Effective October 1, 2022: J9274, Injection, tebentafusp-tebn, 1 microgram for KIMMTRAK – 9/22/22

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Effective For Dates of Service Beginning October 1, 2022


KIMMTRAK Permanent J-Code Now Available


J9274 Injection, tebentafusp-tebn, 1 microgram


KIMMTRAK Coding Details:

HCPCS Code

HCPCS Code Description

NDC

NDC Description

HCPCS Units Per Package

WAC* Per HCPCS Unit

J9274

Injection, tebentafusp-tebn, 1 mcg

80446-0401-01

Single Dose Vial Containing 100 MCG/0.5ML KIMMTRAK Intravenous Solution

100

$187.60

KIMMTRAK is the first and only FDA-approved immunotherapy indicated for adult patients with mUM1


Indication and Important Safety Information Including Boxed Warning

 

Indication

KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

 

Important Safety Information Including Boxed Warning

 

WARNING: CYTOKINE RELEASE SYNDROME

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

 

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

 

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.


Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.


The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.


Please see full Prescribing Information, including BOXED WARNING for CRS.


References: 1 Kimmtrak. Package Insert. Immunocore Ltd; 2022.

Immunocore and KIMMTRAK are registered trademarks of Immunocore Ltd.

©2022 Immunocore Ltd. All rights reserved. CM-US-KIM-2200011 September 2022