CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lymphir (denileukin diftitox-cxdl)

Defines accepted indications, contraindications, exclusion criteria, dosing limits, prior authorization and evidentiary requirements for Lymphir (denileukin diftitox-cxdl) use in cancer treatment for Neighborhood Health Plan of Rhode Island lines of business administered by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLymphir (denileukin diftitox-cxdl)

Policy CodePolicy N/A

Change TypeRevised (Oct 2025)Added (Oct 2024)

Effective Date

Next Review Date2025-10

Key ActionSubmit prior authorization requests to Evolent with evidence from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS Chapter 15 standards.

SourceLink

POLICY UPDATE CHANGES

October 2025: Converted to new Evolent guideline template, replaced previous UM ONC_1510 Lymphir policy, updated references.

October 2024: New policy

1Covered Indications (CTCL Stage I-III relapsed/refractory)

J9161HCPCS drug code

9 mcg/kgSingle dose limit

4Key exclusion categories

Coverage Summary & Indications

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Lymphir (denileukin diftitox-cxdl) is covered with criteria for adult members with relapsed or refractory Stage I‑III cutaneous T‑cell lymphoma (CTCL) after at least one prior systemic therapy. Coverage requires prior authorization administered by Evolent and documentation that the requested use is supported by FDA product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Covered Indication / Initial Therapy

Lymphir is covered when ALL of the following are met:

ALL of the following

Adult member: Patient is an adult member
Policy states use in adult members
Diagnosis of relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL)
Prior therapy: Member has received at least one prior systemic therapy
Evidentiary support: Use is supported by FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements
Required evidentiary support for approval

Top-level holder

Continuation Therapy

Continuation requests for a not-approvable medication are exempt from this policy provided ALL of the following are met:

ALL of the following

No progression: Member has not experienced disease progression on the requested medication
Recent use: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additions: Additional medication(s) are not being added to the continuation request

Top-level holder

Continuation request exemption: continuation requests for a medication that would otherwise be not approvable are exempt if ALL of the following are documented — the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request. Providers should include these items in the request documentation to support continuity of therapy.

Exclusions / Not Medically Necessary & Safety

Exclusion / Not Medically Necessary Criteria

Lymphir is NOT covered when ANY of the following exclusions apply:

ANY of the following

Progression: Disease progression while taking Lymphir (denileukin diftitox-cxdl)
Concurrent therapy: Concurrent use with other anticancer therapies
Dose limit: Dosing exceeds single dose limit of 9 mcg/kgsingle dose <= 9 mcg/kg
Investigational/off-label
- Evidence insufficiency considerations
  - Patient representation: Clinical characteristics of the patient and the cancer are not adequately represented in published evidence
  - Regimen representation: Administered regimen is not adequately represented in the published evidence
  - Outcomes not meaningful: Reported study outcomes do not represent clinically meaningful outcomes (ASCO guidance: HR < 0.80 and OS/PFS benefit >= 3 months preferred)
  - Design inappropriate: Experimental design is inappropriate to address the question
  - Low-quality evidence:

Top-level holder

Contraindications / Warnings (safety monitoring)

Use requires monitoring; withhold or discontinue per severity:

Warnings and monitoring

Boxed warning: US Boxed Warning: Capillary leak syndrome (CLS) can occur, including life-threatening or fatal reactions
Monitoring: Monitor patients for signs and symptoms of CLS during treatment
Withhold/discontinue: Withhold denileukin diftitox until CLS resolves or permanently discontinue based on severity

Top-level holder

Surface thresholds and quick facts

Single dose limit<= 9 mcg/kg

Covered indication(s)Relapsed or refractory Stage I-III cutaneous T‑cell lymphoma (CTCL) after ≥1 prior systemic therapy

Covered HCPCS / J‑codeJ9161 (Injection, denileukin diftitox-cxdl, 1 mcg)

Covered Indications count1

Quick exclusion noteNot covered for dosing > single dose limit, concurrent anticancer therapy, disease progression while on Lymphir, or investigational/off‑label uses lacking sufficient evidence

Prior Authorization, Documentation & Billing Notes

Prior Authorization

Prior authorization requirement and evidentiary support

Evolent authorization is required for reimbursement of Lymphir requests. Approval must be supported by one of the following evidence sources: FDA approved product labeling, CMS‑approved compendia, National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the CMS Medicare Benefit Policy Manual Chapter 15 requirements. Affected billing code: J9161.

J9161

Documentation Required

Documentation for continuation requests

For continuation (renewal) requests when the medication itself would otherwise be not approvable, document that the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of an active authorization, and no additional medications are being added to the regimen.

Document no disease progression on the requested medication
Document prior use within the last year without >30 day lapse of active authorization
Document that no additional medications are being added to the continuation request

Denial Risk

Denial risk for excluded uses

Claims may be denied for uses that meet exclusion criteria: dosing that exceeds a single dose limit of 9 mcg/kg; concurrent use with other anticancer therapies; disease progression while taking Lymphir; or investigational/off-label indications lacking sufficient supporting evidence as defined by the policy.

J9161
Single dose limit: 9 mcg/kg

Documentation Required

Safety monitoring and management

Monitor patients for capillary leak syndrome (CLS), including life‑threatening or fatal reactions. Document monitoring and any clinical decisions to withhold or permanently discontinue denileukin diftitox based on severity.

Monitor patients for signs and symptoms of capillary leak syndrome (CLS)
Withhold denileukin diftitox until CLS resolves, or permanently discontinue based on severity
Document clinical decision-making regarding withholding or discontinuation in the medical record

Clinical Evidence & References

Evidentiary requirements: Evolent requires that requests be supported by one or more recognized sources — FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15. Case reports and meeting abstracts without a full peer‑reviewed article are specifically considered inadequate as sole supporting evidence; non‑randomized trials may be supportive when subject numbers are substantial.

Foss et al. 2025Key trial/publication: Foss FM et al., J Clin Oncol. 2025 Apr;43(10):1198-1209.

PI 2024Manufacturer prescribing information: Lymphir prescribing information, Citius Pharmaceuticals, Inc., 2024.

Background & Definitions

Background: Lymphir (denileukin diftitox-cxdl) is indicated for adult patients with relapsed or refractory Stage I‑III cutaneous T‑cell lymphoma after at least one prior systemic therapy. The product is distributed under HCPCS J‑code J9161 for billing. Evolent manages prior authorization for Lymphir requests and enforces evidentiary expectations as described in the policy, including reliance on FDA labeling, CMS compendia, NCCN or ASCO guidance, or acceptable peer‑reviewed literature.

Definitions — Continuation request exemption: Continuation requests for a not‑approvable medication are exempt when the patient has not progressed on the medication, the therapy was used within the prior year without a > 30‑day lapse in active authorization, and no new medications are being added. Definitions — Sufficient evidence: Sufficient evidence refers to support from CMS‑recognized compendia or acceptable peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements; note that case reports and abstracts without full peer‑reviewed articles are generally inadequate as sole evidence.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLymphir (denileukin diftitox-cxdl)

Policy CodePolicy N/A

Change TypeRevised (Oct 2025)Added (Oct 2024)

Effective Date

Next Review Date2025-10

SourceLink

On This Page

OpenPayer

Lymphir (denileukin diftitox-cxdl)

Coverage Summary & Indications

Continuation Therapy

Exclusions / Not Medically Necessary & Safety

Applicable Codes

Prior Authorization, Documentation & Billing Notes

Clinical Evidence & References

Background & Definitions

Policy Revision History