Submission Processes and Requirements for Health Technology Assessment in Australia, Canada, England, and Spain

OBJECTIVES: The health technology assessment (HTA) submission process is becoming increasingly diverse between countries. This study assesses the HTA requirements in Australia, Canada, England and Spain: four countries where pharmacoeconomic evidence forms an integral part of the value assessment. Technology developers can use these insights to identify where efficiencies can be made in the global market access strategy for new technologies, such as when to submit HTA dossiers.

METHODS: A pragmatic review and desk-based research were conducted in May 2024. Published articles, HTA guidelines, process documents, conference abstracts, and white papers were reviewed to identify country-specific processes. Where available, data were extracted about the general submission process and stakeholders involved (including regulatory, HTA and pricing authorities), as well as the clinical and pharmacoeconomic evidence requirements for HTA submission. Comparisons of the median time from marketing authorization to HTA decision within each country were also conducted. The key findings and between-country differences were synthesized in a narrative summary.

RESULTS: The review identified several areas with implications for market access strategy. All countries offer a parallel regulatory/HTA process. The median HTA review time between 2014 and 2018 was shortest in Australia (125 days) and longest in England (266 days). Australia demonstrated general consistency in HTA review time between submissions (interquartile range = 9 days), and England had the most variation in the duration of HTA reviews (interquartile range = 216 days). All countries require comparative clinical evidence within the indication and pharmacoeconomic evidence. A cost-utility analysis is the preferred analytical tool. However, England also readily accepts cost-effectiveness analysis.

CONCLUSIONS: While the median HTA review time varied between countries, similar requirements in clinical and pharmacoeconomic evidence allow efficiencies in the preparation of submission documentation. Future research should investigate the impact of the EU HTA Regulation on market access and how this could affect strategic decision making.