Systematic review and analysis of evidences on clinical efficacy and cost-effectiveness of biological drugs for the treatment of Ankylosing Spondylitis

Technology: Infliximab and comparator biological such as adalimumab, etanercept, golimumab. Conditions: Ankylosing spondylitis (AS) Issue: Infliximab is registered to be used in patients with AS. The aim of the Report is to evaluate the clinical efficacy and safety of infliximab and comparator biologicals for the treatment of adult AS. Methods: Systematic literature review and analysis as well as meta-analysis (direct and indirect comparison) of published randomised controlled clinical trials (RCT) were performed, all relevant health economics literature were identified ad analysed. Results: Clinical efficacy of biological therapies is based on good clinical evidences regarding to all clinical efficacy endpoints (ASAS20, ASAS40, ASAS 5/6, and BASDAI 50% response). Altogether, 22 trials are included in our meta-analysis, 12 infliximab, 3 adalimumab studies, 6 etanercept and 1 golimumab. Efficacy of biological treatments for the treatment of AS has been established by clinical scientific evidences, significant improvement at all outcomes considered was confirmed. According to the results of indirect comparison, there were no significant difference between biological treatments and placebo in terms of safety and tolerability endpoints. We found no significant difference between the clinical efficacy and safety of infliximab, adalimumab, etanercept and golimumab therapies. Cost-utility analysis of adalimumab and/or infliximab, etanercept and golimumab treatment for AS were performed in the UK, Canada, The Netherlands, Germany, Spain and France. There are no cost-utility studies from Eastern Central Europe. Implications for decision making: Efficacy of infliximab and comparator biologicals for the treatment of Ankylosing Spondylitis (AS) was proved by clinical evidence, significant improvement at all outcomes considered was confirmed. We found no significant differences in efficacy and safety of different biological treatments. Health economics results suggest that biological therapies are cost-effective alternatives for the treatment of AS in group of developed high income countries. There is a lack of health economics results in Central-Eastern European countries however these data are more and more required by governments and funders as part of the company economic dossiers.

Cost-benefit analysis of climate change – A methodological overview of recent studies

Global warming16 has already begun. Climate change has become a self-propelling and self-reinforcing process as a result of the externality associated with greenhouse- gas (GHG) emissions. Although it is an externality related to humankind, according to a number of unique features we should distinguish it from other externalities. Climate change is a global phenomenon in its causes and consequences. The long-term and persistent impacts of climate change will likely continue over centuries without further anthropogenic mechanism. The preindustrial (equilibrium) level of GHG concentration in the atmosphere cannot be restored since it is irreversible, but if we do not stabilise the actual level of atmospheric concentration, the situation will become much worse than it is now. Assessing the impacts of climate change requires careful considerations because of the pervasive uncertainties and risks associated with it.

Cost-Benefit Analysis of Climate Change (a Methodological Overview of Recent Studies)

This paper examines the methodological aspect of climate change, particularly the aggregation of costs and benefits induced by climate change on individuals, societies, economies and on the whole ecosystem. Assessing the total and/or marginal costs of environmental change is difficult because of wide range of factors that have to be involved. The subsequent study tries to capture the complexity of cost assessment on climate change therefore includes several critical factors such as scenarios and modeling, valuation and estimation, equity and discounting.