CorMedix Inc. Supports CMS Policy Updates Regarding Access to Innovative Drug Products
CorMedix welcomes significant CMS policy updates that will enhance hemodialysis patients' access to innovative therapies. Starting January 2025, CMMI's Kidney Care Choices model will exclude TDAPA payments from financial calculations, facilitating access to new drugs including DefenCath®. This change affects over 30% of ESRD patients in the US currently enrolled in KCC programs, removing financial barriers to innovative drug utilization and ensuring patient care choices aren't by cost considerations.
CorMedix accoglie con favore importanti aggiornamenti delle politiche CMS che miglioreranno l'accesso dei pazienti in emodialisi a terapie innovative. A partire da gennaio 2025, il modello Kidney Care Choices di CMMI escluderà i pagamenti TDAPA dai calcoli finanziari, facilitando l'accesso a nuovi farmaci, tra cui DefenCath®. Questa modifica riguarderà oltre il 30% dei pazienti con ESRD negli Stati Uniti attualmente iscritti ai programmi KCC, rimuovendo le barriere finanziarie all'utilizzo di farmaci innovativi e garantendo che le scelte di cura dei pazienti non siano influenzate da considerazioni di costo.
CorMedix da la bienvenida a importantes actualizaciones de políticas de CMS que mejorarán el acceso de los pacientes de hemodiálisis a terapias innovadoras. A partir de enero 2025, el modelo de Opciones de Cuidado Renal de CMMI excluirá los pagos de TDAPA de los cálculos financieros, facilitando el acceso a nuevos medicamentos, incluyendo DefenCath®. Este cambio afecta a más del 30% de los pacientes con ESRD en EE. UU. que actualmente están inscritos en programas KCC, eliminando las barreras financieras para el uso de medicamentos innovadores y asegurando que las decisiones de atención de los pacientes no se vean limitadas por consideraciones de costo.
CorMedix는 혈액투석 환자들이 혁신적인 치료법에 접근할 수 있도록 개선할 CMS 정책의 중요한 업데이트를 환영합니다. 2025년 1월부터 CMMI의 신장 치료 선택 모델은 재정 계산에서 TDAPA 지불을 제외하여 DefenCath®를 포함한 새로운 약물에 대한 접근을 용이하게 할 것입니다. 이 변화는 현재 KCC 프로그램에 등록된 미국의 ESRD 환자의 30% 이상에 영향을 미치며, 혁신적인 약물 사용에 대한 재정적 장벽을 제거하고 환자 치료 선택이 비용 고려 사항에 의해 제약받지 않도록 보장합니다.
CorMedix se réjouit des mises à jour significatives des politiques CMS qui amélioreront l'accès des patients sous hémodialyse à des thérapies innovantes. À partir de janvier 2025, le modèle Kidney Care Choices de CMMI exclura les paiements TDAPA des calculs financiers, facilitant ainsi l'accès à de nouveaux médicaments, y compris DefenCath®. Ce changement concerne plus de 30% des patients atteints d'ESRD aux États-Unis actuellement inscrits dans des programmes KCC, supprimant les barrières financières à l'utilisation de médicaments innovants et garantissant que les choix de soins des patients ne soient pas influencés par des considérations de coût.
CorMedix begrüßt bedeutende Aktualisierungen der CMS-Richtlinien, die den Zugang von Patienten in der Hämodialyse zu innovativen Therapien verbessern werden. Ab Januar 2025 wird das Modell Kidney Care Choices von CMMI die TDAPA-Zahlungen von den finanziellen Berechnungen ausschließen und so den Zugang zu neuen Arzneimitteln, einschließlich DefenCath®, erleichtern. Diese Änderung betrifft über 30% der ESRD-Patienten in den USA, die derzeit in KCC-Programmen eingeschrieben sind, beseitigt finanzielle Hürden für die Nutzung innovativer Medikamente und stellt sicher, dass die Wahl der Patientenversorgung nicht durch Kostenüberlegungen eingeschränkt wird.
- Policy change removes financial barriers for DefenCath adoption in dialysis centers
- Access to over 30% of ESRD patient market through KCC programs
- Potential for broader system-wide implementation of DefenCath across clinics
- Implementation delayed until January 2025
Insights
BERKELEY HEIGHTS, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today highlights key policy changes from CMS that benefit hemodialysis patients. Yesterday, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) released important policy updates that will broaden the access of Medicare patients managing End Stage Renal Disease (ESRD) and on dialysis to innovative new therapies.
Beginning in January 2025, CMMI’s Kidney Care Choices (KCC) value-based care model will carve out Transitional Drug Add-on Payment Adjustments (TDAPA payments) from financial calculations such as benchmarks, performance year expenditures and USPCC trend rates, allowing ESRD patients participating in a KCC to have increased access to certain innovative new drugs, including CorMedix drug product DefenCath® (taurolidine and heparin). Given that more than
Joe Todisco, CorMedix CEO, commented, “CorMedix applauds CMS for making a patient-centered policy change that will align provider incentives with patient care and broaden access to innovation. I am appreciative of the industry stakeholders, patient advocacy organizations, and CorMedix team members that worked closely with CMS to enact this change for the benefit of patient access. This important change will better allow providers to more easily protocolize a product like DefenCath across clinics and patient payor segments system-wide.”
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
FAQ
When will CMS policy changes for TDAPA payments take effect for CRMD's DefenCath?
What percentage of ESRD patients will be affected by the new CMS policy change for CRMD?
How will the new CMS policy affect DefenCath accessibility for CRMD?
