Abstract

Abstract Background Fibromyalgia is a chronic musculoskeletal condition associated with widespread pain, fatigue, and other somatic symptoms that reduce functionality and quality of life. Its significant economic burden for society urges improving the usual clinical practice. Methods This study presents a trial-based cost-utility analysis on a multicomponent intervention programme (MCI) for patients with fibromyalgia compared to the usual clinical care in Catalonia's primary care centres. This economic evaluation was conducted from a societal perspective, a human capital approach, and a one-year time horizon. The study outcomes included direct medical costs, productivity losses, and quality of life. Quality-adjusted life years (QALYs) were calculated using the SF-6Dv2 metric algorithm. Subsequently, crude and adjusted incremental cost-utility ratios (ICUR) were estimated to compare the treatment strategies and one- and two-way deterministic sensitivity analyses were performed. Results The complete case analysis comprised 297 individuals (161 in the intervention group / 136 controls). The obtained crude ICUR of €1,780.75 per QALY gained, and the adjusted ICUR of €851.67 suggested that the increase in participants’ quality of life outweighed the cost increase as they fell below the cost-effectiveness threshold. Furthermore, the sensitivity analyses supported the robustness of the results when variating large cost components and increasing therapeutic adherence, which endorsed the implementation scheme. Conclusions Given its cost-utility for society, the study's results support including the proposed MCI as part of the standard regional practice for patients with fibromyalgia. These findings provide decision-makers with evidence to enhance the healthcare approach to fibromyalgia syndrome, reduce its social burden and improve patients’ quality of life in a context of medical uncertainty. Key messages • The usual clinical practice for fibromyalgia syndrome urges improving its therapeutic approach in a scenario of medical uncertainty. • Patients with fibromyalgia syndrome can benefit from multicomponent intervention programmes that cover physical, psychological and health education needs reducing the economic burden for society.

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