CVS Kidney Care Launches Home Dialysis Clinical Trial

At CVS Health, we are working to fundamentally transform the treatment paradigm for the millions of patients with chronic kidney disease (CKD) and end stage renal disease (ESRD) through CVS Kidney Care, a CVS Health company. We are focused on early identification of kidney disease, targeted patient engagement and ongoing education to help slow disease progression, and increasing access to transplants and home dialysis to optimize care for patients.

As part of our commitment to make home dialysis a real option for more patients, CVS Health has initiated a clinical trial designed to evaluate the safety and efficacy of the HemoCare Hemodialysis System. This innovative device includes unique safety features and is designed to make home hemodialysis simpler for patients. The trial, if successful, is a necessary step to receive market clearance of the HemoCare system by the U.S. Food and Drug Administration.

An estimated 37 million Americans live with CKD and nearly 700,000 have ESRD. Treatment can be challenging and costly for both patients and payors. In fact, dialysis alone costs Medicare approximately $35 billion annually. Despite the enormous cost, patient outcomes are poor, with nearly one in six dialysis patients dying in the first year of treatment.United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018.

Improved Access to Better Treatment Outcomes

Currently, hemodialysis, which uses a machine to mimic the role of a functioning kidney to clean a patient’s blood, is most commonly administered in a dialysis center three times per week for four hours a day. However, an expanding body of scientific literature indicates that clinical outcomes for hemodialysis patients can be improved if treatments are more frequent and longer in duration, which can be challenging to achieve through in-center dialysis.Culleton BF, Walsh M, Klarenbach SW, et al. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA. 2007; 298(11):1291-1299.Kotanko P, Garg AX, Depner T, et al. Effects of frequent hemodialysis on blood pressure: Results from the randomized frequent hemodialysis network trials. Hemodialysis Int. 2015:19(3): 386-401.Nesrallah GE, Lindsay RM, Cuerden MS, et al. Intensive hemodialysis associates with improved survival compared with conventional hemodialysis. J Am Soc Nephrol 2012; 23 (4): 696-705.

CVS Kidney Care will also support other treatment options such as transplant and peritoneal dialysis.

Earlier Identification and Better Patient Education

Many people who have kidney disease don’t know it. In fact, in the U.S., 43 percent of those with severely reduced kidney function are not aware that they have CKD. By promoting early diagnosis, we will work to help delay the onset of dialysis and avoid emergency hospitalization, which is one of the biggest drivers of cost in kidney care.

As we expand our CVS Kidney Care programs and services, we will offer all-inclusive education to diagnosed patients, including face-to-face, personalized support and therapy education, as well as other proven patient engagement strategies. This begins with helping patients better understand the treatment options available to them, as well as educating them on critical factors such as kidney health, diet, comorbidities, and prescription management.

Aligned with HHS Priorities

Recently, an executive order aimed at improving kidney care helped launch a new Advancing Kidney Health initiative of the U.S. Department of Health and Human Services. This marked an important step forward in kidney care as the administration pledged to double the number of kidney transplants performed in the U.S. and reduce end-stage kidney failure by 25 percent by 2030 through better education and care during early forms of the disease.

Furthermore, the administration wants 80 percent of newly diagnosed people with end-stage kidney failure to receive a transplant or move from clinic-based dialysis to less expensive and more effective in-home care by 2025.

Our CVS Kidney Care focus aligns with the core objectives of this new initiative, and we are committed to transforming the health care system to better meet the needs of patients and reduce overall costs. Our unique approach to kidney care is one way that we are doing this as we work to help more people on their path to better health.