Arthritis Res Ther. 2014 Oct 1;16(5):451. [Epub ahead of print] Cost-utility of cognitive behavioural therapy versus U.S. food and drug administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomised controlled trial. Luciano JV, D Amico F, Cerdà-Lafont M, Peñarrubia-María MT, Knapp M, Cuesta-Vargas AI, Serrano-Blanco A, García-Campay Abstract IntroductionCognitive behavioural therapy (CBT) and U.S. Food and Drug Administration (FDA) recommended pharmacological treatments (RPT; pregabalin, duloxetine, and milnacipran) are effective treatment options for fibromyalgia (FM) syndrome and are currently recommended by clinical guidelines. We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT (combination of pregabalin¿+¿duloxetine) and usual care (TAU) groups in the treatment of FM.Methods The economic evaluation was conducted alongside a 6-month, multicentre, randomised, blinded, parallel group, controlled trial. A total of 168 FM patients from 41 general practices in Zaragoza (Spain) were randomised to CBT (n¿=¿57), RPT (n¿=¿56) or TAU (n¿=¿55). The main outcome measures were Quality-Adjusted Life Years (QALYs, assessed using the EuroQoL-5D questionnaire) and improvements in health-related quality of life (HRQoL, assessed using EuroQoL-5D visual analogue scale, EQ-VAS). The costs of healthcare utilisation were estimated from patient self-reports (Client Service Receipt Inventory). Cost-utility was assessed using the net-benefit approach and cost-effectiveness acceptability curves (CEACs).ResultsOn average, the total costs per patient in the CBT group (1,847¿) were significantly lower than patients receiving RPT (3,664¿) or TAU (3,124¿). Patients receiving CBT reported a higher quality of life (QALYs and EQ-VAS scores); the differences between groups were significant only for EQ-VAS. From a complete case analysis approach (base case), the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed, using both QALYs and EQ-VAS as outcomes. These findings were confirmed by bootstrap analyses, net-benefit curves and CEACs. Two additional sensitivity analyses (intention-to-treat analysis and per protocol analysis) indicated that the results were robust. The comparison of RPT versus TAU yielded no clear preference for either treatment when using QALYs, although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS.ConclusionsDue to lower costs, CBT is the most cost-effective treatment for adult FM patients. Implementation in routine medical care would require policymakers to develop more widespread public access to trained and experienced therapists in group-based forms of CBT. Trial registrationCurrent Controlled Trials ISRCTN10804772. Registered 29 September 2008.