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 reviews; coding 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.

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

Coverage Summary

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.