CurrentEmblemHealthPolicy MG.MM.PH.353

Kimmtrak (tebentafusp-tebn) intravenous infusion

Clinical coverage criteria for Kimmtrak (tebentafusp-tebn) for treatment of adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma, including dosing, authorization length, and coding for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyKimmtrak (tebentafusp-tebn) intravenous infusion

Policy CodePolicy MG.MM.PH.353

Change TypeAnnual review — non-material code updates

Effective DateN/A

Next Review DateN/A

Key ActionTreating provider must submit clinical evidence that the member meets the policy criteria to EmblemHealth for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

Updated dosing limits, updated ICD-10 Codes. No criteria changes.

Added code: J9274; Removed codes: C9399 and J9999.

12 monthsLength of authorization

68 mcgMax single dose (weekly)

400 unitsMax HCPCS units/28d

J9274Applicable HCPCS code

Coverage Criteria for Kimmtrak (tebentafusp-tebn)

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Initial Therapy

Covered when ALL of the following are met

Uveal Melanoma Initial Criteria: A. Patient is >= 18 years of age; AND B. Patient has unresectable or metastatic disease; AND C. The tumor is HLA-A*02:01 positive; AND D. Prescribed by or in consultation with an Oncologist.

Renewal Therapy

Renewal criteria — ALL required

Renewal Criteria: 1. Member is responding positively to therapy, as determined by the prescriber; AND 2. Member has not experienced unacceptable toxicity from the drug

Coverage for Kimmtrak (tebentafusp‑tebn) is limited to treatment of adults with HLA‑A*02:01‑positive unresectable or metastatic uveal melanoma. Authorization requires documentation that the patient meets the policy’s age and disease status criteria and that the prescribing clinician is an oncologist or consulted with an oncologist.

Use of Kimmtrak for indications other than HLA‑A*02:01‑positive unresectable or metastatic uveal melanoma is not supported by this policy.

Regimen	Monitoring / Setting	Treatment Duration
Dose escalation: 20 mcg IV on Day 1; 30 mcg IV on Day 8; 68 mcg IV on Day 15	Administer first 3 infusions in an appropriate healthcare setting by IV infusion over 15–20 minutes; monitor during infusion and for at least 16 hours after completion	Continue weekly 68 mcg IV dosing until unacceptable toxicity or disease progression
Ongoing maintenance: 68 mcg IV once weekly after Day 15	Same monitoring as above for initial doses; clinician judgment for ongoing monitoring	Continue until unacceptable toxicity or disease progression

Dosing, Administration, and Limits

Dose / Schedule	Frequency	Monitoring / Administration Notes
20 mcg IV (Day 1) → 30 mcg IV (Day 8) → 68 mcg IV (Day 15) escalation	Single administration per listed day during escalation	First 3 infusions given in appropriate healthcare setting; monitor during infusion and for at least 16 hours post-infusion
68 mcg IV	Once weekly thereafter	Administer no more frequently than once weekly; approve up to 68 mcg per infusion

HCPCS units per 28 days — max billable units

Maximum billable units400 billable units every 28 days

Unit definitionHCPCS unit corresponds to 1 mcg of tebentafusp-tebn (per J9274) as listed in coding

Billing periodMeasured per 28-day period

Billing Codes and Diagnosis Codes

Applicable CPT/HCPCS CodesHCPCSCovered

J9274

Injection, tebentafusp-tebn, 1 mcg; 1 billable unit = 1 mcg

Applicable NDCsNDCCovered

80446-0401-01

Kimmtrak 100 mcg/0.5 mL, single dose vial

Applicable ICD-10 DiagnosesICD-10

C69.30	Malignant neoplasm of unspecified choroid
C69.31	Malignant neoplasm of right choroid
C69.32	Malignant neoplasm of left choroid
C69.40	Malignant neoplasm of unspecified ciliary body
C69.41	Malignant neoplasm of right ciliary body
C69.42	Malignant neoplasm of left ciliary body
C69.60	Malignant neoplasm of unspecified orbit
C69.61	Malignant neoplasm of right orbit
C69.62	Malignant neoplasm of left orbit
C69.90	Malignant neoplasm of unspecified site of unspecified eye

1–10 of 15

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Provider Responsibilities and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. The treating provider must demonstrate the member meets all clinical criteria for tebentafusp (including age ≥18, unresectable or metastatic uveal melanoma, HLA-A*02:01 positive, and prescription by or in consultation with an oncologist).

Patient is ≥ 18 years of age
Unresectable or metastatic uveal melanoma
Tumor is HLA-A*02:01 positive
Prescribed by or in consultation with an Oncologist
Applicable HCPCS: J9274 (tebentafusp-tebn), 1 mcg; 1 billable unit = 1 mcg

Documentation Required

Clinical Evidence Submission and Documentation Requirement

The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria for preauthorization or for post-payment review. Without this documentation, EmblemHealth will be unable to properly review the request and may deny the request.

Submit relevant clinical records, diagnostic test results (including HLA-A*02:01 testing), staging information, and oncology consultation notes.
Failure to provide required documentation may prevent review or result in denial.

Note

Additional Provider Actions

Ensure all authorization requests are submitted by the prescribing oncologist or include documentation of consultation with an oncologist. Include drug-specific coding to support billing.

Include the applicable procedure code: J9274 for tebentafusp-tebn (1 mcg = 1 billable unit).
Attach oncology consultation note if prescribed by non-oncologist.

Drug and Safety Definitions

Kimmtrak (tebentafusp-tebn) — drug description

Drug name (generic)tebentafusp-tebn

Brand nameKimmtrak

Mechanism of actionBispecific gp100 peptide–HLA–directed T cell receptor CD3 T cell engager

IndicationTreatment of adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma

Safety — boxed warning for cytokine release syndrome

Boxed warningBoxed Warning for cytokine release syndrome which may be serious or life-threatening

Clinical implicationPatients require monitoring for CRS during and after infusion per prescribing information

SeverityCRS may be serious or life-threatening

Background and Clinical Context

Kimmtrak is a bispecific gp100 peptide–HLA–directed T‑cell receptor CD3 T‑cell engager indicated for adults with HLA‑A*02:01‑positive unresectable or metastatic uveal melanoma. The agent’s mechanism engages T cells via a gp100 peptide presented by HLA‑A*02:01 to direct cytotoxic activity against tumor cells. Kimmtrak carries a Boxed Warning for cytokine release syndrome. Initial dosing includes an escalation sequence (20 mcg IV Day 1, 30 mcg IV Day 8, 68 mcg IV Day 15) followed by weekly 68 mcg IV maintenance; the first three infusions should be given in an appropriate healthcare setting with monitoring during and for at least 16 hours after infusion.

Policy Revision History

2025-03-26annual_reviewLatest

Annual review updated dosing limits and ICD-10 codes; no coverage criteria changes.

2024-02-14annual_review

Annual review conducted; no coverage criteria changes.

2023-06-14code_update

Removed codes C9399 and J9999; added code J9274; removed ICD-10 codes C69.90, C69.91 and C69.92.

2022-05-12policy_creation

Policy established (New Policy).