How do HTA agencies perceive conditional approval of medicines? Evidence from England, Scotland, France and Canada

•HTA outcomes for conditional approval medicines are highly variable across settings.•Single-arm phase II trials are the most common pivotal study design for conditional approval medicines.•Confirmatory trials are only used for HTA in 30-40% of conditional approval medicines.•The most common uncertainties raised relate to clinical benefit and study design.•Greater use of early dialogue is needed to avoid delays in entry to market.