adjuvant treatment of stage III colon cancer that do not meet the policy’s biomarker and regimen requirements are excluded from coverage. To be eligible, the member’s disease must be confirmed dMMR/MSI‑H or POLE/POLD1 mutation with an ultra‑hypermutated phenotype (TMB >50 mut/Mb), and Tecentriq must be used in combination with FOLFOX or CAPEOX followed by single‑agent maintenance.

Coverage will not be provided for members who have experienced disease progression while on a PD‑1 or PD‑L1 inhibitor.

Requests for reauthorization will be denied when there is evidence of disease progression or unacceptable toxicity while the member is on the current regimen. Reauthorization is only appropriate when documentation shows no progression and no unacceptable treatment‑related toxicity.

Regimens and combination therapies covered

Indication	Regimen / Required Combinations	Authorization Notes
NSCLC — First-line metastatic (non-squamous)
Tecentriq + bevacizumab + paclitaxel + carboplatin
Tecentriq + paclitaxel protein-bound + carboplatin
Authorization: 6 months may be granted for first-line therapy; used as first line in combination with chemotherapy with or without bevacizumab.
NSCLC — First-line metastatic (high PD-L1, single-agent)
Tecentriq as single agent for tumors with PD-L1 ≥ 50% (TC ≥ 50% or IC ≥ 10%) and no EGFR/ALK aberrations
Authorization: May be used as first-line single agent; authorization durations consistent with clinical scenario.
NSCLC — Adjuvant (stage II–IIIA)
Tecentriq as single agent following resection and platinum-based chemotherapy for stage II–IIIA with PD-L1 ≥ 1% (FDA-approved test)
Authorization: 6 months may be granted for adjuvant therapy for stage IB–III PD-L1 positive when no EGFR exon 19 deletions/L858R mutations or ALK rearrangements are present (unless testing not feasible).
NSCLC — Subsequent therapy (progressive disease)
Tecentriq as single agent for metastatic NSCLC after progression on platinum-containing chemotherapy
Authorization: 6 months may be granted for single-agent subsequent therapy.

Requirement	Details
Combination regimen requirements
For NSCLC first-line metastatic non-squamous: Atezolizumab must be used with one of the specified regimens — either with bevacizumab + paclitaxel + carboplatin OR with paclitaxel protein-bound + carboplatin.
For colon cancer (adjuvant, stage III): Atezolizumab must be used in combination with FOLFOX or CAPEOX, followed by single-agent maintenance; member must have dMMR/MSI-H or POLE/POLD1 ultra-hypermutated phenotype (TMB >50 mut/Mb).
For thymic carcinoma: Atezolizumab must be used in combination with carboplatin + paclitaxel followed by single-agent maintenance.
For CLL with Richter's transformation: Atezolizumab must be used in combination with venetoclax + obinutuzumab.
For SCLC (extensive-stage): Atezolizumab must be used in combination with carboplatin + etoposide, followed by maintenance as single agent or with lurbinectedin.
For HCC unresectable/metastatic (and adjuvant following resection/ablation): Atezolizumab must be used in combination with bevacizumab.
Authorization notes
Providers should document tumor biomarker results (PD-L1, EGFR/ALK status, dMMR/MSI-H, TMB, BRAF when applicable) and specify the exact chemo/immunotherapy combination on the prior authorization to avoid denial risk.

Prior Authorization

Provider action: NSCLC usage pathways

Provider action: NSCLC usage pathways — ensure appropriate diagnostic testing and document the chosen regimen. - Confirm and document EGFR and ALK genomic aberration testing before using combination regimens in metastatic NSCLC; if EGFR or ALK aberrations are present, verify progression on indicated targeted therapies prior to atezolizumab use. - For single-agent adjuvant use, document PD-L1 expression (≥ 1%) and absence of EGFR exon 19 deletions/L858R or ALK rearrangements unless testing not feasible. - For high PD-L1 single-agent first-line treatment, document PD-L1 ≥ 50% (TC ≥ 50% or IC ≥ 10%) and absence of EGFR/ALK aberrations. - When requesting authorization for combination regimens, specify the exact chemotherapy backbone (e.g., bevacizumab + paclitaxel + carboplatin OR paclitaxel protein-bound + carboplatin) and attach relevant pathology/molecular reports.

Biomarker and molecular testing requirements

PD-L1 — Thresholds for NSCLC indications

Adjuvant PD-L1 thresholdTumor PD-L1 expression ≥1% on tumor cells is required for adjuvant NSCLC use (stage IB–III).

Frontline single-agent metastatic thresholdTumors must have high PD-L1: TC ≥50% or IC ≥10% by an FDA‑approved test for first‑line single‑agent metastatic NSCLC.

NSCLC EGFR/ALK noteFirst‑line metastatic single‑agent use requires no EGFR or ALK genomic tumor aberrations when testing is feasible.

BRAF V600 — Melanoma requirement

Required mutationBRAF V600 mutation (positive) must be documented for use in combination with cobimetinib and vemurafenib for unresectable or metastatic melanoma.

DocumentationSubmit test results confirming tumor is positive for BRAF V600 mutation (where applicable).

Regimen linkageCoverage tied to use of Tecentriq with cobimetinib and vemurafenib as specified in the melanoma indication.

MSI‑H / dMMR / POLE/POLD1 — Colon adjuvant requirements

Required biomarker statusDisease must be dMMR/MSI‑H or have a POLE/POLD1 mutation with an ultra‑hypermutated phenotype for adjuvant stage III colon cancer coverage.

TMB thresholdWhen POLE/POLD1 mutation is present, tumor mutational burden must be >50 mutations per megabase (TMB >50 mut/Mb).

Regimen requirementTecentriq must be used in combination with FOLFOX or CAPEOX followed by single‑agent maintenance for adjuvant coverage.

EGFR / ALK — NSCLC testing requirements

EGFR/ALK absence requiredFor many NSCLC uses, tumors must lack EGFR exon 19 deletions or L858R mutations and absence of ALK rearrangements unless testing is not feasible due to insufficient tissue.

Progression exceptionPatients with EGFR or ALK aberrations should have disease progression on FDA‑approved targeted therapies for those aberrations before receiving Tecentriq in later lines.

Documentation to submitSubmit test results confirming absence of EGFR exon 19 deletions or L858R mutations or ALK rearrangements when applicable.

dMMR / MSI‑H — Definition / reference

DefinitiondMMR / MSI‑H refers to deficient mismatch repair or microsatellite instability‑high status of the tumor.

Use caseRequired biomarker for adjuvant stage III colon cancer eligibility when pairing with FOLFOX or CAPEOX regimens.

DocumentationTest results confirming MSI‑H or dMMR must be submitted when applicable.

POLE / POLD1 mutation with ultra‑hypermutated phenotype

Ultra‑hypermutated phenotype definitionPOLE or POLD1 mutation with ultra‑hypermutated phenotype is defined as tumor mutational burden greater than 50 mutations per megabase (TMB >50 mut/Mb).

Role in colon cancerRequired for adjuvant stage III colon cancer eligibility when POLE/POLD1 mutation is present.

DocumentationSubmit test results confirming POLE/POLD1 mutation and TMB >50 mut/Mb when applicable.

Documentation Required

Provide required biomarker and molecular test results

Submit supporting laboratory or molecular test reports with the prior authorization request showing the specific biomarker results relevant to the indication.

BRAF V600 mutation test results when applicable (e.g., melanoma).
PD‑L1 tumor expression results when applicable (e.g., NSCLC adjuvant/metastatic thresholds).
Documentation of absence of EGFR exon 19 deletions or L858R mutations and absence of ALK rearrangements when applicable for NSCLC.

Documentation Required

Colon cancer: submit biomarker and regimen documentation

For adjuvant stage III colon cancer requests, include documentation that the tumor is dMMR/MSI‑H or has a POLE/POLD1 mutation with ultra‑hypermutated TMB (>50 mut/Mb) and that atezolizumab will be given in combination with FOLFOX or CAPEOX followed by single‑agent maintenance.

Test report confirming dMMR/MSI‑H or POLE/POLD1 with TMB >50 mut/Mb.
Planned regimen documentation showing combination use with FOLFOX or CAPEOX and intended single‑agent maintenance.

Permitted lines of therapy and maintenance use

first-line | subsequent | maintenance

Line of therapy examples: First‑line, subsequent, and maintenance therapy uses are allowed across indications; specific combinations define first‑line (e.g., with chemotherapy for NSCLC and SCLC) and maintenance scenarios.

first-line

First‑line specific criterion: Requested medication will be used as first‑line therapy either as a single agent or in combination with chemotherapy (with or without bevacizumab) depending on the cancer type and regimen.

adjuvant

Adjuvant specific criterion: Adjuvant use requires disease meeting biomarker criteria where specified (e.g., NSCLC PD‑L1 ≥1% for adjuvant; colon cancer dMMR/MSI‑H or POLE/POLD1 with TMB >50 mut/Mb) and use with the specified adjuvant chemotherapy regimen (where required).

Note

Document NSCLC treatment pathway and testing

For NSCLC, document the intended usage pathway: continued maintenance single‑agent (with or without bevacizumab), first‑line or subsequent therapy in combination with chemotherapy (with or without bevacizumab), or first‑line single‑agent use where indicated.

If applicable, include PD‑L1 and EGFR/ALK testing results (absence of EGFR exon 19 deletions/L858R and ALK rearrangements when feasible).
Indicate whether the request is for maintenance, first‑line, or subsequent therapy and list concomitant therapies (chemotherapy and/or bevacizumab).

Authorization, documentation, and reauthorization actions

Prior Authorization

Prior authorization required — 6 month approvals

Prior authorization is required; when indication‑specific clinical criteria are met, authorization may be granted for a 6‑month period.

See the Coverage Criteria section for indication‑specific requirements that support a 6‑month approval.

Prior Authorization

Authorization duration — initial and reauthorization

Initial authorizations and reauthorizations are typically approved for 6 months; certain indications have defined total‑duration caps for continued treatment.

Adjuvant HCC, NSCLC, and colon reauthorization: may be granted for 6 months (up to 12 months total) if no recurrence or unacceptable toxicity.
Thymic carcinoma reauthorization: may be granted for 6 months (up to 24 months total) if no progression or unacceptable toxicity.

Billing Rule

Document specified combination regimens

Operationally, confirm and document the required combination chemotherapy regimen when the indication specifies combination use; requests lacking regimen documentation may be denied.

Adjuvant colon cancer: FOLFOX or CAPEOX documented.
Thymic carcinoma: carboplatin + paclitaxel documented.
CLL Richter's: venetoclax + obinutuzumab documented.

Documentation Required

Required clinical documentation for PA and reauthorization

Include clinical documentation demonstrating diagnosis, relevant biomarker results, planned or ongoing combination chemotherapy regimens, and treatment dates to support the prior authorization request or reauthorization.

Diagnosis and staging information.
Laboratory/pathology reports for biomarkers (e.g., PD‑L1, BRAF V600, dMMR/MSI‑H, POLE/POLD1 with TMB).
Planned or current combination therapy details and treatment initiation/continuation dates.
For reauthorization, documentation that there is no disease recurrence/progression or unacceptable toxicity.

Denial Risk

Exclude members with prior PD‑(L)1 progression

Do not request coverage for members who have experienced disease progression while receiving PD‑1 or PD‑L1 inhibitor therapy; such members are excluded from coverage under this policy.

Evidence of disease progression on a PD‑1 or PD‑L1 inhibitor will make the member ineligible for coverage.

Denial Risk

CLL (Richter's): combination regimen must be documented

Requests for CLL with Richter's transformation must document that atezolizumab will be used in combination with venetoclax and obinutuzumab; absence of this regimen documentation risks denial.

Provide regimen orders or treatment plan showing concurrent use with venetoclax and obinutuzumab.

Billing codes, dosing, and diagnostic thresholds

Covered/affected billing codesmixed

affected codes

Placeholder — specific HCPCS/CPT/NDC codes referenced in subsequent policy sections (not present in this partial document).

Medication dosing (informational)mixed

840 mg q2w	Intravenous dosing option for Tecentriq (Atezolizumab) for adults (≥18 years) as listed in medication quantity limits.
1200 mg q3w	Intravenous dosing option for Tecentriq (Atezolizumab); also listed as initial 1200 mg every 3 weeks for 4-6 doses for certain indications with maintenance dosing options.
1680 mg q4w	Intravenous dosing option for Tecentriq (Atezolizumab) for adults as listed in medication quantity limits and as a maintenance option for some indications.
15 mg/kg q3w (up to 1200 mg)	Pediatric dosing (≥2 to <18 years): 15 mg/kg every 3 weeks, up to a maximum of 1200 mg every 3 weeks.

PD‑L1 / TMB thresholds

PD‑L1 thresholdsPD‑L1 ≥1% (adjuvant) or high PD‑L1 defined as TC ≥50% or IC ≥10% (frontline single‑agent metastatic).

TMB thresholdUltra‑hypermutated TMB defined as >50 mutations per megabase (TMB >50 mut/Mb).

Use of testsPD‑L1 and TMB testing results should be submitted as part of prior authorization documentation where applicable.

Tumor mutational burden — Definition and reference

TMB numerical thresholdTumor mutational burden (TMB) >50 mutations per megabase is the threshold for the ultra‑hypermutated phenotype used in policy determinations.

Associated biomarkersTMB >50 mut/Mb is associated with POLE/POLD1 ultra‑hypermutated phenotype and may be considered with MSI‑H/dMMR status.

DocumentationSubmit TMB testing results indicating >50 mut/Mb when required for the indication.

Drug background and context

Tecentriq (atezolizumab) is an anti‑programmed death‑ligand 1 (PD‑L1) immune checkpoint inhibitor used across multiple oncology indications. The agent is administered intravenously and is indicated or used in combination regimens for various cancers covered by this policy (for example, lung cancers, hepatocellular carcinoma, melanoma, alveolar soft part sarcoma and select compendial uses). Coverage decisions in this policy are tied to specific tumor biomarkers (such as PD‑L1 expression, dMMR/MSI‑H, POLE/POLD1 with TMB >50 mut/Mb, BRAF V600, and absence of certain EGFR/ALK alterations where applicable) and to FDA‑approved single‑agent or combination regimens and lines of therapy.

Key definitions and phenotype thresholds

PD‑L1 expression — Referenced thresholds

PD‑L1 expression (adjuvant)Adjuvant NSCLC indication requires PD‑L1 expression ≥1% on tumor cells as determined by an FDA‑approved test.

PD‑L1 expression (frontline single‑agent)First‑line single‑agent metastatic NSCLC requires PD‑L1 high expression: TC ≥50% or IC ≥10%.

Test requirementPD‑L1 results must be from an FDA‑approved test where applicable and included in documentation.

Ultra‑hypermutated TMB — Definition and association

Association with POLE/POLD1Ultra‑hypermutated TMB (TMB >50 mut/Mb) is associated with POLE/POLD1 mutations and is used to define eligibility for certain colon cancer adjuvant therapy.

Clinical relevancePresence of POLE/POLD1 mutation plus TMB >50 mut/Mb qualifies as an ultra‑hypermutated phenotype per policy for coverage consideration.

DocumentationSubmit POLE/POLD1 mutation testing and TMB results when applicable.

Ultra‑hypermutated (TMB >50 mut/Mb) — Concise definition

Concise definitionUltra‑hypermutated = tumor mutational burden (TMB) >50 mutations per megabase (TMB >50 mut/Mb).

Policy useUsed to establish eligibility for adjuvant stage III colon cancer when POLE/POLD1 mutation is present.

DocumentationTMB >50 mut/Mb must be demonstrated in submitted test results when required.

dMMR / MSI‑H — Definition

DefinitiondMMR / MSI‑H = deficient mismatch repair or microsatellite instability‑high status of the tumor.

RelevanceRequired biomarker status for adjuvant stage III colon cancer eligibility when paired with FOLFOX or CAPEOX regimens.

Submission noteMSI‑H/dMMR test results must be submitted when applicable for prior authorization review.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyTecentriq (atezolizumab) — coverage criteria for oncology indications

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJun 30, 202618d

Next Review DateN/A

Key ActionObtain prior authorization and submit relevant diagnostic and biomarker documentation (PD-L1, MSI/dMMR or POLE/POLD1 TMB, EGFR/ALK status) to support a 6-month approval.

SourceLink

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