October 2018 Slide of the month

  • Australia had the shortest median time from first world-wide regulatory submission to jurisdictional health technology assessment (HTA) recommendation (497 days) although it had the largest median regulatory submission gap (80 days).
  • Of the 24 new active substances (NASs) that were appraised by all 7 HTA agencies, 7 were submitted to European Medicines Agency for review first, followed by submission to Australia’s Therapeutic Goods Administration (TGA) and Health Canada.
  • As 4 NASs were submitted to Health Canada first, NASs were submitted to Health Canada 31 median days earlier than to TGA. Although NASs took the longest time to reach TGA compared with the other regulatory agencies, Australia had the shortest overall time taken from first world-wide regulatory submission to HTA recommendation. This can be attributed to the TGA/Pharmaceutical Benefits Advisory Committee (PBAC) parallel process. In the parallel process, a TGA delegate provides an overview of regulatory status to PBAC during the HTA recommendation-making process, allowing the agency to potentially make a reimbursement recommendation even before a formal TGA approval is granted.
  • In 2016-2017, France showed the greatest decrease in median rollout time (85 days).

Note:  Regulatory approval to HTA recommendation time was measured because HTA submission dates were available only in some jurisdictions (Australia, Canada, Germany and Poland). Time taken from regulatory approval to HTA recommendation includes company submission strategy and HTA agency review time.

Definitions:  New active substance (NAS): A chemical, biological, biotechnology or radiopharmaceutical substance that has not been previously available for therapeutic use in humans and is destined to be made available as a ‘prescription only medicine’, to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in humans. Regulatory submission gap: Date of submission at the first regulatory agency to the date of regulatory submission to the target agency.

From: Cai J, McAuslane N, Liberti L. 2018. R&D Briefing 69: Review of HTA outcomes and timelines in Australia, Canada and Europe 2014 –2017. Centre for Innovation in Regulatory Science. London, UK.

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