Tremelimumab-actl (Imjudo®)
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. Imjudo is indicated in combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
2. Imjudo is indicated 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.
B. Compendial Uses
1. Recurrent and advanced NSCLC
2. Esophageal and esophagogastric junction cancer
3. Gastric cancer
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Documentation of the absence of EGFR exon 19 deletion and L858R mutations and ALK rearrangements, where applicable (unless testing is not feasible due to insufficient tissue).
B. Documentation of laboratory report confirming microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumor status, where applicable.
III. CRITERIA FOR INITIAL APPROVAL
A. Hepatocellular Carcinoma
Authorization of 1 month for a one-time single dose may be granted for treatment of hepatocellular carcinoma when all of the following criteria are met:
1. The requested medication will be used in combination with durvalumab (Imfinzi)
2. The disease is unresectable/inoperable, metastatic or has extensive liver tumor burden
B. NSCLC
Authorization of 6 months for a total of 5 doses may be granted for treatment of recurrent, advanced or metastatic non-small cell lung cancer when all of the following criteria are met:
1. The requested medication will be used in combination with durvalumab (Imfinzi) and platinum-based chemotherapy
2. The tumor is negative for EGFR exon 19 deletion and L858R mutations and ALK gene mutations.
C. Esophageal, Esophagogastric Junction and Gastric Cancer
Authorization of 1 month for a one-time single dose may be granted for treatment of esophageal, esophagogastric junction or gastric cancer when all of the following criteria are met:
1. The requested medication will be used in combination with durvalumab (Imfinzi) for neoadjuvant treatment
2. The tumor is microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR)
3. The member is medically fit for surgery
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).
REFERENCE
1. Imjudo [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; June 2023.
2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed August 30, 2023.
3. Pietrantonio, Filippo, Raimondi Alessandra, Lonardi Sara, et al. Infinity: A multicenter, single-arm, multi-cohort, phase II trial of tremelimumab and durvalumab as neoadjuvant treatment of patients with microsatellite instability-high (MSI) resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC). Journal of Clinical Oncology. 2023; 4: 358..
ORIGINAL EFFECTIVE DATE: 1/31/2023
MOST RECENT REVIEW DATE: 4/30/2024
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.
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