CurrentmhnPolicy CP.PHAR.693

Denileukin Diftitox-cxdl (Lymphir) for cutaneous T‑cell lymphoma

Medical necessity criteria and coverage rules for Lymphir (denileukin diftitox-cxdl) for commercial, HIM, and Medicaid lines of business administered by Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyDenileukin Diftitox-cxdl (Lymphir) for cutaneous T‑cell lymphoma

Policy CodePolicy CP.PHAR.693

Change TypeRevised (coding and approval duration)

Effective DateDec 1, 2024

Next Review DateNov 25, 2025

Key ActionProvider must submit documentation showing the member meets all approval criteria including diagnosis, prior therapies, staging, and response.

SourceLink

POLICY UPDATE CHANGES

Initial approval duration extended from 6 months to 12 months.

HCPCS code J9161 (denileukin diftitox-cxdl, 1 mcg) was added; miscellaneous codes J3590 and C9399 were removed.

9 mcg/kg/dayMaximum daily dose (CTCL dosing)

Days 1–5Standard dosing schedule

12 monthsApproval duration (initial and renewal)

J9161Designated HCPCS code for drug

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Initial Approval — Cutaneous T‑Cell Lymphoma (CTCL)

Lymphir is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of cutaneous T‑cell lymphoma (CTCL)
See Appendix E for CTCL subtypes
Prescribed by or in consultation with an oncologist or hematologist
Age ≥ 18 years
For CTCL subtypes that are not mycosis fungoides (MF) or Sezary syndrome
- Disease is relapsed or refractory
- Disease is stage I, II, or III
- Failure of at least one prior systemic therapy
Dose requirement (one must be met)
- Dose does not exceed 9 mcg/kg per day on days 1 to 5 of a 21‑day cycle
- 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

Continuation/Renewal — Cutaneous T‑Cell Lymphoma (CTCL)

Renewal is medically necessary when ALL of the following are met:

ALL of the following

Member is currently receiving Lymphir via Centene benefit or documentation supports that member has received Lymphir for at least 30 days
Member is responding positively to therapy
Dose increase requirement (if applicable)
- New dose does not exceed 9 mcg/kg per day on days 1 to 5 of a 21‑day cycle
- New dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use
  Prescriber must submit supporting evidence

Other Diagnoses / Off‑Label Uses

When requested use is not addressed in the main criteria:

ANY of the following

If the drug has undergone a recent label change (within the last 6 months) not yet reflected in this policy, follow the appropriate formulary/no coverage or non‑formulary policy depending on formulary status
See related policies for specific policy numbers
If the requested use is not listed under Section III and the label‑change exception does not apply, refer to the off‑label use policy for the applicable line of business

Not Authorized / Exclusions

Coverage is NOT authorized for:

ALL of the following

Non‑FDA approved indications that are not addressed in this policy unless sufficient documentation of efficacy and safety is provided per off‑label policies

Key Thresholds / Dosing Limits

Maximum dose (CTCL)9 mcg/kg/day

Dosing scheduleIV over 60 minutes on days 1–5 of a 21‑day cycle

Minimum duration on therapy for continuation≥ 30 days

What Providers Must Do / Authorization & Documentation

Prior Authorization

Prescriber specialty requirement

Prescription must be written by or in consultation with an oncologist or hematologist. Prior authorization is implied by the policy administrative process.

Affected HCPCS code: J9161

Documentation Required

Support clinical criteria with documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria, including diagnosis, prior therapies, staging, and response.

Affected HCPCS code: J9161

Documentation Required

Dose justification for off‑label dosing

If the requested or new dose exceeds the standard maximum, the prescriber must submit supporting evidence from practice guidelines or peer‑reviewed literature to justify the off‑label or higher dosing.

Affected HCPCS code: J9161

Denial Risk

Non‑FDA indications without evidence

Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies.

Clinical Background & Safety Notes

Lymphir (denileukin diftitox-cxdl) is an interleukin‑2 (IL‑2) receptor‑directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory stage I–III cutaneous T‑cell lymphoma (CTCL) after at least one prior systemic therapy. It is a purified, more bioactive formulation of the previously marketed Ontak and is provided for use per the FDA‑approved indication in adults.

The product carries a boxed warning for capillary leak syndrome, and clinicians should monitor patients accordingly. The policy designates J9161 as the HCPCS billing code for the product (Injection, denileukin diftitox‑cxdl, 1 mcg) and documents that Lymphir dosing for CTCL follows the established regimen of 9 mcg/kg/day IV over 60 minutes on days 1–5 of a 21‑day cycle unless an evidence‑supported off‑label dosing justification is provided.

OpenPayer

Denileukin Diftitox-cxdl (Lymphir) for cutaneous T‑cell lymphoma

Medical Necessity Criteria for Lymphir (denileukin diftitox-cxdl)

Designated Billing Codes

What Providers Must Do / Authorization & Documentation

Clinical Background & Safety Notes

Defined Terms

Policy Changes & Version Notes

J3590	Unclassified drugs (removed from policy coding list)
C9399	Unclassified drug or biological (removed from policy coding list)

Denileukin Diftitox-cxdl (Lymphir) for cutaneous T‑cell lymphoma

Medical Necessity Criteria for Lymphir (denileukin diftitox-cxdl)

Designated Billing Codes

What Providers Must Do / Authorization & Documentation

Clinical Background & Safety Notes

Cross-References (Read With)

Defined Terms

Policy Changes & Version Notes