Access to Medicines Working Group April 2009
Page last updated: 29 June 2009
The Access to Medicines Working Group (AMWG) met on 8 April 2009.
AMWG recommended the implementation of two pilot programs aimed at streamlining the
Pharmaceutical Benefits Scheme (PBS) processes. The pilots will consist of:
1. Early and extended evaluations of complex submissions – where an applicant will have the opportunity for two phases of evaluation of a
submission by the Pharmaceutical Evaluation Section (PES) and Economic Sub Committee
(ESC) prior to it being considered by the Pharmaceutical Benefits Advisory Committee
(PBAC). The aim of this pilot is to consider if resubmissions to the PBAC would be
reduced by granting the sponsor an extended period, and re-evaluation, to address
areas of uncertainty in utilisation and cost effectiveness. The first, or initial,
evaluation could be conducted earlier in the Therapeutic Goods Administration process
for assessment of the medicine for regulatory approval.
2. Enhanced pre-PBAC submission meetings – where the Department, sponsor and third party stakeholders have the opportunity
to meet and discuss submissions to the PBAC in a structured forum. The aim of this
pilot is to consider if earlier identification of uncertainty in utilisation and cost
effectiveness would reduce the number of re-submissions to the PBAC.
AMWG recommended that the Department of Health and Ageing and Medicines Australia
develop a system of workflow planning for submissions to PBAC to assist effective
management when running these pilots and in informing consumers.
AMWG agreed that a third Joint Policy Conference on Medicines should be held in 2011.
An organising committee for the conference will be established including representation
from the Department, Medicines Australia and other interested parties including consumer
groups. AMWG will finalise the report outlining the outcomes of the Second Joint Medicines
Policy Conference for consideration by the minister prior to publication.
AMWG agreed that the Department should explore providing education for the pharmaceutical
industry and consumers on the impact of social values on the PBAC when considering
medicines for inclusion on the PBS. In addition, further education options to better
equip consumers in providing quality input into the PBAC decision making process will
be explored.
AMWG continues to examine the use of post marketing data and the contributions of
innovation on the drug development process and objectives of the PBS.
David Learmonth
Deputy Secretary
Department of Health and Ageing
Will Delaat
Chairman
Medicines Australia
