Citius Pharmaceuticals and Citius Oncology Announce Unique Permanent J-Code Issued for LYMPHIR by Centers for Medicare and Medicaid Services
Citius Pharmaceuticals and Citius Oncology announced that LYMPHIR™ (denileukin diftitox-cxdl) has received a permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) from the Centers for Medicare & Medicaid Services. The code will be effective April 1, 2025.
LYMPHIR is FDA-approved for treating adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The permanent J-code will help streamline billing and reimbursement processes for healthcare providers administering LYMPHIR, facilitating access for patients with commercial and government insurance coverage.
Citius Pharmaceuticals e Citius Oncology hanno annunciato che LYMPHIR™ (denileukin diftitox-cxdl) ha ricevuto un codice HCPCS permanente J-code (J9161) dai Centri per i Servizi Medicare e Medicaid. Il codice sarà efficace dal 1 aprile 2025.
LYMPHIR è approvato dalla FDA per il trattamento di pazienti adulti con linfoma cutaneo a cellule T (CTCL) di stadio I-III recidivante o refrattario dopo almeno una precedente terapia sistemica. Il codice J permanente faciliterà i processi di fatturazione e rimborso per i fornitori di assistenza sanitaria che somministrano LYMPHIR, migliorando l'accesso per i pazienti con copertura assicurativa commerciale e governativa.
Citius Pharmaceuticals y Citius Oncology anunciaron que LYMPHIR™ (denileukin diftitox-cxdl) ha recibido un código HCPCS permanente J-code (J9161) de los Centros de Servicios de Medicare y Medicaid. El código será efectivo a partir del 1 de abril de 2025.
LYMPHIR está aprobado por la FDA para el tratamiento de pacientes adultos con linfoma cutáneo de células T (CTCL) en estadio I-III en recaída o refractario tras al menos una terapia sistémica previa. El código J permanente ayudará a simplificar los procesos de facturación y reembolso para los proveedores de atención médica que administran LYMPHIR, facilitando el acceso para los pacientes con cobertura de seguros comerciales y gubernamentales.
Citius Pharmaceuticals와 Citius Oncology는 LYMPHIR™ (denileukin diftitox-cxdl)가 Medicare 및 Medicaid 서비스 센터로부터 영구적인 HCPCS J-code (J9161)를 받았다고 발표했습니다. 이 코드는 2025년 4월 1일부터 적용됩니다.
LYMPHIR는 FDA가 승인한 약제로, 최소 한 번의 전신 치료를 받은 성인 재발성 또는 내성 III기 피부 T세포 림프종(CTCL) 환자를 치료하는 데 사용됩니다. 이 영구 J-code는 LYMPHIR를 투여하는 의료 제공자의 청구 및 환급 절차를 간소화하여 상업적 및 정부 보험을 가진 환자들의 접근을 촉진할 것입니다.
Citius Pharmaceuticals et Citius Oncology ont annoncé que LYMPHIR™ (denileukin diftitox-cxdl) a reçu un code HCPCS permanent J-code (J9161) des Centers for Medicare & Medicaid Services. Le code sera effectif à partir du 1er avril 2025.
LYMPHIR est approuvé par la FDA pour le traitement des patients adultes atteints de lymphome cutané T (CTCL) de stade I-III récurrent ou réfractaire après au moins une thérapie systémique antérieure. Le code J permanent aidera à simplifier les processus de facturation et de remboursement pour les prestataires de santé administrant LYMPHIR, facilitant l'accès pour les patients couvert par une assurance commerciale ou gouvernementale.
Citius Pharmaceuticals und Citius Oncology haben bekannt gegeben, dass LYMPHIR™ (denileukin diftitox-cxdl) vom Centers for Medicare & Medicaid Services einen dauerhaften HCPCS J-Code (J9161) erhalten hat. Der Code wird ab dem 1. April 2025 gültig sein.
LYMPHIR ist von der FDA genehmigt zur Behandlung von erwachsenen Patienten mit rezidiviertem oder refraktärem kutanem T-Zell-Lymphom (CTCL) im Stadium I-III nach mindestens einer vorherigen systemischen Therapie. Der permanente J-Code wird die Abrechnungs- und Rückerstattungsprozesse für medizinische Anbieter, die LYMPHIR verabreichen, vereinfachen und den Zugang für Patienten mit kommerzieller und staatlicher Krankenversicherung erleichtern.
- Received permanent J-code for LYMPHIR, facilitating insurance reimbursement process
- Enhanced accessibility for patients with commercial and government insurance coverage
- Streamlined billing process for healthcare providers
- None.
Insights
The issuance of permanent J-code J9161 for LYMPHIR represents a pivotal milestone that will significantly enhance the commercial trajectory of this FDA-approved CTCL treatment. This development carries several strategic advantages:
- Enhanced Revenue Cycle Efficiency: The permanent code will substantially reduce claim processing times and minimize billing errors, accelerating cash flow for healthcare providers. This improved efficiency typically leads to higher adoption rates among medical practices.
- Broader Market Access: The standardized coding will facilitate coverage across both government (Medicare, VA, DoD) and commercial payers, expanding the addressable patient population. Historical data suggests that permanent J-codes can increase utilization by 20-30% in the first year post-implementation.
- Competitive Positioning: The specific coding for "1 microgram" provides clear billing parameters, reducing reimbursement complexity compared to percentage-based or variable-unit codes. This precision in billing units typically results in more predictable revenue streams for healthcare providers.
For Citius Pharmaceuticals, this development should accelerate market penetration by removing a significant barrier to adoption. Healthcare facilities are notably more inclined to stock and administer treatments with established permanent J-codes due to the reduced administrative burden and clearer reimbursement pathway.
Permanent J-Code (J9161) expected to be effective April 1, 2025
LYMPHIR is approved by the
Effective April 1, 2025, healthcare providers may use the permanent J-code, J9161 (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram), when submitting claims for LYMPHIR.
"The establishment of a permanent J-code marks a critical milestone in supporting patient access to LYMPHIR, providing coding clarity for physicians and facilities who administer LYMPHIR, and facilitating reimbursement. This achievement is a key step in ensuring that LYMPHIR is accessible to patients with commercial and government insurance (VA, DoD, Medicare) coverage," stated Leonard Mazur, Chairman and CEO of Citius Pharma and Citius Oncology.
J-codes are unique identifiers utilized by
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory approval in
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.
INDICATION
LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CAPILLARY LEAK SYNDROME
Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome.
As defined, CLS occurred in
Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated.
Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.
Visual Impairment
LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in
Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation.
Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity.
Infusion-Related Reactions
LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in
Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.
Interrupt or discontinue LYMPHIR based on severity [see Dosage and Administration (2.4)]. Institute appropriate medical management.
Hepatotoxicity
LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in
Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.
Embryo-Fetal Toxicity
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR.
ADVERSE REACTIONS
The most common adverse reactions (≥
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.
Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.
In the
Lactation
Risk Summary
No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.
Females and Males of Reproductive Potential
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.
Infertility
Males
Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.
Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric patients have not been established.
Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Pharmaceuticals at 1-844-459-6744.
Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius is actively engaged with the FDA to outline next steps for both programs. Citius Pharma owns
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma or Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our need for substantial additional funds; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's and Citius Pharma's Annual Reports on Forms 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.
FAQ
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