Last Review Date: 10/03/2024

Date of Origin: 10/03/2024

Dates Reviewed: 10/2024

1. Length of Authorization ^{∆ 1}

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

• Adjuvant therapy in Non-Small Cell Lung Cancer (NSCLC) can be renewed up to a maximum of 12 months of therapy.*

2. Dosing Limits

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

• Tecentriq 1,875 mg and 30,000 units/15 mL in a single-dose vial: 1 vial per 21 days

B. Max Units (per dose and over time) [HCPCS Unit]:

• 1,875 mg/30,000 units every 21 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; 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, retifanlimab, toripalimab, tislelizumab, etc.) unless otherwise specified ^∆ (Note: Not applicable when used as switch-therapy with intravenous atezolizumab); AND
• Therapy will not be used concomitantly with intravenous atezolizumab; AND
• Patients <62 kg should use the IV formulation of Tecentriq; AND

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

• Used for metastatic disease; AND

• Used as first-line therapy; AND
  • Used as a single agent; AND
    • Patients has tumors that are negative for actionable molecular markers* (EGFR or ALK genomic tumor aberrations) 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; OR
  • Used in combination with one of the following:

• • Carboplatin, paclitaxel, and bevacizumab
  • Carboplatin and albumin-bound paclitaxel; AND
    • Used for non-squamous disease; AND

• • • Patients have tumors that are negative for actionable molecular markers* (EGFR or ALK genomic tumor aberrations); OR

• Used as subsequent therapy during or after platinum-containing chemotherapy; AND
  • Used as a single agent; AND
    • Patients who are positive for one of the following molecular biomarkers and received prior targeted therapy§: EGFR or ALK rearrangement,; 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 †;  

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

Hepatocellular Carcinoma (HCC) †  Ф ^{1,6,15,16,21,28}

• Used in combination with bevacizumab; AND
• Used as first-line therapy for unresectable or metastatic disease †

Cutaneous Melanoma † ‡ Ф ^1,6,19,20,29

• 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

Alveolar Soft Part Sarcoma (ASPS) † ^1,6,26

• Patient has unresectable or metastatic disease; AND
• Used as a single agent

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

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

4. 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 [including Stevens-Johnson syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN)], myocarditis, pericarditis, vasculitis, solid organ transplant rejection, etc.), severe infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.

NSCLC (adjuvant treatment)

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

5. Dosage/Administration ^{∆ 1,14,27,28}

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drugs
• C9399 – Unclassified drugs or biologicals (hospital outpatient use only)

NDC(s):

• Tecentriq 1,875 mg and 30,000 units/15 mL in a single-dose vial: 50242-0933-xx

7. References

1. Tecentriq Hybreza [package insert]. South San Francisco, CA; Genentech, Inc; September 2024. Accessed September 2024.
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 July 2023.
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, 2024. 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 June 2024.
7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Bladder Cancer. Version 4.2024. National Comprehensive Cancer Network, 2024. 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 June 2024.
8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Non-Small Cell Lung Cancer. Version 5.2024. National Comprehensive Cancer Network, 2024. 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 June 2024.
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^®) Hepatocellular Carcinoma. Version 1.2024. National Comprehensive Cancer Network, 2024. 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 June 2024.
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 3.2024. National Comprehensive Cancer Network, 2024. 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 June 2024.
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 2.2024. National Comprehensive Cancer Network, 2024. 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 June 2024.
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. (2024). Treatment of metastatic urothelial cancer of the bladder and urinary tract. In Lerner SP, Shah S (Eds.), UptoDate. Last updated April 11, 2024. Accessed June 2024. 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.
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28. Qin S, Chen M, Cheng AL, Kaseb AO, et al. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Nov 18;402(10415):1835-1847. doi: 10.1016/S0140-6736(23)01796-8.
29. Ascierto PA, Stroyakovskiy D, Gogas H, et al. Overall survival with first-line atezolizumab in combination with vemurafenib and cobimetinib in BRAFV600 mutation-positive advanced melanoma (IMspire150): second interim analysis of a multicentre, randomised, phase 3 study. Lancet Oncol 2023;24:33-44.
30. Kicken, M.P., Deenen, M.J., Moes, D.J.A.R. et al. An Evidence-Based Rationale for Dose De-escalation of Subcutaneous Atezolizumab. Targ Oncol 19, 779–787 (2024). https://doi.org/10.1007/s11523-024-01087-4.
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Appendix 1 – Covered Diagnosis Codes

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

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