31 million Americans have chronic kidney disease.

For patients with irreversible kidney problems, dialysis is a life-saving therapy.

But, it's also a tough treatment that requires a lot of time.

Now, an artificial kidney may offer patients more freedom.

Dialysis patient Toby Muñoz Junior sits in a chair, three times a week for up to five long hours at a time.

“It just drives me up the wall,” says Toby. “I'm not a sit down person. I can barely make it through a movie theatre watching a movie."

Toby needs dialysis to do the work of his failing kidneys. But the treatments have taken over his life, even forcing him to quit his job.

"The quality of life of dialysis patients leaves a lot to be desired," says Dr. Victor Gura, a kidney specialist at UCLA.

Now, researchers are studying a wearable artificial kidney. It does the same job as dialysis but it's portable, so it offers patients the ability to move while they receive therapy.

"[Patients can] live their life and move around not be tethered to a machine while receiving dialysis therapy,” says Dr. Jonathan Himmelfarb, a professor of medicine at the University of Washington.

The artificial kidney runs continuously on batteries and weighs 10 pounds. Researchers will study the device in up to 10 patients as part of a clinical trial. The goal is to give dialysis patients more freedom.

"We hope to give them basically their life back," says Dr. Gura.

Toby says it would be a welcome change; he wouldn't miss sitting in the dialysis chair.

This clinical trial will be the first human study in the U.S. conducted on the wearable artificial kidney.

The researchers hope the device will allow patients to walk, shop or perform other chores while receiving their treatments.

They believe the portable device would also save money because patients will require fewer medications and hospital visits.

While the current prototype weighs 10 pounds, they hope to make a smaller, lighter version soon.

BACKGROUND: Kidney disease is the eighth leading cause of death in the United States and more than 10 percent of the U.S. population suffers from chronic kidney disease. Kidney disease is the gradual loss of the function of the kidneys. The kidneys filter waste and excess fluid from your blood which is then excreted through urination. Kidney disease is so dangerous because once it reaches an advanced stage, dangerous levels of fluids, electrolytes and wastes can build up in your body. The buildup of these wastes can cause symptoms such as nausea, vomiting, loss of appetite, fatigue or weakness, sleeping problems, changes in urine output, muscle twitches and cramps, swelling of feet and ankles, and a decrease in mental sharpness. Many of the signs and symptoms of kidney disease can be nonspecific and can also be caused by other illnesses. It is best to be checked by a doctor if you notice any signs or symptoms.
(Source: http://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/treatment/con-20026778, http://www.kidneyfund.org/about-us/assets/pdfs/akf-kidneydiseasestatistics-2012.pdf)

TREATMENT: There are several treatments for chronic kidney disease. The correct treatment for you depends on the stage of the illness. Many treatments include:
* High blood pressure medications
* Cholesterol lowering medications
* Anemia medications
If your kidneys are not able to keep up with the waste and fluid clearance on their own, you may go into near or complete kidney failure. This is called end-stage kidney disease. Treatment for end stage kidney disease includes dialysis or a kidney transplant. Many patients with end-stage kidney disease are put on dialysis in order to remove waste products and extra fluid from the blood. A machine is able to filter waste and excess fluids from your blood and return the blood back into your body cleaned. The downside to dialysis is that it is a long process and requires patients to sit for many hours weekly while receiving treatment.
(Source: http://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/treatment/con-20026778)

NEW TECHNOLOGY: A new wearable artificial kidney has been developed and is being tested in clinical trials. In essence, patients will be able to receive dialysis while on the go. The new artificial kidney machine will be wearable and will allow patients to have the freedom from traditional stationary dialysis machines. The wearable artificial kidney does the same job as regular dialysis machines just in a more physiological, or natural way.
(Source: Victor Gura, MD)

FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:

Victor Gura, MD, FASN
310-550-6240
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

...

BALTIMORE––Making a generic drug is easy compared to developing a biosimilar compound, said David Goldsmith, MD, president and senior consultant of Goldsmith Pharmacovigilance and Systems. He, along with Ali McBride, PharmD, clinical coordinator for hematology/oncology at the University of Arizona Cancer Center, walked through the steps of how biosimilars are tested and developed during a symposium held this past week at the Renal Physicians Association’s annual meeting here.

The symposium was sponsored by Hospira, who is currently awaiting U.S. Food and Drug Administration review of its biosimilar Retacrit, a drug that would compete with Amgen’s epoetin alfa and Janssen’s Procrit. Hospira submitted the application last December, making it the fourth company to announce submission of a biosimilar application to the FDA. The drugmaker said it expects FDA notification of acceptance of the submission within 60 days of filing.

The FDA has committed for this fiscal year to act on at least 80% of biosimilar applications within 10 months, according to a Jan. 20 article in FDA News. An FDA’s Oncologic Drugs Advisory Committee voted unanimously recently to recommend approval of Sandoz’s Zarxio, a biosimilar to Amgen’s Neupogen (filgrastim).
While still in its infancy in the U.S., biosimilars have been marketed in Europe for a number of years. Hospira has products in Australian and European markets, including Retacrit, which Hospira launched in Europe in 2008 and Australia in 2011.

Goldsmith and McBride both agreed that the biosimilar path is a complicated one. Unlike generic manufacturers, biosimilar pharmaceutical companies have to notify the company they will be directly competing against that they are developing a similar drug to their original biologic.

But biosimilar companies point to the high cost of biologics to help justify their pursuit: global biological sales are projected to be $221 billion in 2017, up from just $46 billion in 2002. In 2010, eight of the 10 highest expenditure drugs were biologics, accounting for more than $8 billion in Medicare Part B spending. Epoetin for patients on dialysis was at the top of the list, with $2 billion spent on the drug by Medicare in 2010.

Patents losing clout

Part of the pursuit of Amgen’s Epogen by biosimilar manufacturers lies in the upcoming expiration of patents owned by the company.  The FDA has set up requirements for biosimilar manufacturers for testing and validation studies of their drug “to ensure the quality, safety, and efficacy of a biologic.” Such requirements are already set up in Europe for drug manufacturers, including tests to determine comparability to protein structure and product quality to the biologic; in vivo and in vitro assays to confirm functional biosimilarity; preregistration studies to compare efficacy between the biosimilar and the biologic drug, and comparative phase 3 studies of “head-to-head” biosimilar versus the reference biologic studies with patients.

To date, there are 17 biosimilars approved in Europe by the European Medicines Agency, including three Epoetin alpha products.

The FDA has been developing guidelines for the approval of biosimilars since March 2010, and came out with final regulations in September 2014. The overall approach from the FDA will focus on a “totality of evidence” approach, which will lessen the need for extensive animal and clinical testing.

Ultimately, biosimilars could be a significant part of the pharmaceutical market in the near future. The Institute for Healthcare Informatics estimated that manufacturers spent $92 billion on biologics in 2013, up 9.6% from 2012.  But an IMS Health report released in December 2011 predicted that by 2020, the U.S. biosimilar market may be as large as $25 billion. Various sources estimate that biosimilars could save the government $25 billion over the next 10 years.
 

...

Posted: Wednesday, March 25, 2015 8:00 am

Medicare Part C: The choice of advantage plans 0 comments

This article is the third in a series examining what Medicare does and does not cover. This segment addresses Part C, which allows the insured to choose Medicare Advantage plans instead of regular Medicare.

What are Medicare Advantage Plans?

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Posted in Columnists on Wednesday, March 25, 2015 8:00 am.

...

                  LAWRENCE, Mass., March 25, 2015 /PRNewswire/ -- NxStage Medical, Inc. 

                            
                            
                                  
      
      
      
      
      
      
      
                                  
                                    NXTM, -0.92%

                            
                                  
      
      
      
      
      
      
      
                                         a leading manufacturer of dialysis products, today announced the presentation of four new abstracts demonstrating clinical outcomes during the National Kidney Foundation's Spring Clinical Meeting in Dallas, Texas. Three of the abstracts highlight improved survival, reduced cardiovascular hospital readmissions, and increased transplantation for daily home hemodialysis (DHHD) patients using the NxStage® System One™ versus other modalities. The fourth abstract details results from the Company's groundbreaking study that led to the clearance of the System One as the first and only hemodialysis machine cleared for home nocturnal hemodialysis (home NHD).


                  The first three abstracts derive from work conducted by Eric Weinhandl, MS, PhD candidate and Dr. Allan Collins of the Chronic Disease Research Group (CDRG), funded by NxStage. These show:


        29% lower risk of death for incident patients using DHHD vs. patients receiving conventional in-center hemodialysis (IHD), 

          15% lower risk of 30-day readmission after hospitalization for heart failure than peritoneal dialysis (PD) patients and 27% lower than IHD patients, and 

          37% greater incidence of transplant for DHHD patients than PD patients, and 22% greater than IHD patients. 

      The fourth abstract presented at the meeting, from a NxStage-funded registration trial led by Dr. Brigitte Schiller of Satellite Healthcare and Dr. Brent W. Miller of Washington University in Saint Louis, Missouri, details favorable results of 58 ESRD patients receiving home NHD with the NxStage System One. The study demonstrated results of increased clearance, improved phosphorus control, and comparable safety and efficacy to DHHD. The open-label, prospective, two-treatment, two period crossover, non-inferiority study enrolled, trained, and transitioned DHHD patients to home NHD, and subsequently treated them for eight weeks on home NHD.


                  "These new data continue to highlight the benefits, safety, and efficacy of daily home hemodialysis with respect to important, long intractable challenges not fully addressed by conventional dialysis.  The complete alignment of randomized, observational, and epidemiological studies with respect to daily hemodialysis benefits is compelling," said Collins, Director of the Chronic Disease Research Group and Senior Medical Advisor for NxStage. "Moreover, showing that nocturnal hemodialysis may be administered in the home with relative safety and efficacy to gain the first-ever clearance in the U.S. for this indication represents a major milestone in the treatment of kidney disease."


                  "NxStage has long been committed to product innovation and quality clinical research to help improve the lives of patients with kidney failure," said Joe Turk, President of NxStage Medical. "We are delighted that these data will be shared in these important clinical sessions, so that awareness and understanding increase and more patients and their families may ultimately gain access to this life-changing therapy."


                  The posters, numbers 278, 279, 280, and 338, will be presented on Thursday, March 26, 2015 from 6:00 - 7:30pm and remain on display at the Gaylord Texan through Saturday, March 28, 2015.


                  Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.

                  Additional Risks Associated with Nocturnal Home Hemodialysis TherapyThe NxStage System One may be used at night while the patient and care partner are sleeping. Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow or increased treatment time or both, and delayed response to alarms when waking from sleep. Ancillary anticoagulant infusion pumps and fluid leak detection devices may be used to decrease certain risks for home hemodialysis treatments performed at any time, but NxStage requires the use of fluid leak detectors to identify leaks from the vascular access, Cycler and Cartridge when performing nocturnal therapy with the NxStage System One.

                  
        About the NxStage System OneThe NxStage System One is the first and only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy. When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping - at home or on vacation and at a medically appropriate treatment frequency. http://www.nxstage.com/.


                  
        About NxStage MedicalNxStage Medical Inc. 

                            
                            
                                  
      
      
      
      
      
      
      
                                  
                                    NXTM, -0.92%

                            
                                  
      
      
      
      
      
      
      
                                         is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at www.nxstage.com.


                  
        Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2014. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.                                    

                  
        Media contact:    

Kristen K. Sheppard, Esq.  

 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
   

Tel: (978) 332-5923


                  Logo - http://photos.prnewswire.com/prnh/20110503/MM94799LOGO

                  To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-data-show-improved-survival-reduced-cardiovascular-hospital-readmissions-and-increased-transplantation-on-home-hemodialysis-with-the-nxstage-system-one-300055332.html

                  SOURCE  NxStage Medical Inc.


                  
        
      

                  Copyright (C) 2015 PR Newswire. All rights reserved


    

                            
                            
                                  
      
      
      
      
      
      
      
      


            

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