Anthem Blue Cross California Tecentriq (atezolizumab) Form

Overview Coding References Clinical criteria Document history Overview This document addresses the use of Tecentriq (atezolizumab). Tecentriq is an anti-programmed death ligand 1 (PD- L1) monoclonal antibody primarily used to treat non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC). The FDA approved indications for Tecentriq (atezolizumab) includes: • • • • • • • • Individuals requiring first-line or maintenance therapy for metastatic nonsquamous NSCLC Individuals requiring subsequent therapy of metastatic nonsquamous and squamous NSCLC Individuals requiring first-line therapy as single agent for metastatic NSCLC Individuals with extensive-stage small cell lung cancer (SCLC) Individuals requiring first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) Individuals with unresectable or metastatic melanoma in combination with cobimetinib and vemurafenib with BRAF V600 mutation positive disease. Individuals using as adjuvant treatment following resection and platinum-based chemotherapy for Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells Individuals with alveolar soft part sarcoma (ASPS) The National Comprehensive Cancer Network (NCCN) provides additional recommendations with a category 1 or 2A level of evidence for the use of: • • • • Individuals requiring first-line or maintenance therapy for recurrent or advanced nonsquamous NSCLC Individuals requiring subsequent therapy for recurrent or advanced nonsquamous and squamous NSCLC Individuals requiring first-line treatment for metastatic or unresectable hepatocellular carcinoma (HCC) Individuals with extensive stage small cell lung cancer (SCLC). Definitions and Measures Adjuvant treatment: Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy. • • ECOG Performance Status: A scale used to determine the individual's level of functioning. This scale may also be referred to as the WHO (World Health Organization) or Zubrod score which is based on the following scale: 0= Fully active, able to carry on all pre-disease performance without restriction 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2= Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3= Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4= Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5= Dead • • • • Extensive-stage small cell lung cancer: Cancer has spread to other parts of the body and could include the fluid around the lungs. 1 Immune checkpoint inhibitor: A type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. When these proteins are blocked, the “brakes” on the immune system are released and T cells are able to kill cancer cells better. Examples of checkpoint proteins found on T cells or cancer cells include programmed death (PD)-1, PD-ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated antigen (CTLA)-4/B7-1/B7-2 (NCI, 2018). Kinase inhibitor: Type of drug which works by blocking several enzymes that promote cell growth, which has been found to be an effective approach to treat a variety of cancers. Line of therapy: • First-line therapy: The first or primary treatment for the diagnosis. This may include surgery, chemotherapy, radiation therapy or a combination of these therapies. • Second-line therapy: Treatment given when initial treatment (first-line therapy) is not effective or there is disease progression. • Third-line therapy: Treatment given when both initial (first-line therapy) and subsequent treatment (second-line therapy) are not effective or there is disease progression. Locally advanced cancer: Cancer that has spread from where it started to nearby tissue or lymph nodes. Metastatic: The spread of cancer from one part of the body to another. A metastatic tumor contains cells that are like those in the original (primary) tumor and have spread. Neoadjuvant treatment: Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy. Programmed death (PD)-1 proteins: PD-1 proteins are found on T-cells and attach to PD ligands (PD-L1) found on normal (and cancer) cells (see immune checkpoint inhibitor above). Normally, this process keeps T-cells from attacking other cells in the body. However, this can also prevent T-cells from attacking cancer cells in the body. Examples of FDA approved anti-PD-1 agents include Keytruda (pembrolizumab), Opdivo (nivolumab), and Libtayo (cemiplimab). Programmed death ligand (PD-L)-1: The ligands found on normal (and cancer) cells to which the PD-1 proteins attach (see immune checkpoint inhibitor above). Cancer cells can have large amounts of PD-L1 on their surface, which helps them to avoid immune attacks. Examples of FDA approved anti-PD-L1 agents include Bavencio (avelumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab). Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Tecentriq (atezolizumab) Requests for Tecentriq (atezolizumab) may be approved if the following criteria are met: I. Individual has a diagnosis of one of the following: A. First-line treatment of advanced, unresectable, or metastatic hepatocellular carcinoma (HCC) (Label, NCCN 2A); AND 1. 2. 3. Individual is using in combination with bevacizumab (or bevacizumab biosimilar); AND Individual has Child-Pugh Class A; AND Individual has an ECOG performance status of 0-2; OR B. First-line treatment of recurrent, advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC) (Label, NCCN 2A); AND 1. Individual is using in a combination regimen with nab-paclitaxel (paclitaxel, protein-bound) and carboplatin; AND 2. Individual does not have presence of actionable molecular markers*; AND 2 3. Individual has a ECOG performance status of 0-2; OR C. First-line treatment of recurrent, advanced or metastatic nonsquamous NSCLC (Label, NCCN 1, 2A); AND 1. 2. 3. Individual is using in a combination regimen with carboplatin, paclitaxel, and bevacizumab (or bevacizumab biosimilar); AND Individual does not have presence of actionable molecular markers*; AND Individual has a ECOG performance status of 0-1; OR D. Continuation maintenance therapy for recurrent, advanced or metastatic nonsquamous NSCLC (Label, NCCN 1, 2A); AND 1. 2. Individual is using in combination with or without bevacizumab (or bevacizumab biosimilar); AND Individual has confirmation of achievement of tumor response or stable disease following initial cytotoxic therapy (first- line atezolizumab/carboplatin/paclitaxel/bevacizumab regimen or atezolizumab/carboplatin/nab-paclitaxel regimen); AND Individual has a ECOG performance status of 0-2; 3. OR E. Subsequent treatment of recurrent, advanced or metastatic NSCLC (nonsquamous or squamous) (Label); AND 1. Disease has progressed during or following platinum-containing chemotherapy (e.g. cisplatin); AND 2. Individual has a ECOG performance status of 0-2; OR F. Subsequent treatment of recurrent, advanced or metastatic nonsquamous NSCLC (NCCN 1, 2A); AND 1. Disease has progressed during or following treatment with a targeted agent for the expressed oncogene (for example, kinase inhibitors that target EGFR, ALK, ROS1, BRAF, NTRK, or MET mutations); AND Individual is using in a combination regimen with one of the following: 2. a. Carboplatin, paclitaxel, and bevacizumab (or bevacizumab biosimilar); OR b. Carboplatin and nab-paclitaxel (albumin-bound paclitaxel); AND 3. Individual has a ECOG performance status of 0-2; OR G. First-line treatment of recurrent, advanced, or metastatic NSCLC (Label, NCCN 1); AND 1. 2. Individual is using as monotherapy; AND Individual has one of the following: a. b. Individual has PD-L1 expression on tumor cells [TC] that is greater than or equal to 50% [TC ≥ 50%], as confirmed through an FDA-approved test; OR Individual has PD-L1 expression on tumor-infiltrating immune cells [IC] covering greater than or equal to 10% [IC ≥ 10%] of the tumor area, as confirmed by an FDA-approved test; AND 3. 4. Individual does not have presence of actionable molecular markers*; AND Individual has a ECOG performance status of 0-2; OR H. Treatment of stage II to IIIB NSCLC; AND 1. 2. Individual is using as adjuvant therapy following resection; AND Individual has PD-L1 expression on tumor cells [TC] that is greater than or equal to 1% [TC ≥ 1%], as confirmed through an FDA-approved test; OR I. Treatment of unresectable or metastatic Melanoma; AND 1. 2. 3. Individual is using in combination with cobimetinib and vemurafenib; AND Individual has BRAF V600 mutation positive disease with test result confirmed; AND Individual has ECOG performance status of 0-2; OR J. First-line treatment of extensive-stage Small Cell Lung Cancer (SCLC) (Label, NCCN 1); AND 1. Individual is using in combination with etoposide and carboplatin (followed by maintenance atezolizumab monotherapy); OR K. Treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS); AND 1. 2. Individual is 2 years of age or older; AND Individual is using as monotherapy; OR 3 L. Treatment of persistent, recurrent or metastatic small cell neuroendocrine carcinoma of the cervical cancer (NECC); AND 1. Individual is using in combination with etoposide and platinum-therapy (NCCN 2A). Tecentriq may not be approved for the following: I. II. Individual has received treatment with another anti-PD-1 or anti-PD-L1 inhibitor; OR Individual is receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; OR III. When the above criteria are not met and for all other indications. *Note: Actionable molecular markers include EGFR, ALK, ROS1, BRAF, NTRK, MET and RET mutations. The NCCN panel recommends testing prior to initiating therapy to help guide appropriate treatment. If there is insufficient tissue to allow testing for all of these markers, 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 (NCCN 1, 2A). Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J9022 ICD-10 Diagnosis C22.0-C22.9 Injection, atezolizumab, 10 mg [Tecentriq] Malignant neoplasm of liver and intrahepatic bile ducts C34.00-C34.92 Malignant neoplasm of bronchus and lung C43.0-C43.9 Malignant melanoma of skin C49.9 Malignant neoplasm of connective and soft tissue, unspecified C50.011-C50.929 Malignant neoplasm of breast C53.0-C53.9 Malignant neoplasm of cervix uteri C61 Malignant neoplasm of prostate C65.1-C65.9 Malignant neoplasm of renal pelvis C66.1-C66.9 Malignant neoplasm of ureter C67.0-C67.9 Malignant neoplasm of bladder C68.0-C68.9 Malignant neoplasm of the urinary system Z85.118 Z85.3 Z85.51 Personal history of other malignant neoplasm of bronchus and lung Personal history of malignant neoplasm of breast Personal history of malignant neoplasm of bladder Z85.53-Z85.54 Personal history of malignant neoplasm of renal pelvis, ureter Document History Revised: 11/17/2023