ModifiedCentenePolicy CP.PHAR.612

Tremelimumab-actl (Imjudo) coverage criteria

Defines medical necessity and coverage criteria for tremelimumab-actl (Imjudo) for NSCLC, unresectable hepatocellular carcinoma, and select off-label GI cancers (gastric/esophageal/EGJ) in combination regimens, and describes dosing and authorization rules affecting Centene lines of business.

Policy Summary

PayerCentene

PolicyTremelimumab-actl (Imjudo) coverage criteria

Policy CodePolicy CP.PHAR.612

Change TypeMaterial revisions — added off-label GI indication, coding update, reauthorization rules

Effective DateMar 1, 2023

Next Review Date

Key ActionProvider must submit prior authorization with documentation including oncologist consultation, diagnosis, age ≥18, required biomarker results (MSI-H/dMMR when applicable), and attestation of surgical fitness for GI neoadjuvant cases.

SourceLink

POLICY UPDATE CHANGES

Added gastric, esophageal, and esophagogastric junction cancer (off-label) coverage per NCCN with MSI-H/dMMR requirement and provider attestation of surgical fitness.

For uHCC, continuation/re-authorization was revised to not permit re-authorization per package insert.

NSCLC criteria expanded to specify recommended uses for present AND negative actionable molecular biomarkers and to list multiple biomarker-specific indications.

Updated HCPCS code J9347 (tremelimumab-actl, 1 mg) added to coding implications.

Added HCPCS code J9347 for injection, tremelimumab-actl, 1 mg.

Initial approval criteria updated to include gastric, esophageal and esophagogastric junction cancer as off-label NCCN recommended uses and added requirement that disease is MSI-H or dMMR for those indications with provider attestation that member is medically fit for surgery.

For uHCC and for all indications, revised continued therapy section to not permit reauthorizations per the package insert/PI.

For NSCLC, updated NCCN-recommended uses: removed certain actionable biomarker-positive tumors (RET, EGFR exon19/exon21 L858R, ALK, ROS1) and added recommended use for NRG1 gene fusion positive tumors.

Commercial continued approval duration revised from 12 months to standard duration for injectables (6 months or to the member's renewal date, whichever is longer).

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3indications

6 monthsstandard approval duration

single doseuHCC approval

J9347billing code

MSI-H/dMMRrequired biomarker for GI

disallowedreatuthorizations

Coverage Criteria

Initial Therapy — NSCLC

Covered when ALL of the following are met for NSCLC initial therapy

NSCLC Initial Approval: 1. Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Prescribed in combination with durvalumab and platinum-based chemotherapy as one of the biomarker/setting options listed in Section I.A (a–h); 5. Dosing meets weight-based limits: for body weight < 30 kg, Imjudo (tremelimumab-actl) ≤ 1 mg/kg IV q3w in combination with durvalumab 20 mg/kg per regimen and a fifth Imjudo dose at week 16; for body weight ≥ 30 kg, Imjudo ≤ 75 mg IV q3w in combination with durvalumab 1500 mg per regimen and a fifth Imjudo dose at week 16; or dose is supported by practice guidelines/peer-reviewed literature with supporting evidence submitted; 6. Prescribed regimen must be FDA‑approved or recommended by the NCCN compendium.

Initial Therapy — uHCC

Covered when ALL of the following are met for unresectable hepatocellular carcinoma (uHCC)

uHCC Initial Approval: 1. Diagnosis of unresectable, liver‑confined, or metastatic hepatocellular carcinoma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Prescribed in combination with durvalumab; 5. Dosing meets weight-based single-dose limits: for body weight < 30 kg, tremelimumab ≤ 4 mg/kg IV as a single dose with durvalumab 20 mg/kg at Cycle 1 Day 1; for body weight ≥ 30 kg, tremelimumab ≤ 300 mg IV as a single dose with durvalumab 1500 mg at Cycle 1 Day 1; or dose is supported by practice guidelines/peer‑reviewed literature with supporting evidence submitted; 6. Prescribed regimen must be FDA‑approved or recommended by the NCCN compendium; Approval duration: 6 months (one dose); reauthorization not permitted per package insert/PI.

Initial Therapy — Gastric/Esophageal/EGJ (Off-label)

Covered when ALL of the following are met for gastric, esophageal, or esophagogastric junction adenocarcinoma (off-label, neoadjuvant)

GI Neoadjuvant (Off-label): 1. Diagnosis of gastric, esophageal, or esophagogastric junction adenocarcinoma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Prescribed in combination with durvalumab as neoadjuvant therapy; 5. Disease is microsatellite instability‑high (MSI‑H) or deficient mismatch repair (dMMR); 6. Provider attests that member is medically fit for surgery; 7. Dose is within FDA maximum recommended single‑dose or is supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence); 8. Prescribed regimen must be FDA‑approved or recommended by the NCCN compendium; Approval duration: 6 months (one dose).

Updated coverage criteria highlights

Covered when the following NCCN/PI-based conditions are met for the specified indications

GI indications (gastric, esophageal, esophagogastric junction): Member has MSI‑H or dMMR disease AND provider attests member is medically fit for surgery

Approval clarified as one dose only

uHCC continued therapy: Reauthorization not permitted per package insert

Continued therapy disallowed

NSCLC biomarker caveat: Certain actionable biomarker‑positive tumors (RET rearrangement, EGFR exon 19 deletion, EGFR exon 21 L858R, ALK rearrangement, ROS1 rearrangement) have been removed from recommended uses; NRG1 gene fusion positive tumors have been added as recommended uses per NCCN compendium

Apply biomarker‑directed eligibility per NCCN

Requests for non‑FDA approved indications that are not specifically addressed by this policy will be denied unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other evidence of coverage documents.

Per the 1Q 2026 update, the policy removed recommended uses for certain actionable, biomarker‑positive NSCLC tumors: specifically RET rearrangement positive, EGFR exon 19 deletion, EGFR exon 21 L858R, ALK rearrangement positive, and ROS1 rearrangement positive tumors. The same review added a recommended use for NRG1 gene fusion positive NSCLC tumors; apply biomarker‑directed eligibility per the NCCN compendium as cited in the policy.

For all indications listed in Section I, re‑authorization is not permitted. Covered approvals are issued as initial approvals only unless otherwise specified in this policy (for example, continuation/re‑authorization was explicitly disallowed for uHCC per the package insert).

Operationally and per the product labeling, reauthorizations for continued therapy are not permitted — this was clarified for unresectable hepatocellular carcinoma (uHCC) and has been revised to apply across indications in the policy updates, consistent with the package insert/PI.

Covered Regimens and Dosing

Indication	Regimen (weight ≥30 kg)	Regimen (weight <30 kg)	Coverage status
Non‑Small Cell Lung Cancer (recurrent, advanced, or metastatic)	Tremelimumab‑actl 75 mg IV every 3 weeks with durvalumab 1,500 mg IV and platinum‑based chemotherapy for 4 cycles; then durvalumab 1,500 mg IV every 4 weeks as monotherapy with histology‑based pemetrexed as indicated, plus a fifth dose of tremelimumab 75 mg in combination with durvalumab at week 16 (dose 6).	Tremelimumab‑actl 1 mg/kg IV every 3 weeks with durvalumab 20 mg/kg IV and platinum‑based chemotherapy for 4 cycles; then durvalumab 20 mg/kg IV every 4 weeks as monotherapy with histology‑based pemetrexed as indicated, plus a fifth dose of tremelimumab 1 mg/kg in combination with durvalumab at week 16 (dose 6).	Covered

Indication	Tremelimumab dose	Durvalumab dose	Dosing schedule / notes	Coverage status
Unresectable hepatocellular carcinoma (uHCC)	Weight <30 kg: 4 mg/kg IV as a single dose; Weight ≥30 kg: 300 mg IV as a single dose	Weight <30 kg: durvalumab 20 mg/kg IV; Weight ≥30 kg: durvalumab 1,500 mg IV	Administer single dose of tremelimumab with durvalumab on Cycle 1 Day 1, followed by durvalumab monotherapy every 4 weeks; reauthorization not permitted per package insert/policy.	covered (single‑dose approval)

Indication	Eligibility requirement	Regimen	Provider requirement	Coverage status
Gastric, esophageal, or esophagogastric junction adenocarcinoma (neoadjuvant, off‑label)	Tumor must be MSI‑H or dMMR	Single‑dose tremelimumab (as per weight‑based single‑dose limits) administered with durvalumab on Cycle 1 Day 1 followed by durvalumab monotherapy q4w; approval limited to one dose per policy.	Provider must attest that the member is medically fit for surgery (attestation required); prior authorization may be required for durvalumab.	covered (single‑dose, MSI‑H/dMMR with surgical fitness attestation)

Biomarker Requirements

Actionable biomarkers and applicability

Actionable biomarkers listedEGFR, ALK, KRAS, ROS1, BRAF, NTRK1/2/3, MET, RET, ERBB2 (HER2), NRG1, MSI-H/dMMR

Where applied — NSCLCBiomarker assessment required to determine eligibility for NSCLC initial therapy; criteria reference absence of sensitizing EGFR/ALK mutations or presence/absence of other actionable biomarkers per subsection I.A

Where applied — GI neoadjuvantMSI-H/dMMR required for gastric, esophageal, and esophagogastric junction neoadjuvant use (Section I.C)

Where applied — uHCCBiomarker list recorded for completeness; uHCC dosing/approval is weight-based single dose (biomarker not required for uHCC in policy)

Testing implicationApply biomarker-directed eligibility per NCCN compendium and policy subsections; providers must document relevant molecular testing in prior authorization submission

Coding and Billing

Weight-based dosing breakpoint (< 30 kg vs 60; 30 kg)

Weight-based dosing breakpointWeight < 30 kg versus ≥ 30 kg

Continued approval duration

Continued approval durationStandard duration for injectables — 6 months or to the member's renewal date, whichever is longer

Denial Risk

Coding mismatch and provider attestation

Provider attestation is required for GI indications: the ordering provider must attest that the member is medically fit for surgery when the indication requires it. Claims submitted with codes other than those listed may not correspond to coverage and could be denied. Ensure documentation of dose, weight-based calculation, combination therapy (durvalumab, chemotherapy), and the specific indication is available in the medical record to support billing.

Provider Actions and Requirements

Prior Authorization

Prior authorization and required submission

Prior authorization may be required for Imjudo; requests must document that therapy is prescribed by or in consultation with an oncologist, include the diagnosis and that the member is age ≥ 18 years, and show the combination regimen and dosing consistent with this policy.

Document oncologist prescribing or consultation
Include diagnosis and age (≥ 18 years)
Specify combination regimen (e.g., with durvalumab and platinum-based chemotherapy or durvalumab alone) and dosing per policy

Prior Authorization

Prior authorization — follow updated NCCN/PI approval criteria

Prior authorization may be required and approval is tied to the updated NCCN compendium and package insert criteria; providers must follow the policy's initial- and continued-therapy rules (including biomarker and dosing limits) when submitting requests.

Follow updated initial and continued therapy rules per NCCN compendium and PI

Line of Therapy

first-line — top-level node indicating first-line use

Indicates the therapy is intended as first‑line in specified NSCLC scenarios

First‑line use: First‑line therapy for NSCLC when disease lacks sensitizing EGFR mutations or ALK genomic tumor aberrations, or for the specific first‑line molecular subgroups listed (see I.A a–h); some biomarker‑defined uses may be first‑line or subsequent per subsection details.

varies — line of therapy varies per indication

Line of therapy varies by indication and biomarker status per NCCN and PI

Indication‑specific: Follow NCCN compendium recommended uses and the package insert; line of therapy may be first‑line or subsequent depending on the specific biomarker/clinical scenario; apply biomarker restrictions and reauthorization rules as noted in policy.

Definitions and Background

Tremelimumab‑actl is a CTLA‑4 blocking monoclonal antibody administered in combination with durvalumab for specific oncology indications. The policy covers use in metastatic or recurrent non‑small cell lung cancer (in combination with durvalumab and platinum‑based chemotherapy under biomarker‑defined conditions), as a single‑dose combination with durvalumab for unresectable hepatocellular carcinoma (uHCC), and for select NCCN‑recommended off‑label neoadjuvant use in gastric, esophageal, and esophagogastric junction (EGJ) adenocarcinomas when the tumor is MSI‑H or dMMR and the provider attests the member is medically fit for surgery. Recent updates clarified weight‑based dosing breakpoints, added HCPCS code J9347, adjusted continued approval durations for commercial lines, and aligned reauthorization rules with the package insert.

uHCC (unresectable hepatocellular carcinoma) definition

DefinitionuHCC = unresectable hepatocellular carcinoma

Clinical contextIncludes unresectable, liver-confined, or metastatic hepatocellular carcinoma as listed in Section I.B

Dosing implicationuHCC approval is for a single, weight-based tremelimumab dose in combination with durvalumab followed by durvalumab monotherapy

Revision History

2023-05-24coding_added

Added HCPCS code J9347 (Injection, tremelimumab-actl, 1 mg) to coding implications.

2024-07-25policy_revision

Revised continued therapy for unresectable hepatocellular carcinoma (uHCC) to not permit re-authorization per the package insert.

2024-10-23policy_revision

Updated initial approval criteria to add gastric, esophageal, and esophagogastric junction off-label NCCN-recommended uses with MSI-H/dMMR requirement and provider attestation of surgical fitness; clarified prior authorization may be required for durvalumab and revised commercial continued approval duration to standard injectable duration (6 months or to member renewal date).

Policy Summary

PayerCentene

PolicyTremelimumab-actl (Imjudo) coverage criteria

Policy CodePolicy CP.PHAR.612

Change TypeMaterial revisions — added off-label GI indication, coding update, reauthorization rules

Effective DateMar 1, 2023

Next Review Date

SourceLink

On This Page

MSI-H / dMMR (policy-level)

DefinitionMSI-H = microsatellite instability-high; dMMR = deficient mismatch repair

Where requiredRequired for gastric, esophageal, and esophagogastric junction neoadjuvant indications (Section I.C) — disease must be MSI-H or dMMR

DocumentationProvider must attest member is medically fit for surgery when MSI-H/dMMR requirement applies

Policy impactMSI-H/dMMR status is a condition of coverage for the specified off-label GI neoadjuvant uses per NCCN compendium

NRG1 gene fusion (NSCLC update)

NRG1 gene fusion — statusAdded as a recommended NSCLC biomarker-based use (NRG1 gene fusion positive tumors) per 1Q 2026 annual review

Where appliedIncluded among NSCLC recommended uses in Section I.A as a biomarker-directed indication

ReferenceChange documented in Coding Implications / annual review notes (1Q 2026)

Removed actionable biomarkers from NSCLC recommended uses

Removed biomarkersRET rearrangement positive, EGFR exon 19 deletion, EGFR exon 21 L858R, ALK rearrangement positive, ROS1 rearrangement positive tumors were removed from recommended NSCLC uses

Effective changeDocumented in 1Q 2026 annual review notes in Coding Implications

Clinical applicationDo not consider these actionable biomarker-positive tumors as recommended uses for tremelimumab-containing NSCLC regimens per updated policy

Provider attestation required for GI indications: ordering provider must attest member is medically fit for surgery.
Affected code: J9347. Submit claims using the specified HCPCS code and document weight and administered mg/kg or mg dose.
Denial risk if documentation (attestation, indication, dosing details, combination agents) is missing.

Ensure biomarker requirements and dosing limits in the policy are met

Step Therapy

No step therapy sequences specified — approval per criteria

No explicit step therapy sequences are specified in this policy; approval is based on meeting indication- and dosing-specific criteria, including required biomarker status where noted (e.g., MSI-H/dMMR for certain GI neoadjuvant uses).

Provide biomarker results when required (see GI neoadjuvant MSI-H/dMMR and NSCLC biomarker sections)

Note

Operational note — prior authorization clarification for durvalumab

Prior authorization may be required for durvalumab when used in combination; ensure documentation and coding reflect that prior authorization clarification.

Documentation Required

Submit clinical documentation to support approval criteria

Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) that supports the member has met all approval criteria for therapy.

Office chart notes
Relevant laboratory or pathology results (e.g., biomarker testing)
Treatment plan and dosing details

Documentation Required

Provider attestation of surgical fitness required for GI neoadjuvant use

For gastric, esophageal, or esophagogastric junction neoadjuvant indications, the provider must attest that the member is medically fit for surgery as part of the approval requirements.

Include provider attestation of surgical fitness with the authorization request

Denial Risk

Off‑label (non‑FDA) indications require supporting documentation

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 according to the applicable off-label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

If requesting off-label use not in this policy, submit supporting evidence per off-label policies

MSI-H / dMMR definition

Term definitionsMSI-H = microsatellite instability-high; dMMR = deficient mismatch repair

Appendix referenceAbbreviations and definitions listed in Appendix A (Section IV) include MSI-H and dMMR

Clinical relevanceMSI-H/dMMR used as eligibility criteria for specified GI neoadjuvant indications in Section I.C

MSI-H / dMMR requirement note for GI indications

Requirement for GI indicationsPolicy requires disease to be MSI-H or dMMR for gastric, esophageal, and esophagogastric junction neoadjuvant coverage (Section I.C)

Provider attestationProvider must attest that member is medically fit for surgery when requesting neoadjuvant therapy for these GI cancers

Approval quantityApproval clarified as one dose only for these GI indications per 1Q 2026 notes

2025-11-05policy_revisionLatest

Per 1Q 2026 annual review, removed recommended uses for RET, EGFR exon19/exon21 L858R, ALK, and ROS1 positive NSCLC tumors and added recommended use for NRG1 gene fusion positive tumors; clarified one-dose approval for gastric/esophageal/EGJ indications and revised continued therapy to not permit reauthorizations per the package insert for all indications.