Tremelimumab-actl (Imjudo) coverage policy
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Defines medical necessity and prior authorization requirements for tremelimumab-actl (Imjudo) for Ambetter Georgia members across commercial, HIM, and Medicaid lines of business, including FDA-approved and select NCCN-recommended off-label uses in combination with durvalumab.
Added NCCN-recommended off-label uses for gastric, esophageal, and esophagogastric junction cancers to initial approval criteria.
For unresectable hepatocellular carcinoma (uHCC), continued therapy (re-authorization) is not permitted per the package insert.
Updated HCPCS code J9347 (Injection, tremelimumab-actl, 1 mg) included in coding section.
Coverage and Medical Necessity Criteria
Initial Approval Criteria — Non-Small Cell Lung Cancer
Initial Approval Criteria — Non-Small Cell Lung Cancer (must meet all):
NSCLC initial
- Diagnosis and prescriber: Diagnosis of NSCLC; prescribed by or in consultation with an oncologist; age >= 18 years.
- Combination therapy: Prescribed in combination with durvalumab and platinum-based chemotherapy.
- Dosing: Request meets one of: (a) for body weight < 30 kg, dose does not exceed Imjudo 1 mg/kg every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles with a fifth dose of Imjudo 1 mg/kg at week 16; (b) for body weight >= 30 kg, dose does not exceed Imjudo 75 mg every 3 weeks in combination with durvalumab 1500 mg and platinum-based chemotherapy for 4 cycles with a fifth dose of Imjudo 75 mg at week 16; (c) dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).
Initial Approval Criteria — Hepatocellular Carcinoma
Initial Approval Criteria — Hepatocellular Carcinoma (must meet all):
uHCC initial
- Diagnosis and prescriber: Diagnosis of unresectable, liver-confined, or metastatic hepatocellular carcinoma; prescribed by or in consultation with an oncologist; age >= 18 years.
- Combination therapy: Prescribed in combination with durvalumab.
- Dosing: Request meets one of: (a) for body weight < 30 kg, dose does not exceed 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1; (b) for body weight >= 30 kg, dose does not exceed 300 mg as a single dose in combination with durvalumab 1500 mg at Cycle 1/Day 1; (c) dose supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).
Initial Approval Criteria — NCCN Recommended Uses (off-label)
Initial Approval Criteria — NCCN Recommended Uses (off-label) (must meet all):
Initial therapy — general
Initial therapy — general requirements:
Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).
Uses that are non‑FDA approved and either not addressed in this policy or lacking adequate off‑label evidence will be denied unless the prescriber submits supporting documentation meeting the criteria outlined in the applicable off‑label use policies referenced above.
Continued Therapy and Re-authorization Rules
Continued Therapy — All other indications in Section I
Continued Therapy — All other indications in Section I (must meet all):
Continued Therapy — Hepatocellular Carcinoma (re-authorization not permitted)
Continued Therapy — Hepatocellular Carcinoma:
Continuation — non-uHCC specific criteria
Continuation — non-uHCC specific criteria:
Continuation — uHCC specific criteria
Continuation — uHCC specific criteria:
Initial Authorization Requirements
Initial therapy — general (grouped requirements)
Grouped initial therapy requirements (applies to all initial indications):
Billing and Coding
| J9347 | Injection, tremelimumab-actl, 1 mg |
Provider Requirements and Authorization Actions
Prior authorization required
Prior authorization is required for Imjudo (tremelimumab‑actl) requests. Requests must meet the specified initial approval criteria for the indication (NSCLC, uHCC, or NCCN‑recommended off‑label uses), including prescriber specialty, age, required combination therapy, and dosing limits.
- Relevant HCPCS code: J9347 (see coding section).
Step therapy not required; FDA‑ or NCCN‑based regimen
No explicit prior‑step therapy (failure of another agent) is required by this policy. The prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label NCCN‑recommended uses are accepted when criteria are met.
- Regimen must be FDA‑approved or NCCN‑recommended.
Submit supporting clinical documentation
Provider must submit supporting documentation with the request such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.
- Documentation should support diagnosis, prescriber consultation, combination therapy, and dosing justification where applicable.
Non‑covered off‑label indications — supply supporting evidence
Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless the provider supplies sufficient documentation of efficacy and safety as required by the referenced off‑label use policies.
- Off‑label requests must meet evidence requirements in CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid).
Step Therapy and Sequencing
| Step | Requirement |
|---|---|
| No prior step therapy required | No explicit prior-step therapy sequencing (e.g., failure of prior agents) is required; prescribed regimen must be FDA‑approved or recommended by NCCN. |
| Off‑label NCCN‑recommended uses accepted when criteria met | For NCCN‑recommended off‑label indications (gastric; esophageal and esophagogastric junction cancers), requests are allowed when all indication‑specific criteria are met, including combination with durvalumab and dose within FDA maximum or supported by guidelines/literature (prescriber must submit supporting evidence). |
Dosing and Quantity Limits
Definitions
Product and Clinical Background
Tremelimumab‑actl (Imjudo) is a monoclonal antibody that functions as a CTLA‑4 blocking antibody. It is used in combination with durvalumab for the treatment of unresectable hepatocellular carcinoma (uHCC) and, in other regimens, with durvalumab plus platinum‑based chemotherapy for certain patients with metastatic non‑small cell lung cancer (NSCLC) without sensitizing EGFR or ALK alterations. Product availability includes single‑dose vials (e.g., 25 mg and 300 mg).
Site-of-Care
Site of care not specified
Site of care is not specified in this policy; no site‑of‑care requirement is imposed by the criteria.
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