ATEZOLIZUMAB

Guidelines for Use

GUIDELINES FOR USE

Our guideline named ATEZOLIZUMAB (Tecentriq) requires the following rule(s) be met for approval:

1. You have ONE of the following:
1. Stage II to IIIA non-small cell lung cancer (NSCLC: a type of lung cancer)
2. Metastatic non-squamous non-small cell lung cancer (NSq NSCLC: a type of lung cancer that has spread to other parts of the body)
3. Metastatic non-small cell lung cancer (NSCLC: a type of lung cancer that has spread to other parts of the body)
4. Extensive-stage small cell lung cancer (ES-SCLC: a type of lung cancer)
5. Unresectable or metastatic hepatocellular carcinoma (HCC: a type of liver cancer that cannot be removed by surgery or has spread to other parts of the body)
6. Unresectable or metastatic melanoma (a type of skin cancer that cannot be completely removed with surgery or has spread to other parts of the body)
7. Unresectable or metastatic alveolar soft part sarcoma (ASPS: a type of soft tissue cancer that cannot be completely removed with surgery or has spread to other parts of the body)
2. If you have stage II to IIIA non-small cell lung cancer, approval also requires:
1. You are 18 years of age or older
2. Tecentriq will be used as a single agent
3. Tecentriq will be used as adjuvant (add-on) treatment following resection (removal of tissue or organ) and platinum-based chemotherapy (a type of therapy to treat cancer such as cisplatin, carboplatin, oxaliplatin)
4. Your tumor(s) express programmed death-ligand 1 (PD-L1: type of protein) on at least 1 percent of tumor cells, as determined by a Food and Drug Administration (FDA)-approved test
3. If you have metastatic non-squamous non-small cell lung cancer, approval also requires:
1. You are 18 years of age or older
2. You do NOT have epidermal growth factor receptor (EGFR: a type of protein) or anaplastic lymphoma kinase (ALK: a type of protein) genomic tumor abnormalities (type of abnormal gene)
3. Tecentriq will be used in combination with bevacizumab, paclitaxel, and carboplatin OR in combination with paclitaxel protein-bound and carboplatin
4. If you have metastatic non-small cell lung cancer, approval also requires:
1. You are 18 years of age or older
2. You meet ONE of the following:
1. You do NOT have an epidermal growth factor receptor (EGFR: a type of protein) or anaplastic lymphoma kinase (ALK: a type of protein) mutation (abnormal change in a type of gene) AND your disease has gotten worse during or after treatment with a platinum-containing chemotherapy (such as cisplatin, carboplatin, oxaliplatin)
2. You do NOT have an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation, AND you have tumor(s) that have high programmed death-ligand 1 (PD-L1: type of protein) expression (PD-L1 stained at least 50 percent of tumor cells) OR PD-L1 stained tumor-infiltrating immune cells covering at least 10 percent of the tumor area, as determined by a Food and Drug Administration (FDA) approved test
3. You have an anaplastic lymphoma kinase (ALK) mutation, and your disease has gotten worse during or after treatment with a platinum-containing chemotherapy (such as cisplatin, carboplatin, oxaliplatin) AND ALK-directed therapy (such as Xalkori [crizotinib], Zykadia [ceritinib])
4. You have an epidermal growth factor receptor (EGFR) mutation, and your disease has gotten worse during or after treatment with a platinum-containing chemotherapy (such as cisplatin, carboplatin, oxaliplatin) AND EGFR-directed therapy (such as Tarceva [erlotinib], Iressa [gefitinib], Gilotrif [afatinib])
5. If you have extensive-stage small cell lung cancer, approval also requires:
   1. You are 18 years of age or older
   2. Tecentriq will be used in combination with carboplatin and etoposide
6. If you have unresectable or metastatic hepatocellular carcinoma, approval also requires:
   1. You have NOT previously been treated with systemic therapy (treatment that targets the entire body)
   2. Tecentriq will be used in combination with bevacizumab
7. If you have unresectable or metastatic melanoma, approval also requires:
   1. Tecentriq will be used in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf)
   2. Your cancer is BRAF V600 mutation (abnormal change in a type of gene) positive
8. If you have unresectable or metastatic alveolar soft part sarcoma, approval also requires:
   1. You are 2 years of age or older