PurposePatients with severe COPD are at high risk of experiencing disease exacerbations, which require additional treatment and are associated with elevated mortality and increased risk of future exacerbations. Some patients continue to experience exacerbations despite receiving triple inhaled therapy (ICS plus LAMA plus LABA). Roflumilast is recommended by the Global Initiative for Chronic Obstructive Lung Disease as add-on treatment to triple inhaled therapy for these patients. This cost-effectiveness analysis compared costs and quality-adjusted life-years for roflumilast plus triple inhaled therapy vs triple inhaled therapy alone, using data from the REACT and RE2SPOND trials.Patients and methodsPatients included in the analysis had severe to very severe COPD, FEV1 <50% predicted, symptoms of chronic bronchitis and ≥2 exacerbations per year. Our model was adapted from a previously published and validated model, and the analyses conducted from a UK National Health Service perspective. A scenario analysis considered a subset of patients who had experienced at least one COPD-related hospitalization within the previous year.ResultsRoflumilast as add-on to triple inhaled therapy was associated with non-significant reductions in rates of both moderate and severe exacerbations compared with triple inhaled therapy alone. The incremental cost-effectiveness ratio (ICER) for roflumilast as add-on to triple inhaled therapy was £24,976. In patients who had experienced previous hospitalization, roflumilast was associated with a non-significant reduction in the rate of moderate exacerbations, and a statistically significant reduction in the rate of severe exacerbations. The ICER for roflumilast in this population was £7,087.ConclusionsRoflumilast is a cost-effective treatment option for patients with severe or very severe COPD, chronic bronchitis, and a history of exacerbations. The availability of roflumilast as add-on treatment addresses an important unmet need in this patient population.

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apy. Methods: Observational, non-interventional, prospective, single-center study of 1 year follow-up from ITB implant onward. Results: 20 consecutive patients with ITB indication were recruited; 13 received an ITB implant during the study period; 1 implant was rejected and thus explanted. 12 patients, of whom 10 had spasticity due to spinal-cord injury, 1 to multiple sclerosis and 1 to adrenoleukodistrophy, provided data for the study and 9 completed follow-up. After 12 months of ITB, mean changes from baseline were: -2.6 on the Penn scale (p= 0.011), -1.1 (p= 0.059) and -2.8 (p= 0.011) on the Ashworth upper and lower scale, respectively and +4.4 on the FIM scale (p= 0.075). Mean utility gain, assessed with the HUI3 scale, was 0.054 (p= 0.091) after 1 year. Mean total ITB test and permanent implant cost per patient were € 528 and € 14,225, respectively. Mean quarterly spending on oral antispastics decreased by € 42 at month 12, while consumption of intrathecal baclofen stabilized after 6 months at € 39. At baseline, 4 patients received botulinum injections, while none did at the end of follow-up. Catheter-related adverse events occurred in 2 out of 12 patients, with a total mean cost per event of € 2.387. While waiting to receive ITB, spasticity-related hospitalizations due to urological complications occurred in 2 out of 20 patients, with a mean cost of € 9.044 per event; no such events were observed after ITB implant. ConClusions: Clinical outcomes of patients with N-FDS improved after ITB. Initial therapy costs were considerable, but were partially offset by savings in drugs and spasticity-related events after 1 year follow-up. Results should be interpreted cautiously because of the small number of observations. objeCtives: To assess clinical outcomes, health care resource utilization and associated costs of intrathecal baclofen therapy (ITB) for the treatment of non-focal disabling spasticity (N-FDS) in patients who are resistant or intolerant to oral ther-