BlueCross BlueShield of Tennessee Medical Policy Manual

Atezolizumab

NDC CODE(S)

50242-0917-XX Tecentriq 1200 MG/20ML SOLN (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 the body’s own anti-tumor immune response, leading to decreased tumor growth.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*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.

      • 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 therapy

          • Individual has a performance status score of 0-2

          • Individual with genomic tumor aberrations has progressed following systemic therapy for those aberrations (e.g., EGFR, ALK, etc.)

        • Used in combination with carboplatin, paclitaxel, and bevacizumab and ALL of the following:

          • Individual has nonsquamousrecurrent (excluding locoregional recurrent without evidence of disseminated disease), advanced, or metastatic disease

          • Individual has a performance status of 0-1 for ANY ONE of the following:

            • Used as first-line therapy for genomic tumor aberration (e.g., EGFR, ALK, ROS1 and 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 or  BRAF V600E-mutation positive or PD-L1 ≥ 50% and EGFR, ALK negative or unknown 

            • Used as subsequent therapy for genomic tumor aberration (e.g., EGFR, ALK, and ROS1) positive and prior targeted therapy or BRAF V600E-mutation positive or PD-L1 ≥ 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

        • 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 has genomic tumor aberration (e.g., EGFR, ALK, etc) 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%

          • 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

          • May be 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

  • Erlotinib

  • Afatinib

  • Gefitinib

  • Osimertinib

  • Dacomitinib

ALK rearrangement-positive tumors

  • Crizotinib

  • Ceritinib

  • Brigatinib

  • Alectinib

ROS1 rearrangement-positive tumors

  • Crizotinib

  • Ceritinib

BRAF V600E-mutation positive tumors

  • Dabrafenib/Trametinib

PD-L1 expression-positive tumors (≥50%)

  • Pembrolizumab

  • Atezolizumab

 

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications

1200 mg intravenously every 21 days

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.

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

Lexicomp Online. (2018, June). AHFS DI. Atezolizumab. Retrieved January 16, 2019 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019,January). Atezolizumab. January 16, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Atezolizumab. Retrieved January 16, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. Tecentriq® (atezolizumab) injection, for intravenous use.  Retrieved January 16, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s001lbl.pdf.

ORIGINAL EFFECTIVE DATE: 6/7/2016

MOST RECENT REVIEW DATE:  5/31/2019

ID_MRx

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

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

All indications (or specifics)

10 mg = 1 billable unit

120 billable units every 21 days