Genzyme Corp. (NASDAQ: GENZ) today said it welcomed the Centers for Medicare and Medicaid Services' (CMS) decision not to include oral medications without IV equivalents in Medicare's End Stage Renal Disease (ESRD) patient benefit. According to the final rule, these medications, including Genzyme's Renvela® (sevelamer carbonate), will not be included in the bundle until January 1, 2014.
"Genzyme is encouraged by CMS' final decision, as we believe it will put the needs of the patients first by providing the time needed to collect data to document the current standard of care, enabling assessment in the future of any unintended negative consequences that the new bundled payment system may have on the management and outcomes of dialysis patients," said Dan Regan, senior vice president and general manager of Genzyme's renal business. "We look forward to working with CMS and the nephrology community to establish quality measures for treating CKD and related mineral and bone disorders (MBD) to protect the quality of care each patient receives."
In the United States, 100,000 CKD patients start dialysis treatment every year and protections for quality of care and adequate treatment reimbursement are critical for this vulnerable patient population. CMS' decision to delay the inclusion of ESRD-specific oral drugs, including phosphate binders and calcimimetics, helps reduce the potential for conflict between best clinical practices and economic incentives. CMS is expected to finalize quality measures for dialysis and CKD-MBD in the coming months.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
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Renvela® (sevelamer carbonate) is indicated in the United States for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Renvela is contraindicated in patients with bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. Uncommon cases of bowel obstruction and perforation have been reported. Serum bicarbonate and chloride levels should be monitored. Vitamins D, E, K (coagulation parameters), and folic acid levels should be monitored. The most frequently occurring adverse reactions in a short-term study with sevelamer carbonate tablets were nausea and vomiting. In a short-term study of sevelamer carbonate powder dosed three times daily, adverse events were similar to those reported for sevelamer carbonate tablets. In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation. Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renvela. Patients should be informed to take Renvela with meals and to adhere to their prescribed diets. Please visit http://www.renvela.com/ for full Prescribing Information.
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