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- W2766146870 abstract "Ascertain the value of the orphan drug selexipag (Uptravi®) in PAH compared to the main therapeutic alternative in Spain through MCDA. Literature review (PICOTs methodology, indexed, grey literature, primary and secondary search) completed with reference documents (regional and hospital evaluations, clinical guidelines). EVIDEM framework (v. 4.0) weighted by 45 Spanish national and regional evaluators was used. A panel of 32 multidisciplinary experts (cardiologists, pulmonologists, rheumatologists, internists, hospital pharmacists, decision-makers and patient representatives) assessed and validated the adapted framework. The relative value contribution of selexipag vs. iloprost was obtained considering criteria scoring and weighting assigned by the panel. Comparative value analysis was supported by real clinical practice experience with iloprost reported by clinicians given that data for selexipag (oral) and iloprost (inhalated) come from non-comparative (design, population and variables) clinical trials. When compared with iloprost, selexipag was considered a new oral drug for PAH which adds value in the following MCDA quantitative criteria (scale -5 to +5): relative efficacy (2.3±1.8), patient reported outcomes (2.5±1.9), preventive benefit (2.8±1.0), therapeutic benefit (3.0±0.7), other medical costs (2.3±1.6) and other non-medical costs (2.1±1.5). Based on clinical trial outcomes, selexipag was considered to have a potentially slightly worse safety profile (-0.3±1.8) although it was acknowledged that adverse events were transient, dose dependent and easily managed with symptomatic treatment. PAH is an orphan indication considered a serious disease with high mortality and important unmet needs. MCDA methodology allowed detailed analysis and discussion of overall value of selexipag in PAH treatment in a systematic, objective, pragmatic and transparent way from the key stakeholders’ point of view and relative to alternative treatment with iloprost in Spain. The use of reflective MCDA methodology favoured discussion between panel members about what constitutes value in PAH which may be useful in drug evaluation and decision-making processes." @default.
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- W2766146870 date "2017-10-01" @default.
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- W2766146870 title "Determining The Value of Selexipag For The Treatment of Pulmonary Arterial Hypertension (PAH) In Spain By Multi-Criteria Decision Analysis (MCDA)" @default.
- W2766146870 doi "https://doi.org/10.1016/j.jval.2017.08.971" @default.
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