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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 07/01/2022 Title: Kimmtrak
Revision Date: Document: BI702:00
CPT Code(s): C9095
Public Statement

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Kimmtrak (tebentafusp) requires prior authorization.

2)    Kimmtrak is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.


Medical Statement

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

 

 

Continued Therapy

A. Uveal Melanoma (must meet all

1. 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;

2. 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

 

 

Codes Used In This BI:

 

C9095 – Inj, tebentafusp-tebn, 1mcg


Reference

1. Kimmtrak Prescribing Information. Conshohocken, PA: Immunocore Commercial Limited; January 2022. Available at: https://www.kimmtrak.com/. Accessed February 16, 2022.

2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2022. Available at: http://www.clinicalpharmacology-ip.com/. Accessed February 16, 2022.

3. National Comprehensive Cancer Network. Melanoma: Uveal Version 2.2021 Available at: https://www.nccn.org/professionals/physician_gls/pdf/uveal.pdf. Accessed February 10, 2022.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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