posted 01-14-2000 08:51 AM               

(What follows is a small portion of the April issue of the National Renal Administrators Association's (NRAA) President's Letter. For information on joining the NRAA and receiving complete print and electronic versions of up-to-the-minute and in-depth reports on all ESRD issues, visit the NRAA web site.)

Board Members Tony Messana and Steve Bucher and Gwen Gampel participated in the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) Task Force on Daily Dialysis meeting April 11- 12 at the National Institutes of Health campus in Bethesda, Maryland. The purpose of the meeting was to discuss the development of a clinical trial on short daily hemodialysis and long nocturnal nightly hemodialysis to determine its efficacy for coverage under the Medicare program.

It was an outstanding conference which presented the ESRD community at its best in terms of focus, content of discussions and commitment by all those who participated.  The two day conference included a who’s who of all of the ESRD stakeholders including researchers, nephrologists, daily dialysis providers, the major chains, NRAA, RPA, ANNA, NKF and government staff from HCFA and the NIDDK.

Josephine Briggs,MD, Director of the NIDDK closed the meeting with an announcement that the NIDDK in conjunction with HCFA would conduct a clinical trial to estimate the magnitude of the benefit from daily dialysis.  She said she was moved by the experiences of those who were providing daily hemodialysis and optimistic about the outcome of the clinical trial.  She also saw the urgency in obtaining hard evidence from the clinical trial given the current mortality rate.

Jeff Kang, MD, Director of the Office of Clinical Standards and Quality at HCFA stated that while there was a lot of anecdotal evidence on the benefits of daily hemodialysis HCFA had to make its coverage decision based on scientific evidence.  For HCFA the key questions are: Who can benefit?  What is the dose response curve? What method is most effective?  While he repeatedly stressed that cost effectiveness was not a criteria for HCFA’s coverage decision process HCFA did need to identify the costs of providing daily hemodialysis in order to establish fair reimbursement. HCFA would also be looking at the "down stream" benefits of daily hemodialysis in terms of reduced hospitalizations and physician visits and reduced need for EPO and outpatient prescription drugs. For Kang the bottom line was if the outcomes improved, then HCFA should cover daily hemodialysis.

Briggs outlined the process by which the clinical trial will be developed.  The report of the meeting will be posted on the NIDDK’s web site in a few weeks.  NIDDK expects to have "concept approval" of the clinical trial by the end of May and will then draft the RFP which will likely go out in June.  A steering committee of successful grantees will develop and finalize the protocol and funding of the trial will be established in about six months.  HCFA will set the reimbursement amount for the daily hemodialysis treatments and the actual clinical trial will likely begin next spring.

The first day of the meeting included sessions on: (1) mechanisms of efficacy, solute kinetics; (2) background on issue, current results, experience; (3) trial design issues; and (4) industry roundtable on economic issues.  Four breakout sessions continued over a working dinner on the trial design for short daily hemodialysis, trial design for long nocturnal hemodialysis, economic issues and epidemiological monitoring.

On the second day the trial design recommendations were presented from the working groups.  For the short daily hemodialysis clinical trial the major recommendations include:

• The Research Question: What is the effect of morbidity and mortality with the use of daily hemodialysis versus three times a week hemodialysis?


• Design: Six times a week. Set the goal as the weekly standard/Kt/V based on six treatments.


• Intervention: Use DOQI™ guidelines, no reuse, high flux membranes and no specification of machine. Strive for randomization.


• Eligibility: Choose high risk patients but not those for whom death is imminent, on dialysis at least three months and recruit extremes of body volume.


• Outcomes to be Measured: Total mortality.  Secondary outcome: Morbidity, hospitalizations, cardiovascular disease, quality of life, employment, eligibility for transplantation, hematocrit level, blood pressure, and access failure.


• Duration of Trial: At least one year


• Stop Mechanism: If the trial shows clear benefit then the trial should be stopped and HCFA should go forward with reimbursement.


• Grandfathering: Allow others in the clinic to join.

For the long nocturnal daily hemodialysis clinical trial the major recommendations include:

• Design: Six times a week.


• Venue: Home, skilled nursing facility or in-center.


• Eligibility: Sample everyone but try to over sample for cardiovascular patients.


• Outcomes to be Measured: Mortality and other outcomes measures include hospitalization, MI, CVA creatinin, albumin, LV etc, biochemical, and quality of life.  Secondary outcomes: nutrition, cardiovascular measures and hemotalyic measures.


• Duration of Trial: One year


• Randomization: Strive for randomized clinical trial based on patients instead of whole dialysis facility.


• Payment Issues To Consider: Perhaps pilot economic study for reimbursement to providers. Will reimbursement serve as precedent for future payment policy, be based on the composite rate or a variant,  reflect number of treatments, and exclude MSP patients from eligibility.

(End of Gwen Gampel's report.)

April 20, 2001 - Aksys, Ltd. announced their first quarter results (link no longer available). Aksys continues to prepare for the commercial launch of the Personal Hemodialysis (PHD™) System expected to occur during the second half of 2001, pending clearance from the US Food and Drug Administration.

April 7, 2001 - A workshop of the Task Force on Daily Hemodialysis is scheduled for April 11-12 at the National Institute of Health in Bethesda, MD.

Medicare payment policy, also known as the composite rate, is based on three-times-a-week dialysis. In the past few years, hemodialysis on a daily basis has been tested at a few centers. Two forms of daily dialysis are currently in use: long nocturnal dialysis and short day-time dialysis. Preliminary information from these recent experiences has generally been positive. This workshop will share data from the current daily dialysis programs and will identify the essential features of a randomized clinical trial of daily hemodialysis. The workshop will serve as a basis for the potential development of an RFA for a clinical trial(s).

Here is the workshop daily agenda.

March 29, 2001 - This month's American Journal of Kidney Diseases (AJKD) has an article and editorial about daily hemodialysis. The article offers data from a small study that shows that daily hemodialysis reduces the overall cost of treating ESRD patients by reducing hospitalizations.

The abstract of the article, "The Case for Daily Dialysis: Its Impact on Costs and Quality of Life" is available on-line. (web link is no longer available)

March 14, 2001 - Here is more recent information on daily hemodialysis:

American Nephrology Nurses Association (ANNA) Statement: "Daily Hemodialysis (DHD)/Nocturnal Hemodialysis (NHD) Position"

Abstract from Blood Purification journal: "A Comparative Study of Blood Pressure Control with Short In-Center versus Long Home Hemodialysis"

March 6, 2001 - Here are recent scientific papers and business news on the topics of daily hemodialysis and home hemodialysis:

Abstract from AJKD Supplement: "Short Daily Hemodialysis and Nutritional Status"

Abstract from AJKD Supplement: "Clinical Outcome of Daily Dialysis"

Abstract from Kidney International Supplement: "Does convective dialysis therapy applied daily approach renal blood purification?"

Aksys, Ltd. issued a press release on the exhibit of their Personal Hemodialysis System (PHD™) at the recent dialysis conference in New Orleans. (link no longer available)

The Aksys stock price has dropped sharply in the last two months.

February 6, 2001 - Aksys, Ltd. announced their fourth quarter and fiscal 2000 report yesterday. (link is no longer available)

For the year ended December 31, 2000, Aksys reported a net loss of $15.7 million. For 1999, they reported a net loss of $11.3 million. The company has submitted a 510(k) notification to the FDA for their Personal Hemodialysis System (PHD™) and are awaiting a response. With 510(k) approval, Aksys will be able to sell the PHD in the US.

January 30, 2001 - Aksys, Ltd. today unveiled its plan to commercialize the PHD™ Personal Hemodialysis System. (link is no longer available)

Aksys is currently targeting to have 18,000 -23,000 patients on the PHD System in the U.S. by 2006. With a forecasted U.S. dialysis patient population of 375,000 at that time, this would represent a 5% market share and annual revenues to Aksys of approximately $400 million.

January 16, 2001 - Aksys, Ltd. announced its submission of a 510k Premarket Notification to the FDA requesting clearance to market the PHD(TM) Personal Hemodialysis System in the U.S. (link is no longer available)

November 17, 2000 - Aksys, Ltd. announced today that they have completed the clinical trialsof their home hemodialysis system that are required for the FDA 510(k) submission.

October 19, 2000 - Aksys, Ltd. reported their third quarter results and nine months ending September 30, 2000. Aksys is working on a new home hemodialysis machine.

Aksys President and CEO Bill Dow stated, "On October 16, the twentieth patient completed the clinical trial. To date patients have dialyzed nearly 2,000 times on the PHD System, including over 1,500 treatments in the patients' homes. We now have the data we need for the 510(k) submission to the FDA, which we intend to file by the end of this year."

July 12, 2000 - Here are two stories about the development of a new, easy-to-use, home hemodialysis machine:

Aksys, Ltd. announced this week that nine of the required twenty patients have completed the necessary protocol of treatments for the clinical trials of their Personal Hemodialysis (PHD(TM)) System.

This story from the Kansas City Star provides background information on the inventor of this new machine. (link is no longer available)

Home hemodialysis may be the next significant trend in treatment modalities for end-stage renal disease patients. Points to consider:

• Improvements in technology have made home hemodialysis machines much easier to operate and less labor intensive. The Internet makes remote monitoring of treatments easy and practical.
  
• The cost of nursing/technician labor is nearly eliminated. The costs of treating ESRD patients would not increase.
  
• With daily home hemodialysis, weekly clearances are greatly increased and many of the ESRD patient dietary restrictions can be relaxed.
  
• Many outpatient dialysis clinics may become home hemodialysis training centers staffed by RN's and certified technician trainers.
  
• Many patients will prefer being able to control and manage their dialysis treatments, schedule, and environment.

March 14, 2000 - Aksys, Ltd. announced today that the first three patients are now dialyzing at home using their Personal Hemodialysis System (PHD™).

January 14 - Aksys, Ltd. announced this week that the clinical trials of their Personal Hemodialysis System (PHD™) have begun. The Aksys stock price rose over 40% in response to the news.

There are a number of companies currently working on an easy-to-operate home hemodialysis machine. As the most expensive component of an in-center hemodialysis treatment is nursing labor, this new generation of hemodialysis machines may offer governments and insurance companies a less expensive treatment modality. This new technology may also make daily hemodialysis, with all its long-term health benefits, an affordable reality.

The Aksys, Ltd. web site has a number of articles about Daily Hemodialysis. (link is no longer available)

Here is a search result listing from the National Library of Medicine's PubMed search tool for the topic "home hemodialysis".

Here is the table of contents of the second issue of the Home Hemodialysis Today journal (May 2000).

[This message has been edited by Gary Peterson (edited 02-19-2003).]

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