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.

Az Európai Unió kibővítésének hatása a lisszaboni stratégia hatékonyságára. Tapasztalatok az Európa 2020 stratégia tervezéséhez (The effects of EU enlargement on the effectiveness of the Lisbon strategy - conclusion for the Europe 2020 strategy)

A tanulmány azt vizsgálja, hogy a lisszaboni stratégia utódja, az Európa 2020 stratégia esetén indokolt lehet-e a régi és az új tagállamok eltérő kezelése. Mindehhez elsősorban a lisszaboni stratégia tapasztalatait, illetve a tagállamok teljesítményét tekinti át. Arra következtetésre jutottunk, hogy a kutatás-fejlesztés valamint a környezeti fenntarthatósági szempontot tükröző energiaintenzitási mutató esetében kiemelten szükséges a stratégia finomhangolása. A K+F célkitűzés csak hosszú távon releváns a felzárkózó országok számára, rövid távon elsősorban a kohéziót hatékonyabban támogató beruházásélénkítésre kell helyezni a hangsúlyt. A differenciált megközelítés a foglalkoztatási területre is igaz. E terület sajátossága azonban, hogy a tagállamok közötti törésvonal itt nem az EU15-ök és az EU12-ek között húzódik, hanem megfigyelhető a jól ismert észak-dél törésvonal is. A foglalkoztatás terén tehát a déli tagállamok differenciált kezelése is indokolt lehet. / === / The paper asks whether the differential treatment of EU member states would be warranted in case the successor of the Lisbon Strategy, the Europe 2020 Strategy. It examines the performance of member states in the past decade, and arrives to the conclusion that some "fine-tuning" would be required in case of the new strategy, especially in the fields of R&D and energy intensity. R&D is only relevant for the new member states in the longer run, in the short run however policies promoting cohesion seem more important. Differential treatment would also be required in issues related to employment, but here the main divide is not between the old and new member states, but rather between the northern and southern ones.