Drug Development and Launch Timeline Analysis Across 6 High-Income Countries: From Pivotal Trial to HTA

OBJECTIVES: This study aims to (1) investigate the time intervals between key steps in drug development and launch: pivotal clinical trial, regulatory approval, and HTA decision and (2) explore the impact of drug characteristics, clinical trial design, regulatory pathways, and firm characteristics on these timelines.

METHODS: HTA agency websites in England, Scotland, Germany, France, Canada and Australia were screened to compile a full list of HTA outcomes over a ten-year period (2014-2024). Clinicaltrials.gov and regulatory agency websites were screened to identify and extract matching clinical trial and regulatory approval data. Kaplan-Meier and Cox proportional hazard survival analyses were employed to examine the impact of attributes on the timelines. Based on the multivariable analysis, a model was established to predict approval timing and countries’ sequence and displayed through a Shiny dashboard, using R (version 4.4.1).

RESULTS: Preliminary analysis of 218 drug-indication pairs revealed a median clinical development time of 1619 days and a median time from MA to HTA of 268 days. Medicines for infectious diseases had the shortest clinical development time (1051 days) and time between MA and HTA outcome (183 days), while treatments for rare diseases had the longest clinical development time (2101 days) and time from MA to HTA outcome (323 days). Median time from MA to HTA was highly variable across agencies, ranging from 158 days (IQWiG) to 342.5 days (NICE). In Cox regression, orphan status and shorter clinical development time were associated with longer time from MA to HTA. All log-rank test results and coefficients for mentioned variables were statistically significant at the 0.05 threshold.

CONCLUSIONS: There are substantial disparities in drug development timelines and HTA outcomes across countries and therapeutic areas. These findings underscore the need for tailored strategies to expedite HTA processes and ensure equitable access to medicines.