External Evaluation of Pharmaceutical Benefits Advisory Committee (PBAC) And Health Technology Related Submissions.

The Office of Health Technology Assessment Branch (OHTA), in the Technology Assessment and Access Division, Department of Health, is undertaking an ‘Open’ Request for Tender (RFT) to source expert organisations to evaluate external submissions from pharmaceutical sponsors to the Pharmaceutical Benefits Advisory Committee (PBAC) for pharmaceutical products and vaccines.

The successful tenderers will be required to deliver high quality evaluations to the Department each PBAC cycle (for meetings in March, July and November) scrutinising the claims in submissions for pharmaceutical products and vaccines. The Economics Sub-Committee (ESC), Drug Utilisation Sub-Committee (DUSC) and the PBAC use these evaluations to inform their decision making and to provide sound, evidence based recommendations to the Minister for Health about which medicines should or should not be listed on the Pharmaceutical Benefits Scheme (PBS), or vaccines that should or should not be included on the National Immunisation Program (NIP).

In cooperation with the PBAC Assessment Section, the successful tender/s will undertake the following tasks, including but not limited to:

•evaluating and preparing high quality commentaries (also called Evaluation Reports) on each of the category 1 and 2 submissions and standard re-entry resubmissions to the PBAC that are allocated to that consultant.

•providing expert economic modelling assistance to the HTA Section for activities such as preparation of risk share funding agreements.

•providing expert assistance to OHTA staff in preparation of any commentaries prepared ‘in house’.

•being available to listen to and provide input on relevant items at ESC meetings (either remotely or in person).

Each evaluation is required to be done to a specified deadline and takes between five and eight weeks to complete. The resulting evaluation report can be 60-120 pages in length, depending on complexity of the submission. The commentary typically scrutinises all of the sponsor’s claims for their product in light of the quality and quantity of evidence presented in the submission, and identifies the key clinical and economic issues for the PBAC to consider.