Access to Medicines Working Group 10 December 2010
Page last updated: 25 November 2011
The Access to Medicines Working Group (AMWG) had its eleventh meeting on 10 December
2010, the first after relevant legislation had passed through Parliament on 22 November
2010.
Given the passage of legislation through Parliament, the AMWG reviewed and agreed
on the monitoring framework for implementation of MoU provisions. The AMWG considered
progress of these provisions related to stable pricing policy, access and system predictability
to ensure they were on target with expectations.
The AMWG agreed on frameworks, commencing 1 January 2011, to improve prompt patient
access to new medicines via Managed Entry Scheme and parallel regulatory and reimbursement
processes. The Managed Entry Scheme would allow sponsors to seek earlier listing for
products in areas of high unmet clinical need while continuing to generate further
information regarding the product’s potential value. By removing the need to have
a positive TGA delegate’s overview prior to PBAC lodgement, sponsors would be able
to progress regulatory and reimbursement pathways in parallel, potentially reducing
time to PBS listing.
The AMWG noted progress on activities related to the MoU designed to observe and predict
trends in the PBS market in Australia. From 1 January, activities to monitor trends
and drivers of PBS growth, horizon scanning to smooth expectations over workflow and
government expenditure over forward years, a mechanism to capture information regarding
the effect of reductions in price of F2 medicines on the entry of new medicines, and
tracking of Cabinet considerations of new PBS listings would all commence.
The AMWG noted the stakeholder engagement activities in order to ensure the smoothest
possible introduction of statutory price reductions and Expanded and Accelerated Price
Disclosure requirements. The Department of Health and Ageing had commenced comprehensive
education activities regarding the new process including the revised data collection
and calculation timeframes.
David Learmonth
Deputy Secretary
Department of Health and Ageing
Will Delaat
Chairman
Medicines Australia
