CurrentAnthemPolicy CC-0211

Medical Drug Clinical Criteria

Clinical criteria for medical-benefit coverage (prior authorization) of Kimmtrak (tebentafusp-tebn) for adult patients with unresectable or metastatic uveal melanoma who are HLA-A*02:01 positive. Includes HCPCS billing code and applicable ICD-10 diagnosis ranges; documents review history.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria

Policy CodePolicy CC-0211

Change TypeAnnual reviewscoding updates

Effective DateJul 1, 2022

Next Review Date

Key ActionRequests for Kimmtrak are subject to clinical review and may be approved when all listed criteria (age >=18, unresectable/metastatic uveal melanoma, HLA-A*02:01 positive, ECOG 0-1) are met; otherwise request may be denied.

SourceLink

POLICY UPDATE CHANGES

02/21/2025 - Annual Review: No criteria changes. Coding Reviewed: Removed ICD-10-CM C69.50-C69.52 from range C69.30-C69.62 and updated descriptions.

02/23/2024 - Annual Review: No criteria changes. Added references. Coding Reviewed: No changes.

02/25/2022 - New document for Kimmtrak clinical criteria established; HCPCS and ICD-10 coding updates over 2022 effective dates noted.

1Covered Indication (uveal melanoma)

4ICD-10 code ranges listed

1HCPCS code listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Background: Kimmtrak (tebentafusp-tebn) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. The NCCN provides a Category 1 rating for this FDA indication. The agent carries a black box warning for cytokine release syndrome (CRS).

Scope summary: Coverage stance: covered_with_criteria. Effective date: 2022-07-01. Last review date: 2025-02-21. This policy establishes clinical prior authorization criteria for medical-benefit coverage of Kimmtrak for adults (age >= 18 years) with unresectable or metastatic uveal melanoma who are HLA-A*02:01-positive and meet performance status requirements.

Coverage / Approval Criteria

Requests for Kimmtrak (tebentafusp-tebn) may be approved if the following criteria are met (Label, NCCN 1, NCT04960891):

Age: Individual is 18 years of age or older>= 18 years
Diagnosis: Individual has a diagnosis of unresectable or metastatic uveal melanoma
Unresectable = unable to be removed with surgery; metastatic = spread of cancer
Genotype: Individual is using Kimmtrak for the treatment of HLA-A*02:01 positive genotype uveal melanomaHLA-A*02:01 positive
Performance status: Individual has an ECOG performance status of 0-1ECOG 0-1

Not Approved

Requests for Kimmtrak (tebentafusp-tebn) may not be approved when the approval criteria are not met and for other indications.

Failure to meet approval criteria: Any of the approval criteria (age >=18, unresectable or metastatic uveal melanoma diagnosis, HLA-A*02:01 positive, ECOG 0-1) not met
Other indications: Use for indications other than unresectable or metastatic HLA-A*02:01-positive uveal melanoma

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required per medical benefit review

Requests for Kimmtrak are subject to clinical review and may be approved when all listed criteria are met (age ≥18, unresectable or metastatic uveal melanoma, HLA-A*02:01 positive genotype, ECOG performance status 0-1). Requests that do not meet these criteria may be denied.

J9274

Documentation Required

Document HLA genotype and ECOG status

Provider must document HLA-A*02:01 positive genotype and ECOG performance status 0-1 in the medical record to support approval.

Denial Risk

Denial risk for non-indicated use

Claims may not be approved for indications other than unresectable or metastatic HLA-A*02:01–positive uveal melanoma, or when any of the approval criteria (age ≥18, diagnosis, HLA-A*02:01 positive, ECOG 0-1) are not met.

Clinical Evidence

Evidence summary: The NCCN assigns a Category 1 rating for Kimmtrak in uveal melanoma. Key published evidence includes Nathan et al., N Engl J Med 2021;385:1196-1206, which demonstrated an overall survival benefit with tebentafusp in metastatic uveal melanoma. A referenced clinical trial is NCT04960891.

Safety note: Kimmtrak carries a black box warning for cytokine release syndrome (CRS), which may be serious or life-threatening and occurred in patients receiving the drug.

Background & Definitions

Background and mechanism: Kimmtrak (tebentafusp-tebn) is a bispecific gp100 peptide‑HLA‑directed CD3 T cell engager designed to direct T cells to gp100-expressing uveal melanoma cells in the context of HLA‑A*02:01. Indication: for HLA‑A*02:01‑positive adult patients with unresectable or metastatic uveal melanoma. High-level safety: includes a black box warning for cytokine release syndrome (CRS), which can be serious or life‑threatening.

definitions:["Unresectable: Unable to be removed with surgery.","Metastasis: The spread of cancer from one part of the body to another.","Melanoma: A type of cancer that begins in the melanocytes (malignant melanoma)."]

Revision History

02/25/2022added

Initial policy creation and coding additions, including addition of HCPCS J9274 effective 10/01/2022 and overall effective date 07/01/2022.

02/23/2024revised

Annual review: references updated; no clinical or coding changes.

02/21/2025revisedLatest

Annual review: no clinical criteria changes. Coding reviewed and ICD-10-CM range updated by removing C69.50-C69.52 from C69.30-C69.62 and descriptions updated.