PD63 Impact Of Parallel Submission On The Rollout Time and Health-Technology-Assessment Recommendation Of New-Active-Substances

Introduction Australia and Canada have parallel submission processes that allow companies to submit their dossier the respective Health-Technology-Assessment (HTA) body before market authorization is issued, aiming provide timelier access drugs. The objective of this study investigate associations submissions with rollout times HTA recommendations new active substances (NASs). Methods Public data from 208 appraisals were collected Pharmaceutical Benefits Advisory Committee (PBAC) Canadian Agency for Drugs Technology in Health (CADTH) NASs obtaining regulatory approval between 2012 2020. We implemented multivariable logistic linear regression models allowing type (parallel or sequential) jurisdiction (Australia Canada) examine first recommendation (positive positive restrictions vs negative) time (regulatory recommendation), respectively. Results A total 121 followed a submission. therapeutic products most used antineoplastic agents (Anatomical Therapeutic Chemical Code=L;47.11%). similar proportion chemical biotechnological submissions. Multivariable showed presented 14-months decrease when compared sequential (p<0.001). Regarding jurisdictions, longer seen (β:4.0, p-value=0.024). Parallel no association recommendation. had higher odds receiving (Odds Ratio:4.84, 95% confidence interval:2.63-9.18) Conclusions Antineoplastic main using Appraisals following considerably faster than those traditional submission, illustrating advantage approach did not an impact on recommendation, indicating although quicker, decision was affected. has more restrictive criteria regarding timing Australia, which may lead disparities time.