Last Review Date: 03/04/2025

Date of Origin:  09/05/2024

Dates Reviewed:  09/2024, 03/2025

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

• 6000 billable units per 21-day cycle

3. Initial Approval Criteria¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Patient does not have significant cardiac disease that requires on-going treatment [e.g., congestive heart failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI)]; AND
• Patient does not have significant or uncontrolled infections requiring systemic anti-infective therapy; AND

Universal Criteria ¹

• Patient’s serum albumin is greater than or equal to 3 g/dL; AND
• Patient will be regularly assessed for signs and symptoms of capillary leak syndrome (e.g., more than one of the following: hypotension, edema, serum albumin <3 g/dL); AND
• Patient will have an ophthalmic examination at baseline and periodically throughout therapy as clinically indicated; AND
• Used as single agent systemic therapy; AND

Cutaneous T-Cell Lymphoma (CTCL) - Mycosis Fungoides/Sezary Syndrome † ‡ Ф ^1-4

• 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 Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND

• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: capillary leak syndrome (CLS), severe visual impairment, severe infusion-related reactions, severe hepatotoxicity, etc.; AND

• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

5. Dosage/Administration ¹
6. Billing Code/Availability Information

HCPCS Code:

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

NDC:

• Lymphir 300 mcg lyophilized cake for reconstitution in a single-dose vial: 52658-7777-xx

7. References

1. Lymphir [package insert]. Cranford, NJ; Citius Pharmaceuticals, Inc.; August 2024. Accessed January 2025.
2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) denileukin diftitox-cxdl. National Comprehensive Cancer Network, 2025. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2025.
3. Foss FM, Kim YH, Prince HMM, et al. Efficacy and Safety of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302. Blood 2022; 140 (Supplement 1): 1491–1492. doi: https://doi.org/10.1182/blood-2022-166916.
4. Prince HMM, Geskin LJ, Akilov OE, et al. Safety and Tolerability of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302. Blood 2022; 140 (Supplement 1): 6577–6578. doi: https://doi.org/10.1182/blood-2022-167564

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A