Tebentafusp-tebn (Kimmtrak) Form

Tebentafusp-tebn (Kimmtrak®) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.
FDA Approved Indication(s) Kimmtrak is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Kimmtrak is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Uveal Melanoma (must meet all):

1. Diagnosis of unresectable or metastatic uveal melanoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is HLA-A*02:01-positive;
   5. Request meets one of the following (a or b): a. Dose does not exceed 20 mcg (1 vial) on Day 1, 30 mcg (1 vial) on Day 8, 68 mcg (1 vial) on Day 15, and 68 mcg (1 vial) weekly thereafter; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
      Approval duration: 6 months
      B. Other diagnoses/indications (must meet 1 or 2):

2. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Tebentafusp-tebn b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

3. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Uveal Melanoma (must meet all):
4. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Kimmtrak for a covered indication and has received this medication for at least 30 days;
5. Member is responding positively to therapy;
   3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 68 mcg (1 vial) weekly; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months
      B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
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   CLINICAL POLICY Tebentafusp-tebn IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CRS: cytokine release syndrome FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable.
   Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s): cytokine release syndrome (CRS) V. Dosage and Administration
   Indication Uveal melanoma 20 mcg on Day 1, 30 mcg on Day 8, 68 mcg on Dosing Regimen Maximum Dose 68 mcg /week Day 15, then 68 mcg once every week thereafter
   VI. Product Availability
   Injection in vial: 100 mcg/0.5 mL VII.