CVS develops medical device to corner home dialysis market

CVS pharmacy
CVS initiated the program in a belief it can improve on existing home dialysis technologies. (Mike Mozart/CC BY 2.0)

CVS Health is developing a home dialysis medical device. The pharmacy chain is set to start a clinical trial later this year with a view to securing FDA approval and offering an at-home dialysis service by 2020.

Woonsocket, Rhode Island-based CVS established itself as a national brand through its pharmacies but over the past decade or so it has broadened its scope, notably by merging with pharmacy benefit manager (PBM) Caremark Rx and striking a deal to buy insurer Aetna. Now, CVS is moving onto turf traditionally colonized by medical device manufacturers.

As part of a broader move into kidney care and dialysis treatment, CVS is developing a medical device. CVS initiated the program in a belief it can improve on existing home dialysis technologies. 

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“In order to really make home hemodialysis viable, we needed a simpler device designed with patient use in mind, versus nurse use, and designed with the intent to be simpler, safer and easier without sacrificing effectiveness,” Alan Lotvin, head of CVS’s specialty pharmacy unit, told MarketWatch.

CVS will start a clinical trial of the device late in the third quarter. If everything goes to plan, CVS will win FDA approval of the device and be ready to enter the market in the second half of 2020. CVS will work with service providers to trial and manufacture the device.

The strategy, if successful, could change where dialysis patients are treated and the devices they use. Home dialysis offers greater convenience—plus potential for better outcomes if it enables longer, more frequent sessions—than in-center treatment. However, despite being available for years, home dialysis accounts for a tiny fraction of the U.S. market. 

Companies such as NxStage Medical have tried to move the sector forward by developing smaller, more portable dialysis machines better suited for home use. Those efforts made enough of an impact for Fresenius Medical Care, the dominant force in dialysis services and devices, to pen a $2 billion deal to buy NxStage. But are yet to translate into a sea change in where patients are treated.

The stage is now set for such a shift. Assuming Fresenius gets approval for the NxStage takeover, it and CVS will go toe to toe for the home dialysis market in the years to come. That could provide the push needed to take home dialysis mainstream, particularly as CVS ownership of a PBM and expected control of an insurer clears some of the financial, bureaucratic barriers to uptake. 

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