CurrentCareSourcePolicy N/A

Imjudo (tremelimumab-act) — Coverage and Prior Authorization Criteria (Medical Benefit)

Defines prior authorization, coverage criteria, dosing, and approved indications for Imjudo (tremelimumab-act) in combination with durvalumab (Imfinzi) for oncology indications affecting adult patients under CareSource medical benefit.

Policy Summary

PayerCareSource

PolicyImjudo (tremelimumab-act) — Coverage and Prior Authorization Criteria (Medical Benefit)

Policy CodePolicy N/A

Change TypeAdded indicationsclarified mutation language

Effective Date

Next Review DateOct 16, 2024

Key ActionObtain prior authorization and document diagnosis, line of therapy, relevant molecular/MSI status, and dosing consistent with the criteria.

SourceLink

POLICY UPDATE CHANGES

Esophageal and Esophagogastric Junction Cancer added as a condition of approval for neoadjuvant MSI-H/dMMR adenocarcinoma.

Gastric cancer added as a condition of approval for neoadjuvant MSI-H/dMMR locoregional disease.

For NSCLC, descriptor 'exon 21' was added to the EGFR mutation option (exon 19 deletion or exon 21 L858R).

2FDA indications

2Other supported uses

30HCC approval length (days)

6NSCLC approval length (months)

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Recommended Authorization Criteria

Hepatocellular Carcinoma (HCC) — coverage when ALL listed criteria are met

Covered when ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age.
Patient has hepatocellular carcinoma (HCC) that is unresectable and liver‑confined and, according to the prescriber, is deemed ineligible for transplant; OR patient has extrahepatic metastatic disease and, according to the prescriber, is deemed ineligible for resection, transplant, or locoregional therapy.
Either liver‑confined unresectable disease (ineligible for transplant) OR extrahepatic metastatic disease (ineligible for resection/transplant/locoregional therapy) is acceptable.
Imjudo (tremelimumab-actl) is used in combination with Imfinzi (durvalumab intravenous infusion).
Imjudo is used as first‑line systemic therapy.
The medication is prescribed by or in consultation with an oncologist.
Dosing
- Patient weighs ≥ 30 kg: approve a single dose of 300 mg administered by intravenous infusion.
- Patient weighs < 30 kg: approve a single dose of 4 mg/kg administered by intravenous infusion.

Non-Small Cell Lung Cancer (NSCLC) — coverage when ALL listed criteria are met

Covered when ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age.
Non‑small cell lung cancer (NSCLC) that is recurrent, advanced, or metastatic.
Imjudo is used in combination with Imfinzi (durvalumab intravenous infusion).
Imjudo is used as first‑line therapy (or as indicated below for certain molecular profiles when used as first‑line or subsequent therapy as noted).
The tumor is negative for actionable molecular markers (examples: EGFR mutations, ALK rearrangements, ROS1, ERBB2 (HER2) exon 20, etc.), OR the tumor has specific actionable markers but the use of Imjudo in combination with durvalumab is consistent with FDA‑approved or guideline‑supported indications described below.

Esophageal/EGJ and Gastric Cancer (neoadjuvant MSI‑H/dMMR) — coverage when ALL listed criteria are met (supportive evidence)

Other uses with supportive evidence — covered when ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age.
Diagnosis of esophageal or esophagogastric junction (EGJ) adenocarcinoma OR locoregional gastric cancer as specified below.
Tumor is microsatellite instability‑high (MSI‑H) or deficient mismatch repair (dMMR).
Imjudo is used as neoadjuvant therapy in combination with Imfinzi (durvalumab intravenous infusion).
According to the physician, the patient is medically fit for surgery.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Requests for use outside of the indications and criteria above are not recommended for approval and will be reviewed according to medical necessity policies and available published evidence; criteria will be updated as new published data become available.

Dosing and Regimens Covered

Regimen	Indication	Coverage
Single IV dose: 300 mg for patients >= 30 kg OR 4 mg/kg for patients < 30 kg administered once in combination with Imfinzi; Imfinzi continued every 4 weeks as single agent until disease progression or unacceptable toxicity
Indication: Hepatocellular carcinoma as first-line systemic therapy (adult patients >= 18 years) when used in combination with Imfinzi
Coverage: Approve for 30 days when all HCC criteria are met per policy (prior authorization recommended)

Regimen	Indication	Coverage
For patients >= 30 kg: Imjudo 75 mg IV every 3 weeks in combination with Imfinzi 1,500 mg IV and platinum-based chemotherapy for 4 cycles; one additional Imfinzi dose with pemetrexed (histology-based) at cycle 5, then schedule switched to q4w; a fifth dose of Imjudo 75 mg IV is administered with Imfinzi at Week 16; Imfinzi continued until progression or unacceptable toxicity
Alternative weight-based option: Imjudo 1 mg/kg IV every 3 weeks for patients < 30 kg in combination with Imfinzi (weight-based Imfinzi dosing described in source)
Indication: Non‑Small Cell Lung Cancer (recurrent, advanced, or metastatic) as first‑line therapy in combination with Imfinzi and platinum‑based chemotherapy when molecular criteria per policy are met; approve for 6 months when criteria satisfied

Regimen	Indication	Coverage
Single IV dose of 300 mg administered in combination with Imfinzi; Imfinzi schedule per prescriber (neoadjuvant use)
Indication: Neoadjuvant therapy for Esophageal/Esophagogastric junction adenocarcinoma or Gastric locoregional disease with MSI‑H or dMMR in adult patients medically fit for surgery
Coverage: Approve for 30 days when all neoadjuvant MSI‑H/dMMR criteria are met (prior authorization recommended)

Relevant Codes and Dosing Thresholds

Covered HCPCS (example)HCPCS

J9229

Tremelimumab-act (Imjudo), per 1 mg (example billing HCPCS - document does not list exact code)

Patient weight thresholds for dosing

Patients >= 30 kg (HCC & neoadjuvant esophageal/gastric)Single IV dose of 300 mg administered in combination with Imfinzi (durvalumab); Imfinzi continued per regimen.

Patients < 30 kg (HCC)Weight-based dosing: 4 mg/kg as a single IV dose administered in combination with Imfinzi.

Patients >= 30 kg (NSCLC) — fixed-dose optionImjudo 75 mg IV every 3 weeks in combination with Imfinzi 1,500 mg IV and platinum-based chemotherapy for 4 cycles (with planned additional Imfinzi dosing then q4w).

Patients < 30 kg (NSCLC) — weight-based optionImjudo 1 mg/kg IV every 3 weeks in combination with Imfinzi and platinum-based chemotherapy (alternative weight-based regimen).

Prescriber Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for medical benefit coverage of Imjudo. Approval is recommended for those who meet the Recommended Authorization Criteria and for the listed indications. All approvals are provided for the duration noted in the policy (authorized in months; 1 month = 30 days). Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Imjudo, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., an oncologist).

Prior Authorization recommended for medical benefit coverage of Imjudo
Approvals follow the Recommended Authorization Criteria and listed indications
Approvals provided for the duration noted (1 month = 30 days)

Documentation Required

Dose Exceptions Reviewed Case-by-Case

Requests for doses outside of the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).

Indicated Lines of Therapy

First-line — criteria node for first-line use

First-line use requirement:

First-line: Imjudo is used as first-line systemic therapy in combination with Imfinzi (durvalumab intravenous infusion).

First-line and subsequent — criteria node for first-line or subsequent therapy as described

First-line or subsequent therapy as described for molecularly defined NSCLC scenarios:

First-line and subsequent: Imjudo is used as first-line therapy in combination with Imfinzi plus platinum-based chemotherapy; OR Imjudo is used as first-line or subsequent therapy in specified mutation-positive scenarios per guideline-directed sequencing and the prescriber's plan (e.g., certain EGFR, ALK, ROS1, BRAF, MET, NTRK, RET, ERBB2/HER2 alterations or select EGFR exon mutations as detailed in the prescriber documentation).

Neoadjuvant — criteria node for neoadjuvant use

Testing and Biomarker Criteria

MSI-H / dMMR

BiomarkerMicrosatellite instability-high (MSI-H) or deficient mismatch repair (dMMR)

Required settingNeoadjuvant therapy for esophageal/EGJ adenocarcinoma and locoregional gastric cancer when patient is medically fit for surgery.

DocumentationPrescriber must document MSI‑H or dMMR status to meet neoadjuvant coverage criteria.

PD-L1 (tumor proportion score)

BiomarkerPD‑L1 (tumor proportion score)

Threshold>= 1% — required per guidelines for NSCLC first‑line recommendation when negative for actionable molecular markers.

Background and Mechanism

Imjudo (tremelimumab-act) is a monoclonal antibody targeting the CTLA-4 pathway and is used in combination with durvalumab (Imfinzi) as part of systemic immunotherapy regimens for select cancers. The policy addresses its use per approved and supported indications — including unresectable hepatocellular carcinoma and certain non-small cell lung cancers — and recognizes emerging neoadjuvant applications (for MSI-H/dMMR esophageal, esophagogastric junction, and gastric adenocarcinomas) when given together with durvalumab. Use should follow the dosing and regimen details in the Covered Regimens and be prescribed by or in consultation with an oncologist.