Anthem Blue Cross California Imfinzi (durvalumab) Form

Overview Clinical criteria Overview This document addresses the use of Imfinzi (durvalumab). Imfinzi is a programmed death-ligand 1 (PD-L1) blocking antibody. The FDA approved indications for Imfinzi include: • • • • • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with gemcitabine and cisplatin, as treatment of adults with locally advanced or metastatic biliary tract cancer (BTC) in combination with tremelimumab-actl (Imjudo) for the treatment of adults with unresectable hepatocellular carcinoma in combination with tremelimumab-actl (Imjudo) and platinum-based chemotherapy, for the treatment of adults with metastatic NSCLC, with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The National Comprehensive Cancer Network (NCCN) provides category 1 and 2A recommendations for use in NSCLC, SCLC, and biliary tract cancer also. NCCN also provides a 2A recommendation for use in persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) in combination with etoposide and a platinum-based chemotherapy. This recommendation cites data which is extrapolated from the studies for the use in extensive stage small cell lung cancer (Horn L, et al 2018, Luis Paz-Ares, et.al. CASPIAN 2019). Though the recommendation provides use to second-line or subsequent therapy, these studies only discuss first-line therapy. Other Uses The NCCN panel provides 2A recommendations for use in Stage II NSCLC. The panel noted that a few patients in the PACIFIC trial were Stage II (Antonia SJ et al. 2018; Gray JE et.al 2020; Hui R, et.al. 2019). However, no additional trial data or studies are available to support use in this population. NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). The FDA had granted Imfinzi with its bladder cancer indication through the accelerated approval program in 2017, with continued approval contingent upon verification of clinical benefit in confirmatory trials. In the current NCCN compendia, NCCN no longer provides these bladder cancer recommendations. Definitions and Measures 1 Consolidation therapy: Any drug or medical treatment that is used to kill remaining cancer cells. Also called intensification therapy or post-remission therapy. ECOG or Eastern Cooperative Oncology Group Performance Status: A scale and criteria used by doctors and researchers to assess how an individual’s disease is progressing, assess how the disease affects the daily living abilities of the individual, and determine appropriate treatment and prognosis. 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, for example, light house work, office work 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4 = Completely disabled. Cannot carry on any self-care. 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. 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. Limited-stage small cell lung cancer: Cancer is confined to 1 part of the chest, and radiation therapy could be an option. Locally advanced cancer: Cancer that has spread only to nearby tissues or lymph nodes. Metastasis: 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. 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. Imfinzi (durvalumab) Requests for Imfinzi (durvalumab) may be approved if the following criteria are met: I. Individual has a diagnosis of Non-Small Cell Lung Cancer (NSCLC) (Label, NCCN 1, 2A); AND A. Disease type is one of the following: 1. Disease is confirmed (histologically or cytologically) stage III locally advanced, unresectable NSCLC disease; OR 2. Disease is confirmed (histologically or cytologically) stage II, unresectable NSCLC; AND B. Disease has not progressed after definitive chemoradiation; AND 2 C. D. E. F. G. Individual is using as consolidation therapy; AND Individual is using until disease progression or a maximum of 12 months of treatment (NCCN 2A); AND Individual has not previously received treatment with another anti-PD-1 or anti-PD-L1 agent; AND Individual has a current ECOG performance status of 0-2; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; OR II. OR III. OR IV. OR V. OR VI. OR VII. Individual has a diagnosis of NSCLC (Label, NCCN 1, NCCN 2A); AND A. Individual has recurrent, advanced or metastatic NSCLC disease with no prior chemotherapy or any other systemic therapy; AND Individual is using in combination with Imjudo (tremelimumab-actl) and platinum-based chemotherapy; AND B. C. Negative for actionable molecular biomarkers (including but not limited to EGFR, KRAS, ALK, ROS1, D. E. BRAF, NTRK 1/23, MET, RET, and ERBB2 (HER2); AND Individual has not received treatment with another anti-PD-1 or anti-PD-L1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; Individual has a diagnosis of NSCLC (NCCN 2A); AND A. Individual is using as continuation maintenance therapy in one of the following ways: 1. As a single agent for recurrent, advanced, or metastatic disease after initial systemic therapy with 2. durvalumab/tremelimumab-actl plus chemotherapy; OR In combination with pemetrexed for recurrent, advanced, or metastatic disease after initial systemic therapy with durvalumab/tremelimumab-actl and platinum-based chemotherapy; AND B. C. Individual is using until disease progression or unacceptable toxicity following positive tumor response or stable disease following initial systemic therapy; AND Individual has a ECOG performance status of 0-2; Individual has a diagnosis of extensive stage Small Cell Lung Cancer; AND A. Individual is using as first line therapy in combination with etoposide and either cisplatin or carboplatin for four (4) cycles (followed by maintenance Imfinzi monotherapy); AND Individual has not received treatment with another anti-PD-1 or anti-PD-L1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; B. C. Individual has a diagnosis of locally advanced or metastatic biliary tract cancer (Label, NCCN 1); AND A. B. C. D. Individual is using in combination with gemcitabine and cisplatin; AND Individual has a current ECOG performance status of 0-2; AND Individual has not previously received treatment with another anti-PD-1 or anti-PD-L1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; Individual has a diagnosis of unresectable hepatocellular carcinoma (uHCC) (Label, NCCN 1, 2A); AND A. Individual is using in one of the following ways: 1. 2. Individual is using in combination with Imjudo (tremelimumab-actl) for initial therapy; OR Individual is using as a single agent after initial therapy with tremelimumab-actl (Imjudo) until disease progression or unacceptable toxicity; AND B. C. D. E. Individual has Child-Pugh Class A; AND Individual has a current ECOG performance status of 0-1; AND Individual has not received treatment with another anti-PD-1 or anti-PDL1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; Individual has a diagnosis of persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) (NCCN 2A); AND A. Individual is using as first-line therapy; AND 3 OR IX. B. C. D. Individual is using in combination with etoposide and either cisplatin or carboplatin for four (4) cycles (followed by maintenance Imfinzi monotherapy); AND Individual has not received treatment with another anti-PD-1 or anti-PD-L1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; Individual has a diagnosis of Esophageal and esophagogastric junction cancers or Gastric cancer (NCCN 2A); AND A. B. C. Individual is using as neoadjuvant therapy; AND Individual is using in combination with Imjudo (tremelimumab-actl); AND Individual has microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) tumors. Requests for Imfinzi (durvalumab) may not be approved when the above criteria are not met and for all other indications. 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 J9173 ICD-10 Diagnosis C22.0 C24.0 C24.1 C24.8 C24.9 Injection, durvalumab, 10 mg [Imfinzi] Liver cell carcinoma Malignant neoplasm of extrahepatic bile duct Malignant neoplasm of ampulla of Vater Malignant neoplasm of overlapping sites of biliary tract Malignant neoplasm of biliary tract, unspecified C34.00-C34.92 Malignant neoplasm of bronchus and lung Z85.110-Z85.118 Personal history of malignant neoplasm of bronchus and lung Z92.21 Z92.3 Personal history of antineoplastic chemotherapy Personal history of irradiation Document History Revised: 11/19/2023