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Performance-based managed entry agreements (PB-MEAs) might allow patient access to new medicines, but practical hurdles make competent authorities for pricing and reimbursement (CAPR) reluctant to implement PB-MEAs. We explored if the feasibility of PB-MEAs might improve by better aligning regulatory postauthorization requirements with the data generation of PB-MEAs and by active collaboration and data sharing. Reviewers from seven CAPRs provided structured assessments of the information available at the European Medicines Agency (EMA) Web site on regulatory postauthorization requirements for fifteen recently authorized products. The reviewers judged to what extent regulatory postauthorization studies could help implement PB-MEAs by addressing uncertainty gaps. Study domains assessed were: patient population, intervention, comparators, outcomes, time horizon, anticipated data quality, and anticipated robustness of analysis. Reviewers shared general comments about PB-MEAs for each product and on cooperation with other CAPRs. Reviewers rated regulatory postauthorization requirements at least partly helpful for most products and across domains except the comparator domain. One quarter of responses indicated that public information provided by the EMA was insufficient to support the implementation of PB-MEAs. Few PB-MEAs were in place for these products, but the potential for implementation of PB-MEAs or collaboration across CAPRs was seen as more favorable. Responses helped delineate a set of conditions where PB-MEAs may help reduce uncertainty. In conclusion, PB-MEAs are not a preferred option for CAPRs, but we identified conditions where PB-MEAs might be worth considering. The complexities of implementing PB-MEAs remain a hurdle, but collaboration across silos and more transparency on postauthorization studies could help overcome some barriers. ispartof: International Journal Of Technology Assessment In Health Care vol:37 issue:e83 pages:1-11 ispartof: location:England status: Published online

Introduction Alcohol hangover is the most commonly experienced next day consequence of heavy drinking. The symptoms experienced during this post-intoxication state develop when blood alcohol concentration (BAC) returns to zero. The feeling of general misery can persist up to 24 h and can significantly affect planned activities and cognitive functioning. Objective To examine the effects of alcohol hangover on driving performance. Methods In N=47 healthy volunteers, driving performance was tested the morning following heavy drinking (alcohol hangover) and on a control day (no alcohol). Subjects performed a standardized 100-km highway driving test in the STISIM driving simulator. Primary outcome measure was the Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car. In addition, self-reported driving quality and driving style measures were scored. Results Driving performance was significantly worse during alcohol hangover (ΔSDLP = +1.85 cm; p=0.005). Driving impairment during alcohol hangover was supported by subjective measures. During alcohol hangover, driving quality was rated as significantly worse (p=0.0001), less safe, less considerate, less predictable, and less responsible (p=0.001). Subject reported being significantly more tensed during hangover and more effort was needed to perform the driving test (p=0.001). Conclusion Driving is significantly impaired during alcohol hangover. The magnitude of driving impairment is higher than that observed after administering alcohol to achieve a BAC of 0.05% (ΔSDLP = +1.7 cm), i.e. the legal limit for driving in many countries.