INTRODUCTION: As health technology assessment (HTA) bodies introduce more rigorous requirements, the submission process is becoming increasingly diverse between countries. This study assesses the HTA submission processes and requirements in Australia, Canada, England, France and Germany. This allows the identification of where efficiencies can be made in the global market access strategy, such as when to submit HTA dossiers.
METHODS: A pragmatic review and desk-based research were conducted in November 2023. Published articles, HTA guidelines, process documents, conference abstracts, and white papers were reviewed to identify country-specific processes with implications for market access strategy. Where available, information was extracted about the general submission process and stakeholders involved (including regulatory, HTA and pricing authorities), clinical evidence requirements, and pharmacoeconomic evidence requirements for HTA submission. Comparisons of the median time from marketing authorization to HTA decision within each country allowed the identification of efficiencies in individual HTA submission processes. A narrative summary of the key findings and between-country differences will be presented.
RESULTS: The review identified several areas with implications for market access strategy. The median HTA review time was shortest in Australia (125 days) and longest in England (266 days). Australia and Canada have both sequential and parallel regulatory/HTA processes. The median time taken from regulatory approval to HTA recommendation was faster than the sequential process in both countries. All countries require comparative clinical evidence within the indication. The weight placed on pharmacoeconomic evidence varies between countries. In Germany, economic evaluation is yet to play a real role. Requirements for additional information after HTA submission occurred within all HTA bodies.
CONCLUSIONS: HTA processes in Canada, Australia, England, France, and Germany differ from one another. This will likely affect the market access strategy for health technology developers. Similar requirements 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.