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 22, 2025
Next Review:      September 20, 2026
 

Related MDC: NONE

IMJUDO^® (tremelimumab-actl)

Summary

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

In combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC).
 
In combination with durvalumab + platinum-based chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC), without sensitizing EGFR mutations or ALK genomic aberrations.

objective

To define medical necessity criteria for Imjudo use in unresectable HCC and metastatic NSCLC, aligned with FDA approval and NCCN guideline recommendations.

Policy Statements

Imjudo may be considered medically necessary for the indications above when criteria outlined in this policy 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 specified.

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.

BACKGROUND

Mechanism: CTLA-4 blockade enhances T-cell activation.

FDA Approvals:

HCC (Oct 2022, based on HIMALAYA trial: durvalumab + single priming dose of tremelimumab improved OS vs sorafenib).

NSCLC (Nov 2022, based on POSEIDON trial: durvalumab + tremelimumab + platinum chemo improved OS vs chemo alone).

Key Trials:

HIMALAYA: OS benefit in uHCC, median OS 16.4 mo vs 13.8 mo.

POSEIDON: Median OS 14.0 mo vs 11.7 mo with chemo.

ReGULATORY STATUS

FDA approved: October 2022 (uHCC), November 2022 (NSCLC).

NCCN: Lists tremelimumab + durvalumab regimens for HCC and NSCLC in eligible patients (Category 1/2A).

RATIONAL

Imjudo expands immunotherapy by adding CTLA-4 priming to PD-L1 blockade (durvalumab). Provides survival benefit in uHCC and NSCLC where other checkpoint inhibitors alone may be insufficient.

PRACTICE GUIDELINES AND POSITION STATEMENTS

NCCN HCC Guidelines (2023–2025): Durvalumab + tremelimumab is a recommended first-line systemic therapy for unresectable HCC.

NCCN NSCLC Guidelines (2023–2025): Durvalumab + tremelimumab + platinum-based chemo is a first-line option for metastatic NSCLC without EGFR/ALK aberrations.

MEDICARE NATIONAL COVERAGE

No specific NCD. Local coverage may apply.

OTHER CRITERIA

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

References

1. Imjudo (tremelimumab) Prescribing Information. AstraZeneca Pharmaceuticals LP. Revised July 2024.
  
2. Abou-Alfa GK, et al. Tremelimumab + durvalumab in unresectable HCC (HIMALAYA). NEJM. 2022.
  
3. Rizvi NA, et al. Tremelimumab + durvalumab + platinum chemo in NSCLC (POSEIDON). J Clin Oncol. 2023.
  
4. NCCN Guidelines: Hepatobiliary Cancers. Version 2024.
  
5. NCCN Guidelines: NSCLC. Version 2024.
  

Codes

Applicable Modifiers

N/A

Policy History