CurrentCentenePolicy N/A

Clinical Policy: Tremelimumab-actl (Imjudo) coverage

Policy governing medical necessity criteria, dosing, and authorization requirements for tremelimumab-actl (Imjudo) for covered indications (NSCLC, unresectable hepatocellular carcinoma, select off-label GI cancers) for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyTremelimumab-actl (Imjudo) coverage

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMar 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating the member meets the policy's approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsstandard initial approval duration

one doseuHCC approval

weight & fixeddosing strategies

Commercial,HIM,Medicaidlines of business

J9347referenced HCPCS

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Initial Approval — NSCLC

Covered when ALL of the following are met for NSCLC:

NSCLC initial therapy: Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer; prescribed by or in consultation with an oncologist; patient age >= 18 years; prescribed in combination with durvalumab and platinum-based chemotherapy per Appendix D; disease has no sensitizing EGFR mutations or ALK genomic tumor aberrations when used as first-line combination with chemotherapy (see Appendix D) unless a specified molecular subset listed (e.g., EGFR exon 20 insertion, BRAF V600E, MET exon 14, NTRK fusions, RET rearrangements, ERBB2 mutations) for which first-line or subsequent use is allowed as specified; dosing follows weight-based or fixed-dose parameters (for body weight >=30 kg, do not exceed 75 mg every 3 weeks; for body weight <30 kg, 1 mg/kg every 3 weeks) and includes the option for a fifth dose at week 16 as specified in dosing guidance; prescribed regimen must be FDA-approved or recommended by NCCN or supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence for off-label uses).age >= 18; weight decision at 30 kg

Approval duration: 6 months

Initial Approval — uHCC

Covered when ALL of the following are met for unresectable hepatocellular carcinoma:

uHCC initial therapy: Diagnosis of unresectable or metastatic hepatocellular carcinoma; prescribed by or in consultation with an oncologist; patient age >= 18 years; prescribed in combination with durvalumab; dosing is single-dose tremelimumab 4 mg/kg IV (or 300 mg fixed if >=30 kg) on Cycle 1 Day 1 with durvalumab 20 mg/kg (or 1,500 mg fixed), followed by durvalumab single-agent every 4 weeks; prescribed regimen must be FDA-approved or recommended by NCCN or supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence); prior authorization may be required.age >= 18

Approval duration: 6 months (one dose)

Off-label — Gastric/Esophageal neoadjuvant (MSI-H/dMMR)

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

GI neoadjuvant MSI-H/dMMR: Diagnosis of gastric, esophageal, or esophagogastric junction adenocarcinoma; disease is microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR); prescribed by or in consultation with an oncologist; prescribed in combination with durvalumab as neoadjuvant therapy; provider attestation that member is medically fit for surgery; dose is within FDA maximum recommended dose or supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence); prescribed regimen must be FDA-approved or recommended by NCCN.MSI-H or dMMR

Approval duration: 6 months

Continuation Therapy

Continued therapy authorization restrictions:

Continued therapy general: Re-authorization is not permitted for unresectable hepatocellular carcinoma (uHCC) single-dose regimen; for all other covered indications, member must be responding positively to therapy and currently receiving medication via Centene benefit (or documentation supports at least 30 days prior receipt); if request is for a dose increase, new dose must not exceed specified weight-based or fixed maximums or must be supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence); Medicaid/HIM renewal up to 12 months; Commercial approval 6 months or to the member's renewal date, whichever is longer.>=30 days prior therapy for continuation

No re-authorization for uHCC

Non–FDA–approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the plan’s off‑label use requirements (see policies CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid) or submits applicable evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for any specific coverage provisions that apply to this policy.

Uses that are not listed in this policy and that lack sufficient supporting evidence per the plan’s off‑label use policies are considered not authorized / not covered. Providers seeking coverage for off‑label uses must submit supporting practice guidelines or peer‑reviewed literature and follow the referenced off‑label use pathways.

Covered Regimens and Dosing

Regimen	Dosing details	Maintenance / special notes
Tremelimumab-actl + durvalumab plus platinum-based chemotherapy (NSCLC)	Tremelimumab-actl 1 mg/kg IV every 3 weeks (weight <30 kg) OR 75 mg IV every 3 weeks (weight ≥30 kg)	Given with durvalumab 20 mg/kg (weight <30 kg) OR 1500 mg (weight ≥30 kg) for 4 cycles with platinum-based chemotherapy; then durvalumab maintenance every 4 weeks. A fifth dose of tremelimumab is administered at week 16 (in combination with durvalumab dose 6). Histology‑based pemetrexed may be given as applicable.

Regimen	Dosing details	Maintenance / special notes
Tremelimumab-actl single-dose + durvalumab (unresectable HCC)	Single dose tremelimumab-actl 4 mg/kg IV (weight <30 kg) OR 300 mg IV (weight ≥30 kg) given on Cycle 1 Day 1	Given in combination with durvalumab 20 mg/kg (weight <30 kg) OR 1500 mg (weight ≥30 kg) at Cycle 1 Day 1; thereafter durvalumab single‑agent every 4 weeks. Approval duration: one dose (no re‑authorization for uHCC).

Source / guidance	Scope of recommended uses	Notes
NCCN Drugs & Biologics Compendium; Imjudo (tremelimumab-actl) prescribing information	Includes FDA‑approved indications and NCCN‑recommended uses, and select off‑label recommended uses (e.g., gastric, esophageal, esophagogastric junction cancers per NCCN) as referenced in the compendium	Policy references NCCN compendium and Imjudo PI for recommended regimens; off‑label uses require supporting guideline or peer‑reviewed literature as documented by prescriber.

Line of Therapy

first-line and subsequent — top-level node about allowed line(s) of therapy

Allowed lines of therapy:

NSCLC lines of therapy allowed: First-line therapy for disease without sensitizing EGFR or ALK alterations (in combination with durvalumab and platinum-based chemotherapy); first-line therapy for EGFR exon 20 insertion mutation positive disease; first-line or subsequent therapy for BRAF V600E, MET exon 14, NTRK1/2/3 fusions, RET rearrangements, ERBB2 (HER2) mutations; subsequent therapy for select EGFR mutations or after specified targeted therapies as listed in initial criteria.

first-line — specification for first-line use

First-line specification:

uHCC line: Indicated as first-line therapy for unresectable hepatocellular carcinoma when given as single-dose tremelimumab in combination with durvalumab per FDA approval (followed by durvalumab maintenance).

Biomarker Requirements

Required biomarker negative/positive status (EGFR, ALK, KRAS, ROS1, BRAF V600E, MET exon 14, NTRK1/2/3, RET, ERBB2 (HER2), MSI-H/dMMR)

Required biomarker panelEGFR, ALK, KRAS, ROS1, BRAF V600E, MET exon 14, NTRK1/2/3, RET, ERBB2 (HER2), MSI-H/dMMR are specified by the policy as relevant molecular biomarkers for determining eligibility (absence of sensitizing EGFR/ALK alterations required for NSCLC combination with chemotherapy; MSI-H/dMMR required for certain GI neoadjuvant uses)

Actionable exclusion for NSCLC first-lineNo sensitizing EGFR mutations or ALK genomic tumor aberrations for first-line NSCLC combination with durvalumab and chemotherapy is required per criteria

Other NSCLC molecular subsets addressedPolicy allows first-line or subsequent therapy for BRAF V600E, MET exon 14 skipping, NTRK1/2/3 fusions, RET rearrangements, ERBB2 mutations, and selected KRAS (including G12C) per regimen guidance

GI neoadjuvant requirementFor gastric/esophageal/esophagogastric adenocarcinoma neoadjuvant use, disease must be MSI-H or dMMR

Documentation expectationPrescriber must document molecular test results supporting biomarker status as part of authorization

MSI-H / dMMR (biomarker callout)

DefinitionMSI-H = microsatellite instability-high as listed in the policy's abbreviation key

Clinical requirementPolicy requires disease to be MSI-H for off-label neoadjuvant use in gastric, esophageal, or esophagogastric junction adenocarcinoma

Authorization implicationProvider attestation that member is medically fit for surgery is required when MSI-H/dMMR neoadjuvant use is requested

Coding and Product Information

Product availability/NDCNDC

NDC not listed

Product availability: single-dose vials 25 mg/1.25 mL and 300 mg/15 mL

Referenced HCPCS CodesHCPCS

J9347

Injection, tremelimumab-actl, 1 mg

Body weight decision point — 30 kg threshold for fixed vs weight-based dosing

Decision threshold30 kg is the weight cutpoint used to select weight-based versus fixed dosing for both NSCLC and uHCC regimens

<30 kg dosing implicationUse weight-based dosing (e.g., 1 mg/kg for NSCLC; 4 mg/kg single dose for uHCC) for patients under 30 kg

>=30 kg dosing implicationUse fixed-dose alternatives (e.g., 75 mg for NSCLC; 300 mg single dose for uHCC) for patients 30 kg or greater

Vial strengths — 25 mg/1.25 mL; 300 mg/15 mL

Available vial strengths25 mg/1.25 mL and 300 mg/15 mL are listed as single-dose vial presentations

Dosing correspondence300 mg vial corresponds to the fixed 300 mg dose used for patients >=30 kg in the uHCC single-dose regimen

Practical note25 mg strength supports preparation of weight-based doses (e.g., 1 mg/kg or 4 mg/kg) as specified in regimen guidelines

Product availability — single-dose vial presentations

PresentationProduct is supplied as single-dose vials per product availability section

Listed vial sizesSingle-dose vials available in 25 mg/1.25 mL and 300 mg/15 mL presentations

Billing implicationSingle-dose vial presentations may affect dosing preparation/administration and documentation for claims

Provider Actions and Billing Requirements

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization is required. Provider must demonstrate the member meets all approval criteria. Approval duration: 6 months for initial approval (or the plan’s standard injectable duration/to the member’s renewal date, whichever is longer, per line of business).

Approval duration: 6 months (initial)
Provider must demonstrate criteria met at time of request

Documentation Required

Documentation Requirement

Provider must submit documentation supporting that the member has met all approval criteria. Failure to submit required documentation may result in denial of the authorization request.

Required documentation may include office chart notes, laboratory results, imaging, pathology reports, operative notes, and prior treatment history.

Documentation Required

Required Clinical Documentation

Required clinical documentation includes office notes, relevant labs (e.g., MSI/MMR testing if applicable), pathology reports, imaging, treatment history, and any supporting peer‑reviewed literature or practice guidelines for off‑label uses. Provider attestation that the member is medically fit for any recommended procedures (e.g., surgery) may be required.

MSI‑H or dMMR testing results when required
Evidence supporting dosing/regimen for off‑label use (peer‑reviewed literature or guidelines)

Note

Formulary / Off‑Label Pathway

If the requested drug use is not on the formulary/PDL or the indication is not listed, follow the plan’s non‑formulary or off‑label use policies for the applicable line of business. Refer to the listed plan policies for specific processes and criteria.

Commercial non‑coverage/non‑formulary references: CP.CPA.190 (commercial)
Health Insurance Marketplace references: HIM.PA.33 / HIM.PA.103 / HIM.PA.154 as applicable
Medicaid references: CP.PMN.255 / CP.PMN.16 / CP.PMN.53 as applicable

Billing Rule

Attestation and Billing/Coding Requirements

Billing: Use HCPCS code J9347 (Injection, tremelimumab‑actl) on claims. Provider attestation and supporting clinical documentation may be required to validate coding and medical necessity. Coding or documentation deficiencies (including incorrect or missing HCPCS J9347 usage) may result in claim denial.

HCPCS: J9347 — Injection, tremelimumab‑actl
Include required clinical attestation/documentation with prior authorization submission and keep on file for claims support.

Definitions

EGFR definition

TermEGFR: epidermal growth factor receptor

Context in policyEGFR sensitizing mutations must be absent for NSCLC first-line combination with durvalumab and chemotherapy

Appendix referenceEGFR abbreviation appears in Appendix A: Abbreviation/Acronym Key

MSI-H definition

TermMSI-H: microsatellite instability-high

Clinical useMSI-H status is required for the policy's off-label neoadjuvant indication in gastric/esophageal cancers

SourceDefined in Appendix A: Abbreviation/Acronym Key

dMMR definition

TermdMMR: deficient mismatch repair

Clinical usedMMR disease satisfies the biomarker requirement for off-label neoadjuvant gastric/esophageal indications; provider attestation for surgical fitness is required

SourceDefined in Appendix A and referenced within the gastric/esophageal neoadjuvant criteria

uHCC definition

TermuHCC: unresectable hepatocellular carcinoma

Policy regimenPolicy covers tremelimumab single-dose (4 mg/kg or 300 mg if >=30 kg) with durvalumab followed by durvalumab maintenance for unresectable HCC

Approval notePrior authorization may be required for uHCC; approval duration noted as one dose/standard regimen per policy

NSCLC definition

TermNSCLC: non-small cell lung cancer

Policy roleNSCLC eligibility requires diagnosis of recurrent, advanced, or metastatic NSCLC and absence of sensitizing EGFR/ALK alterations for first-line combination use

Age requirementPolicy specifies patient age >= 18 years for NSCLC indications

NCCN compendium (definition/reference)

Reference compendiumNCCN Drugs and Biologics Compendium is cited as a referenced source for recommended uses and off-label indications in the policy

Guideline linkagePolicy requires regimens to be FDA-approved or recommended by NCCN (or prescriber must submit peer-reviewed evidence for off-label uses)

Specific NCCN guidelines referencedNCCN NSCLC, Hepatocellular Carcinoma, Gastric, and Esophageal guideline references are listed in policy references

Revision History

2024-10-22references_update

References and compendia citations (NCCN, Imjudo prescribing information) were reviewed and updated with sources accessed October 22, 2024.

2024-11-15annual_review

1Q 2024 annual review: added gastric, esophageal, and esophagogastric junction cancer to initial approval criteria for off-label NCCN‑recommended uses; removed inactive HCPCS codes and updated references.

2024-10-23annual_review

1Q 2025 annual review (noted in log): per NCCN compendium for NSCLC, added recommended uses for present and negative actionable molecular biomarkers and revised NCCN recommended uses section to include gastric, esophageal, and esophagogastric junction cancers.

2024-07-25continued_therapy_update

Revised continued therapy for uHCC to not permit re-authorization per the package insert.

2023-05-24coding_update

Added/updated HCPCS code J9347 for tremelimumab-actl in the policy's coding section.

2023-03-01effective_dateLatest

Policy effective date established.

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