18 December 2018 - The mean value for 2018 should serve as the baseline for the strategic agreement between the Department of Health and Medicines Australia to improve market access timelines.

19 new (single entity) medicines and one new gene therapy were listed on the PBS this year. The average period from the date of PBAC recommendation to the date of PBS listing was 274 days (9.1 months).  This high value is driven by the delayed PBS listing of afatinib maleate (Giotrif), which was recommended by the PBAC in 2013 (1,179 days).

The average period from the date of TGA registration (date of TGA decision) to the date of PBS listing was 509 days (16.8 months) and the average period from the date of initial PBAC submission (date of cut-off) to the date of PBS listing was 520 days (17.2 months). These results indicate the regular use of the TGA-PBAC parallel process.

These analyses have not included the listing of:

• New indications on the PBS
  
• New combination products on the PBS
  
• New vaccines on the National Immunisation Program
  
• New medicines on the Life Saving Drugs Program
  

Further analyses are available upon request.