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Genzyme Encouraged By CMS Decision To Delay Oral Drug Inclusion In Dialysis Patient Benefit

March 23, 2017

Genzyme Corp. (NASDAQ: GENZ) 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.

About Renvela

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.

Genzyme Corp.

View drug information on Renvela.