HTA reforms face ‘complex and costly’ overhaul, Urgency mounts as patients await government action

The long-awaited release of the Health Technology Assessment (HTA) Review’s final report, initially submitted to the government in May, was unveiled at Medicines Australia’s PharmAus meeting in Canberra overnight. However, the announcement offered limited details on implementation timelines and funding commitments from the Department of Health.

Minister for Health and Aged Care, Mark Butler, confirmed the formation of an independent implementation group to drive the reforms forward. The Review report outlines 50 recommendations aimed at overhauling systems and pathways to expedite patient access to essential treatments and health technologies.

Adjunct Professor Debora Picone, Chair of the HTA Review Reference Committee, noted “Implementing such a multifaceted program of reforms will be complex and costly. It also needs to occur in sync with other reforms arising from The New Frontier inquiry, where the Australian Government has made a commitment to advance these reforms.”

Liz de Somer, CEO of Medicines Australia and the industry’s representative on the Reference Committee, emphasised the significance of these reforms.

“The recommendations reflect what has been the most comprehensive review of Australia’s HTA in more than 30 years. The input from stakeholders has been tremendous and provided a clear picture of where improvement is needed,” she said.

Christine Cockburn, CEO of Rare Cancers Australia, said “We’re pleased that so many of the issues that we have been seeking to address over the last 12 years at RCA have been recognised. We are looking forward to working with the government and partners across the sector to swiftly implement these necessary changes, improve consumer participation, and tackle the current delays and inequities in our system to ensure equitable access for all cancer patients in Australia.”

One of the key issues identified is the current inefficiency in regulatory and reimbursement timelines. Due to limited use of parallel processing, the Therapeutic Goods Administration (TGA) and Pharmaceutical Benefits Advisory Committee (PBAC) assessments are largely sequential. This often results in delays, with the time from application for regulatory approval to a positive HTA recommendation extending up to 95 weeks. In some cases, more resubmissions or longer periods between submissions further protract the process.

The medicines industry has pushed for aggressive targets to cut delays in patient access, recommending a 60-day timeframe for PBS listing following ARTG registration for all submissions. However, the HTA Review report proposes more achievable timelines for government that, while improved, fall short of the industry’s optimistic goal. It calls for over 90% of medicines demonstrating superiority to be listed on the PBS within 6 – 12 months of ARTG registration.

“This is a significant reduction from the current timeline of ~22 months,” the report noted. “Vaccines and life saving medicines for people with ultra rare diseases could also be subsidised faster in 18 – 22 weeks and 4 weeks, respectively.”

The report calls for the establishment of a “bridging fund” for therapies with high unmet clinical needs. This fund would provide quicker, more equitable access while managing the uncertainty and risk that often contribute to delays.

AstraZeneca welcomed the release of the report, with a spokesperson noting, “We are working with a fantastic group of diverse stakeholders who are passionate about finding a solution to enable the Australian Government to subsidise therapies faster.

“A bridging fund could provide cancer therapies to patients at the time they are registered with the TGA and possibly years earlier than they are listed on the PBS. Other countries have bridging funding mechanisms and we think Australia could also make this happen for patients who don’t have time to wait for PBS access.”

The Co-design Working Group (CWG) also put forward its own set of recommendations to the Department of Health on how to increase patient and consumer input earlier in the HTA process.

Sharon Winton, CWG Chair, said “We are seeking a system that is built on transparency and inclusion that can be realised via a roadmap of collaborative action that will lead to the changes that give all Australians access to the right healthcare regardless of where they live.”

Key recommendations from the CWG report include expanding consumer participation in HTA processes, elevating consumer evidence in decision-making, and creating a feedback loop to ensure consumers understand how their input informs HTA decisions and outcomes.

While several important recommendations aim to address inequities in access for First Nations people, there were no specific references relating to culturally and linguistically diverse (CALD) communities or other underserved groups in the CWG report or the HTA Review report.

A coalition of leading cancer organisations, including Cancer Council, Cancer Nurses Society of Australia, Clinical Oncology Society of Australia, Private Cancer Physicians of Australia and Medical Oncology Group of Australia, said “We support any measures that increase community member and healthcare professional engagement, ensuring that this occurs as early as possible and frequently throughout the process, and all outputs or decisions made because of that input are transparently shared with the community.”

The CWG report also highlighted the need for funding and resources to support the implementation of the recommendations.

“Many of the opportunities to enhance consumer engagement across the HTA pathway represent discrete projects and new processes that will require funding from sources within, and outside of, the Department. Investing in processes will uphold and further develop collaboration between consumers, the medicines industry, the Department and other stakeholders,” the report noted.

Minister Butler said, “With health technologies, the opportunity cost of a dollar spent needlessly or on the wrong therapy is enormous. It isn’t measured in dollars and cents, but in months and years, and time lost with loved ones.

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

Medicines Australia underscored the urgency of implementing the HTA reforms.

“Industry stands ready to constructively participate in the implementation group alongside patients, patient advocacy groups, clinicians, and the government. We need an implementation plan and timelines, and we need to begin the co-design work that is needed to deliver these reforms.

“We cannot lose reform momentum, patients are waiting,” emphasised de Somer.

In reimagining healthcare, Health Industry Hub^TM is the ONLY one-stop-hub uniting the diversity of Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change. The exclusive leadership and influencer podcasts and vodcasts offer unparalleled insights and add immense value to our breaking news coverage.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.