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Rockwell launches Triferic; awaits CMS approval of reimbursement code
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Rockwell Medical Inc. recently announced it would begin commercial sales of its dialysate iron product Triferic in the United States.
The company has developed multiple formulations of Triferic for the treatment of anemia in adult patients on hemodialysis. Rockwell expects to file a new drug application with the FDA for its next formulation, IV Triferic, within the second quarter of 2019.
“Dialysate Triferic is an innovative physiological alternative to existing IV iron formulations,” Marcos Rothstein, MD, professor of medicine in the division of nephrology at Washington University School of Medicine in St. Louis, said in a press release. “Dialysate Triferic does not increase iron stores. It has had no cases of anaphylaxis and the infection rate is similar to placebo. Additionally, in patients with reticuloendothelial block, it overcomes functional iron deficiency.”
Rockwell’s short-term objectives in marketing Triferic include increasing awareness of the product within the dialysis community, building and enhancing relationships with key opinion leaders and supporting medical education of nephrologists and other clinicians.
The company announced on May 1 that CMS had issued a preliminary recommendation that, if finalized, would establish a new level II Healthcare Common Procedure Coding System (HCPCS) code, or J-code (J1444), for Triferic powder packet. If finalized, this J-code for the powder packet would be separate and distinct from the existing J-code (J1443) that describes Triferic solution. The effective date for the code is July 1.
“We are pleased that CMS has issued a preliminary recommendation to establish a new J-code to identify the Triferic powder packet,” Stuart Paul, president and CEO of Rockwell Medical, said in a press release. “If finalized, the recommended J-code would help provide additional clarity for coding and claims processing in connection with distinct Triferic products.”
For the Triferic launch, Paul said the company would focus on dialysis centers that were part of its trial program, as well as select medium-sized, small and independent dialysis organizations that constitute approximately 25% of the U.S. market. Based on the expected sales cycle at dialysis clinics, the company does not expect material sales for dialysate Triferic in the second quarter of 2019.
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