CurrentViva HealthPolicy IC-0658

Kimmtrak (tebentafusp-tebn) (Intravenous) - Coverage Criteria

Defines prior authorization, dosing, eligibility, and renewal criteria for intravenous tebentafusp (Kimmtrak) for members of Viva Health with unresectable or metastatic uveal melanoma who are HLA-A*02:01 positive.

Policy Summary

PayerViva Health

PolicyKimmtrak (tebentafusp-tebn) (Intravenous) - Coverage Criteria

Policy CodePolicy IC-0658

Change TypeNo material changes

Effective DateMar 1, 2022

Next Review DateNov 4, 2025

Key ActionObtain prior authorization and document HLA-A*02:01 positivity and administration of the first three infusions (Days 1, 8, 15) without Grade ≥2 hypotension.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization validity

400max HCPCS units / 28 days

≥18minimum patient age

HLA-A*02:01companion diagnostic

J9274HCPCS code

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Initial Approval Criteria

Covered when ALL of the following are met:

Initial Eligibility: Patient is at least 18 years of age;

Initial Eligibility: Patient has received the first three infusions (Days 1, 8, 15) in an appropriate healthcare setting and did not experience Grade 2 or worse hypotension (hypotension requiring medical intervention);

Initial Eligibility: Patient has unresectable or metastatic uveal melanoma (including choroid, ciliary body, or orbit primary);

Initial Eligibility: Patient is HLA-A*02:01 positive as determined by an FDA-approved or CLIA-compliant test;

Initial Eligibility: Patient does not have clinically significant cardiac disease or impaired cardiac function (examples: congestive heart failure NYHA grade ≥ 2, uncontrolled hypertension, clinically significant arrhythmia requiring treatment, QT interval > 470 msec, congenital long QT syndrome, acute myocardial infarction or unstable angina within 6 months);

Initial Eligibility: Patient does not have symptomatic or untreated brain metastases.

Renewal Criteria

Renewal covered when ALL of the following are met:

Renewal Criteria: Patient continues to meet the universal and other indication-specific relevant criteria (including concomitant therapy requirements and performance status) identified in the initial criteria;

Renewal Criteria: Absence of unacceptable toxicity from the drug (examples include persistent or severe cytokine release syndrome, severe dermatologic reactions, severe elevated liver enzymes);

Renewal Criteria: Evidence of disease response or stabilization as demonstrated by decrease in tumor size or no progression of disease.

Coverage excludes members who are HLA‑A*02:01 negative, who have clinically significant cardiac disease or impaired cardiac function as specified (examples include congestive heart failure NYHA ≥2, uncontrolled hypertension, arrhythmia requiring medical treatment, QT interval >470 msec or congenital long QT syndrome, or recent acute myocardial infarction/unstable angina within 6 months), or who have symptomatic or untreated brain metastases.

Use of tebentafusp (Kimmtrak) is not permitted for members younger than 18 years. Initial authorization requires the patient to be at least 18 years of age as part of the coverage criteria.

Regimen	Dosing schedule	Coverage status
Kimmtrak (tebentafusp) — uveal melanoma
20 mcg on Day 1; 30 mcg on Day 8; 68 mcg on Day 15; then 68 mcg once weekly thereafter until unacceptable toxicity or disease progression
Covered with criteria

Coding

Covered HCPCS CodeHCPCSCovered

J9274

Injection, tebentafusp-tebn, 1 mcg; 1 billable unit = 1 mcg

Covered Diagnosis Codes (ICD-10)ICD-10Covered

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
C69.60	Malignant neoplasm of unspecified orbit
C69.61	Malignant neoplasm of right orbit
C69.62	Malignant neoplasm of left orbit

Max HCPCS units (inv-07)

Maximum billing units400 billable units every 28 days

HCPCS unit definition1 billable unit = 1 mcg of tebentafusp (per J9274 description)

Billing intervalMeasured over a 28-day period for authorization and claims adjudication

ImplicationEnsure total billed units across all claims do not exceed 400 units within any 28-day window

Provider Actions & Documentation

Prior Authorization

Prior Authorization Validity

Prior authorization is required. Initial authorization is provided for 6 months after the member has completed the first three infusions (Day 1, 8, and 15). Renewals may be requested every 6 months and are granted only if renewal criteria are met.

Initial PA validity: 6 months (starts after completion of first three infusions: Day 1, 8, 15).
Renewal cadence: may be renewed every 6 months thereafter.

Step Therapy

Prerequisite / Step Therapy

No prerequisite or step therapy is required prior to initial authorization. For renewal, prior authorization may be continued only if the member demonstrates continued clinical benefit and absence of unacceptable toxicity.

No prerequisite therapy required for initial approval.
Renewal requires: continued meeting of universal and indication-specific criteria and absence of unacceptable toxicity (e.g., persistent/severe cytokine release syndrome, severe dermatologic reactions, severe elevated liver enzymes).
Renewal also requires disease response (stabilization or decrease in tumor size/spread).

Documentation Required

Required Documentation

The following documentation must be provided to support initial authorization and renewals: verification of HLA-A*02:01 positive status, record that the first three infusions (Day 1, 8, 15) were administered in an appropriate healthcare setting without Grade ≥2 hypotension, and clinical records supporting absence of disqualifying cardiac disease and other universal criteria.

HLA-A*02:01 genotype positive result from FDA-approved or CLIA-compliant test.
Medical record documentation of first three infusions (dates: Day 1, 8, 15) and infusion setting.
Documentation that patient did not experience Grade 2 or worse hypotension during initial three infusions.
Clinical records showing absence of clinically significant cardiac disease (e.g., CHF NYHA ≥2, uncontrolled HTN, arrhythmia requiring treatment, QT > 470 msec, recent MI/unstable angina < 6 months).
For renewal: documentation of continued clinical benefit (stabilization or tumor reduction) and absence of unacceptable toxicity.

Denial Risk

Triggers for Coverage Denial

Coverage will be denied if any of the following disqualifying conditions are present: patient is under 18 years of age; patient did not receive the first three infusions in an appropriate setting or experienced Grade 2 or worse hypotension during them; patient lacks documented HLA-A*02:01 positivity; patient has disqualifying cardiac disease, untreated symptomatic brain metastases, or other excluded clinical conditions.

Age < 18 years — not eligible for coverage.
Failure to document administration of Day 1, 8, 15 infusions in appropriate healthcare setting.
Occurrence of Grade 2 or worse hypotension during the initial three infusions.
No documented HLA-A*02:01 positive genotype (per FDA-approved or CLIA-compliant test).
Presence of clinically significant cardiac disease or impaired cardiac function as specified (e.g., CHF NYHA ≥2, uncontrolled hypertension, clinically significant arrhythmia requiring treatment, QT interval > 470 msec, recent MI/unstable angina < 6 months).
Symptomatic or untreated brain metastases.

Definitions

Unacceptable toxicity — definition and examples (inv-13)

DefinitionUnacceptable toxicity = adverse effects of the drug severe enough to warrant discontinuation or to preclude renewal of authorization

Examples providedPersistent or severe cytokine release syndrome; severe dermatological reactions; severe elevated liver enzymes

Cardiac considerationsClinically significant cardiac disease or impaired cardiac function (e.g., NYHA ≥2 heart failure, uncontrolled hypertension, arrhythmia requiring treatment, QT >470 msec, recent MI/unstable angina <6 months) are exclusionary for initiation and may influence toxicity assessment

Renewal criteria linkAbsence of unacceptable toxicity is required for renewal — authorization may be renewed only if unacceptable toxicity is not present

Clinical actionDiscontinue or withhold treatment if patient develops listed severe toxicities or other intolerable adverse effects consistent with policy examples

Background

Tebentafusp (Kimmtrak) is indicated for patients with unresectable or metastatic uveal melanoma and is covered only when key clinical safeguards are met. Members must have tumor HLA‑A*02:01 positivity confirmed by an FDA‑approved or CLIA‑compliant test. Initial treatment requires administration of the first three infusions (Days 1, 8, and 15) in an appropriate healthcare setting without occurrence of Grade ≥2 hypotension. Patients with significant cardiac impairment, recent major cardiac events, or symptomatic/untreated brain metastases are not eligible for coverage. Treatment is continued until unacceptable toxicity or disease progression per policy renewal criteria.

OpenPayer

Kimmtrak (tebentafusp-tebn) (Intravenous) - Coverage Criteria

Coverage Criteria

Covered Regimens / Dosing

Biomarker Requirements

Coding

Provider Actions & Documentation

Line of Therapy

Definitions

Background