CurrentCareSourcePolicy N/A

Oncology (Injectable) Lymphir Utilization Management Medical Policy

Defines prior authorization and medical necessity criteria, dosing, prescribing specialist requirement, and noncoverage conditions for Lymphir (denileukin diftitox-cxdl) for treatment of relapsed or refractory Stage I-III cutaneous T-cell lymphoma in adults.

Policy Summary

PayerCareSource

PolicyOncology (Injectable) Lymphir Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNew policy

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve only patients meeting the policy Criteria and Dosing.

SourceLink

POLICY UPDATE CHANGES

New policy created for Lymphir (denileukin diftitox-cxdl) with review date 10/23/2024.

1FDA-approved indication referenced

>=18Minimum age

3Serum albumin threshold (g/dL)

Coverage Summary

Defines prior authorization and medical necessity criteria for Lymphir (denileukin diftitox-cxdl) for the treatment of relapsed or refractory Stage I-III cutaneous T‑cell lymphoma in adults, including age ≥ 18 years, prior systemic therapy, serum albumin requirement, specialist prescribing requirement, and dosing limits. The policy references the FDA‑approved indication and NCCN guidance and includes a boxed warning for capillary leak syndrome and potentially life‑threatening reactions.

Recommended Authorization Criteria (Initial Therapy)

Recommended Authorization Criteria

Coverage of Lymphir is recommended in those who meet the following criteria:

Age: Patient is >= 18 years of age>= 18 years
Diagnosis of relapsed or refractory Stage I-III cutaneous T-cell lymphoma (e.g., mycosis fungoides/Sezary syndrome)
Prior therapy: Patient has received at least one prior systemic therapy
Policy overview states indicated after at least one systemic therapy
Serum albumin is >= 3 g/dL>= 3 g/dL
Delay administration if serum albumin is below threshold
Specialist prescribing: Medication is prescribed by or in consultation with an oncologist (physician who specializes in the condition treated)
Approval requires prescription by or consultation with a specialist

Dosing Criteria / Authorization Limits

Approve when dosing meets the following:

Dose per day: Dose up to 9 mcg/kg/day of actual body weight9 mcg/kg/day
Administration frequency: Administered by intravenous infusion no more frequently than five times in each 21-day treatment cycleno more than 5 doses per 21-day cycle
Treatment duration: Treatment may continue until disease progression or unacceptable adverse events
Extended approvals allowed if patient continues to meet Criteria and Dosing

Numeric thresholds

Serum albumin>= 3 g/dL

Dose per day9 mcg/kg/day

FrequencyNo more than 5 doses per 21-day cycle

Conditions Not Recommended for Approval

Coverage is not recommended when the circumstance is not listed in Recommended Authorization Criteria:

Not recommended uses: Use for indications, stages, or clinical circumstances not specified in the Recommended Authorization Criteria
Criteria will be updated as new published data are available

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization recommended

Prior Authorization is recommended for medical benefit coverage of Lymphir; approval recommended only for patients meeting the policy Criteria and Dosing.

Documentation Required

Specialist prescribing requirement

Lymphir must be prescribed by or in consultation with a physician who specializes in the condition treated (e.g., oncologist).

Documentation Required

Serum albumin requirement

Document serum albumin ≥ 3 g/dL prior to initiation; delay administration if serum albumin is below threshold.

Billing Rule

Dosing and frequency billing constraint

Authorize/bill for up to 9 mcg/kg/day actual body weight, administered IV no more frequently than five times per each 21-day treatment cycle.

Documentation Required

Continuation / extended approval

Extended approvals allowed if patient continues to meet Criteria and Dosing; doses outside documented dosing considered case-by-case by clinician (Medical Director or Pharmacist).

Clinical Evidence & References

Evidence items: NCCN Primary Cutaneous Lymphoma Clinical Practice Guidelines in Oncology (version 3.2024 Aug 22, 2024); Lymphir intravenous infusion [prescribing information], Citius Pharmaceuticals; August 2024. Note: Lymphir carries a boxed warning for capillary leak syndrome and life‑threatening or fatal reactions.

Background & Definitions

Lymphir (denileukin diftitox‑cxdl) is an IL‑2 receptor‑directed cytotoxin indicated for adults with relapsed or refractory Stage I‑III cutaneous T‑cell lymphoma after at least one systemic therapy. The product carries a boxed warning for capillary leak syndrome and potentially life‑threatening or fatal reactions. NCCN guidelines (version 3.2024 Aug 22, 2024) recommend Lymphir as a preferred regimen in certain settings (for example stage IIB with generalized tumor lesions in combination with skin‑directed therapy) and as "useful in certain circumstances" for other specified stages.

Lymphir: Denileukin diftitox‑cxdl intravenous infusion, IL‑2 receptor directed cytotoxin.

Policy Summary

PayerCareSource

PolicyOncology (Injectable) Lymphir Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNew policy

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve only patients meeting the policy Criteria and Dosing.

SourceLink

On This Page

OpenPayer

Oncology (Injectable) Lymphir Utilization Management Medical Policy

Coverage Summary

Recommended Authorization Criteria (Initial Therapy)

Dosing Criteria / Authorization Limits

Conditions Not Recommended for Approval

Provider Actions / Prior Authorization

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History