Transforming kidney care

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An estimated 37 million Americans live with chronic kidney disease (CKD) and nearly 700,000 have end stage renal disease (ESRD). Treatment can be challenging and costly for both patients and payers. In fact, dialysis alone costs Medicare approximately $120 billion annually. Yet, despite the enormous cost, patient outcomes are poor, with nearly one in six dialysis patients dying in the first year after starting treatment.United States Renal Data System. 2019 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, 2019.

At CVS Health, we are working to fundamentally transform the treatment paradigm for the millions of patients with CKD and ESRD through CVS Kidney Care, a CVS Health company. Specifically, our CKD management program is focused on early identification of kidney disease, targeted patient engagement and ongoing education to help slow disease progression.

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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 chronic kidney disease. 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.

Our CKD care management program is focused on helping people understand their condition, delay the need for dialysis, and make confident treatment decisions when the time comes. For more information, visit the CVS Kidney Care website.

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There is hope. A system that pays for kidney health, rather than kidney sickness, would produce much better outcomes, often at a lower cost, for millions of Americans.

Alex M. Azar III, U.S. Secretary of Health and Human Services

Aligned with HHS priorities

In 2019, an executive order aimed at improving kidney care helped launch a new Advancing Kidney Health initiative of the Department of Health and Human Services (HHS). 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 ESRD 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 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 uniquely positions us to help advance and support the administration’s directives to improve early detection of and expand treatment options for kidney care. Across our CVS Health enterprise, 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. 

Visit the CVS Kidney Care website to learn more about our offerings.

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CVS Health Announces Start of Clinical Trial for New Home Hemodialysis Device

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HemoCare Hemodialysis System designed for home dialysis to enable patients to benefit from longer treatment as compared to in-center treatments

Represents next step in company-wide strategy to help improve kidney disease diagnosis and management

WOONSOCKET, R.I., July 17, 2019 /PRNewswire/ -- CVS Health (NYSE: CVS) today announced the initiation of a clinical trial designed to evaluate the safety and efficacy of the HemoCare Hemodialysis System for administration of home hemodialysis. The innovative device includes safety features and is designed to make home hemodialysis simple for patients. Home hemodialysis helps facilitate longer, more frequent dialysis treatments as compared to in-center treatments, and published clinical research has found that longer, more frequent hemodialysis treatments result in better health outcomes in appropriate patient populations.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. The clinical trial of up to 70 patients will be conducted at up to ten sites in the United States.

"We're working now to change the kidney care paradigm by bringing to market programs and tools to improve early detection of kidney disease and provide comprehensive education and support to help delay the transition to dialysis," said Alan Lotvin, M.D., Executive Vice President and Chief Transformation Officer, CVS Health. "For those patients who do progress to dialysis, we are working to bring a new solution to the consumer that addresses the current barriers to and limitations of existing dialysis options, and we are working closely with the U.S. Food and Drug Administration as we evaluate this device."

Currently, hemodialysis, which uses a machine to clean a patient's blood, is most commonly administered in a dialysis center three times per week. However, an expanding body of scientific literature indicates that clinical outcomes for hemodialysis patients can be improved if treatments are longer in duration, which can be challenging to achieve via in-center dialysis.

During the trial, investigators will measure the safety and performance of the HemoCare Hemodialysis System. In the initial phase of the trial conducted at medical facilities, clinical study subjects and their caregivers will receive training on the system and will then transition to home-based dialysis. Primary study endpoints include adverse events as well as regular tests to measure the dose efficacy of dialysis delivered by the device. The HemoCare Hemodialysis System was developed in collaboration with DEKA Research & Development Corp.

"DEKA designed this device with patients in mind to help make home dialysis safe and simple," said Dean Kamen, founder of DEKA Research & Development Corp. "CVS Health is uniquely positioned to redefine identification, education and treatment for chronic kidney disease, making them our ideal partner."

The clinical evaluation of the HemoCare Hemodialysis System and the early kidney disease identification and stratification programs are solutions of CVS Kidney Care, a CVS Health company. CVS Kidney Care is developing a series of comprehensive solutions for all commercial and government payers that are focused on improving health and outcomes for people living with chronic kidney disease (CKD) and end stage renal disease (ESRD).

In addition, CVS Kidney Care aligns with the core objectives of the recently announced Advancing Kidney Health initiative. Led by the U.S. Department of Health and Human Services' (HHS), the new effort aims to help improve early detection of and expand treatment options for kidney disease while working to reduce unnecessary health care costs for both patients and payers.

"We have been working to fundamentally disrupt the kidney care market and rapidly innovate in an area that has stagnated for decades, and we applaud the administration for taking bold steps toward advancing kidney care as they are helping to rethink how to make kidney transplant and home dialysis mainstays of therapy," added Dr. Lotvin. "CVS Kidney Care is uniquely positioned to help deliver on the core tenets of this new HHS initiative in a way that no one else can, and we look forward to working together to help transform the kidney treatment experience for millions of Americans."

More than 37 million Americans have kidney disease, and nearly 700,000 have ESRD. Of those with ESRD, more than 500,000 of these patients are on active dialysis and more than 120,000 new ESRD cases are diagnosed each year. Financially, this disease represents a huge cost burden, costing Medicare $35 billion annually related to dialysis patient care. Despite this high level of spending, outcomes for dialysis patients are poor, with one in six dialysis patients dyingUnited 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. in the first year after starting treatment.

Health care providers, patients, caregivers and patient organizations who want to learn more about the HemoCare Hemodialysis System clinical trial can reach us at KidneyCare@CVSHealth.com or learn more at www.cvshealth.com/kidneycare.

About CVS Health
CVS Health is the nation's premier health innovation company helping people on their path to better health. Whether in one of its pharmacies or through its health services and plans, CVS Health is pioneering a bold new approach to total health by making quality care more affordable, accessible, simple and seamless. CVS Health is community-based and locally focused, engaging consumers with the care they need when and where they need it. The Company has more than 9,900 retail locations, approximately 1,100 walk-in medical clinics, a leading pharmacy benefits manager with approximately 94 million plan members, a dedicated senior pharmacy care business serving more than one million patients per year and expanding specialty pharmacy services. CVS Health also serves an estimated 38 million people through traditional, voluntary and consumer-directed health insurance products and related services, including a rapidly expanding Medicare Advantage offering and a leading standalone Medicare Part D prescription drug plan. The Company believes its innovative health care model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at https://www.cvshealth.com.

Media Contact:

Christina Beckerman
CVS Health
401-770-8868
Christina.Beckerman@CVSHealth.com

 

Investor Contact:

Joe Krocheski
CVS Health
860-273-0896

KrocheskiJ@Aetna.com

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