CVS Enters Home Dialysis Market with New Device

CVS Health announced a new initiative focused on chronic kidney disease and dialysis, which builds upon the company’s focus on driving innovation in the management of chronic disease to help improve patient health outcomes while managing costs. This new program will focus on early identification of kidney disease and expansion of home dialysis in order to optimize care for patients with chronic kidney disease. CVS Health’s unique enterprise assets along with the company’s introduction of a truly innovative new home hemodialysis technology, position the company as a positive disruptor in the field with the ability to help reshape and redefine the kidney care space.
 
“In dialysis today, there is an enormous unmet medical need with high levels of mortality, frequent hospitalizations and poor quality of life for affected patients,” said Alan Lotvin, M.D., executive vice president and head of CVS Specialty. “As we explored this area it became clear that our enterprise assets from our experience with complex patient home care through Coram, the breadth of our chronic disease management capabilities with CVS Specialty and Accordant, and our deep payor relationships at CVS Caremark will enable us to create a unique value proposition to help reshape dialysis treatment.”
 
CVS Health will be approaching this new initiative in a staged approach with phases focused on early disease identification and patient education, followed by the development of a comprehensive home dialysis program, for both hemodialysis and peritoneal dialysis. As part of the home dialysis program, CVS Health will be initiating a pivotal clinical trial to demonstrate the safety and efficacy of a new home hemodialysis device in support of a planned FDA submission to obtain market clearance. The device has been designed with features intended to make home hemodialysis simple and safe for patients, in order to facilitate longer, more frequent treatments. In published clinical research, longer, more frequent hemodialysis treatments lead to better outcomes in appropriate patient populations.
 
“Diagnosing kidney disease early is the only way to prevent kidney failure and cardiovascular complications,” said Joseph Vassalotti, M.D., chief medical officer, National Kidney Foundation and a board-certified nephrologist. “There is an urgent need to increase patient awareness of not only the disease itself but also of the treatment options available for both early and chronic kidney failure or end-stage renal disease. Many patients believe in-center dialysis is their only kidney failure treatment choice, and do not know about patient-centered options, including home dialysis or kidney transplant,” added Dr. Vassalotti.
 
“While in-center dialysis clinics are currently the most common choice for hemodialysis treatment, published clinical research has shown improved cardiac health, metabolic control, and survival for patients who are treated with longer, more frequent dialysis treatments. This treatment paradigm is best delivered in the convenience of a patient’s home,” said Bruce Culleton, M.D., vice president and chief medical officer, CVS Specialty. “CVS Health is uniquely positioned to build a solution that will enable us to identify and intervene earlier with patients to optimize the management of chronic kidney disease, while at the same time making home dialysis therapies a real option for more patients.”
 
Nearly 700,000 Americans have End Stage Renal Disease (ESRD), with close to 500,000 of these patients on active dialysis and more than 120,000 new ESRD cases diagnosed each year. Financially, this disease represents a huge cost burden, costing Medicare nearly $65 billion a year for chronic kidney disease care, and another $34 billion directly related to dialysis patient care. Despite this high level of spending, outcomes for Medicare patients treated with traditional in-center hemodialysis, for example, are poor with mortality rates up to 10 times higher than among the general Medicare population.