Economic analysis of alvimopan in North American Phase III efficacy trials.
OBJECTIVE
The economic effect of the use of alvimopan in four randomized, double-blind, placebo-controlled, Phase III, North American efficacy trials was analyzed.


METHODS
Patients were eligible for the study if they were 18 years or older, were undergoing laparotomy for partial small or large bowel resection with primary anastomosis, and were scheduled for postoperative pain management with opioid-based i.v. patient-controlled analgesia. Patients analyzed in the North American Phase III trials received placebo or alvimopan 12 mg orally before surgery. Doses were administered twice daily beginning the day after surgery until hospital discharge or for a maximum of 15 doses.


RESULTS
Compared with placebo, alvimopan was associated with a significantly shorter mean time to gastrointestinal (GI) recovery and a significantly shorter mean time to a written discharge order. Alvimopan was also associated with a mean hospital length of stay (LOS) of one full day less than placebo. The mean cost of alvimopan based on a mean of 8.9 12-mg doses was $558.00; the alvimopan cost at the upper limit of allowed dosing was $937.50. Combining the alvimopan and hospital costs for each patient, total costs for the alvimopan group were estimated to be lower than for the placebo group.


CONCLUSIONS
In a post hoc analysis, alvimopan was associated with significantly faster upper and lower GI recovery after bowel resection and a mean LOS reduction of one day compared with placebo. The mean estimated hospital cost was $879-$977 less for patients who received alvimopan compared with placebo. The base-case and sensitivity analyses suggest that, on average, the use of alvimopan compared with placebo may have a cost-saving effect in the hospital setting.
Bell
Timothy J
TJ
GlaxoSmithKline, Research Triangle Park, NC 27709, USA. timothy.j.bell@gsk.com
Poston
Sara A
SA
Kraft
Michael D
MD
Senagore
Anthony J
AJ
Delaney
Conor P
CP
Techner
Lee
L
D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D016527:Drug Costs; D017850:Economics, Pharmaceutical; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000191:economics* / Q000633:toxicity; D006801:Humans; D008297:Male; D008875:Middle Aged; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000191:economics* / Q000633:toxicity; D010880:Piperidines / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
D005765:Gastrointestinal Agents; D009292:Narcotic Antagonists; D010880:Piperidines; C419502:alvimopan