BlueCross BlueShield of Tennessee Medical Policy Manual

Atezolizumab (Tecentriq®)

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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

          I.    INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

A.    FDA-Approved Indications

1.     Non-small cell lung cancer (NSCLC)

a.     Tecentriq, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.

b.     Tecentriq, as a single-agent, is indicated for the first line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (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, with no EGFR or ALK genomic tumor aberrations.

c.     Tecentriq, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment, of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

d.     Tecentriq, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

e.     Tecentriq as a single agent is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq.

2.     Small cell lung cancer (SCLC)

Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

3.     Hepatocellular Carcinoma (HCC)

Tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.

4.     Melanoma

Tecentriq, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

5.     Alveolar Soft Part Sarcoma (ASPS)

Tecentriq, as a single agent, is indicated for the treatment of adult and pediatric patients age 2 years and older with unresectable or metastatic ASPS.

B.    Compendial Uses

1.     Urothelial carcinoma

a.     Bladder cancer

b.     Primary carcinoma of the urethra

c.     Upper genitourinary tract tumors

d.     Urothelial carcinoma of the prostate

2.     Non-small cell lung cancer (NSCLC)

3.     Malignant Peritoneal Mesothelioma, Pericardial Mesothelioma, Tunica Vaginalis Testis Mesothelioma

4.     Cervical Cancer

All other indications are considered experimental/investigational and not medically necessary.

         II.    REQUIRED DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

A.    Test results confirming PD-L1 tumor expression (where applicable)

B.    Test results confirming tumor is positive for BRAF V600 mutation (where applicable)

C.    Test results confirming the presence of EGFR exon 19 deletions or L858R mutations or ALK rearrangements (where applicable)   

       III.    EXCLUSIONS

Coverage will not be provided for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy

       IV.    CRITERIA FOR INITIAL APPROVAL

A.    Urothelial Carcinoma - Bladder Cancer

Authorization of 6 months may be granted for treatment as a single agent for bladder cancer when the requested medication is used as first line therapy in cisplatin ineligible members whose tumors express PD-L1 (defined as PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 5% of the tumor area) or in members who are not eligible for any platinum containing chemotherapy regardless of PD-L1 expression for any of the following:

1.     Stage II or Stage IIIa disease if tumor is present following reassessment of tumor status 2-3 months after primary treatment with either concurrent chemoradiotherapy, radiotherapy alone, or TURBT

2.     Stage IIIb disease as downstaging systemic therapy or following partial response or progression after primary treatment with concurrent chemoradiotherapy

3.     Locally advanced or metastatic disease

4.     Metastatic or local recurrence post-cystectomy

5.     Muscle invasive local recurrence or persistent disease in a preserved bladder

B.    Urothelial Carcinoma - Primary Carcinoma of the Urethra

Authorization of 6 months may be granted for treatment as a single agent for primary carcinoma of the urethra when the requested medication is used as first line therapy for recurrent, locally advanced or metastatic disease in cisplatin ineligible members whose tumors express PD-L1 (defined as PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 5% of the tumor area) or in members who are not eligible for any platinum containing chemotherapy regardless of PD-L1 expression.

C.    Urothelial Carcinoma - Upper Genitourinary Tract Tumors or Urothelial Carcinoma of the Prostate

Authorization of 6 months may be granted for treatment as a single agent for upper genitourinary tract tumors or urothelial carcinoma of the prostate when the requested medication is used as first line therapy for locally advanced or metastatic disease in cisplatin ineligible members whose tumors express PD-L1 (defined as PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 5% of the tumor area) or in members who are not eligible for any platinum containing chemotherapy regardless of PD-L1 expression.

D.    Non-Small Cell Lung Cancer (NSCLC)

1.     Authorization of 6 months may be granted for treatment of recurrent, advanced or metastatic non-small cell lung cancer when there are no EGFR exon 19 deletions or L858R mutations or ALK rearrangements (unless testing is not feasible due to insufficient tissue) and any of the following criteria are met:

a.     The requested medication will be used as continued maintenance therapy as a single agent or in combination with bevacizumab.

b.     The requested medication will be used as first line or subsequent therapy in combination with chemotherapy.

c.     The requested medication will be used as first line therapy for PD-L1 expression positive (≥50%) tumors as a single agent.

2.     Authorization of 6 months may be granted for treatment of recurrent, advanced or metastatic non-small cell lung cancer as single agent subsequent therapy.

3.     Authorization of 6 months may be granted for treatment of stage II to IIIB non-small cell lung cancer that is PD-L1 positive as single agent adjuvant therapy. 

E.    Small Cell Lung Cancer (SCLC)

Authorization of 6 months may be granted for treatment of small cell lung cancer when the requested medication will be used as initial treatment in combination with etoposide and carboplatin (followed by single agent maintenance) for extensive-stage disease.

F.    Hepatocellular Carcinoma (HCC)

Authorization of 6 months may be granted for treatment of unresectable or metastatic HCC when the requested medication will be used as initial treatment in combination with bevacizumab.

G.    Melanoma

Authorization of 6 months may be granted for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma when the requested medication will be used in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf).

H.    Malignant Peritoneal Mesothelioma, Pericardial Mesothelioma, Tunica Vaginalis Testis Mesothelioma

Authorization of 6 months may be granted for the subsequent treatment of malignant peritoneal mesothelioma, pericardial mesothelioma, or tunica vaginalis testis mesothelioma when used in combination with bevacizumab.

I.      Alveolar Soft Part Sarcoma (ASPS)

Authorization of 6 months may be granted for the treatment of unresectable or metastatic alveolar soft part sarcoma when used as a single agent.

J.     Cervical Cancer

Authorization of 6 months may be granted for the treatment of persistent, recurrent or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) when used in combination with etoposide and either cisplatin or carboplatin.

        V.    CONTINUATION OF THERAPY  

A.    Adjuvant treatment of Non-Small Cell Lung Cancer (NSCLC)

Authorization of 6 months may be granted (up to 12 months total) for continued treatment in members requesting reauthorization of adjuvant therapy of non-small cell lung cancer who have not experienced disease recurrence or an unacceptable toxicity.

B.    All other indications

Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section IV when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

MEDICATION QUANTITY LIMITS

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.

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).

REFERENCES

1.     Tecentriq [package insert]. South San Francisco, CA: Genentech, Inc.; December 2022.

2.     The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed January 25, 2023.

ORIGINAL EFFECTIVE DATE: 6/7/2016

MOST RECENT REVIEW DATE: 4/1/2024

ID_CHS

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.