An economic evaluation of pregabalin versus usual care in the management of community-treated patients with refractory painful diabetic peripheral neuropathy in primary care settings

Objective: To estimate the cost-effectiveness of pregabalin versus usual care (UC) in the management of community-treated patients with refractory painful diabetic peripheral neuropathy (pDPN) in primary care settings (PCS) in Spain. Methods: Data was extracted from a 12-week registry study assessing costs of neuropathic pain in Spain. Pregabalin-naive outpatients treated with UC or newly prescribed pregabalin were selected for inclusion in the cost-effectiveness analysis. Effectiveness was expressed as quality-adjusted life years (QALY) gain. Perspectives of the Spanish National Health System (NHS) and society (2006) were applied for cost calculations. Results were expressed as incremental cost-effectiveness ratio (ICER). Bootstrapping techniques (10,000 re-samples) were used to obtain the probabilistic ICER and the cost-effectiveness acceptability curve. Results: A total of 189 patients were included in the economic analysis. Compared with UC, pregabalin was associated with higher QALY gain in a period of 12-weeks; 0.0406 +/- 0.0343 versus 0.0285 +/- 0.0350 (p = 0.167). Overall total costs ((sic)1368 +/- 1229 vs. (sic)1258 +/- 1474; p = 0.587) and healthcare costs ((sic)628 +/- 590 vs. (sic)469 +/- 420; p = 0.134) were similar for both pregabalin and UC, respectively. ICERs for pregabalin varied from (sic)5302 (95% CI: dominant; (sic)144,105) for total costs to (sic)14,381 (dominant; (sic)115,648) for healthcare costs. Probabilistic sensitivity analyses showed that 79-84% of ICERs were below the threshold of (sic)30,000/QALY. This study suggests that pregabalin may be cost-effective in the management of community-treated refractory outpatients, with pDPN when compared with usual care in the primary care setting in Spain. These findings may help policy makers when making health decision in the management of diabetes in the community. (C) 2012 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.