BlueCross BlueShield of Tennessee Medical Policy Manual

Atezolizumab (Tecentriq®)

NDC CODE(S)

50242-0917-XX TECENTRIQ 60MG/ML Solution (GENENTECH

50242-0918-XX TECENTRIQ 60MG/ML Solution (GENENTECH

DESCRIPTION

Atezolizumab is a monoclonal antibody that binds to programmed death-ligand 1 (PD-L1), a transmembrane protein which may be expressed on tumor cells and/or tumor-infiltrating immune cells and are often increased.  By binding to the receptors on PD-L1, atezolizumab prevents its binding to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells.  This releases the PD-L1/PD-1 mediated inhibition of the immune response and activates

POLICY

·         Atezolizumab is considered medically necessary for the treatment of the following if the medical appropriateness criteria are met.  (See Medical Appropriateness below.)

·         Atezolizumab for the treatment of other conditions/diseases is considered investigational.  

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

·         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, etc.) unless otherwise specified; AND

Urothelial Carcinoma (Bladder Cancer)

·         Used as a single agent; AND

·         Patient has one of the following diagnoses:

§  Used for recurrent (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes) or metastatic disease; OR

§  Used for stage T3-4, cN1-2 disease or cN1-2 palpable inguinal lymph nodes; OR

·         Used as first-line therapy in cisplatin-ineligible patients*; AND

* Note:

·  Cisplatin-ineligible comorbidities may include the following: GFR < 60 mL/min, PS ≥ 2, hearing loss of ≥ 25decibels (dB) at two contiguous frequencies, or grades ≥ 2 peripheral neuropathy. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.

·        Carboplatin-ineligible comorbidities may include the following: CrCl < 30 mL/min, PS ≥ 3, grade ≥ 3 peripheral neuropathy, or NYHA class ≥ 3, etc.

Breast Cancer

·         Used in combination with albumin-bound paclitaxel; AND

·         Patient has unresectable locally advanced, recurrent, unresectable (local or regional), or metastatic triple-negative disease (TNBC); AND

·         Patient has a PD-L1 expression (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area) as determined by an FDA-approved or CLIA-compliant test**

Non-Small Cell Lung Cancer (NSCLC)

·         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 for EGFR, ALK, ROS1, BRAF, NTRK1/2/3 gene fusion, MET exon 14 skipping mutation, and RET rearrangement negative* tumors 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 test**; AND

Ø  Used as a single agent; OR

§  Used for non-squamous disease as one of the following:

ù  Used in patients with PS 0-1 for EGFR, ALK, ROS1, BRAF, NTRK1/2/3 gene fusion, MET exon 14 skipping mutation, and RET rearrangement negative* tumors and PD-L1 <1%

ù  Used in patients with PS 0-2 for EGFR, ALK, ROS1, BRAF, NTRK1/2/3 gene fusion, MET exon 14 skipping mutation, and RET rearrangement negative* tumors and PD-L1 ≥1%

ù  Used in patients with PS 0-1 for BRAF V600E-mutation, NTRK1/2/3 gene fusion, or MET exon-14 skipping mutation; AND

Ø  Used in combination with carboplatin, paclitaxel, and bevacizumab; OR

Ø  Used in combination with carboplatin and albumin-bound paclitaxel; OR

§  Used as a single agent; OR

§  Used for non-squamous disease as one of the following:

ù  Used in patients with PS 0-1 for BRAF V600E-mutation, NTRK1/2/3 gene fusion or MET exon-14 skipping mutation

ù  Used in patients with PS 0-1 and ROS1 positive tumors after prior targeted therapy; AND

Ø  Used in combination with carboplatin, paclitaxel, and bevacizumab; OR

Ø  Used in combination with carboplatin and albumin-bound paclitaxel; OR

§  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

 

* Note: If there is insufficient issue to allow testing for all of EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET, and RET, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes.

Small Cell Lung Cancer (SCLC)

·    Patient has extensive stage disease (ES-SCLC) (excluding patients with poor PS 3-4 not due to SCLC); AND

Hepatocellular Carcinoma (HCC)

·         Used as first-line therapy in combination with bevacizumab; AND

·         Patient has Child-Pugh Class A disease; AND

·         Patient has unresectable or inoperable (e.g., performance status, comorbidity or with minimal or uncertain extrahepatic-disease) disease, extensive liver tumor burden, or metastatic disease

Cutaneous Melanoma

·         Patient has BRAF V600 mutation-positive disease; AND

·         Patient has unresectable or metastatic disease*; AND

·         Used as first-line therapy in combination with cobimetinib and vemurafenib

 

* Metastatic disease includes stage III clinical satellite/in transit metastases or local satellite/in-transit recurrence in patients with limited resectable and unresectable disease, unresectable nodal recurrence, and disseminated (unresectable) distant metastatic disease

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

Genomic Aberration/Mutational Driver Targeted Therapies

(Note: not all inclusive, refer to guidelines for appropriate use)

Sensitizing EGFR mutation-positive tumors

ù  Afatinib

ù  Erlotinib

ù  Dacomitinib

ù  Gefitinib

ù  Osimertinib

ALK rearrangement-positive tumors

ù  Alectinib

ù  Brigatinib

ù  Ceritinib

ù  Crizotinib

ù  Lorlatinib

ROS1 rearrangement-positive tumors

ù  Ceritinib

ù  Crizotinib

ù  Entrectinib

BRAF V600E-mutation positive tumors

ù  Dabrafenib ± Trametinib

ù  Vemurafenib

NTRK Gene Fusion positive tumors

ù  Larotrectinib

ù  Entrectinib

PD-1/PD-L1 expression-positive tumors (≥1%)

ù  Pembrolizumab

ù  Atezolizumab

ù  Nivolumab ± ipilimumab

MET Exon-14 skipping mutations

ù  Capmatinib

ù  Crizotinib

ù  Teporinib

RET rearrangement-positive tumors

ù  Selpercatinib

ù  Cabozantinib

ù  Vandetanib

ù  Pralsetinib

 

RENEWAL 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 Initial Approval Criteria; 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, etc.

Continuation Maintenance Therapy for NSCLC or SCLC

·         Refer to Initial Approval Criteria

DOSAGE/ADMINISTRATION

INDICATION

DOSE

NSCLC, TNBC, SCLC, HCC, UC

The recommended dosage is administered intravenously until disease progression or unacceptable toxicity:

ù  840 mg every 2 weeks or

ù  1200 mg every 3 weeks or

ù  1680 mg every 4 weeks

Cutaneous Melanoma

The recommended dosage is administered intravenously until disease

progression or unacceptable toxicity:

ù  840 mg every 2 weeks or

ù  1200 mg every 3 weeks or

ù  1680 mg every 4 weeks

 

*Prior to initiating TECENTRIQ, patients should receive a 28 day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

DOSING LIMITS

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

168 billable units every 28 days

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION  

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

1.     Tecentriq [package insert]. South San Francisco, CA; Genentech, Inc; April 2021. Accessed April 2021.

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=B1F0B909CCF90 C71B9C490C37BFE6647&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, 20210. 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 April 2021.

7.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 6.2020. National Comprehensive Cancer Network, 20210. 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 April 2021.

8.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 4.2021. National Comprehensive Cancer Network, 2021. 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 April 2021.

9.     Gupta S, Sonpavde G, Grivas P, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019 Mar 1;37(7_suppl):451.

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. Version1.2021. National Comprehensive Cancer Network, 2021. 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 CCN.org. Accessed April 2021.

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 3.2021. National Comprehensive Cancer Network, 20210. 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 April 2021.

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®) Breast Cancer. Version 3.2021. National Comprehensive Cancer Network, 2021. 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  April 2021.

21.  Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Cutaneous Melanoma: Cutaneous. Version 2.2021. National Comprehensive Cancer Network, 2020. 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 April 2021.

22.  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.

23.  Lexicomp Online. (2021, February). AHFS DI. Atezolizumab. Retrieved April 29, 2021 from Lexicomp Online with AHFS.

24.  MICROMEDEX Healthcare Series. Drugdex Evaluations. (2021, April). Atezolizumab. Retrieved April 29, 2021 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE: 6/7/2016

MOST RECENT REVIEW DATE:   8/31/2021

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