Medicare Advantage

Medical Policy

Title:

Tebentafusp-tebn (Kimmtrak®)

Policy #:

MA08.143b

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Tebentafusp-tebn (Kimmtrak®) is considered medically necessary and, therefore, covered as a first-line treatment for the treatment of HLA-A*02:01--positive uveal melanoma in adult individuals when both of the following criteria are met:

The individual has unresectable or metastatic uveal melanoma.
The individual did not receive prior systemic therapy for metastatic or advanced uveal melanoma or localized liver-directed therapy.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for tebentafusp-tebn (Kimmtrak®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

An Individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

When coverage of tebentafusp-tebn (Kimmtrak®) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.

Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

ECOG Performance Status
Grade	ECOG
0	Fully active, able to carry on all pre-disease performance without restriction
1	Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work)
2	Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3	Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4	Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5	Dead

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

DRUG INFORMATION

In accordance with US Food and Drug Administration (FDA) prescribing information, tebentafusp-tebn (Kimmtrak®) is administered 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week thereafter.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, tebentafusp-tebn (Kimmtrak®) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Tebentafusp-tebn (Kimmtrak®) a bispecific gp100 peptide-HLA-directed CD3 T cell engager, was approved by the FDA on January 25, 2022, for the treatment of HLA-A*02:01--positive adult individuals with unresectable or metastatic uveal melanoma.

PEDIATRIC USE

The safety and effectiveness of tebentafusp-tebn (Kimmtrak®) for the treatment of HLA-A*02:01--positive unresectable or metastatic uveal melanoma have not been established in pediatric individuals.

Description

Tebentafusp-tebn (Kimmtrak®) is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLAA*02:01) on the cell surface of uveal melanoma tumor cells. Tebentafusp-tebn is produced by recombinant DNA technology in Escherichia coli cells.

Tebentafusp-tebn (Kimmtrak®) was evaluated in IMCgp100-202, a randomized, open-label, multicenter trial (NCT03070392) as first-line therapy for metastatic uveal melanoma for individuals with metastatic uveal melanoma. The study enrolled (N=378) individuals who were HLA-A*02:01 genotype--positive identified by a central assay. Individuals were excluded if they received prior systemic therapy for metastatic or advanced uveal melanoma or localized liver-directed therapy.

Individuals were randomized (2:1) to receive tebentafusp-tebn (Kimmtrak®) to receive a weekly intravenous infusion, administered at 20 mcg on day 1, 30 mcg on day 8, 68 mcg on day 15, and 68 mcg once every week thereafter or investigator's choice of pembrolizumab, ipilimumab, or dacarbazine. The treatment was stopped for disease progression unless the individual was otherwise benefiting from the treatment, or for unacceptable toxicity. The primary efficacy outcome was overall survival (OS). Additional efficacy outcomes were progression-free survival (PFS) and objective response rate (ORR) per RECIST. The median age was 64 years (range 23 to 92 years); 50% of treated individuals were female; 87% were white, and 12% were unreported or unknown race. Baseline ECOG performance status was 0 (73%), 1 (21%), or 2 (0.3%); 36% had elevated LDH level; and 94% had liver metastasis. Overall survival at 1 year was 73% in the tebentafusp group and 59% in the control group (hazard ratio for death, 0.51; 95% confidence interval [CI], 0.37 to 0.71; P<0.001) in the intention-to-treat population. Progression-free survival was also significantly higher in the tebentafusp group than in the control group (31% vs. 19% at 6 months; hazard ratio for disease progression or death, 0.73; 95% CI, 0.58 to 0.94; P = 0.01).

UVEAL MELANOMA

Uveal melanoma (UM) is an intraocular tumor that arises from the uveal tract, with 3–5% of tumors involving the iris, 5–8% the ciliary body, and 90% the choroid. The disease occurs mainly in Caucasians, and it is associated with blond hair, light eyes, and a fair skin.

Uveal melanoma (UM) is the most common primary intraocular malignancy in adults and metastasizes in 50% of cases. The presence of an inflammatory phenotype is a risk factor for the development of metastases. This inflammatory phenotype is characterized by the presence of high numbers of lymphocytes and macrophages, and a high expression of the HLA Class I and II antigens. An abnormal expression of HLA Class I may influence cytotoxic T lymphocyte (CTL) as well as natural killer (NK) cell responses.

OFF-LABEL INDICATIONS

There may be additional indications contained in the policy section of this document due to evaluation of criteria highlighted in the company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

Centers for Medicare & Medicaid Services' (CMS). Guidance for Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage. 08/07/2018. Available at: https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/Downloads/MA_Step_Therapy_HPMS_Memo_8_7_2018.pdf.

ClinicalTrials.gov.Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma. ClinicalTrials.gov Identifier: NCT03070392. First Posted: March 3, 2017; Last Update Posted: November 9, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03070392?term=NCT03070392&draw=2&rank=1. Accessed February 10, 2022.

Immunocore, Ltd., Milton Park Abingdon, Oxfordshire United Kingdom. Tebentafusp-tebn (Kimmtrak®) labeling.01/2022. Available at: https://www.immunocore.com/application/files/1816/4422/3424/Approved_USPI_02_04_22_for_commercial_printing_and_website.pdf. Accessed February 10, 2022.

Elsevier’s Clinical Pharmacology Compendium .Tebentafusp-tebn (Kimmtrak®).[Clinical Key Web site]. 02/04/22. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed February 10, 2022.

Lexi-Drugs Compendium. Tebentafusp-tebn (Kimmtrak®). [Lexicomp Online Web site]. 01/28/2022. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 10, 2022.

Souri Z, Wierenga A, Mulder A et. al., HLA Expression in Uveal Melanoma: An Indicator of Malignancy and a Modifiable Immunological Target. Cancers. 2019; 11(8), 1132. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6721545/. Accessed February 21, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Tebentafusp-tebn (Kimmtrak®). [FDA Web site]. Original: 01/25/22. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed January 4, 2022.

US Food and Drug Administration (FDA). Tebentafusp-tebn (Kimmtrak®) prescribing information & approval letter. [FDA Web site]. 01/2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s000lbl.pdf. Accessed January 4, 2022.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

C69.30 Malignant neoplasm of unspecified choroid

C69.31 Malignant neoplasm of right choroid

C69.32 Malignant neoplasm of left choroid

C69.40 Malignant neoplasm of unspecified ciliary body

C69.41 Malignant neoplasm of right ciliary body

C69.42 Malignant neoplasm of left ciliary body

HCPCS Level II Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT Tebentafusp-tebn (Kimmtrak®):

J9274 Inj, tebentafusp-tebn, 1 mcg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA08.143b:

11/26/2025	This policy has been reissued in accordance with the Company's annual review process.
04/03/2024	This policy has been reissued in accordance with the Company's annual review process.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
04/19/2023	This policy has been reissued in accordance with the Company's annual review process.
10/01/2022	This policy has been identified for the HCPCS code update, effective 10/01/2022. The following HCPCS codes termed from this policy: C9095 Inj, tebentafusp-tebn, 1 mcg J9999 Not otherwise classified, antineoplastic drugs The following HCPCS codes have been added to this policy: J9274 Injection, tebentafusp-tebn, 1 microgram

Revisions From MA08.143a:

07/01/2022

This policy has been identified for the HCPCS code update, effective 07/01/2022.

The following HCPCS codes termed from this policy:
C9399 Unclassified drugs or biologics

The following HCPCS codes have been added to this policy:
C9095 Inj, tebentafusp-tebn, 1 mcg

Revisions From MA08.143:

03/28/2022

This version of the policy will become effective 03/28/2022.

This new policy has been issued to communicate the Company’s coverage position and criteria for tebentafusp-tebn (Kimmtrak®).

Version Effective Date:

1/1/2024

Version Issued Date: