CVS Health reveals more details about plans for CKD care, home dialysis

Editor’s Note: CVS Health Corporation recently announced a new initiative focused on early identification of chronic kidney disease and the expansion of home dialysis to optimize care for patients. The company will focus on early identification and patient education, followed by the development of a comprehensive home program for hemodialysis and peritoneal dialysis. CVS Health will initiate a clinical trial to demonstrate a new home hemodialysis device in support of a planned FDA submission to obtain market clearance. The device has been designed to make home hemodialysis safe and simple, company officials said. Nephrology News & Issues asked Bruce Culleton, MD, vice president and chief medical officer of CVS Specialty, about the development of the chronic kidney disease (CKD) care approach and the plans for new home dialysis machines.

NN&I: This initiative is described by CVS Health as an initial focus on the detection of CKD in earlier stages. What expertise does the company bring to the table that can accomplish the goal?

Bruce Culleton, MD: We plan to utilize medical and pharmacy claims data and predictive analytics algorithms, in accordance with HIPAA, to identify people most at risk for kidney disease and progression to kidney failure. Our AccordantCare nurses will engage these individuals to educate them on their risk, important tests and the need to see a nephrologist. This team will continue to work with individuals that progress toward [end-stage renal disease] ESRD. We plan to utilize the predictive analytics platform we’ve built for adherence programs as well as our AccordantCare programs for other conditions to inform and build this new initiative.

NN&I: Is the company aiming for a particular CKD stage that should require intervention?

Culleton: CVS Health plans to focus our initial efforts on identifying stage 3 patients who are at high risk of progressing and stage 4 patients. Many of these patients may not be aware of the extent of their kidney disease and there may still be an opportunity to delay the need for renal replacement therapy. It is also an optimal time to begin transplant and dialysis modality education. We will also have separate disease management programs directed to patients with diabetes and hypertension who do not have advanced kidney disease.

NN&I: The announcement of this initiative includes mention of a second phase that would involve developing technology for the peritoneal dialysis and home hemodialysis market. What expertise does the company bring to the table on equipment technology?

Culleton: Our enterprise assets extend well beyond drug prescriptions. 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 payer relationships at CVS Caremark will enable us to create a unique value proposition to help reshape dialysis treatment. We have also hired employees with medical device experience and we are working with a world-class technology development partner with deep experience in medical device development.

NN&I: Can you provide a timetable for these new products? Or is the plan to work with companies with products already FDA approved?

Culleton: Proven devices are available today for peritoneal dialysis, which we will be looking to support down the line. While existing products are available for home hemodialysis, we are developing new technology intended to make longer, more frequent treatments easy, safe and simple. We are working with a partner but are not at liberty to disclose the name of this partner at this time. We plan to release more information in the coming months. With regard to a time frame, we expect to begin our clinical trials in 2018. We prefer not to disclose our expected timelines for clinical trial completion and FDA review.

NN&I: Peritoneal dialysis has been a success story but use of home hemodialysis remains at a low 2% of the ESRD population. Does CVS have some ideas on how to make that work in a largely for-profit provider community?

Culleton: Yes. We have many ideas to make this work within the current reimbursement structure. We will be expanding the company’s presence in kidney care, developing strategic partnerships, recruiting talent and engaging with the kidney disease community over the coming months. – by Mark E. Neumann

Disclosure: Culleton reports no relevant financial disclosures.

Editor’s Note: CVS Health Corporation recently announced a new initiative focused on early identification of chronic kidney disease and the expansion of home dialysis to optimize care for patients. The company will focus on early identification and patient education, followed by the development of a comprehensive home program for hemodialysis and peritoneal dialysis. CVS Health will initiate a clinical trial to demonstrate a new home hemodialysis device in support of a planned FDA submission to obtain market clearance. The device has been designed to make home hemodialysis safe and simple, company officials said. Nephrology News & Issues asked Bruce Culleton, MD, vice president and chief medical officer of CVS Specialty, about the development of the chronic kidney disease (CKD) care approach and the plans for new home dialysis machines.

NN&I: This initiative is described by CVS Health as an initial focus on the detection of CKD in earlier stages. What expertise does the company bring to the table that can accomplish the goal?

Bruce Culleton, MD: We plan to utilize medical and pharmacy claims data and predictive analytics algorithms, in accordance with HIPAA, to identify people most at risk for kidney disease and progression to kidney failure. Our AccordantCare nurses will engage these individuals to educate them on their risk, important tests and the need to see a nephrologist. This team will continue to work with individuals that progress toward [end-stage renal disease] ESRD. We plan to utilize the predictive analytics platform we’ve built for adherence programs as well as our AccordantCare programs for other conditions to inform and build this new initiative.

NN&I: Is the company aiming for a particular CKD stage that should require intervention?

Culleton: CVS Health plans to focus our initial efforts on identifying stage 3 patients who are at high risk of progressing and stage 4 patients. Many of these patients may not be aware of the extent of their kidney disease and there may still be an opportunity to delay the need for renal replacement therapy. It is also an optimal time to begin transplant and dialysis modality education. We will also have separate disease management programs directed to patients with diabetes and hypertension who do not have advanced kidney disease.

NN&I: The announcement of this initiative includes mention of a second phase that would involve developing technology for the peritoneal dialysis and home hemodialysis market. What expertise does the company bring to the table on equipment technology?

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Culleton: Our enterprise assets extend well beyond drug prescriptions. 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 payer relationships at CVS Caremark will enable us to create a unique value proposition to help reshape dialysis treatment. We have also hired employees with medical device experience and we are working with a world-class technology development partner with deep experience in medical device development.

NN&I: Can you provide a timetable for these new products? Or is the plan to work with companies with products already FDA approved?

Culleton: Proven devices are available today for peritoneal dialysis, which we will be looking to support down the line. While existing products are available for home hemodialysis, we are developing new technology intended to make longer, more frequent treatments easy, safe and simple. We are working with a partner but are not at liberty to disclose the name of this partner at this time. We plan to release more information in the coming months. With regard to a time frame, we expect to begin our clinical trials in 2018. We prefer not to disclose our expected timelines for clinical trial completion and FDA review.

NN&I: Peritoneal dialysis has been a success story but use of home hemodialysis remains at a low 2% of the ESRD population. Does CVS have some ideas on how to make that work in a largely for-profit provider community?

Culleton: Yes. We have many ideas to make this work within the current reimbursement structure. We will be expanding the company’s presence in kidney care, developing strategic partnerships, recruiting talent and engaging with the kidney disease community over the coming months. – by Mark E. Neumann

Disclosure: Culleton reports no relevant financial disclosures.