CurrentHealth NetPolicy CP PHAR.575

Tebentafusp-tebn (Kimmtrak) coverage and coding implications

Defines medical necessity criteria, prior authorization and coding guidance for tebentafusp-tebn (Kimmtrak) for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma across Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyTebentafusp-tebn (Kimmtrak) coverage and coding implications

Policy CodePolicy CP PHAR.575

Change TypeNo material change

Effective DateJun 1, 2022

Next Review Date

Key ActionObtain prior authorization demonstrating criteria are met, including diagnosis, HLA-A*02:01 positivity, oncology involvement, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9274HCPCS code

6 monthsInitial approval

12 monthsContinued approval

100 mcgPresentation

Coverage Criteria for Tebentafusp-tebn (Kimmtrak)

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Initial Approval for Kimmtrak: Member has a diagnosis of unresectable or metastatic uveal melanoma; age > 18 years; prescribed by or in consultation with an oncologist; disease is HLA-A*02:01-positive; requested dose does not exceed the induction and maintenance dosing schedule (20 mcg on day 1, 30 mcg on day 8, 68 mcg on day 15 and 68 mcg weekly thereafter); prescribed regimen is FDA-approved or recommended by NCCN; if an off-label dose is requested, the dose must be supported by practice guidelines or peer-reviewed literature with prescriber submission of supporting evidence.

inv-02: Continuation Therapy

Covered for continued therapy when ALL of the following are met

Continued Therapy for Kimmtrak: Member is currently receiving Kimmtrak via the benefit or documentation supports current receipt for a covered indication for at least 30 days; member is responding positively to therapy; new or continued dose does not exceed 68 mcg weekly; if a dose increase is requested, the new dose must be supported by practice guidelines or peer-reviewed literature with prescriber submission of supporting evidence; prescribed regimen is FDA-approved or recommended by NCCN.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CPCPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Initial Therapy — Approval Criteria and Dosing

inv-13: Initial Therapy

Initial approval criteria and dosing

Initial Therapy: Diagnosis of unresectable or metastatic uveal melanoma; age >18 years; prescribed by or with an oncologist; disease confirmed HLA-A*02:01-positive; dosing follows induction schedule (20 mcg on day 1, 30 mcg on day 8, 68 mcg on day 15) with maintenance 68 mcg weekly thereafter; prescribed regimen must be FDA-approved or recommended by NCCN; any off-label dosing requires supporting practice guidelines or peer-reviewed literature with prescriber evidence submission.

Approval duration: 6 months

Continuation Therapy — Requirements for Continued Coverage

inv-14: Continuation Therapy

Requirements for continued coverage

Continuation: Member has received Kimmtrak for at least 30 days or is currently receiving Kimmtrak via the benefit; there is evidence of positive clinical response to therapy; continued or requested dose does not exceed 68 mcg weekly; requests for dose increases must be supported by practice guidelines or peer-reviewed literature with prescriber evidence submission; prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate that all approval criteria are met for the requested indication (e.g., diagnosis of unresectable or metastatic uveal melanoma, HLA-A*02:01 positivity, prescribed by or in consultation with an oncologist, member age > 18, and requested dosing within policy limits). Prescribers should allow time for prior authorization review and submit all required documentation at time of request.

Affected policy number: CP PHAR.575
Approval duration: Initial 6 months; Continued therapy 12 months
Prescribed regimen must be FDA‑approved or recommended by NCCN

Denial Risk

Non‑FDA Indication Denial Risk

Requests for non‑FDA approved indications (off‑label uses) may be denied unless the provider submits sufficient documentation of efficacy and safety per the applicable off‑label use policy for the member's line of business. Refer to CP.CPA.190 (commercial), HIM.PA.154 (marketplace) and CP.PMN.53 (Medicaid) as applicable for off‑label review requirements.

Non‑FDA indications require supporting evidence (practice guidelines or peer‑reviewed literature).
If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized), follow off‑label policy routing.

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, pathology and testing reports, and other clinical information) supporting that the member has met all approval criteria. For example, documentation must include diagnosis details, HLA‑A*02:01 test results, oncologist involvement (prescribing or consultation), prior treatment history, response to therapy for continuation requests, and any literature or guideline citations when seeking coverage for an off‑label dose or regimen.

Include HLA‑A*02:01 test result when applicable
Include physician notes confirming oncologist prescribing or consultation
For continuation: documentation of at least 30 days of therapy and positive response
For dose increases or off‑label dosing: submit supporting practice guideline or peer‑reviewed literature

Note

Formulary / Off‑Label Routing

Formulary and non‑formulary routing: If the drug or requested use is on the formulary/PDL, follow the applicable line‑of‑business coverage and no‑coverage criteria policies (CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP.PMN.255 for Medicaid). For drugs not on the formulary/PDL, route to the non‑formulary policies (CP.CPA.190 commercial, HIM.PA.103 marketplace, CP.PMN.16 Medicaid). If there has been a recent label change within the past 6 months not yet reflected in this policy, refer to the referenced formulary/off‑label policies for routing.

Commercial formulary/no‑coverage: CP.CPA.190
Marketplace formulary/no‑coverage: HIM.PA.33 (or HIM.PA.103 for non‑formulary routing)
Medicaid PDL/no‑coverage: CP.PMN.255 (or CP.PMN.16 for non‑formulary routing)
Recent label changes (≤ 6 months) may require referral to updated formulary/off‑label guidance

Step Therapy / Routing Rules

Step	Routing requirement
1	If the drug is on the formulary (commercial, health insurance marketplace) or on the PDL (Medicaid), follow the no-coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, CP PMN.255 for Medicaid); if the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the same formulary/no-coverage policies.
2	If the drug is NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), follow the non‑formulary policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, CP PMN.16 for Medicaid).
3	If the requested use (diagnosis, age, dosing regimen) is not listed in the policy’s exclusions and the formulary/non‑formulary routing above does not apply, refer to the off‑label use policy for the relevant line of business (including CP PMN.53 for Medicaid).

Background

Kimmtrak (tebentafusp‑tebn) is a bispecific gp100 peptide–HLA‑directed CD3 T cell engager indicated for HLA‑A*02:01‑positive adults with unresectable or metastatic uveal melanoma. Prescribers should note the drug carries a boxed warning for cytokine release syndrome (CRS). Dosing includes an induction schedule of 20 mcg on day 1, 30 mcg on day 8, and 68 mcg on day 15, with 68 mcg weekly maintenance thereafter; the product is supplied as a 100 mcg/0.5 mL vial.