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.

Modeling the fiscal impacts caused by climate change

Aim of the paper: The purpose is to gather the practices and to model the impacts of climate change on fiscal spending and revenues, responsibilities and opportunities, balance and debt related to climate change (CC). Methodology of the paper: The methodology will distinguish fiscal cost of mitigation and adaptation, besides direct and indirect costs. It will also introduce cost benefit analyses to evaluate the propensity of policy makers for action or passivity. Several scenarios will be drafted to see the different outcomes. The scenarios shall contain the possible losses in the natural and artificial environment and resources. Impacts on public budget are based on damage of income opportunities and capital/wealth/natural assets. There will be a list of actions when the fiscal correction of market failures will be necessary. Findings: There will be a summary and synthesis of estimation models on CC impacts on public finances, and morals of existing/existed budgeting practices on mitigation. The model will be based on damages (and maybe benefits) from CC, adjusted with probabilities of scenarios and policy making propensity for action. Findings will cover the way of funding of fiscal costs. Practical use, value added: From the synthesis of model, the fiscal cost of mitigation and adaptation can be estimated for any developed, emerging and developing countries. The paper will try to reply, also, for the challenge how to harmonize fiscal and developmental sustainability.

Public price of climate change

Aim of the paper: The purpose is to gather the practices and to model the impacts of climate change on fiscal spending and revenues, responsibilities and opportunities, balance and debt related to climate change (CC). Methodology of the paper: The methodology will distinguish fiscal cost of mitigation and adaptation, besides direct and indirect costs. It will also introduce cost benefit analyses to evaluate the propensity of policy makers for action or passivity. Several scenarios will be drafted to see the different outcomes. The scenarios shall contain the possible losses in the natural and artificial environment and resources. Impacts on public budget are based on damage of income opportunities and capital/wealth/natural assets. There will be a list of actions when the fiscal correction of market failures will be necessary. Findings: There will be a summary and synthesis of estimation models on CC impacts on public finances, and morals of existing/existed budgeting practices on mitigation. The model will be based on damages (and maybe benefits) from CC, adjusted with probabilities of sce-narios and policy making propensity for action. Findings will cover the way of funding of fiscal costs. Practical use, value added: From the synthesis of model, the fiscal cost of mitigation and adaptation can be estimated for any developed, emerging and developing countries. The paper will try to reply, also, for the challenge how to harmonize fiscal and developmental sustainability.