Neighborhood Health Plan RI Imjudo Coverage Update

Coverage Criteria for Imjudo (tremelimumab)

Hepatocellular Carcinoma (HCC) - Initial Therapy

Covered when ALL of the following are met for Hepatocellular Carcinoma (HCC):

HCC eligibility: Member has unresectable hepatocellular carcinoma (Child-Pugh Class A and/or BCLC stage B or C) with no prior systemic treatment, including prior checkpoint inhibitor.

Treatment regimen: Imjudo (tremelimumab) will be used for one cycle as first-line therapy in combination with Imfinzi (durvalumab), followed by continuation of Imfinzi (durvalumab).

Single cycle of Imjudo only as part of the tremelimumab + durvalumab regimen.

Non-Small Cell Lung Cancer (NSCLC) - Initial Therapy

Covered when ALL of the following are met for Non‑Small Cell Lung Cancer (NSCLC):

NSCLC eligibility: Member has not received prior systemic therapy for recurrent/metastatic or Stage IV NSCLC AND tumor is negative for EGFR and ALK (coverage regardless of PD-L1 expression).

Treatment regimen and dose limits: Imjudo (tremelimumab) will be used as first-line therapy in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for up to 4 cycles, followed by maintenance durvalumab with one additional dose of Imjudo (tremelimumab).Maximum of 5 total doses of Imjudo (tremelimumab)

Indication	Regimen	Line of therapy	Dose limits / notes
Unresectable hepatocellular carcinoma (Child‑Pugh Class A and/or BCLC stage B or C) with no prior systemic therapy
One cycle of tremelimumab (Imjudo) in combination with durvalumab (Imfinzi), then continuation with durvalumab
First‑line
Single one‑time cycle of Imjudo only as part of the tremelimumab + durvalumab regimen; no prior checkpoint inhibitor

Indication	Regimen	Line of therapy	Dose limits / notes
Recurrent/metastatic or Stage IV non‑small cell lung cancer (NSCLC) with no prior systemic therapy; tumor negative for EGFR and ALK (coverage regardless of PD‑L1)
Tremelimumab (Imjudo) with durvalumab (Imfinzi) plus platinum‑based chemotherapy for up to 4 cycles, followed by maintenance durvalumab with one additional dose of tremelimumab; optional pemetrexed per histology
First‑line
Maximum of 5 total doses of Imjudo (tremelimumab); Imjudo given for up to 4 induction cycles with 1 additional maintenance dose as described

Requests for Imjudo (tremelimumab) will be excluded when the proposed use is investigational or an off‑label indication lacking sufficient evidence. Sufficient evidence is defined by lack of support in CMS‑recognized compendia or acceptable peer‑reviewed literature and includes situations where the clinical characteristics of the patient or the cancer are not adequately represented in the published evidence, the regimen evaluated is not comparable to the regimen requested, reported outcomes are not clinically meaningful, or the evidence is limited to uncontrolled case reports or meeting abstracts without full peer‑reviewed publication.

When determining whether an off‑label use is supported, reviewers will consider the study design, subject numbers, applicability of outcomes (for example, ASCO thresholds such as a hazard ratio < 0.80 or survival benefit of at least 3 months for OS/PFS), and whether nonrandomized trials provide adequate supportive evidence. Uses relying primarily on anecdotal case reports or abstracts without full articles will generally be considered insufficient.

Coverage is not allowed for members who demonstrate disease progression while receiving Imjudo or who have previously received a checkpoint inhibitor (examples: dostarlimab‑gxly, atezolizumab, nivolumab, pembrolizumab, ipilimumab). Such clinical histories are exclusionary and will result in denial of the request.

Requests will be excluded when proposed dosing exceeds the policy’s single‑dose or total dose limits for the specified indications. For Hepatocellular Carcinoma (HCC), treatment that exceeds a single dose of 300 mg for weight ≥30 kg or 4 mg/kg for weight <30 kg, or that exceeds the one‑time administration allowance, is excluded. For Non‑Small Cell Lung Cancer (NSCLC), dosing that exceeds a single dose of 75 mg for weight ≥30 kg or 1 mg/kg for weight <30 kg, or that exceeds the maximum of 5 total doses, is excluded.

An investigational or off‑label use is defined as any indication or regimen for Imjudo (tremelimumab) that is not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Evaluation of evidence sufficiency will consider whether the patient and regimen are represented in published studies, whether outcomes are clinically meaningful (for example using ASCO recommended thresholds), the appropriateness of study design for the question, and whether evidence is limited to nonrandomized trials, case reports, or abstracts without full peer‑reviewed publication.

Uses that do not meet these evidence standards are considered not medically necessary and will be excluded from coverage.

Coding and Dose Limits

Covered HCPCS CodesHCPCSCovered

J9347

Injection, tremelimumab-actl, 1 mg

Imjudo single-dose limits — HCC and NSCLC per weight-based and fixed-dose rules

HCC — weight ≥30 kgSingle-dose limit 300 mg per dose

HCC — weight <30 kgSingle-dose limit 4 mg/kg per dose

NSCLC — weight ≥30 kgSingle-dose limit 75 mg per dose

NSCLC — weight <30 kgSingle-dose limit 1 mg/kg per dose

Maximum total doses — NSCLC max 5 doses; HCC single one-time dose only

NSCLC — maximum total dosesMaximum of 5 total doses of Imjudo (tremelimumab)

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required; Evolent processes requests

Prior authorization is required for Imjudo (tremelimumab) and all medication requests are processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

HCPCS code J9347 applies to tremelimumab, 1 mg (see coding).

Step Therapy

Continuation (renewal) exemption conditions

Continuation (renewal) requests may be exempt from prior authorization requirements only if all of the following are met: no disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request.

If any of the three conditions are not met, a new prior authorization must be submitted to Evolent.

Regimens and Administration

Indication	Regimen details	Eligibility / requirements
Unresectable hepatocellular carcinoma (Child‑Pugh Class A and/or BCLC stage B or C) with no prior systemic treatment
One cycle of tremelimumab (Imjudo) in combination with durvalumab (Imfinzi), then continuation with durvalumab
Member must have no prior systemic therapy including prior checkpoint inhibitors; tremelimumab limited to a single cycle as part of this regimen

Indication	Regimen details	Eligibility / requirements
Recurrent/metastatic or Stage IV NSCLC; no prior systemic therapy; tumor negative for EGFR and ALK (PD‑L1 not required)
Tremelimumab (Imjudo) combined with durvalumab (Imfinzi) and platinum‑based chemotherapy for up to 4 cycles (induction), followed by maintenance durvalumab with one additional dose of tremelimumab; pemetrexed may be used per histology
Maximum of 5 total tremelimumab doses (up to 4 during induction plus 1 maintenance); first‑line use only; no prior systemic therapy

Key Definitions

Child-Pugh score — Class A/B/C numeric ranges

Child-Pugh Class A5–6 points

Child-Pugh Class B7–9 points

Child-Pugh Class C10–15 points

BCLC staging — Barcelona Clinic Liver Cancer staging referenced for HCC eligibility

BCLC referenceBarcelona Clinic Liver Cancer (BCLC) staging system is referenced for HCC eligibility

Eligible stages for unresectable HCCBCLC stage B or C

Staging components

Line of Therapy

first-line — HCC first-line nodal criteria (top-level node)

first-line: First-line therapy: one cycle of Imjudo (tremelimumab) in combination with durvalumab (Imfinzi) followed by durvalumab continuation; no prior systemic treatment including prior checkpoint inhibitor.

first-line — NSCLC first-line nodal criteria (top-level node)

first-line: First-line therapy for recurrent/metastatic or Stage IV NSCLC: Imjudo (tremelimumab) combined with durvalumab (Imfinzi) and platinum-based chemotherapy; no prior systemic therapy.

Biomarker Requirements

EGFR, ALK — tumor must be negative for EGFR and ALK

EGFR status requirementTumor must be negative for EGFR

ALK status requirementTumor must be negative for ALK

Indication contextRequired for NSCLC first-line eligibility (no prior systemic therapy)

PD-L1 — PD-L1 testing not required for coverage

PD-L1 testingNot required for coverage; eligibility is regardless of PD-L1 expression

ContextApplies to NSCLC first-line regimen combined with durvalumab and chemotherapy

Background

Imjudo (tremelimumab) is an immune checkpoint inhibitor used in combination regimens, most notably with durvalumab (Imfinzi). It is authorized by this policy as a one‑cycle tremelimumab administration in combination with durvalumab for unresectable hepatocellular carcinoma (followed by durvalumab continuation) and as part of a first‑line regimen for metastatic or Stage IV non‑small cell lung cancer when given with durvalumab and platinum‑based chemotherapy (with up to 5 total tremelimumab doses permitted).

OpenPayer

Imjudo (tremelimumab) — Coverage Criteria (Hepatocellular Carcinoma; Non‑Small Cell Lung Cancer)