50242-0917-XX Tecentriq 1200 MG/20ML SOLN (GENENTECH
50242-0918-xx Tecentriq 840 MG/14ML SOLN (GENENTECH)
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 the body’s own anti-tumor immune response, leading to decreased tumor growth.
Atezolizumab is considered medically necessary for the treatment of the following if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Bladder Cancer/Urothelial Carcinoma
Breast Cancer [Triple Negative (TNBC)]
Non-Small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (SCLC)
Atezolizumab for the treatment of other conditions/diseases is considered investigational.
Atezolizumab is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Individual has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., cemiplimab, nivolumab, pembrolizumab, durvalumab, avelumab, etc.) unless otherwise specified
Diagnosis of ANY ONE of the following:
Bladder Cancer/Urothelial Carcinoma with ALL of the following:
Used as a single agent
Further diagnosed as ANY ONE of the following:
Locally advanced or metastatic Urothelial Carcinoma
Disease recurrence post-cystectomy
Primary Carcinoma of the Urethra and ANY ONE of the following:
Used for recurrent or metastatic disease and the individual does not have recurrent stage T3-4 disease or palpable inguinal lymph nodes
Used as primary treatment as a single agent for clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal lymph nodes
Metastatic Upper GU Tract Tumors
Metastatic Urothelial Carcinoma of the Prostate
Used as first-line therapy in cisplatin-ineligible individuals and ANY ONE of the following:
Individual is carboplatin-ineligible
Individual has a PD-L1 expression of ≥5% (As confirmed using an FDA approved assay– http://www.fda.gov/companiondiagnostics)
Used as Subsequent therapy after previous platinum treatment*
*If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum-based therapy. Patients with comorbidities (e.g., hearing loss, neuropathy, poor PS, renal insufficiency, etc.) may not be eligible for cisplatin. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.
Breast Cancer and ALL of the following:
Used in combination with albumin-bound paclitaxel
Individual has triple-negative disease (TNBC) that is unresectable locally advanced, recurrent or metastatic
Individual has a PD-L1 expression of ≥ 1% (As confirmed using an FDA approved assay– http://www.fda.gov/companiondiagnostics)
Non-small cell lung cancer (NSCLC) and ANY ONE of the following:
Used as single agent and ALL of the following
Used as subsequent therapy in individual with recurrent (excluding locoregional recurrent without evidence of disseminated disease), advanced, or metastatic disease
Disease has progressed during or following cytotoxic (e.g., platinum-containing) therapy
Individual has a performance status score of 0-2
Individual with genomic tumor aberrations has progressed following systemic therapy for those aberrations (i.e.,EGFR, ALK,)
Used in combination with carboplatin, paclitaxel, and bevacizumab and ALL of the following:
Individual has nonsquamous recurrent (excluding locoregional recurrent without evidence of disseminated disease), advanced, or metastatic disease for ANY ONE of the following:
Used as first-line therapy for genomic tumor aberration (i.e., EGFR, ALK) negative or unknown (Every effort needs to be made to establish the genetic alteration status. A blood assay may be used if a tissue assay is not feasible), and PD-L1 expression-positive (≥50%) in individuals with PS 0-2
Used as first-line therapy for genomic tumor aberration (i.e. EGFR, ALK, ROS1, BRAF) negative or unknown (Every effort needs to be made to establish the genetic alteration status. A blood assay may be used if a tissue assay is not feasible), and PD-L1 expression <50% or unknown in individuals with PS 0-1
Used for BRAF V600E-mutation positive tumors in individuals with PS 0-1
Used as subsequent therapy for genomic tumor aberration ( i.e. EGFR, ALK, ROS1) positive and prior targeted therapy in individuals with PS 0-1
Used as subsequent therapy for PD-L1 expression-positive (≥ 50%) and EGFR, ALK negative or unknown (Every effort needs to be made to establish the genetic alteration status. A blood assay may be used if a tissue assay is not feasible), with no prior platinum doublets therapy in patients with PS 0-1
Used as continuation maintenance therapy and ALL of the following:
Individual has nonsquamous recurrent (excluding locoregional recurrent without evidence of disseminated disease), advanced, or metastatic disease
Individual is genomic tumor aberration (i.e.EGFR, ALK) negative or unknown (Every effort needs to be made to establish the genetic alteration status. A blood assay may be used if a tissue assay is not feasible), and PD-L1 expression positive ( >50%)
Individual has a performance status of 0-2
Individual achieved tumor response or stable disease following initial therapy in combination with carboplatin, paclitaxel, and bevacizumab
Used as a single agent or in combination with bevacizumab
Small Cell Lung Cancer(SCLC) and ALL of the following:
Used in combination with etoposide and carboplatin
Used as initial treatment for extensive stage disease
Genomic Aberration Targeted Therapies
(not all inclusive)
Sensitizing EGFR mutation-positive tumors
ALK rearrangement-positive tumors
ROS1 rearrangement-positive tumors
BRAF V600E-mutation positive tumors
PD-L1 expression-positive tumors (≥50%)
Atezolizumab is considered medically appropriate for renewal therapy for 6 months if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Tumor response is indicated with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, e.g., severe infusion reactions, immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, skin reactions, etc.), severe infection, ocular inflammatory toxicity, myasthenic syndrome, Guillain-Barre syndrome, meningoencephalitis, pancreatitis, etc.
Continuation Maintenance Therapy for NSCLC and individual continues to meet initial approval criteria
DOSAGE & ADMINISTRATION
Triple Negative Breast Cancer
840 mg intravenously on days 1 and 15 of a 28-day cycle until disease progression or unacceptable toxicity
All other indications
1200 mg intravenously every 21 days until disease progression or unacceptable toxicity
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Refer to DOSAGE LIMITS below
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.
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.
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).
Lexicomp Online. (2019, February). AHFS DI. Atezolizumab. Retrieved April 11, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, March). Atezolizumab. April 11, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Atezolizumab. Retrieved April 11, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2019, March). Center for Drug Evaluation and Research. Tecentriq® (atezolizumab) injection, for intravenous use. Retrieved April 11, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s001lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/7/2016
MOST RECENT REVIEW DATE: 7/31/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit