Managed Care - July 2008 - (Page 52) TOMORROW’S MEDICINE ambulation, early diet advancement and solids by the second day after surgery, as tolerated. The primary endpoint for all studies was time to achieve resolution of postoperative ileus, a clinically defined composite measure of both upper and lower gastrointestinal recovery. The most objective measures of intestinal recovery are considered — tolerance to solid food and first bowel movement. Also recorded was time from surgery to time of discharge order. The efficacy for those having an abdominal hysterectomy has not been established and is not in the FDA-approved indication. Thus the data collected will only be from those who had bowel resection. A total of 1,877 patients who had a bowel resection were studied. The average age was 61, with equal proportions of men and women. The most common indications for surgery were GI cancer and diverticular disease. In each of the five studies, alvimopan accelerated the time to recovery of GI function and time to discharge order written as compared to placebo. The mean treatment difference ranged from 10.7 hours to 26.1 hours. Across the studies, alvimopan recipients had their discharge orders written 13 to 21 hours earlier than comparable placebo recipients. There was no increased pain as measured by the visual analog scale pain intensity score, nor was there an increase in the amount of postoperative opioid administered. Overall, the side effects in patients receiving alvimopan in short-term surgical clinical trials were mild and not significantly different from those in patients receiving placebo. Long-term use was studied at lower doses for as long as a year. Although a causal relationship was not established, in these studies, myocardial infarction was reported more often in those receiving active drug than in those receiving placebo. Alvimopan is contraindicated in people who have taken therapeutic doses of opioids for more than seven consecutive days immediately before taking alvimopan. Cost implications Post-operative ileus lengthens the stay of patients undergoing abdominal surgery. Anything that promises to shorten stays in a cost-efficient manner is going to demand the attention of those at financial risk for these longer hospital stays. In the case of colon resections, both commercial payers and those at risk under the Medicare DRG system will be looking at alvimopan. Entereg has a wholesale acquisition cost (WAC ) of $62.50 per dose. Assuming maximal use of 15 doses, the total cost, including administration, is about $1,000. Depending on the actual reduction in hospital length of stay and the actual incremental cost of the additional time, as well as payment methodology, alvimopan may or may not save money for hospitals or managed care organizations. Given that managed care commercial contracts commonly pay a full day charge for any part of a day that crosses midnight, a discharge order written a few hours earlier might in some cases save a hospital daily charge unit. Hospitals may view this a bit differently for Medicare patients, as their costs are accumulating as the clock ticks because they are paid through diagnosis-related groups. Patient experience is also sorely needed as there may be quality-of-life reasons to use this product. Although a case may be made for patient satisfaction and reduced discomfort, the manufacturer did not present quality-of-life data in the package insert. Because of the safety concerns, the manufacturer has set up a restricted distribution process. It can only be purchased by hospitals that are now performing bowel resections and that have registered in the Entereg Access Support and Education (EASE) Program. The EASE program is designed to maintain the benefits associated with short-term use of the product and to avoid diversion for patients and physicians searching for a solution to chronic bowel dysfunction related to chronic opioid use. The hospitals must have processes and systems that prevent more than 15 doses per patient per event. Although the data shared in the PI is not compelling from a managed care or cost perspective, alvimopan is a breakthrough in the search for solutions to real problems facing patients undergoing bowel resection. MC 52 MANAGED CARE / JULY 2008
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