CVS to Test a Device For Dialysis at Home -- WSJ
July 18 2019 - 3:02AM
Dow Jones News
By Anna Wilde Mathews
This article is being republished as part of our daily
reproduction of WSJ.com articles that also appeared in the U.S.
print edition of The Wall Street Journal (July 18, 2019).
CVS Health Corp. is making an ambitious move into kidney care,
launching a clinical trial for a new home-dialysis device designed
by the firm of Dean Kamen, the Segway inventor.
The company is delving into unusual territory for a drugstore
and health insurer. The plan will make it a medical-device firm and
a provider of dialysis, the complex blood-cleansing procedure vital
to patients suffering from kidney failure. CVS holds exclusive U.S.
rights to the HemoCare device, which was created by Mr. Kamen's
firm, Deka Research & Development Corp.
CVS will work to capitalize on an initiative announced last week
by the Trump administration, which wants to move more dialysis into
the home, rather than dialysis centers, where most U.S. patients
currently get the procedure. Dialysis is covered by Medicare,
including for patients under the age of 65. The care of patients
with end-stage renal disease is a major cost for the program,
amounting to around $35 billion in 2016, or roughly 7% of total
spending under traditional Medicare.
The Department of Health and Human Services said increased use
of home dialysis could reduce costs and "preserve or enhance the
quality of care."
Alan Lotvin, executive vice president at CVS, said the company
is making a broader push into care for patients with kidney
disease, including managing the care of those who aren't yet
eligible for dialysis. CVS plans to offer home dialysis services,
both using the new device and a different method known as
peritoneal dialysis, but it doesn't expect to perform dialysis in
its own facilities or stores, he said. The new device is expected
to be leased or sold to other providers, he said.
"We think that this is a really important step forward for the
care of patients," Dr. Lotvin said.
CVS said the clinical trial of the HemoCare device focuses on
demonstrating its safety and efficacy and winning approval from the
Food and Drug Administration. The trial is expected to enroll
approximately 70 patients throughout the country. It will compare
the results for the device when it is operated by a nurse with what
happens when the dialysis is performed at home by the patient and a
partner. CVS said the trial is expected to be completed around the
end of 2020, and the company aims to have the device in the market
in late 2021.
"We've gone to extraordinary lengths to build safety systems
focused on the idea that the device will be used by a patient" in
the home, said Mr. Kamen, who is known as the inventor of the
Segway electric two-wheeled people mover but has also helped create
an array of other devices, several in the health-care category. He
said the new home-dialysis device is designed to be simple and
intuitive to operate.
CVS declined to comment on financial details of its deal with
Deka. Mr. Kamen said that CVS helped fund the development of the
device, and Deka will be paid a licensing fee based on "how
successful they are in the marketplace." Deka will oversee the
device's manufacturing, he said.
Kidney care is part of CVS's effort to become a health-care
provider for people with chronic conditions, a touchstone of its
nearly $70 billion deal to acquire insurer Aetna Inc.
CVS is under pressure to show financial benefits and paths to
growth tied to the deal, and its shares have been languishing in
recent months after the company issued earnings projections for the
year that fell short of investor expectations.
Dialysis patients often have multiple health problems, making
their care far more complex than the types of procedures
traditionally offered in retail clinics.
In entering the dialysis business, CVS will be taking on DaVita
Inc. and Fresenius Medical Care North America, a subsidiary of a
German company, which dominate the U.S. dialysis market. DaVita and
Fresenius, which themselves offer home-dialysis options, have
longstanding ties to kidney-care doctors who oversee the care of
patients, analysts said.
"Nephrologists are everything," said John Ransom, an analyst at
Raymond James. "They're the gatekeeper to where you go and what
your plan of care is."
Dr. Lotvin said CVS is well-positioned to compete in kidney
care, pointing to the new technology of the device and its lack of
the fixed cost of a center network, as well as relationships with
health-care payers.
Write to Anna Wilde Mathews at anna.mathews@wsj.com
(END) Dow Jones Newswires
July 18, 2019 02:47 ET (06:47 GMT)
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