Kimmtrak®
Drug - Kimmtrak® (tebentafusp-tebn) [Immunocore Commercial LLC.]
October 2022
Therapeutic area - Oncology, Injectable
Initial approval criteria
- Patient is at least 18 years of age AND
- Patient has received the first three infusions (i.e., Day 1, 8, 15) in an appropriate healthcare setting and did not experience any Grade 2 or worse hypotension (i.e., hypotension requiring medical intervention) AND
Universal Criteria
- Patient does not have a clinically significant cardiac disease or impaired cardiac function (i.e., congestive heart failure [NYHA grade ≥ 2], uncontrolled hypertension or clinically significant arrhythmia requiring medical treatment, QT interval > 470 msec or congenital long QT syndrome, acute myocardial infarction or unstable angina pectoris < 6 months prior to start of therapy) AND
- Patient does not have symptomatic or untreated brain metastases AND
Uveal Melanoma
- Patient has unresectable or metastatic disease AND
- Patient has HLA-A*02:01 genotype positive disease as determined by an FDA-approved or CLIA compliant test AND
- Patient has not received prior systemic therapy for metastatic or advanced uveal melanoma or localized liver-directed therapy (Note: Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease)
Initial approval is for 6 months (after the initial first three infusions)
Renewal criteria
- Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in the initial approval criteria AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: persistent/severe cytokine release syndrome, severe dermatological reactions, severe elevated liver enzymes, etc. AND
- Patient has received the first three infusions (i.e., Day 1, 8, 15) in an appropriate healthcare setting and did not experience any Grade 2 or worse hypotension (i.e., hypotension requiring medical intervention) AND
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
- Renewal approval is for 6 months
Quantity limits
Administer Kimmtrak intravenously according to the following schedule:
- 20 mcg on Day 1
- 30 mcg on Day 8
- 68 mcg on Day 15 then
- 68 mcg once every week thereafter
Billing for Kimmtrak
Kimmtrak must be billed as a medical claim.
Questions?
MHCP Provider Resource Center 651-431-2700 or 800-366-5411
