Futurescapes: expectations in Europe for relative effectiveness evidence for drugs in 2020. (August 2015)

• Record Type: Journal Article
• Authors: Towse, Adrian; Garau, Martina; Mohr, Penny; Messner, Donna A
• Is Part Of: Journal of comparative effectiveness research. Volume 4:Number 4(2015)
• Page Start: 401
• Page End: 418
• Publication Date: 2015-08
• Subjects: adaptive licensing -- coverage with evidence development -- drug development -- electronic health records -- HTA methods -- performance-based risk sharing agreements -- relative effectiveness; Medical care -- Research -- Periodicals; Medical care -- Research -- Evaluation -- Periodicals; Medical care -- Decision making -- Periodicals; Evidence-based medicine -- Periodicals; Medicine, Comparative -- Periodicals; 362.1072
• DOI: 10.2217/cer.15.7
• Languages: English
• ISSNs: 2042-6305

Abstract

Aim: Explore key factors influencing future expectations for the production of evidence of relative effectiveness (RE) for drugs in Europe in 2020; construct three plausible future scenarios for RE evidence generation.Materials & methods: Semi-structured key informant interviews and three rounds of modified Delphi to gather expert perspectives and develop future scenarios.Results & conclusion: Most influential factors were degree of regulator use of postmarketing authorization (postlaunch) efficacy studies and adaptive licensing; degree of pan-European health technology assessment body coordination in reviewing prelaunch evidence and demanding postlaunch studies; the nature of regulator – health technology assessment body interaction. The most likely scenario entailed some change with postlaunch regulatory studies driving the likely nature of RE evidence generated.