Recent Updates:
CorMedix formally submitted an HCPCS application for a J-Code to theCenter for Medicare and Medicaid Services (CMS) onDecember 8, 2023 for DefenCath, and CMS has confirmed the application is under review. The Company continues to engage in discussions with CMS related to the appropriate outpatient reimbursement structure for DefenCath and remains committed to its pursuit of separate payment under Medicare Part B as the appropriate reimbursement mechanism for the product. CMS has not yet made a determination or provided a timeline for a final decision.
- The Company estimates the timing for DefenCath commercial availability at
April 15, 2024 for the inpatient setting, and no sooner thanJuly 1, 2024 for the outpatient setting, depending on a final determination from CMS related to outpatient reimbursement.
- The Company has received significant interest from providers since DefenCath’s
November 2023 approval. Several large and medium sized health systems have committed to put DefenCath through their P&T formulary processes in 2024, a necessary first step toward obtaining utilization in the inpatient setting.
- To begin the P&T formulary process at hospitals and health systems,
CorMedix may need to establish its list price for DefenCath prior to a final CMS determination on outpatient reimbursement. In such an instance, the Company expects to establish a list price based on the market dynamics for both inpatient contracting as well as a Transitional Drug Add-On Payment (TDAPA) framework for outpatient reimbursement.CorMedix would then subsequently revise the list price downward should CMS make a determination in favor of separate payment under Medicare Part B.
CorMedix expects to provide further detail on the DefenCath market opportunity as we receive clarity from CMS regarding outpatient reimbursement.
- The Company believes it has sufficient cash, cash equivalents and available resources to fund the commercial launch.
About
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. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, including, but not limited to, the commercial launch of DefenCath, including the timing of availability of DefenCath for inpatient and outpatient settings and the ability to staff a field team in time for commercial launch, the interest in DefenCath by health systems, CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations, including the commercial launch of DefenCath, 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, including: the risks and uncertainties related to the ability to have sufficient DefenCath available for commercial launch, CorMedix’s ability to contract with health systems for the use of DefenCath, market conditions, CorMedix’s ability to manage its cash resources and the impact on current, planned or future research. These and other risks are described in greater detail in CorMedix’s filings with the
Investor Contact:
Managing Director
daniel@lifesciadvisors.com
(617) 430-7576
Source:
2024 GlobeNewswire, Inc., source