Publish Date:

12/18/2023

Last Review Date:

11/19/2023

Overview

Coding

References

Clinical Criteria

Document History

Overview

This document addresses the use of Imjudo (tremelimumab-actl). Imjudo is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4 mediated inhibition of T-cell activation. The FDA approved indication for Imjudo (tremelimumab-actl)

• in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)
• in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Imjudo is an intravenous infusion as a weight based single dose in combination with durvalumab. Immune-mediated adverse reactions, which may be severe or fatal, can potentially occur with this combination.

The National Comprehensive Cancer Network® (NCCN) provides additional recommendations for the following uses:

• Non-Small Cell Lung Cancer (NCCN 1, 2A)
• Esophageal and Esophagogastric Junction Cancers (NCCN 2A)
• Hepatocellular Carcinoma (NCCN 1)
• Gastric Cancer (NCCN 2A)

Definitions and Measures

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:

1. Fully active, able to carry on all pre-disease performance without restriction
2. 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
3. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
4. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
5. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
6. Dead

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.

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.

Imjudo (tremelimumab-actl)

Requests for Imjudo (tremelimumab-actl) may be approved if the following criteria are met:

1. Individual has a diagnosis of unresectable hepatocellular carcinoma (uHCC) (Label, NCCN 1); AND
   Individual is using in combination with durvalumab (Imfinzi) for initial therapy; AND
   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. ; AND
   Individual is using as a one-time, single-administration treatment.
2. Individual has a diagnosis of Non-small cell lung cancer (NSCLC) (Label, NCCN 1, 2A); AND
   A. Individual has recurrent, advanced, or metastatic NSCLC disease with no prior chemotherapy or any other systemic therapy; AND
   B. Individual is using in combination with durvalumab (Imfinzi) and platinum-based chemotherapy; AND
   C. Negative for actionable molecular biomarkers (including but not limited to EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET and ERBB2 (HER2); AND
   D. Individual has not received treatment with another anti-PD-1 or anti-PDL1 agent; AND
   E. Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant;
3. Individual has a diagnosis of Esophageal and esophagogastric junction cancers or Gastric cancer (NCCN 2A); AND
   F. Individual is using as neoadjuvant therapy; AND
   G. Individual is using in combination with durvalumab (Imfinzi); AND
   H. Individual has microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) tumors.

Requests for Imjudo (tremelimumab-actl) 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

J9347
Injection, tremelimumab-actl, 1 mg [Imjudo]

ICD-10 Diagnosis

• C22.0-C22.9
  Malignant neoplasm of liver and intrahepatic bile ducts
• C34.00-C34.92
  Malignant neoplasm of bronchus and lung

Document History

Revised: 11/19/2023