Observational studyInternational journal of technology assessment in health care2026
HTA submission strategies and their associations with rollout times and type of HTA recommendation in Australia and Canada.
Observational study in International journal of technology assessment in health care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesAustralia 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.
methodsThis 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.
results229 HTA appraisals (126/229 parallel) were included. Parallel submissions were associated with a 14.0-month shorter rollout time compared to sequential submissions (
conclusionsNASs 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.