Last Review Date: 03/02/2023

Date of Origin: 06/28/2016

Dates Reviewed: 06/2016, 08/2016, 10/2016, 02/2017, 04/2017, 08/2017, 11/2017, 02/2018, 05/2018, 06/2018, 09/2018, 12/2018, 03/2019, 04/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 08/2020, 12/2020, 03/2021, 05/2021, 09/2021, 11/2021, 12/2021, 03/2022, 06/2022, 09/2022, 12/2022, 01/2023, 03/2023

I. Length of Authorization ^∆,1

Coverage will be provided for 6 months and may be renewed (unless otherwise specified).

• Adjuvant therapy in NSCLC can be authorized up to a maximum of 12 months of therapy.

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Tecentriq 1,200 mg single-use vial: 1 vial per 21 days
• Tecentriq 840 mg single-use vial: 1 vial per 14 days

2. Max Units (per dose and over time) [HCPCS Unit]:
   • MPeM and Cervical Cancer: 120 billable units every 21 days
   • All other indications: 168 billable units every 28 days

III. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age (unless otherwise specified); AND

Universal Criteria

• Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., nivolumab, pembrolizumab, durvalumab, avelumab, cemiplimab, dostarlimab, nivolumab/relatlimab-rmbw, etc.) unless otherwise specified ^∆; AND

Non-Small Cell Lung Cancer (NSCLC) † ‡ ^{1,5,6,8,11,12,17,23}

• Patient has recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND

• Used as first-line therapy; AND
  • Used for tumors that are negative for actionable molecular markers* and PD-L1 ≥ 50% (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test or CLIA-compliant testv; AND
    • Used as a single agent; OR
  • Used for non-squamous disease in one of the following:

• • Patients with PS 0-1 who have tumors that are negative for actionable molecular markers* and PD-L1 <1%
  • Patients with PD-L1 expression positive tumors (PD-L1 ≥ 1%) that are negative for actionable molecular biomarkers*

• • Patients with PS 0-1 who are positive for one of the following molecular mutations: EGFR exon 20, KRAS G12C, BRAF V600E, NTRK1/2/3 gene fusion, MET exon-14 skipping, RET rearrangement, or ERBB2 (HER2); AND
    • Used in combination with carboplatin, paclitaxel, and bevacizumab; OR
    • Used in combination with carboplatin and albumin-bound paclitaxel; OR
• Used as subsequent therapy; AND
  • Used as a single agent; OR
  • Used for non-squamous disease in one of the following:

• • Patients with PS 0-1 who are positive for one of the following molecular mutations: BRAF V600E, NTRK1/2/3 gene fusion, MET exon-14 skipping, or RET rearrangement
  • Patients with PS 0-1 who are positive for one of the following molecular mutations and received prior targeted therapy§: EGFR exon 19 deletion or exon 21 L858R tumors, EGFR S768I, L861Q, and/or G719X mutation, ALK rearrangement, or ROS1 rearrangement; AND
    • Used in combination with carboplatin, paclitaxel, and bevacizumab; OR
    • Used in combination with carboplatin and albumin-bound paclitaxel; OR
• Used as continuation maintenance therapy in patients who have achieved a tumor response or stable disease following initial therapy; AND
  • Used in combination with bevacizumab following a first-line regimen with atezolizumab, carboplatin, paclitaxel, and bevacizumab for non-squamous histology; OR
  • Used as a single agent following a first-line regimen with atezolizumab, carboplatin, and albumin-bound paclitaxel for non-squamous histology; OR
  • Used as a single agent following a first-line regimen with single agent atezolizumab; OR

• Used as adjuvant therapy as a single agent; AND
  • Tumor expresses PD-L1 ≥1% as determined by an FDA-approved test or CLIA-compliant testv; AND
  • Used following resection and previous adjuvant chemotherapy; AND
    • Patient has stage II to IIIA disease †; OR
    • Patient has stage IIIB (T3, N2) disease ‡; AND
      • • • • •  
    • Disease is negative for EGFR exon 19 deletion or exon 21 L858R mutations, or ALK rearrangements

Small Cell Lung Cancer (SCLC) † ‡ Ф ^1,6,14,18

• Patient has extensive stage disease (ES-SCLC); AND
  • Used as first-line therapy in combination with etoposide and carboplatin; OR
  • Used as single-agent maintenance therapy after initial therapy with atezolizumab, etoposide, and carboplatin

Hepatocellular Carcinoma (HCC) † ‡ Ф ^1,6,15,16,21

• Used as first-line therapy in combination with bevacizumab; AND
• Patient has Child-Pugh Class A hepatic impairment; AND
  • Patient has unresectable or metastatic disease; OR
  • Patient has liver-confined disease that is inoperable by performance status, comorbidity, or with minimal or uncertain extrahepatic-disease; OR
  • Patient has extensive liver tumor burden

Malignant Peritoneal** Mesothelioma (MPeM) ‡ ^6,24

• Used as subsequent therapy in combination with bevacizumab

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

Cutaneous Melanoma † ‡ Ф ^1,6,19,20

• Patient has BRAF V600 mutation-positive disease as detected by an FDA approved or CLIA compliant testv; AND
• Used in combination with cobimetinib and vemurafenib; AND
  • • • • Patient has unresectable or metastatic disease; AND
    • Used as first-line therapy; OR
    • Used as subsequent therapy for disease progression or intolerance if BRAF/MEK and/or PD(L)-1 checkpoint inhibition not previously used; OR
  • Used as re-induction therapy in patients who experienced disease control (i.e., complete response, partial response, or stable disease with no residual toxicity) from prior combination BRAF/MEK + PD(L)-1 checkpoint inhibitor therapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation

Alveolar Soft Part Sarcoma (ASPS) † Ф ^1,26

• Patient is at least 2 years of age; AND
• Used as a single agent; AND
• Patient has unresectable or metastatic disease that is not curable by surgery

Cervical Cancer ‡ ^6,14

• Patient has small cell neuroendocrine carcinoma of the cervix (NECC); AND
• Used as first-line or subsequent therapy (if not used previously as first-line therapy) for persistent, recurrent, or metastatic disease; AND
• Used in combination with etoposide AND either cisplatin or carboplatin

vIf confirmed using an FDA approved assay - http://www.fda.gov/companiondiagnostics

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria ^{∆ 1,6}

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis/renal dysfunction, rash/dermatitis, etc.), severe infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.

Cutaneous Melanoma (re-induction therapy)

• Refer to Section III for criteria

Continuation Maintenance Therapy for NSCLC or SCLC

• Refer to Section III for criteria

NSCLC (adjuvant treatment)

• Patient has not exceeded a maximum of twelve (12) months of therapy

V. Dosage/Administration ^{∆ 1,14,25}

VI. Billing Code/Availability Information

HCPCS Code:

• J9022 – Injection, atezolizumab, 10 mg; 10 mg = 1 billable unit

NDC(s):

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

VII. References

1. Tecentriq [package insert]. South San Francisco, CA; Genentech, Inc; December 2022. Accessed January 2023.
2. Ventana Product Library, Roche Pharmaceuticals. VENTANA PD-L1 [SP142] Assay. http://www.ventana.com/ventana-pd-l1-sp142-assay-2/ and product label https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160006C.pdf. Accessed May 2018.
3. U.S. Food and Drug Administrations (FDA). Division of Drug Information. Health Alert. http://s2027422842.t.en25.com/e/es?s=2027422842&e=88882&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=3f0714083e82421a8af346a664bedbfb&elqaid=3588&elqat=1. Accessed May 2018.
4. Balar AV, Galsky MD, Rosenberg JE, et al. Atezolizumab as first-line therapy in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 January 07; 389(10064): 67–76. doi:10.1016/S0140-6736(16)32455-2.
5. Socinski MA, Jotte RM, Cappuzzo F, et. al. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med 2018; 378:2288-2301. DOI: 10.1056/NEJMoa1716948.
6. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) atezolizumab. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2023.
7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Bladder Cancer. Version 1.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2023.
8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Non-Small Cell Lung Cancer. Version 2.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2023.
9. Gupta S, Bellmunt J, Plimack ER, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2022 June 1;40(16_suppl):4577.
10. Rosenberg JE, Hoffman-Censits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4.
11. West H, McCleod M, Hussein M, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):924-937. doi: 10.1016/S1470-2045(19)30167-6. Epub 2019 May 20.
12. Rittmeyer A, Barlesi F, Waterkamp D, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13.
13. Schmid P, Adams S, Rugo HS, et al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20.
14. Horn L, Mansfield AS, Szczesny A, et al. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
15. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Hepatobiliary Cancers. Version 5.2022. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2023.
16. Pishvaian MJ, Lee MS, Ryoo B, et al. Updated safety and clinical activity results from a Phase Ib study of atezolizumab + bevacizumab in hepatocellular carcinoma (HCC). ESMO 2018 Congress. Munich, Germany; 2018.
17. De Marinis F, Jassem J, Spigel DR, et al. 480TiP IMpower110: Phase III study on 1L atezolizumab (atezo) in PD-L1–selected chemotherapy (chemo)-naive NSCLC patients (pts). Annals of Oncology. 2016 Dec 1;27(suppl_9).
18. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Small Cell Lung Cancer. Version 3.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2023.
19. Gutzmer R, Stroyakovskiy D, Gogas H, et al. Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAFV600 mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020;395(10240):1835-1844. doi:10.1016/S0140-6736(20)30934-X.
20. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Melanoma: Cutaneous. Version 1.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2023.
21. Finn RS, Qin S, Ikeda M, et al; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905.
22. Bellmunt, J. (2023). Treatment of metastatic urothelial cancer of the bladder and urinary tract. In Lerner SP, Shah S (Eds.), UptoDate. Accessed February 20, 2023. Available from https://www.uptodate.com/contents/treatment-of-metastatic-urothelial-cancer-of-the-bladder-and-urinary-tract?search=cisplatin%20ineligible&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.
23. Felip E, Altorki N, Zhou C, et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20.
24. Raghav KPS, Overman MJ, Liu S, et al. A phase II trial of atezolizumab and bevacizumab in patients with relapsed/refractory and unresectable malignant peritoneal mesothelioma. Journal of Clinical Oncology 2020 38:15_suppl, 9013-9013.

25. De Santis M, Bellmunt J, Mead G, et al. Randomized phase II/III trial assessing gemcitabine/ carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: phase II--results of EORTC study 30986. J Clin Oncol. 2009 Nov 20;27(33):5634-9. doi: 10.1200/JCO.2008.21.4924. Epub 2009 Sep 28.
26. Naqash AR, O'Sullivan Coyne GH, Moore N, et al. Phase II study of atezolizumab in advanced alveolar soft part sarcoma (ASPS). Journal of Clinical Oncology 2021 39:15_suppl, 11519-11519.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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