The purpose of this study was to compare the cost-effectiveness of duloxetine versus routine treatment in management of diabetic peripheral neuropathic pain (DPNP). Two hundred thirty-three patients with DPNP who completed a 12-week, double-blind, placebo-controlled, randomized, multicenter duloxetine trial were re-randomized into a 52-week, open-label trial of duloxetine 60 mg twice daily versus routine treatment. Routine treatment included pain management therapies. Effectiveness was measured by using the bodily pain domain (BP) of the Medical Outcomes Study Short Form 36 (SF-36). Costs were analyzed from 3 perspectives: third party payer (direct medical costs), employer (direct and indirect medical costs), and societal (patient's out-of-pocket costs and total medical costs). Costs of study medications were not included because of limited data. Bootstrap method was applied to calculate statistical inference of the incremental cost-effectiveness ratio (ICER). Routine treatment most frequently used included gabapentin (56%), venlafaxine (36%), and amitripytline (15%). From employer and societal perspectives, duloxetine was cost-effective (ICER= -342 dollars and -429 dollars, respectively, per unit of SF-36 BP; both P <or= .03) and the dominant therapy compared with routine DPNP treatment (both P < .05). From payer perspective, duloxetine trended toward cost-effectiveness (ICER= -249 dollars per unit of SF-36 BP; P <or= .06). These results, however, reflect the controlled environment of a clinical trial. An analysis of real-world data would be beneficial.
Perspective: Evaluation of the cost and benefit of new pharmacologic treatments is highly desired by decision makers. From both employer perspective and societal perspective (including patient's out-of-pocket costs), this study demonstrated that duloxetine was more cost-effective than routine treatment in management of DPNP.