health.gov.au/internet/main/publishing.nsf/Content/AECB791C29482920CA25724400188EDB/$File/PBAC4.3.2(01DEC08).pdf). In some specific circumstances, a possible alternative to NIP listing is a co-funding arrangement (the patient/consumer pays a subsidised proportion of the full cost) under the PBS as applies to publically funded drugs that are prescription-based. The

ATAGI Pre-submission Advice is provided to both PBAC and to the submitting company (known as the KU-57788 purchase sponsor). This process is designed to ensure that the vaccine manufacturer fully understands the formal public health and technical considerations that are material to the public interest, with the exception of cost-effectiveness, which is the province of PBAC. Following submission of a company’s application to the PBAC for NIP or PBS listing of a vaccine, preliminary evaluation by the PBAC Secretariat with key PBAC members may result in further questions to ATAGI regarding a range of matters pertaining to the submission. This may include a request to verify a claim made in the dossier (for example, regarding

an immunologic correlate of protection), or to clarify interpretation of a specific piece of evidence. In response to a formally communicated set of questions copied to the manufacturer, the AWP prepares a post-submission advice that is presented to ATAGI for modification Caspase inhibitor if required and endorsement. This advice is then second communicated to the PBAC and copied to the manufacturer. Parallel to this, a detailed commentary on the sponsor’s submission is prepared for the PBAC by a consultant under contract to the Department of Health. The PBAC also has an Economic Sub-committee (ESC) that reviews and interprets the economic analyses in these submissions and provides written advice. Both of these documents are also copied

to the manufacturer, which has an opportunity to respond. Formal determination on the application is then made by the PBAC. This process, its assumptions and economic principles remains subject to some continuing debate and discussion [1], [2] and [3], but is widely accepted by industry, and healthcare professionals. Funding decisions for vaccines are made by the Government. If PBAC makes a positive recommendation the Government is not obliged to fund a new vaccine, but the Government cannot fund a vaccine without a positive recommendation from PBAC. There is no time limit set for the Government to make its funding decision. Price negotiation is handled by the Australian Government’s Pharmaceutical Benefits Pricing Authority (PBPA, http://www.health.gov.au/internet/main/publishing.nsf/Content/pbs-pbpa-policies-contents∼pbs-pbpa-policies-intro).