Tremelimumab-actl (Imjudo) — CPB 1019 | AETNA Coverage Update

Aetna modified CPB 1019 for tremelimumab-actl (Imjudo), effective December 6, 2025. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its Imjudo coverage policy under CPB 1019 Aetna system, covering three tumor types: hepatocellular carcinoma, non-small cell lung cancer, and esophageal/gastric cancers. The primary billing code is HCPCS J9347 (injection, tremelimumab-actl, 1 mg), and this policy governs commercial plans only — Medicare members follow a separate pathway. If your oncology or infusion team bills J9347, this update changes what you need to document before submitting.

---

Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Tremelimumab-actl (Imjudo) — CPB 1019
Policy Code	CPB 1019
Change Type	Modified
Effective Date	December 6, 2025
Impact Level	High
Specialties Affected	Medical Oncology, Hematology/Oncology, Infusion, Gastroenterology, Thoracic Oncology
Key Action	Update prior authorization workflows for J9347 to match indication-specific dose limits and biomarker requirements before submitting any new claims

---

Aetna Imjudo Coverage Criteria and Medical Necessity Requirements 2025

Aetna's tremelimumab-actl coverage policy requires precertification for every claim. Call (866) 752-7021 or fax (888) 267-3277 before the first dose. Without an approved prior authorization, your J9347 claim will deny — no exceptions.

The policy covers three distinct indications, and each has its own dose limit and criteria stack. Getting the indication wrong — or missing a single criterion — is the fastest path to a claim denial. Read each set of criteria separately.

Hepatocellular Carcinoma (HCC)

Aetna covers tremelimumab-actl for HCC as a one-time single dose under two clinical scenarios.

First-line treatment: All three of the following must be met:

#	Covered Indication Copy
1	Used in combination with durvalumab (Imfinzi, HCPCS J9173)
2	Disease is unresectable or extrahepatic/metastatic
3	Member is ineligible for transplant

Subsequent-line treatment: All three of the following must be met:

#	Covered Indication Copy
1	Used in combination with durvalumab (J9173)
2	Disease is unresectable or extrahepatic/metastatic
3	Member has not been previously treated with an anti-CTLA-4-based regimen

The real issue on the HCC side is that one-time single dose limit. This is not a maintenance drug in this setting. If your team submits J9347 more than once for an HCC patient, expect a denial. Document the transplant ineligibility or the anti-CTLA-4 treatment history explicitly in your prior auth request — Aetna will look for it.

The ICD-10 code for HCC is C22.0. The policy notes it is covered only when used in combination with durvalumab. Code pairings matter here — both J9347 and J9173 should appear on the claim.

Non-Small Cell Lung Cancer (NSCLC)

For NSCLC, Aetna covers tremelimumab-actl for up to five total doses. This is the only indication where multiple doses are authorized under this coverage policy. Both criteria must be met:

#	Covered Indication Copy
1	Used in combination with durvalumab (J9173) and platinum-based chemotherapy (J9045 for carboplatin, J9060 for cisplatin)
2	Tumor is negative for EGFR exon 19 deletion and exon 21 L858R mutations, ALK, RET, and ROS1 rearrangements

That second criterion is where most authorizations will get stuck. Your oncologist needs molecular testing results before you can get prior auth approved. CPT 81235 covers EGFR gene analysis. Make sure that result is documented and attached to the precertification request — Aetna will not approve J9347 for NSCLC without evidence the tumor lacks those actionable driver mutations.

NSCLC maps to the C34 family of ICD-10 codes. This is a broad set of codes covering bronchus and lung malignancies. Use the most specific code that matches the documented tumor site and laterality.

Esophageal, Esophagogastric Junction, and Gastric Cancer

Aetna covers tremelimumab-actl as a one-time single dose for neoadjuvant treatment in this setting. All three criteria must be met:

#	Covered Indication Copy
1	Used in combination with durvalumab (J9173)
2	Tumor is microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR)
3	Member is medically fit for surgery

The MSI-H/dMMR requirement is a hard stop. No biomarker documentation, no authorization. The fit-for-surgery requirement adds a second layer — your authorization request needs clinical documentation supporting surgical candidacy.

Diagnosis codes in this group run from C15.3–C15.9 (esophagus) and C16.0–C16.9 (stomach). Use the most specific code. If your documentation says esophagogastric junction, code to the specific site if the physician has specified it.

---

Aetna Imjudo Exclusions and Non-Covered Indications

Aetna considers all other indications for tremelimumab-actl experimental, investigational, or unproven. This is a blanket exclusion. If a provider wants to use Imjudo outside of HCC, NSCLC, or esophageal/gastric cancer — or inside those tumor types but outside the criteria above — Aetna will not cover it under this policy.

For guidance on coverage disputes outside these three indications, consult your compliance officer — CPB 1019 does not address appeal procedures. If your oncologist is using Imjudo for a different indication, you should not expect reimbursement under this policy. Talk to your compliance officer before submitting a claim for any use outside these three indications.

---

Coverage Indications at a Glance

---

Aetna Imjudo Billing Guidelines and Action Items 2025

The effective date is December 6, 2025. If your team is already billing J9347, audit every open authorization now.

Copy Action Items

If your volume on J9347 is significant — especially in a health system or large oncology group — loop in your compliance officer before December 6, 2025 to review how these criteria apply across your current patient panel.

---

CPT, HCPCS, and ICD-10 Codes for Tremelimumab-actl Under CPB 1019

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J9347	HCPCS	Injection, tremelimumab-actl, 1 mg

Key ICD-10-CM Diagnosis Codes

Sub-site descriptions for C15.x and C16.x reflect standard ICD-10-CM terminology and are not provided by the source policy. The full ICD-10 list under CPB 1019 includes 111 codes, primarily within the C34 family for NSCLC. Use the most specific code supported by your documentation. Review the full list at the Aetna CPB 1019 source.

---