Creating an at-home blood dialysis industry has been a struggle.

Health
The Home Cure
Creating an at-home blood dialysis industry has been a struggle.
Robert Langreth 11.24.08
Forbes.com

Software Engineer Colin Mackay was 32 when a mysterious autoimmune disease destroyed his kidneys in 2001. By last year two transplants had failed; doctors told him he would have to go on dialysis three times a week for the rest of his life. Mackay, now 39, would arrive at work at dawn on dialysis days so he could leave in time for the four-hour treatment. The treatment was so exhausting that he went straight to bed as soon as he got home. On the off-days toxins built up, making him bloated and twitchy. He slept badly and rarely had the energy to entertain his kids.

Then his wife heard about a home dialysis treatment from University of Pennsylvania nephrologist Joel Glickman. It uses a new portable machine from NxStage Medical in Lawrence, Massachusetts that allows patients to treat themselves at home in six shorter sessions per week. Mackay started the home treatment in September and had more energy almost immediately. His blood pressure sank to normal because he didn't have so much fluid buildup. For the first time in years he can play soccer with his 7-year-old and 5-year-old. "This is a breath of fresh air. I feel infinitely better," he says. "My kids have gotten back a father."

Kidney dialysis is that rare medical procedure that hasn't changed much in decades. More than 300,000 Americans with renal failure, often caused by diabetes, trudge to dialysis centers on a rigid thrice-weekly schedule. A kidney transplant is salvation, but organs are scarce. Dialysis keeps patients alive by removing excess fluid and toxins with expensive blood-filtering machines. It can be an unpleasant existence. Patients often gain a lot of weight, and the ups and downs in fluid buildup stress the body and heart. A fifth of dialysis patients die in their first year, a number that hasn't improved since the early 1990s.

"We provide a very expensive therapy with high mortality and poor quality of life. We should be saying this is unacceptable," says Michael Kraus, a nephrologist at Indiana University School of Medicine. He is one of a small group of doctors allying with medical device firms hoping to shake up the status quo. They are arranging dialysis treatment schedules to be followed at home, either in short daily sessions or longer ones overnight. The goal is to better mimic the function of the kidneys, which work continuously.

Kraus started a home dialysis program in 2004 and now has 65 patients on the treatment. With daily treatment "people will live better and will live longer," he predicts. "There is no question about it, patients feel better," says Glickman.

Both doctors use NxStage's $21,000 machine, approved for home use in 2005. (Glickman and Kraus are NxStage scientific advisers.) The appliance, the size of a microwave, replaces behemoths the size of filing cabinets. A key innovation is that all of the sophisticated filtration is done in a disposable cartridge, eliminating the need for elaborate cleaning. "You slide the cartridge in, close the door, and away you go," says patient Mackay.

So far only 1% of blood dialysis patients are being treated at home. NxStage hopes to get this up to 15% someday but faces formidable obstacles selling its device through dialysis centers. Medicare won't routinely pay for more than three treatments a week, which comes out to $2,000 a month. NxStage charges dialysis centers $1,500 a month to lease its machine with supplies to the patient. That leaves centers limited profit, unless they plead for extra payments. Patients need 20 days of training and a partner to be on hand. There's also no proof from randomized trials that more frequent treatment saves lives or prevents hospitalizations. "I don't think there is sufficient evidence to justify a widespread change to six-times-a-week dialysis," says Stanford University nephrologist Glenn Chertow, who is running a big, randomized trial on more frequent in-center treatment.

NxStage is unprofitable, and its shares have dropped 70% this year. Another firm supplying home dialysis equipment went bust last year. "The average nephrologist is cynical whether patients really want to do this at home. It is so much easier to send them to the dialysis center," admits NxStage Chief Executive Jeffrey Burbank.

But interest in home machines is rising. Baxter International already sells supplies for peritoneal dialysis, an older nonblood method that pours dialysis fluid into the belly via a catheter and uses the abdominal lining itself as a filter. Last year it started working with noted medical-device inventor Dean Kamen to devise a home blood dialysis machine. Baxter kidney unit president Bruce McGillivray won't reveal details but predicts "a big transformation of the industry" if home machines catch on. Between both blood and peritoneal methods, a third of patients could benefit, he says.

Home Dialysis Plus in Portland, Oregon has an all-in-one dialysis machine that is half the weight of NxStage's and uses ink-jet technology from Hewlett-Packard to continuously mix small amounts of dialysis solution on the fly. "This will improve patients' lives and lower costs," says company founder Michael Baker. Meanwhile, UCLA researcher Martin Roberts is designing a wearable artificial kidney. His six-pound machine uses peritoneal dialysis but has catalysts and enzymes that remove the toxins from dirty solution so the liquid can be reused. Human trials for both are two years off.

Thirty-six-year-old Vanessa Evans has been on dialysis for a decade and switched to NxStage in 2005. On a conventional schedule she got pounding headaches and puffed up so much between treatments that her clothes would no longer fit, despite a long list of dietary restrictions. Now she eats what she wants and does dialysis with her two toddlers while they watch cartoons at night. "I never want to go back,'' she says, even though she admits managing all the supplies "can be daunting."

Home dialysis was fairly common in the 1960s, when the treatment was new and extremely expensive. Congress' decision in 1972 to cover dialysis gave rise to chains of outpatient centers that now treat 90% of U.S. patients. Two companies, DaVita in El Segundo, California and Germany's Fresenius Medical Care, dominate the in-center market. NxStage has partnered with DaVita. Fresenius sees the home market remaining small, but it is working on a wearable artificial kidney.

Interest in home treatment perked up in the 1990s when University of Toronto doctors reported good results with overnight treatments on conventional machines. Toronto's Andreas Pierratos says 85% of his overnight patients are still alive after five years, double the rate with traditional treatment. It is unclear whether the populations are comparable; those on the home method tend to be younger and more capable. Last year a University of Calgary trial found that people on overnight dialysis (with traditional machines) needed fewer hypertension drugs and their thickened heart muscles shrank, according to the results in the Journal of the American Medical Association.

But that study had only 52 patients. A much bigger government trial could prove that more frequent dialysis prevents serious health problems, but results won't come until 2010. "We suck up a lot of money in this field. [The feds] want outcomes data before they will pay" for more sessions, says Kaiser Permanente nephrologist Victoria Kumar. She has found that her NxStage patients save the health reimbursement money because of fewer hospital days.

Harvey Wells, a 56-year-old programmer in Texas, has been using NxStage since 2007. This summer he took his machine, two grandchildren and a nephew on a cross-country trip in his motor home. "It befuddles me why more people don't try it," he says.

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