HTA submission strategies and their associations with rollout times and type of HTA recommendation in Australia and Canada

Abstract Objectives Australia and Canada have parallel submission processes allowing companies to submit dossiers to the respective health technology assessment (HTA) body before marketing authorization is issued, aiming to provide more timely access to drugs. This study investigated the associations of submission strategies with new active substance (NAS) rollout times and HTA recommendations. Methods This retrospective observational study analyzed HTA appraisals by the Pharmaceutical Benefits Advisory Committee (PBAC) and Canada’s Drug Agency (CDA-AMC) for NASs that received their first HTA recommendation between 2019 and 2023. Regulatory and HTA dates were sourced from public records. We implemented logistic regression to examine associations of HTA recommendation (optimal vs non-optimal). Linear regression was used to test associations of rollout time. Models were adjusted for submission sequence, country, therapeutic area, expedited review, conditional review, top R&D spenders, and year of HTA recommendation. Results 229 HTA appraisals (126/229 parallel) were included. Parallel submissions were associated with a 14.0-month shorter rollout time compared to sequential submissions ( p < 0.001). Rollout times in Canada were 6.0 months longer than those in Australia. Parallel submissions were associated with higher odds of receiving an optimal recommendation compared to sequential submissions (OR: 2.2; 95 percent CI: 1.2–4.2; p = 0.013). The odds of obtaining an optimal first HTA recommendation were higher in Canada than in Australia. Conclusions NASs following parallel submission showed faster rollout times than those following traditional sequential submission. Moreover, parallel submissions were associated with higher odds of receiving an optimal recommendation. These findings highlight the value of aligning regulatory and HTA processes.