1. Assessment routes and timelines in Australia (2011)
Process map of national-level regulatory and reimbursement systems*
Timelines by each agency
Median time (days)
Review process
Median time (days)
Regulatory approval
400
Pricing and reimbursement
305
This slide illustrates the median timelines of the review process by regulatory authority and health technology assessment (HTA)/payer agencies for Australia. The process map provides an overview of the national-level regulatory and reimbursement system for new pharmaceutical products.
For each product, companies provided data on the dates that the product was submitted to the respective agencies for review and the dates that the companies received information about the decision of these reviews. These dates were used to calculate the review time by individual agencies for each product and subsequently the agencies median review time.
Applications can be submitted for HTA assessment prior to the market authorisation decision, however the Pharmaceutical Benefits Advisory Committee (PBAC) decision will be delayed until the market authorisation decision. The median review overlap (defined as submission to PBAC prior to Therapeutic Goods Administration [TGA] approval) was 50 days.
Data derived from CIRS HTA Atlas programme: Process Map Report - A systematic comparison of healthcare systems; CIRS 2011 HTA Industry Benchmarking Report.
Number of products = 7
Number of companies = 4
* Data source: CIRS HTA Atlas