CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Kimmtrak (tebentafusp-tebn)

Defines clinical and utilization management criteria for authorization of Kimmtrak (tebentafusp-tebn) for members, including indications, exclusions, coding, and review authority. Applies to utilization management and pharmacy specialty drug authorization processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Kimmtrak (tebentafusp-tebn)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

Key ActionObtain prior authorization and bill using HCPCS code J9274 when inclusion criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

HLA-A*02:01Biomarker required

68 mcgSingle dose limit

J9274HCPCS code

Metastatic/unresectableIndication scope

<30-day lapseContinuation rules

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Initial and Continuation Therapy

Covered when ALL of the following are met

Initial therapy for uveal melanoma: Member has HLA-A*02:01-positive unresectable or metastatic uveal melanoma

Kimmtrak (tebentafusp-tebn) may be used as monotherapy

Continuation therapy general rules: For continuation: member has not experienced disease progression on Kimmtrak; the medication was used within the last year without a lapse of more than 30 days of active authorization; no additional medications are being added to the continuation request

Continuation requests meeting these conditions are exempt from initial-therapy denial per policy

Coverage will be denied when any of the policy exclusion conditions are met. Key exclusions include: disease progression while on Kimmtrak (tebentafusp-tebn); dosing that exceeds the single dose limit of 68 mcg; and concurrent use with other anti-cancer therapies. Requests that involve investigational or off-label uses lacking sufficient evidence (per the policy’s evidentiary standards) are also excluded.

Use of Kimmtrak for indications not approved by the FDA or not supported by CMS-recognized compendia or acceptable peer-reviewed literature is not approvable. The policy defines sufficient evidence by criteria including adequate representation of the patient population and regimen in published studies, clinically meaningful outcomes (generally at least a 3-month benefit in OS or PFS), appropriate study design, and exclusion of uncontrolled evidence such as case reports or abstracts without full peer-reviewed publication.

Continuation Therapy

Continuation requests may be approved if all continuation conditions are met

Continuation conditions: Member has not experienced disease progression on the requested medication AND the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization AND additional medication(s) are not being added to the continuation request

Continuation exemption applies when these conditions are satisfied

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved when inclusion criteria are met and exclusion criteria are absent. Continuation requests for a medication previously authorized are exempt from new authorization when the member has not experienced disease progression on the medication, the medication was used within the last year without a lapse of >30 days from an active authorization, and no additional medications are being added to the continuation request.

Prior authorization required when inclusion criteria are met
Continuation requests exempt if no progression, ≤30 day lapse from prior authorization, and no new agents added

Documentation Required

Supporting Documentation Required

Supporting documentation must be provided with the request. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Include documentation of HLA-A*02:01 test results for uveal melanoma patients, clinical records showing diagnosis and disease status, prior authorization history (if continuation), and dosing details.

Acceptable evidence: FDA labeling; CMS compendia; NCCN or ASCO guidelines; peer-reviewed literature meeting CMS manual Chapter 15
Include HLA-A*02:01 test result for uveal melanoma
Include prior authorization history and dosing details

Step Therapy

There is no step therapy sequence required for initiation of Kimmtrak beyond meeting the stated inclusion criteria; members meeting criteria may be considered for therapy without prior trial of alternative agents.

No step therapy requirements specified

Denial Risk

Common Denial Triggers

Common reasons for denial include evidence of disease progression while on Kimmtrak, requests for dosing exceeding the single‑dose limit of 68 mcg, concurrent use with other anti‑cancer therapies, investigational or off‑label uses lacking sufficient evidence (not supported by CMS compendia or acceptable peer‑reviewed literature), incomplete supporting documentation (including missing HLA‑A*02:01 status), or failure to meet continuation-request conditions.

Denial triggers: documented disease progression on Kimmtrak
Denial triggers: requested single dose >68 mcg
Denial triggers: concurrent use with other anti‑cancer therapies
Denial triggers: off‑label/ investigational use without sufficient CMS‑recognized evidence
Denial triggers: missing HLA‑A*02:01 documentation or other required clinical records

Background

Kimmtrak (tebentafusp-tebn) is a biologic immunotherapy indicated for HLA-A*02:01-positive unresectable or metastatic uveal melanoma. The agent demonstrated an overall survival benefit in pivotal studies (IMCgp100-202) and must be used in accordance with FDA labeling and supporting oncology literature. Prior authorization and billing use HCPCS code J9274 (Injection, tebentafusp-tebn, 1 microgram). Continuation may be approved when the member has not experienced disease progression on Kimmtrak and there has been no lapse of more than 30 days in active authorization.

OpenPayer

Drug Policy: Kimmtrak (tebentafusp-tebn)

Coverage Criteria for Kimmtrak (tebentafusp-tebn)

Initial Therapy

Continuation Therapy

Billing and Coding

Provider Actions and Requirements

Site of Care

Definitions

Background