vp-0278
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Tecentriq™ (atezolizumab) (Intravenous)

Policy Number: VP-0278

Last Review Date: 03/03/2020

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

I. Length of Authorization

Coverage will be provided for six months and may be renewed.

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 vials per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

All Indications:

  • 84 billable units every 14 days

III. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; AND
  • Patient must be at least 18 years old; 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, etc.) unless otherwise specified; AND

Bladder Cancer/Urothelial Carcinoma †

  • Used as a single agent; AND
  • Patient has one of the following diagnoses:
  • Locally advanced or metastatic urothelial carcinoma; OR
  • Local bladder cancer recurrence or persistent disease in a preserved bladder; OR
  • Local bladder cancer recurrence post-cystectomy; OR
  • Recurrent or metastatic primary carcinoma of the urethra; AND
    • Patient does not have recurrence of stage T3-4 disease or palpable inguinal lymph nodes; OR
    • Patient has recurrent or metastatic clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal lymph nodes (primary treatment only); OR
  • Metastatic upper genitourinary tract tumors; OR
  • Metastatic urothelial carcinoma of the prostate; AND
  • Used as subsequent therapy after previous platinum treatment*; OR
  • Used as first-line therapy in cisplatin-ineligible patients*; AND
  • Patient is carboplatin-ineligible*; OR
  • Patient has a PD-L1 expression of ≥ 5% as determined by an FDA-approved or CLIA-compliant test §

* Note:

  • If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum-based therapy if the patient is still platinum eligible (see below for cisplatin- or carboplatin-ineligible comorbidities).
  • Cisplatin-ineligible comorbidities may include the following:  GFR < 60 mL/min, PS ≥ 2, hearing loss of ≥ 25 decibels (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: GFR < 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 triple-negative disease (TNBC) that is unresectable locally advanced, recurrent, or metastatic; AND
  • Patient has a PD-L1 expression of ≥ 1% 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 non-squamous disease in combination with carboplatin, paclitaxel, and bevacizumab OR in combination with carboplatin and nab-paclitaxel; AND
    • Used as first-line therapy for genomic tumor aberration (i.e., EGFR, ALK, ROS1, BRAF) negative ; OR
    • Used as first-line or subsequent therapy for BRAF V600E-mutation positive or NTRK gene fusion positive tumors in patients with PS 0-1; OR
    • Used as subsequent therapy for genomic tumor aberration (i.e., EGFR, ALK, ROS1 §§) positive and prior targeted therapy in patients with PS 0-1; OR
  • Used as continuation maintenance therapy in patients with non-squamous disease and a PS ≤ 2; AND
    • Used in combination with bevacizumab in patients with a tumor response or stable disease following first-line therapy with atezolizumab, carboplatin, paclitaxel, and bevacizumab regimen; OR
    • Used as a single agent in patients with a tumor response or stable disease following first-line therapy with atezolizumab, carboplatin, and albumin-bound paclitaxel regimen; OR
  • Used as subsequent therapy as a single-agent in patients with a PS ≤ 2

Small Cell Lung Cancer (SCLC) †

  • Patient has extensive stage disease (ES-SCLC) (excluding patients with poor PS 3-4 not due to SCLC); AND
    • Used as initial therapy in combination with etoposide and carboplatin; OR
    • Used as single-agent maintenance therapy after initial therapy with etoposide and carboplatin; AND
  • Must not be used for relapsed disease in patients on maintenance therapy with atezolizumab or durvalumab at the time relapse (NOTE: If relapse occurred >6 months after atezolizumab or durvalumab maintenance therapy, patient should be re-treated with carboplatin + etoposide alone or cisplatin + etoposide alone)

Genomic Aberration Targeted Therapies (not all inclusive) §§

Sensitizing EGFR mutation-positive tumors

  • Erlotinib
  • Afatinib
  • Gefitinib
  • Osimertinib
  • Dacomitinib

ALK rearrangement-positive tumors

  • Crizotinib
  • Ceritinib
  • Brigatinib
  • Alectinib
  • Lorlatinib

ROS1 rearrangement-positive tumors

  • Crizotinib 
  • Ceritinib

BRAF V600E-mutation positive tumors

  • Dabrafenib/Trametinib

NTRK Gene Fusion positive tumors

  • Larotrectinib

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

  • Pembrolizumab
  • Atezolizumab

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

FDA Approved Indication(s); Compendia Recommended Indication(s)

IV. Renewal Criteria

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: severe infusion reactions, immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, etc.), severe infection, etc.

Continuation Maintenance Therapy for NSCLC or SCLC

  • Refer to Section III for criteria

V. Dosage/Administration

Indication

Dose

Triple Negative Breast Cancer (TNBC)

Administer 840 mg intravenously on days 1 and 15 of a 28-day cycle until disease progression or unacceptable toxicity

Urothelial Carcinoma (UC)

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

  • 840 mg every 2 weeks or
  • 1200 mg every 3 weeks or
  • 1680 mg every 4 weeks

Non-Small Cell Lung Cancer (NSCLC)

Single Agent

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

  • 840 mg every 2 weeks or
  • 1200 mg every 3 weeks or
  • 1680 mg every 4 weeks

Combination Therapy

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

  • 1200 mg every 3 weeks; then revert to single-agent therapy dosing after completion of 4-6 cycles of combination therapy

Small-Cell Lung Cancer (SCLC)

Single Agent

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

  • 840 mg every 2 weeks or
  • 1200 mg every 3 weeks or
  • 1680 mg every 4 weeks

Combination Therapy with carboplatin and etoposide

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

  • 1200 mg every 3 weeks; then revert to single-agent therapy dosing after completion of 4 cycles of carboplatin and etoposide

VI. Billing Code/Availability Information

HCPCS code:

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

NDC:

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

VII. References

  1. Tecentriq [package insert]. South San Francisco, CA; Genentech, Inc; December 2019. Accessed February 2020.
  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, 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 February 2020.
  7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 3.2020. National Comprehensive Cancer Network, 2019. 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 2020.
  8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 3.2020. 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 February 2020.
  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, Szczęsna 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.
  1. CGS Administrators, LLC. Local Coverage Article (LCA): Billing and Coding: Atezolizumab (Tecentriq) - J9022 (A56830).  Centers for Medicare & Medicaid Services, Inc. Updated on 09/23/2019 with effective date 09/26/2019. Accessed February 2020.
  2. Palmetto GBA. Local Coverage Article (LCA): Billing and Coding: Chemotherapy (A56141). Centers for Medicare & Medicaid Services, Inc. Updated on 10/29/2019 with effective date 11/07/2019. Accessed February 2020.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C50.011

Malignant neoplasm of nipple and areola, right female breast

C50.012

Malignant neoplasm of nipple and areola, left female breast

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right male breast

C50.022

Malignant neoplasm of nipple and areola, left male breast

C50.029

Malignant neoplasm of nipple and areola, unspecified male breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C61

Malignant neoplasm of prostate

C65.1

Malignant neoplasm of right renal pelvis

C65.2

Malignant neoplasm of left renal pelvis

C65.9

Malignant neoplasm of unspecified renal pelvis

C66.1

Malignant neoplasm of right ureter

C66.2

Malignant neoplasm of left ureter

C66.9

Malignant neoplasm of unspecified ureter

C67.0

Malignant neoplasm of trigone of bladder

C67.1

Malignant neoplasm of dome of bladder

C67.2

Malignant neoplasm of lateral wall of bladder

C67.3

Malignant neoplasm of anterior wall of bladder

C67.4

Malignant neoplasm of posterior wall of bladder

C67.5

Malignant neoplasm of bladder neck

C67.6

Malignant neoplasm of ureteric orifice

C67.7

Malignant neoplasm of urachus

C67.8

Malignant neoplasm of overlapping sites of bladder

C67.9

Malignant neoplasm of bladder, unspecified

C68.0

Malignant neoplasm of urethra

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C78.00

Secondary malignant neoplasm of unspecified lung

C78.01

Secondary malignant neoplasm of right lung

C78.02

Secondary malignant neoplasm of left lung

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

D09.0

Carcinoma in situ of bladder

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.3

Personal history of malignant neoplasm of breast

Z85.51

Personal history of malignant neoplasm of bladder

Z85.59

Personal history of malignant neoplasm of other urinary tract organ

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 Articles may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-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/Article):

Jurisdiction(s): 15

NCD/LCD/Article Document (s): A56830

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID= A56830&bc=gAAAAAAAAAAAAA

Jurisdiction(s): J&M

NCD/LCD/Article Document (s): A56141

https://www.cms.gov/medicare-coverage-database/search/article-date

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC