6.2 Evaluation of submissions
All major submissions have information requirements that address clinical, economic, financial and medicine use matters. These issues may be complex, and need to be carefully evaluated in accordance with the PBAC Guidelines, and with the principles of HTA.
The department engages suitably qualified and experienced entities to assess major submissions of pharmaceutical products and vaccines, and undertake project work related to PBS listings.
Each evaluation entity is required to demonstrate efficient and effective processes to manage the documentation appropriately, consistent with the department’s confidentiality and conflict of interest requirements.
6.2.1 Role and composition of external evaluation entities
To provide the best evaluation of submissions for the PBAC and its subcommittees, evaluation entities are required to:
- undertake evaluations in a given timeframe
- remain up to date with the latest methodological developments in HTA
- have adequate quality assurance processes
- be prepared to work with OHTA.
The department undertakes an open tender process approximately every four years, to engage suitable entities to evaluate submissions.
6.2.2 Conduct of the external evaluation process
Evaluation entities are allocated major submissions to evaluate. The entities have up to 10 weeks to review the clinical, economic, financial and medicine use information provided in each submission.
An evaluation document, known as a ‘commentary’, is prepared for each allocated submission. The commentary is included in the agenda papers of DUSC, ESC and the PBAC, and is also provided to the sponsor. The sponsor can provide a response, the ‘Pre-subcommittee response’, for the PBAC and ESC, and where the submission has been selected, for DUSC to consider.
The evaluation entity can support ESC during consideration of the major submissions. ESC can request additional analyses of the clinical information, the economic model or financial estimates. These are provided to the PBAC with the ESC Advice. The additional analyses are also provided to the sponsor with the ESC Advice.