OBJECTIVES: The aim of this research was to compare if there has been any change in the duration of the Health Technology Assessment (HTA) process in the post-COVID era by comparing the median days from Marketing Authorization (MA) to publication of the HTA report in H1 2023 vs H1 2022.

METHODS: We conducted a search of the HTAs to identify single drug assessments in original indications and extensions of indications published in the first half (H1) of 2023 and H1 2022. NICE, G-BA, ZIN, NoMA, CADTH, AOTMiT and Medicinrådet provide information on the analysed timepoints (regulatory approval, HTA start, decision, and publication of the HTA reports dates) in both periods and were therefore included. For HTAs from H1 2023 and H1 2022, we compared the median numbers of days from MA to HTA start (period 1), from HTA start to the decision date (period 2) and from the decision date to the publication date (period 3).

RESULTS: The analysis identified 76 HTA reports for H1 2022 and 85 HTA reports for H1 2023. The duration of the total HTA process increased by 68 days (from 232 days in H1 2022 to 353 days in H1 2023). Median time in period 1 increased by 120 days in H1 2023, while periods 2 and 3 decreased by 39 and 14 days, respectively. Timelines increased in the Netherlands, Norway and the UK, although a shortening has been observed in Canada. For HTAs with negative recommendations, the total duration of HTA process increased by 128 days, while for HTAs with positive recommendations it decreased by 52 days.

CONCLUSIONS: In the post-COVID era, the median time from MA to HTA report publication has increased in most countries. This delay was noted in period 1 of the HTA process and mainly for HTAs with negative recommendation.