Kimmtrak (tebentafusp-tebn)
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Clinical criteria governing prior authorization and medical necessity determinations for Kimmtrak (tebentafusp-tebn) for treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma under the medical benefit.
No material clinical or coverage changes in this revision.
Coverage Criteria
Approval criteria
Requests for Kimmtrak (tebentafusp-tebn) may be approved if the following criteria are met:
Listed as an approval pathway
Matches FDA label and NCCN 1
Requests may not be approved when the criteria above are not met and for all other indications.
Initial Therapy Criteria
Initial therapy criteria
Initial approval criteria
Pediatric approval listed
Per label and NCCN
Coding
| J9274 | Injection, tebentafusp-tebn, 1 microgram [Kimmtrak] |
| C69.30-C69.32 | Malignant neoplasm of choroid |
| C69.40-C69.42 | Malignant neoplasm of ciliary body |
| C69.60-C69.62 | Malignant neoplasm of orbit |
Provider Actions & Requirements
Prior Authorization Required
Prior authorization is required for Kimmtrak (tebentafusp-tebn). Requests will be considered only when the clinical criteria in the policy are met (age, diagnosis of unresectable or metastatic uveal melanoma, HLA-A*02:01 positive genotype, and ECOG performance status 0-1).
- Policy number: CC-0211
- Drug: Kimmtrak (tebentafusp-tebn)
Step Therapy
No step therapy or prior conventional therapy is required for Kimmtrak under this policy.
Required Documentation
Documentation must support: diagnosis of unresectable or metastatic uveal melanoma; positive HLA-A*02:01 genotype; ECOG performance status 0-1; and patient age consistent with policy criteria.
- Include pathology/imaging or clinical notes confirming unresectable or metastatic uveal melanoma
- Laboratory/genetic report confirming HLA-A*02:01 positivity
- Clinical notes documenting ECOG performance status (0-1)
- Documentation of patient age
Denial Triggers
Requests may be denied when required criteria or documentation are missing or do not meet the policy (e.g., diagnosis not unresectable/metastatic uveal melanoma; HLA-A*02:01 negative or unknown; ECOG >1; age outside criteria).
Site of Care
No site-of-care restrictions specified
The policy does not impose any specific site-of-care or infusion center restrictions for administration of Kimmtrak.
Step Therapy
| Step | Requirement |
|---|---|
| {"text":"1","status":""},{"text":"No step therapy requirements or prior conventional therapy requirements are specified in this policy.","status":""} |
Background
Kimmtrak (tebentafusp-tebn) is a bispecific gp100 peptide–HLA-directed CD3 T cell engager indicated for treatment of HLA-A*02:01–positive adult patients with unresectable or metastatic uveal melanoma. The agent carries a boxed warning for cytokine release syndrome, which can be serious or life‑threatening; clinicians and infusion centers should be prepared to monitor and manage CRS per established protocols. Prior authorization is required and approval is contingent on meeting the policy’s clinical criteria (diagnosis of unresectable or metastatic uveal melanoma, documented HLA‑A*02:01 positivity, and ECOG performance status 0-1), with a pediatric approval pathway for individuals under 19 years of age noted separately.
Definitions
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