Broadening the Evidence Report

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Australia’s national health technology assessment (HTA) processes include the assessment of all prescription medicines where a listing on the Pharmaceutical Benefits Schedule (PBS) is sought. Listing on the PBS ensures subsidised, affordable and equitable access to medicines for Australian patients. It is especially important for high cost new medicines that may deliver significant improvements in health outcomes for areas such as cancer and rare or complex conditions. 

This HTA process is conducted by the Pharmaceutical Benefits Advisory Committee (PBAC), supported by a range of contracted technical review groups and subcommittees. It is established in the context of the National Medicines Policy, which includes the objective of equitable and affordable access to medicines. HTA has been part of the PBAC process for 25 years, with this early introduction and long-standing application resulting in Australia being regarded as an international leader in the field. 

The PBAC process aspires to be consultative and reflective of Australian community values, as well as flexible and fit for purpose. However, at the same time, it is necessary for the PBAC process to operate efficiently given the number of manufacturer submissions received for each of its three 17 week cycles every year. 

Note that patients and patient advocates are termed ‘consumers’ in the Australian HTA processes. We have used this term when referring to the Australian processes. However, because most other jurisdictions and most literature in this area uses the term ‘patients’, we have also used this term when referring to HTA processes outside Australia. We regard the terms as interchangeable. 

Over the past 10-15 years there has been an evolution in the way in which consumers can engage and participate. While the evolution has been welcomed, there is a general sense among stakeholders that the processes for engagement and participation could be further improved, to really do justice to the consumer perspective and to broaden the evidence considered by the PBAC. Internationally (including in Australia), there has been a move to accelerate regulatory processes and timelines. While this is seen to be beneficial in terms of access for patients, it brings an increase in uncertainty regarding the quantity and quality of evidence required for HTA purposes. Consequently, the patient / consumer perspectives are even more critical, as they can contribute to addressing that uncertainty. 

BMS Australia commissioned Biointelect to research the perspectives of Australian stakeholders to obtain insights on the experiences of consumers and views on areas for improvement. This was done via desk research, in depth stakeholder interviews, an on-line survey and a workshop involving several advocacy organisations. 

Biointelect also interviewed a range of experts associated with patient / consumer engagement in other HTA jurisdictions, notably England, Scotland and Canada. While it is not the intention of this report to argue that Australia’s HTA process should look like any of these, it was clear that some of the issues and frustrations experienced in Australia could be improved upon by learning from some of the international practices and examples.

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