3.3 Managing outcomes processes transparently
Publishing documents as part of the process of listing of medicines on the PBS is consistent with the objectives of the Australian Government’s National Medicines Policy. This policy states that consumers and health practitioners should be encouraged to understand the costs, benefits and risks of medicines. Consistent with this policy, both the PBAC and the Drug Utilisation Sub-Committee (DUSC) releases outcome statements and reports about the use of medicines that are currently listed on the PBS.
Currently, three sets of documents associated with the PBAC consideration of medicines and two sets of information about medicine utilisation are publicly released. Further information about these documents is outlined below. The consumer Medicine Status Website also provides information for consumers on the PBS listing process.
3.3.1 PBAC Agenda
A list of submissions that will be considered by the PBAC is published on the PBS website 14 weeks before the date of the PBAC meeting. An updated agenda will be published 9 weeks before the date of the PBAC meeting to reflect lodgement of Early Re-entry or Early Resolution Pathway resubmissions. Submissions related to requests that only consider the price of a medicine or vaccine are not included on the published agenda.
A list of DUSC reports on the utilisation of listed PBS medicines to be considered by the PBAC at the upcoming meeting is provided at the same time as the list of submissions.
3.3.2 PBAC Outcomes
The outcomes provide the decision and a summary of the reasons for the decision (see Section 7.3).
3.3.3 PBAC Public Summary Documents
Public Summary Documents (PSDs) are a publicly available version of the PBAC recommendations (the PBAC Minutes) and are usually available 16-18 weeks after the PBAC meeting (see Section 7.4). The publication of PSDs provides information on the evidentiary basis for PBAC recommendations and the rationale for these recommendations.
3.3.4 Drug Utilisation Sub-Committee Outcome Statements
The DUSC Outcome Statements provide a high-level summary of the topics discussed at each DUSC meeting. This includes summarised results and DUSC’s views on analyses of utilisation of PBS medicines and of therapeutic areas (multiple medicines in a treatment area) considered at that meeting. The Outcome Statement also provides notice of the PBS medicines and therapeutic areas selected for consideration at future DUSC meetings.
3.3.5 Drug Utilisation Sub-Committee Utilisation Analysis Public Release Documents
The DUSC Utilisation Analysis Public Release Documents provide public access to the DUSC utilisation analysis reports. DUSC considers that the reports will assist stakeholders – including consumers, health professionals, researchers and pharmaceutical companies – to better understand how PBS medicines are currently being used, the methods DUSC employs to analyse utilisation of PBS medicines, and the PBS data available for these analyses. The reports may also outline how the current use of PBS medicines in clinical practice compares with the projected use as recommended by the PBAC.
3.3.6 Medicine Status Website
The Medicine Status Website (MSW) centralises the key information available on how to list a medicine on the PBS. It also enable users to track a medicine’s progress through the PBS listing process; clearly articulates how consumers can contribute to PBAC decision making; and increases understanding of the activities involved in the PBS listing process.