Government releases HTA review

For patient groups, the optimisation of real-world data and randomised controlled trial evidence in HTA reviews could signal an improvement

As part of PharmAus24, the Australian Government has officially released the final report of the Health Technology Assessment (HTA) Review, as well as the companion Enhance HTA Report.

The HTA Review Report and Enhance HTA Report makes a total of 60 recommendations across a range of areas, including improving access to new health technologies, tackling inequity, and making HTA processes simpler and easier for consumers and clinicians to participate in.

Health Minister Mark Butler was clear in the need for reform.

“The goal is faster access to the best therapies, at a cost that patients and the community can afford. Value for money remains paramount, because value is at the heart of patient benefit,” he said.

“Good reform must be jointly owned. Landing it will take time and the collective effort of governments, experts, patients and industry.”

Key recommendations from the report include:

• A unified, national HTA pathway and committee approach for all health technology evaluation.
• A single front door mechanism for vaccine sponsors to make submissions for the National Immunisation Program (NIP) to the TGA, ATAGI and the PBAC.
• Expand the advisory role of the Pharmaceutical Benefits Advisory Committee (PBAC) to enable it to make HTA recommendations to the Minister for Health and Aged Care for a broader range of health technologies.
• The Pharmaceutical Benefits Advisory Committee (PBAC) to become the sole HTA advisory committee for assessing and recommending funding of therapies for ultra-rare diseases.
• Establish a bridging funding program to facilitate earlier, temporary subsidised access to promising, time-critical, therapies of high added therapeutic value that address high unmet clinical need (HUCN) for patients.
• Develop and implement an Australia-specific framework to optimise timely access to relevant real-world data (RWD) for HTAs, to supplement available randomised controlled trial (RCT) evidence.
• Establish a First Nations Advisory Committee, reporting to the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC).

For patient groups, the optimisation of real-world data and randomised controlled trial evidence in HTA reviews could signal an improvement in the weighting of this evidence in decision making, however the Review is clear in its signalling that this should be used to determine treatment effectiveness only when certain conditions are met.

Overall, further consultation was a key theme, with several recommendations highlighting the need for the Australian Government develop processes, in consultation with stakeholders.

Minister Butler flagged that the Government would establish an implementation group to guide the HTA reform, to be led by an eminent Australian and will include representation from the Commonwealth and state and territory governments, as well as industry, consumers and clinicians, as well as the expertise of a health economist.

Copies of the Review are available at www.health.gov.au/resources/collections/hta-review-final-report-collection