The Access to Medicines Working Group (AMWG) had its twelfth meeting on 19 May 2011.
The AMWG noted that commitments made under the Memorandum of Understanding (MoU) are well progressed and on track.
The AMWG noted that 31 major submissions had been received at the July meeting of PBAC with 12 of these participating in parallel processing. Both the Department and Medicines Australia had conducted a number of industry information sessions about the Parallel TGA and PBAC submission process and the Managed Entry Scheme (MES). More information can be found athttp://www.pbs.gov.au/info/publication/factsheets/shared/framework-for-introduction-of-parallel-TGA-and-PBAC-processes
The AMWG continues working towards formally documenting the impact on the pricing of PBS medicines of using lower comparator prices where those comparators are listed in the F2 formulary. The AMWG noted that the Department and Medicines Australia were working towards agreement on the types of data to be collected for this issue. The AMWG also agreed on a monitoring framework for post-PBAC processes.
AMWG noted progress towards adopting new integrated and coordinated arrangements for assessing co-dependencies in technologies across the PBS and the Medicare Benefits Scheme (MBS). These arrangements aim to improve predictability and efficiency of processes, in order to expedite patient access to targeted medicines. The AMWG agreed to convene a working group to manage transitional arrangements and review any issues associated with implementation.
AMWG noted the post-market surveillance measure announced in the 2011-12 Federal Budget, which aims to fill existing gaps in data collection on use of medicines following their listing on the PBS. This measure aligns with the National Medicines Policy (NMP) priority of monitoring medicines in use and will contribute to an enhanced NMP framework. Under this measure, NPS Better choices, Better health has an extended role in collecting relevant data.
Finally, the AMWG was informed of the imminent meeting of the Pharmaceutical Industry Discussion Group convened to discuss issues arising from the Further PBS Reforms.
Department of Health and Ageing