spotlight on health Easing The Financial Burden On KidneyPatients (NAPSA)}—Approximately 20 million Americans suffer from chronic kidney disease (CKD), a diagnosis that can be daunting without the proper information and support. Of this population, close to 500,000 have CKD Stage 5, the most serious form of this disease, which is a growing problem in the United States. In fact, the number of people with kidney failure nearly doubled between 1990 and 2000, putting incredible pressure on the U.S. health care system. CKD Stage 5 requires regular dialysis, a procedure that artifi- cially removes toxic wastes from the body. Due to the complexity of CKD Stage 5, many patients develop additional health conditions, which may require patients to take up to 11 different medications a day. For example, many dialysis patients develop a common condition called hyperphosphatemia— high levels of phosphorus in the blood—which requires them to take a phosphate binder with every meal. Consistent treatment is essen- tial because the condition can lead to mineral deposits in the heart and blood vessels, as well as bone disease and death. Besides the obvious mental and physical pressures these stressful circumstances bring upon patients, the financial burden can often be overwhelming. With the annual cost of treating kidney failure in the United States already around $30 billion, the financial impact the disease has upon society will only continueto intensify. Most patients who suffer from CKD rely on Medicare to help pay for treatments. Unfortunately, new reports show that almost half of the individuals who were enrolled in Medicare’s prescription drug plans in 2006 were impacted by the Medicare Part D coverage gap, knownasthe “doughnuthole.” This is a period of time when beneficiaries have reachedthe initial coverage limit and become responsible for the total costs of all their medication. Of course, taking an essential drug, such as a phosphate binder, is a lifetime commitment and can get very expensive, making it difficult for some peopleto afford. To help patients get access to FOSRENOL(a noncalcium phosphate binder), Shire Pharmaceuticals, a @ leader in kidney care, is adding a new Medicare Part D component to its existing FOSRENOL lat hand Patient Assistance Program. With this addition, qualifying patients enrolled in a Medicare Part D program who cannotafford their co-paymentsor co-insurance, along with those facing the Medicare Part D “doughnuthole,” may now receive FOSRENOL free of charge.” The original at hand patient assistance offering is designed to help individuals who have no coverage for FOSRENOL under prescription drug benefits, Medicare, Medicaid or other state-funded programs by providing the treatment free of charge* or ata shared (reduced) cost. Patients and health care pro- viders can find out more about the program by calling the at hand toll-free hotline at (866) 325-8223. Trained representatives are avail- able to answer questions and help enroll patients from Monday through Friday, 9 a.m. to 5 p.m. (EDT). For more information about CKD Stage 5, the FOSRENOL lat hand Patient Assistance Program or FOSRENOL, visit www.fosrenol.com. *In the event that a patient is enrolled in either Medicare Part D or the Patient Assistance Program, he or she will be provided product in monthly quantities only up to the end of the calendar year (for example, a patient approved in Novemberwill receive a 60-day supply). ~------------------------- 2-2 ----- 2 === OX. = 2-2 -------------- === === 2-2 =e =e Note to Editors: Important Safety Information: During clinical trials, the most common side effects of FOSRENOL*were gastrointestinal, and included nausea, vomiting, and diarrhea. Nausea and vomiting generally lessened over time as patients continued with their treatment. Patients who stopped treatment usually reported gastrointestinal side effects as the reason for stopping. Other side effects reported in trials included dialysis graft complications, headache, abdominal pain, and low blood pressure. Although studies were not designed to detect differences in risk of bone fracture and mortality, there were no differences demonstrated in patients treated with FOSRENOL compared to alternative therapy for up to 3 years. The duration of treatment exposure and time of observation in the clinical program were too short to conclude that FOSRENOL*does not affect the risk of bone fracture or mortality beyond 3 years. While lanthanum has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown. Ifyou suffer from acute stomach ulcer, colon inflammation and colon ulcers, Crohn’s disease, or bowel obstruction, it is important to know that patients with these conditions were not included in FOSRENOL-?clinical studies—please discuss with your doctor. Don’t take FOSRENOL-*if you are nursing or pregnant, or if you are under 18 years of age. Please visit www.fosrenol.com for Full Prescribing Information.
