Futurescapes: expectations in Europe for relative effectiveness evidence for drugs in 2020.
OBJECTIVE
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.


METHODS
Semi-structured key informant interviews and three rounds of modified Delphi to gather expert perspectives and develop future scenarios.


CONCLUSIONS
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.
Office of Health Economics, 7th Floor, Southside, 105 Victoria Street, Westminster, London, SW1E 6QT, UK.
Adrian
A
Towse
Office of Health Economics, 7th Floor, Southside, 105 Victoria Street, Westminster, London, SW1E 6QT, UK.
Martina
M
Garau
Patient-Centered Outcomes Research Institute (PCORI), 1828 L Street, NW, 9th Floor, Washington, DC 20036, USA.
Penny
P
Mohr
Center for Medical Technology Policy, World Trade Center Baltimore, 401 East Pratt Street, Suite 631, Baltimore, MD 21202, USA.
Donna A
DA
Messner
D057186:Comparative Effectiveness Research / Q000379:methods*; D003697:Delphi Technique; D055808:Drug Discovery / Q000379:methods*; D005060:Europe; D006801:Humans; D007407:Interviews as Topic; D055553:Prescription Drugs
D055553:Prescription Drugs
HTA methods; adaptive licensing; coverage with evidence development; drug development; electronic health records; performance-based risk sharing agreements; relative effectiveness