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 and –$429, respectively, per unit of SF-36 BP; both P ≤ .03) and the dominant therapy compared with routine DPNP treatment (both P < .05). From payer perspective, duloxetine trended toward cost-effectiveness (ICER= –$249 per unit of SF-36 BP; P ≤ .06). These results, however, reflect the controlled environment of a clinical trial. An analysis of real-world data would be beneficial.
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.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to The Journal of Pain
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- Pharmacologic management part 1.Pain Med. 2004; 5: S28-S47
- Duloxetine, 60 mg once daily, for major depressive disorder.J Clin Psychiatry. 2002; 63: 308-315
- Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression.J Psychiatr Res. 2002; 36: 383-390
- Diabetic neuropathy.Am J Health Syst Pharm. 2004; 61: 103-173
- Advances in neuropathic pain.Arch Neurol. 2003; 60: 1524-1534
- Painful diabetic polyneuropathy.Diabetes Res Clin Pract. 2000; 47: 123-128
- Duloxetine vs placebo in patients with painful diabetic neuropathy.Pain. 2005; 116: 109-118
- The health care costs of DPN in the U.S.Diabetes Care. 2003; 26: 1790-1795
- Pain severity affects perceived health status in patients with diabetic peripheral neuropathy. 2004 (ISPOR 9th Annual International Meeting, May 16-19, Arlington, VA)
- Cost-effectiveness of automated external defibrillators on airlines.JAMA. 2001; 286: 1482-1489
- Management of painful diabetic neuropathy.Drugs Aging. 2001; 18: 737-749
- SAS Institute Inc, Cary, NC2001: 35-53 SAS system for mixed models.
- Accounting for dropout bias using mixed-effects models.J Biopharm Stat. 2001; 11: 9-21
- Estimating health utility index from SF-36.Med Decis Making. 2001; 21: 105-112
- Resampling and multiplicity in cost-effectiveness inference.J Biopharm Stat. 1999; 9: 563-582
- Cost-effectiveness inferences from bootstrap quadrant confidence levels.J Biopharm Stat. 2005; 15: 419-436
- Expanded screening for HIV in the United States.N Engl J Med. 2005; 352: 586-595
- Epidemiology and impact on quality of life of postherpatic neuralgia and painful diabetic neuropathy.Clin J Pain. 2002; 18: 350-354
- The spectrum of neuropathy in diabetes and impaired glucose tolerance.Neurology. 2003; 60: 108-111
- SF-36 physical & mental health summary scales. (2nd edition). QualityMetric, Inc, Lincoln, RI2001
- Economic burden of illness for employees with painful conditions.J Occup Environ Med. 2005; 47: 884-892
- Economic burden and co-morbidities of atrial fibrillation in a privately insured population.Curr Med Res Opin. 2005; 21: 1693-1699
- The economic burden of schizophrenia in the United States in 2002.J Clin Psychiatry. 2005; 66: 1122-1129
- Annual physician fee schedule payment amount file (downloadable version). 2002 (Available at: http://cms.hhs.gov/providers/pufdownload/carrpuf.asp. Accessed February 20, 2004)
U.S. Bureau of Labor Statistics. CPI and average wage data series. Available at: http://data.bls.gov. Accessed December 12, 2003
Accepted: January 3, 2006
Received in revised form: December 10, 2005
Received: July 12, 2005
Supported by research contract through Eli Lilly and Company.
© 2006 American Pain Society. Published by Elsevier Inc. All rights reserved.
ScienceDirectAccess this article on ScienceDirect
- Letter to the EditorThe Journal of PainVol. 7Issue 11
- PreviewThe article entitled “Cost-Effectiveness of Duloxetine Versus Routine Treatment for U.S. Patients With Diabetic Peripheral Neuropathic Pain”4 is misleading. The authors conclude that duloxetine is cost-effective, but they have not accurately quantified the costs of care because they have not considered the cost of duloxetine or the alternatives used in “routine care.” The authors state that drug costs were excluded because “the study arms were not designed for direct drug cost comparisons” and “complete information on the dosage and length of therapy for the routine care group was not obtained for cost calculations.” Since medication costs represent a large proportion of the cost of care of these patients, the authors do not have sufficient data to perform a meaningful cost-effectiveness analysis.