CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kimmtrak (tebentafusp-tebn) coverage criteria

Defines accepted indications, contraindications, exclusion criteria, coding, applicable lines of business, and clinical/documentation expectations for coverage of Kimmtrak (tebentafusp-tebn), primarily for HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKimmtrak (tebentafusp-tebn) coverage criteria

Policy CodePolicy N/A

Change TypeRevised; Added coding

Effective DateN/A

Next Review DateN/A

Key ActionMedication requests must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1459 Kimmtrak guideline.

Added coding information section with HCPCS code J9274.

Added Evolent disclaimer language and references in January 2025.

1Covered Indications (listed)

1HCPCS drug code listed

68 mcgSingle dose maximum

Coverage Summary

Scope: Kimmtrak (tebentafusp-tebn) is covered with criteria for use as monotherapy in adult patients with HLA-A*02:01-positive unresectable or metastatic uveal melanoma. Coverage relies on the FDA-approved product labeling and evidence from CMS‑recognized compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards. The policy lists HCPCS code J9274 for billing (1 mcg units).

Medical Necessity / Exclusion Criteria

Initial / Medically Necessary criteria for Kimmtrak

Covered when ALL of the following are met:

ALL of the following

Indication: Adult member has unresectable or metastatic uveal melanoma.
Member is HLA-A*02:01-positive.
Use as monotherapy (not concurrently with other anti-cancer therapies).
Medication use is supported by one of: FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Continuation criteria (maintenance of prior authorization)

Continuation requests exempt from policy if ALL of the following are met:

ALL of the following

The member has not experienced disease progression while on the requested medication.
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

Exclusion / Not medically necessary criteria

Not covered when ANY of the following apply:

ANY of the following

Disease progression while on Kimmtrak (tebentafusp-tebn).
Dosing that exceeds single dose limit of 68 mcg.68 mcg
Concurrent use with other anti-cancer therapies.
Investigational use for an off-label indication lacking sufficient evidence or not generally accepted by the medical community.
- Examples of insufficient evidence considerations: Clinical characteristics of the patient and cancer not adequately represented in published evidence.

Safety/Monitoring requirements (boxed warning)

Warnings/monitoring required:

ALL of the following

Cytokine release syndrome (CRS) has occurred and may be serious or life-threatening.
Monitor patients for at least 16 hours following the first 3 infusions and then as clinically indicated.

Provider Actions & Requirements

Prior Authorization

Authorization requirement

Medication requests for tebentafusp-tebn must be processed and authorized by Evolent. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

J9274

Documentation Required

Clinical evidence support

Use must be supported by FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial conditions

Requests will be excluded or denied under any of the following conditions.

Disease progression while on therapy
Single dose exceeds 68 mcg
Concurrent use with other anti-cancer therapies
Investigational or off-label uses lacking sufficient evidence per policy

Documentation Required

Continuation authorization requirements

For continuation (renewal) requests, provide documentation that all continuation criteria are met.

Evidence that the member has not experienced disease progression while on the medication
Evidence the medication was used within the last year with no lapse greater than 30 days from an active authorization
No new medication(s) are being added to the continuation request

Documentation Required

Safety monitoring after initial infusions

Monitor patients for cytokine release syndrome (CRS) following initial infusions.

Monitor for at least 16 hours after each of the first three infusions and thereafter as clinically indicated

Background, Evidence & Definitions

Background: The guideline bases coverage decisions on the FDA labeling and recognized compendia/guidelines (CMS‑approved compendia, NCCN, ASCO, or peer‑reviewed literature meeting CMS Chapter 15). There is a US boxed warning for cytokine release syndrome (CRS); patients should be monitored for at least 16 hours after each of the first three infusions and then as clinically indicated. Exclusion criteria include disease progression on Kimmtrak, single-dose dosing that exceeds 68 mcg, and concurrent use with other anti-cancer therapies. The policy also excludes investigational or off-label uses that lack sufficient evidence as defined by the guideline. Coding information includes HCPCS code J9274 (injection, tebentafusp-tebn, 1 microgram).

Evidence	Reference
Key trial	IMCgp100-202 (Nathan P et al.), NEJM 2021 showing overall survival benefit in metastatic uveal melanoma
Prescribing information	Kimmtrak prescribing information, Immunocore Commercial LLC, 2024

Definitions: "Sufficient evidence" follows CMS compendia and Medicare Benefit Policy Manual Chapter 15 standards — evidence must be supported by CMS‑recognized compendia or acceptable peer‑reviewed literature, consider whether patient and regimen characteristics are represented, ensure regimen fidelity and appropriate study design, and demonstrate clinically meaningful outcomes (ASCO examples such as hazard ratio < 0.80 and at least a 3‑month OS/PFS benefit); case reports and meeting abstracts without full peer‑reviewed articles are generally insufficient.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKimmtrak (tebentafusp-tebn) coverage criteria

Policy CodePolicy N/A

Change TypeRevised; Added coding

Effective DateN/A

Next Review DateN/A

Key ActionMedication requests must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

On This Page

OpenPayer

Kimmtrak (tebentafusp-tebn) coverage criteria

Coverage Summary

Medical Necessity / Exclusion Criteria

Coding

Provider Actions & Requirements

Background, Evidence & Definitions

Revision History