Introduction: Fibromyalgia is a neuropathic syndrome which is more common in adult females. Pregabalin is the first medicine which was approved by the United States Food and Drug Administration for treatment of fibromyalgia. In this study we aimed to evaluate the cost-efficacy of pregabalin in the treatment of fibromyalgia in Iran.
Material and methods: To evaluate the efficacy of pregabalin, a systematic review was carried out by conducting a wide literature search for the main outcomes of interest that were pain score reduction from the baseline and the percentage of patients with more than 50% pain reduction. To evaluate costs of treatment, only the direct medical costs were considered. The calculated incremental cost-effectiveness ratio (ICER) were compared with one and three times the gross domestic product (GDP) per capita as the threshold to evaluate the economic condition of treatment to be “highly cost-effective”, “cost-effective” or “not cost-effective”.
Results: Out of 4012 searched reports, only four reports were included in the study, all of which were randomized controlled trials with placebo controls. The calculated ICERs for pregabalin 450 mg/day and 600 mg/day with both available forms of brand and generic medicines in the country were in the range of 44–1170 US dollars (USD) and 48–814 USD, which in all cases could be considered as highly cost-effective. Pregabalin 150 mg/day based on available evidence does not have significant efficacy in comparison to placebo. But for pregabalin 300 mg/day, no decision can be made based on current data.
Conclusions: Our analysis indicated that generic pregabalin in the treatment doses of 450 mg/day and 600 mg/day is highly cost-effective.