Medical Drug Criteria (MDC)

Policy Num:       P1.001.011
Policy Name:   IMJUDO^® (tremelimumab-actl)
Policy ID:          [P1.001.011] [Ac/L /MDC/ P+ ][0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

Related MDC: NONE

IMJUDO^® (tremelimumab-actl)

Summary

Imjudo is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated:

• 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.

Policy Statements

Initiation of Imjudo meets the definition of medical necessity when used to treat the established indications and the specific criteria below are met.

Policy Guidelines

Coverage eligibility for Imjudo will be considered when the criteria established below is met.

•    Hepatocellular Carcinoma (HCC): Coverage will be provided for one dose only and may not be renewed.

•    Non-Small Cell Lung Cancer (NSCLC): Coverage will be provided for five doses only and may not be renewed.

DOSAGE/ADMINISTRATION

Imjudo (tremelimumab-actl) is administered as an intravenous infusion after dilution as recommended:

Unresectable Hepatocellular Carcinoma (uHCC)

• Patients with a body weight 30 kg and more: A single dose of  Imjudo(tremelimumab-actl) 300 mg followed by durvalumab (Imfinzi) 1,500 mg at Day 1 of Cycle 1. Continue durvalumab (Imfinzi) 1,500 mg as a single agent every 4 week
• Patients with a body weight less than 30 kg: A single dose of Imjudo(tremelimumab-actl) 4 mg/kg followed by durvalumab(Imfinzi) 20 mg/kg at Day 1 of Cycle 1. Continue durvalumab(Imfinzi) 20 mg/kg as a single agent every 4  weeks

Metastatic Non-small Cell Lung Cancer (NSCLC)

Weigh patients prior to each Imjudo (tremelimumab) infusion. Imjudo (tremelimumab) is administered for a total of up to 5 doses; the Imjudo (tremelimumab) schedule is dependent on cycle number.

    Patients with a body weight of 30 kg and more                                                                                                                                                                                                                                                            

• Cycles 1 through 4: 75 mg IV on day 1 every 3 weeks for cycles 1 through 4 (in combination with durvalumab and platinum-based chemotherapy).
• Cycle 5: No Imjudo (tremelimumab) dose is administered (see "Note" below). Durvalumab is administered during cycle 5.
• Cycle 6: 75 mg IV on day 1 (in combination with durvalumab); cycle 6 begins at week 16 (there is a 4-week interval between cycles 5 and 6). After cycle 6, continue durvalumab until disease progression or unacceptable toxicity.

          Note: If patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining Imjudo (tremelimumab) doses (up to a total of 5) should be administered after the platinum-based chemotherapy phase (in combination with                   durvalumab) every 4 weeks.

   Patients with a body weight less than 30 kg                                                                                                                                                                                                                                                           

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

Coverage is provided under the following conditions:

•    Patient is at least 18 years of age; AND

Hepatocellular Carcinoma (HCC) 

• Used as first-line therapy in combination with durvalumab; AND
• Patient has unresectable disease and is not a transplant candidate; OR
• Patient has liver-confined disease that is inoperable by performance status, comorbidity, or with minimal or uncertain extrahepatic disease; OR
• Patient has metastatic disease or extensive liver tumor burden.

Non-Small Cell Lung Cancer (NSCLC) 

• Patient has recurrent, advanced, or metastatic disease;  AND 
• No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations; AND
• Used in combination with durvalumab and platinum-based chemotherapy.

Renewal Approval Criteria 

•    Coverage may NOT be renewed.

EXCLUSION CRITERIA

NONE

BENEFIT APPLICATION

BlueCard/National Account Issues: Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Population Reference No. 1 Policy Statement

OTHER CRITERIA

Validate that the treatment regimen is following the most up to date NCCN guidelines recommendations.

References

1.    Imjudo (tremelimumab) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Revised: 07/2024

Codes

Applicable Modifiers

N/A

Policy History