Análisis de impacto presupuestal de la introducción de fingolimod en el tratamiento de esclerosis múltiple en Colombia: a budget impact analysis

introduction: multiple sclerosis (ms) is associated with long-term disability and significant social impact. first-line disease modifying treatments for ms (interferons and glatiramer acetate) have moderate efficacy and must be administered in daily or weekly injections. the introduction of fingolimod, a molecule with superior efficacy in reducing ms relapses compared to interferon-beta 1a justifies a budget impact analysis from a colombian health system perspective. objetives: to develop a budget impact analysis, for years 2012 to 2016, of the introduction of fingolimod in the colombian health system. materials and methods: using the perspective of the colombian health system, we designed a budget impact model to determine the effect that the introduction of fingolimod for patients with relapsing-remitting ms would have on the resources of the health system. clinical data and prevalence were obtained from published literature, costs were collected from local sources. a monte carlo simulation was done as part of the sensitivity analysis. exchange rate used was 2,565 pesos per euro (july 2011). results: total annual net costs (2012-2016) for the scenario without fingolimod were, in million euros, €8.17, €€8.69, €9.11, €9.62, and €10.13. in the fingolimod scenario net costs were: €8.19, €8.74, €9.16, €9.71 and €10.29. on the other hand, fingolimod was associated with 91 relapses averted in this five-year period. monte carlo simulation does not show relevant differences in costs between both scenarios. conclusion: under these assumptions, the introduction of fingolimod in colombian health care system does not imply a significant budget impact but represents an important reduction in the number ms relapses.