Duloxetine Emerges as Most Cost-Effective Drug for Fibromyalgia in JAMA study
USA: In a comparative modeling study of medications for fibromyalgia, duloxetine at 120 mg/day showed the best overall cost-effectiveness, with pregabalin at 450 mg/day also performing well. Based on published data comparing the cost and clinical efficacy of amitriptyline, duloxetine, pregabalin, and milnacipran, researchers found that duloxetine offered the greatest value among commonly prescribed treatments.
Fibromyalgia is a chronic pain disorder associated with substantial functional impairment, reduced quality of life, and significant economic burden for both patients and health systems. Although several pharmacological options are recommended in clinical guidelines, including FDA-approved agents such as duloxetine, pregabalin, and milnacipran, off-label use of amitriptyline remains common because of its low acquisition cost. However, limited direct economic comparisons have made it difficult for clinicians and policymakers to determine which therapies deliver the best value in patients with moderate to severe disease.
To address this gap, Sarah S. Downen from the Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, and colleagues conducted a decision analytical modeling study published in JAMA Network Open.
The investigators used a Markov cohort state transition model to estimate lifetime costs and quality-adjusted life-years (QALYs) associated with various fibromyalgia treatment strategies. Model inputs, including transition probabilities, health state utilities, and both direct and indirect costs, were drawn from previously published sources. The simulated cohort reflected adults aged 18 years or older with moderate to severe fibromyalgia, with analyses conducted between September 2024 and February 2025.
The study evaluated multiple dosing strategies of amitriptyline, pregabalin, duloxetine, and milnacipran from both US health care payer and societal perspectives. The modeled population was predominantly female, with a mean age of approximately 48 years, consistent with epidemiological data for fibromyalgia. Key outcomes included expected lifetime costs, QALYs, incremental cost-effectiveness ratios, and incremental net monetary benefit across commonly used willingness-to-pay thresholds.
The researchers reported the following findings:
- From the health care payer perspective, duloxetine 120 mg/day was associated with greater health benefits than amitriptyline at a slightly higher cost, yielding a low incremental cost-effectiveness ratio.
- Pregabalin 450 mg/day did not demonstrate superior cost-effectiveness compared with duloxetine 120 mg/day when only direct medical costs were considered.
- When societal costs, including productivity losses, were taken into account, both duloxetine 120 mg/day and pregabalin 450 mg/day became cost-saving relative to amitriptyline.
- Milnacipran and lower-dose regimens of duloxetine and pregabalin consistently showed poorer economic value and were less cost-effective than amitriptyline across analyses.
- At a willingness-to-pay threshold of $100,000 per QALY, duloxetine 120 mg/day achieved the highest incremental net monetary benefit from both health care payer and societal perspectives.
- Pregabalin 450 mg/day demonstrated economic advantage only when broader societal costs were included in the analysis.
Overall, the findings suggest that duloxetine at 120 mg/day represents the most economically attractive treatment option for moderate to severe fibromyalgia, with pregabalin at higher doses offering value primarily when indirect costs are taken into account. The authors note that these results may help guide more value-based treatment selection in routine clinical practice.
Reference:
Downen SS, Farag HM, Davies A, et al. Cost-Effectiveness of Pregabalin, Duloxetine, and Milnacipran vs Amitriptyline for Moderate to Severe Fibromyalgia. JAMA Netw Open. 2026;9(2):e2557536. doi:10.1001/jamanetworkopen.2025.57536
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