CurrentViva HealthPolicy IC-0766

Lymphir (denileukin diftitox-cxdl) IV — Coverage Criteria

This policy defines medical necessity criteria, dosing, coding, and authorization rules for coverage of Lymphir (denileukin diftitox-cxdl) IV in adults with cutaneous T-cell lymphoma (mycosis fungoides / Sézary syndrome) for Viva Health members.

Policy Summary

PayerViva Health

PolicyLymphir (denileukin diftitox-cxdl) IV — Coverage Criteria

Policy CodePolicy IC-0766

Change TypeNo material change

Effective DateApr 1, 2025

Next Review DateMar 4, 2025

Key ActionObtain prior authorization; authorize coverage for up to 6 months with a maximum of 6000 billable units per 21-day cycle (HCPCS J9161).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization

6000max units / cycle

>=18min patient age

9 mcg/kg D1-5dosing schedule

J9161HCPCS

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Initial Therapy Criteria

Covered when ALL of the following are met:

Initial approval: Patient is at least 18 years of age; AND patient does not have significant cardiac disease that requires ongoing treatment (examples: congestive heart failure, severe coronary artery disease, cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or myocardial infarction); AND patient does not have significant or uncontrolled infections requiring systemic anti-infective therapy; AND serum albumin >= 3 g/dL; AND patient will be regularly assessed for signs and symptoms of capillary leak syndrome (e.g., hypotension, edema, serum albumin <3 g/dL); AND patient will have an ophthalmic examination at baseline and periodically throughout therapy as clinically indicated; AND drug is used as single-agent systemic therapy; AND indication-specific criteria for CTCL (see below).

CTCL indication-specific: EITHER: used as primary systemic therapy AND patient has stage IB-III mycosis fungoides; OR: used as subsequent therapy after at least one prior systemic therapy AND patient has stage I, II, or III disease.

FDA-approved and compendia-recommended indications noted in source

Continuation/Renewal Criteria

Renewal permitted when ALL of the following are met:

Renewal: Patient continues to meet the universal and indication-specific relevant criteria (including concomitant therapy requirements and performance status) identified in Initial Therapy; AND absence of unacceptable toxicity from the drug (examples: capillary leak syndrome, severe visual impairment, severe infusion-related reactions, severe hepatotoxicity); AND disease response to treatment defined as stabilization of disease or decrease in size of tumor or tumor spread.

Initiation of therapy is excluded for patients with significant cardiac disease requiring ongoing treatment. Examples include congestive heart failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or recent myocardial infarction (MI).

Renewal of coverage is permitted only when the patient continues to meet the universal and indication-specific criteria and there is an absence of unacceptable toxicity. Examples of unacceptable toxicity that may preclude renewal include capillary leak syndrome (CLS), severe visual impairment, severe infusion-related reactions, and severe hepatotoxicity. Additionally, renewal requires documented disease response defined as stabilization of disease or a decrease in tumor size or tumor spread.

Regimen	Dose & Schedule	Treatment Duration	Coverage
Cutaneous T‑Cell Lymphoma (CTCL)	9 mcg/kg/day IV on Days 1–5 of a 21‑day cycle	Continue until disease progression or unacceptable toxicity	Covered with criteria

Billing Codes and Diagnostic Codes

Covered HCPCS CodesHCPCSCovered

J9161	Injection, denileukin diftitox-cxdl, 1 mcg; 1 billable unit = 1 mcg
J9999	Not otherwise classified, antineoplastic drug (Discontinue use on 04/01/2025)

Covered ICD-10 Diagnosis CodesICD-10Covered

C84.00	Mycosis fungoides, unspecified site
C84.01	Mycosis fungoides, lymph nodes of head, face, and neck
C84.02	Mycosis fungoides, intrathoracic lymph nodes
C84.03	Mycosis fungoides, intra-abdominal lymph nodes
C84.04	Mycosis fungoides, lymph nodes of axilla and upper limb
C84.05	Mycosis fungoides, lymph nodes of inguinal region and lower limb
C84.06	Mycosis fungoides, intrapelvic lymph nodes
C84.07	Mycosis fungoides, spleen
C84.08	Mycosis fungoides, lymph nodes of multiple sites
C84.09	Mycosis fungoides, extranodal and solid organ sites

1–10 of 20

1/2

NDCNDC

NDC: 52658-7777-xx

Lymphir 300 mcg lyophilized cake for reconstitution in a single-dose vial

inv-08: Serum albumin

Serum albumin threshold>= 3 g/dL

PurposeBaseline safety parameter to assess risk for capillary leak syndrome and suitability for therapy

MonitoringObtain baseline serum albumin and monitor periodically during treatment per clinical judgement

inv-09: Maximum HCPCS units per cycle

Maximum HCPCS units per 21-day cycle<= 6000 units per 21-day cycle

Billing unit definitionHCPCS J9161: 1 billable unit = 1 mcg (effective 04/01/2025)

Authorization implicationQuantity limit enforced on prior authorization (max 6000 billable units per cycle)

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization and Quantity Limits

Prior Authorization Required: Prior authorization (PA) is required for coverage. Authorization length: 6 months. Maximum billing: 6000 billable units per 21-day cycle. HCPCS effective date: J9161 (denileukin diftitox-cxdl) 1 mcg = 1 billable unit, effective 04/01/2025.

Prior authorization required
Authorization length: 6 months
Max 6000 billable units per 21-day cycle
HCPCS: J9161 effective 04/01/2025

Step Therapy

Prerequisite Therapy / Line of Therapy

Prerequisite therapy: Policy allows use as primary systemic therapy or as subsequent therapy after at least one prior systemic therapy depending on disease stage. For cutaneous T‑cell lymphoma (CTCL): can be used as primary systemic therapy for stage IB–III mycosis fungoides, or as subsequent therapy after ≥1 prior systemic therapy for stage I–III disease.

Used as primary systemic therapy for stage IB–III mycosis fungoides
Or used as subsequent therapy after at least one prior systemic therapy for stage I–III disease

Documentation Required

Required Clinical Documentation

Required clinical documentation: Document baseline and periodic ophthalmic examinations; baseline serum albumin and periodic monitoring (albumin must be ≥3 g/dL at baseline and patients monitored for drops); regular assessment for capillary leak syndrome (CLS) signs/symptoms (e.g., hypotension, edema, falling albumin); performance status and concomitant therapy details; documentation of absence of unacceptable toxicity. Include indication-specific documentation (stage, prior therapies) and supporting diagnosis codes.

Baseline and periodic ophthalmic exams
Baseline serum albumin ≥3 g/dL and periodic albumin monitoring
Regular assessment for capillary leak syndrome (hypotension, edema, albumin <3 g/dL)
Performance status documentation and concomitant therapy details
Indication/stage documentation and prior systemic therapy history
Include appropriate ICD-10 diagnosis code from Appendix 1 (e.g., C84.xx)

Denial Risk

Clinical Exclusion and Response Requirements

Clinical exclusion and response requirements — denial risk items: DO NOT approve if any of the following are present: patient age <18 years; significant cardiac disease requiring ongoing treatment (e.g., CHF, severe CAD, cardiomyopathy, uncontrolled arrhythmia, unstable angina, recent MI); significant or uncontrolled infection requiring systemic anti‑infective therapy; baseline serum albumin <3 g/dL. For renewal, require absence of unacceptable toxicity (examples: CLS, severe visual impairment, severe infusion reactions, severe hepatotoxicity) and evidence of disease response or stabilization (decrease in tumor size or spread or disease stabilization).

Age <18 years — not eligible
Significant cardiac disease requiring ongoing treatment (CHF, severe CAD, cardiomyopathy, uncontrolled arrhythmia, unstable angina, recent MI) — exclusion
Uncontrolled systemic infection requiring anti‑infective therapy — exclusion
Baseline serum albumin <3 g/dL — exclusion
Renewal requires absence of unacceptable toxicity (e.g., CLS, severe visual impairment, severe infusion reactions, severe hepatotoxicity) and evidence of disease response or stabilization

OpenPayer

Lymphir (denileukin diftitox-cxdl) IV — Coverage Criteria

Coverage Criteria for Lymphir (denileukin diftitox-cxdl)

Approved Regimens and Dosing

Billing Codes and Diagnostic Codes

Prior Authorization, Documentation, and Provider Responsibilities

Permitted Line(s) of Therapy

Key Definitions

Clinical Background