PMU59 The IMPACT of COVID-19: A Comparison of the Number of Regulatory and Health Technology Assessments between the First SIX Months of 2019 and 2020

Objectives: To explore the possible consequences of COVID-19 on the number of European Medicines Agency (EMA) and health technology assessments (HTA) of drugs in France, Germany and the UK, this research aimed to compare the number of decisions made between the first six months of 2019 and 2020 Methods: All publicly available assessment reports were identified from the EMA, HAS, G-BA and NICE websites from January 1 to June 31 for both 2019 and 2020, and the number of decisions were analyzed A sub-analysis was done on the number of approvals and rejections for EMA and NICE, and SMR and ASMR levels for France Results: EMA decisions increased from 37 to 52 with an increase in the proportion of approvals (92% in 2019 versus 96% in 2020) In Germany, the number was not significantly different, as it decreased only by 2 decisions (56 in 2019 versus 54 in 2020) Conversely, in France and the UK, the number of decisions has notably decreased by almost a third for France (248 in 2019 versus 181 in 2020), and about 35% for the UK (34 in 2019 versus 22 in 2020) In France, no relevant difference in the distribution of ASMR and SMR levels has been observed In the UK, the proportion of approvals has decreased (82% in 2019 versus 73% in 2020) Conclusions: The number of HTA decisions in France and in the UK has seen a significant decrease while assessments by the G-BA remained stable The pandemic may have impacted France and the UK’s capacity for drug assessment secondary to ad hoc priority changes in the health care system considering that they were impacted more than Germany in terms of mortality burden The increase in EMA approvals may indicate the endeavour to allow timely access to safe and efficacious remedies amidst the health crisis