Australia Is Implementing Its HTA Policy and Methods Review in Stages

The Health Technology Assessment Policy and Methods Review examined how Australia assesses medicines and other health technologies for public funding, including through the Pharmaceutical Benefits Advisory Committee (PBAC). Its final report, published on 10 September 2024, contains 50 recommendations on access, equity and simpler HTA processes. A companion report on enhanced consumer engagement contains 10 recommendations aimed at strengthening the voice of consumers and patients.

Among the methods recommendations, Recommendation 39 proposes a reduced base-case discount rate, no lower than 3.5 per cent, for technologies with upfront costs and long-term benefits. Recommendation 44 concerns the concepts of high unmet clinical need and high added therapeutic value, which are used in current PBAC guidelines but, as the implementation group noted, have no agreed definition in Australia.

The Minister for Health established an Implementation Advisory Group, chaired by Professor Andrew Wilson, to turn the recommendations into a sequenced reform plan and to help develop a draft government response. The group’s interim report was released in 2025 and outlined progress, early insights and next steps. The government responded with near-term actions, including a rolling review of the PBAC Guidelines that prioritises comparator selection and the discount rate, and the development of a stakeholder engagement framework focused on consumer and patient involvement.

Official material stated that the group’s final report and proposed implementation roadmap were expected to be provided to the government in January 2026. A search of public sources did not locate a published final report or a formal government response to all 50 recommendations at the time of checking. Trade press has reported that the Department of Health referred to a significant implementation cost and to a funding proposal in the 2026–27 Budget cycle.

The Review also addressed processes as well as methods, including the timeliness of assessments, the role of consumers and patients, and the treatment of technologies for which conventional evidence is difficult to generate. Its recommendations were intended to be implemented over several years, which is why the government established a dedicated implementation group rather than responding to all recommendations at once.

The Department of Health’s HTA improvements page reports that, in early 2026, experts held targeted consultations to define the concepts of high unmet clinical need and high added therapeutic value. The same page reports that a consumer engagement framework for HTA was published on 7 July 2026, setting out a shared approach to engaging consumers across HTA processes, and that the department planned regular webinars from late 2026, beginning with an information session on Strategic Agreements.

The PBAC’s April 2026 update stated that the first phase of the rolling guidelines review focuses on comparator selection and discount rates, and the July 2026 PBAC meeting agenda listed an update on amendments to the PBAC Guidelines for these two areas. The final revised text had not been located at the time of checking.

Sponsors should expect changes to arrive in stages rather than as a single reform package. The changes most likely to affect submissions in the near term are those on comparator selection and the discount rate, which bear directly on clinical claims and economic models. Definitions of high unmet clinical need and high added therapeutic value may later influence how the PBAC weighs evidence and uncertainty.

Companies planning Australian submissions should follow the Department of Health and PBAC pages for final guideline text and implementation dates. This brief by Pubrica is for information and does not represent the views of the Australian Government or the PBAC.

Sponsors may also wish to engage with the consultations the Department of Health is running on implementation. The HTA improvements page notes that industry consultation will occur separately from the consumer reference group, and the department has indicated it will continue to consult on implementation and related matters. Participation gives sponsors an opportunity to comment on practical effects of proposed changes before they are finalised.