HTA Policy Update

Section Editors: Sandra Nestler-Parr, PhD, MPhil, MSc; Ramiro E. Gilardino, MD, MSc

This issue provides a summary of the recently concluded HTA Policy and Methods Review in Australia. We invite suggestions for relevant topics and guest editorials for future issues. Please contact the Value & Outcomes Spotlight editorial office with your suggestions.

Enhancing the HTA Framework in Australia: Recommendations of the HTA Policy and Methods Review

Adam Gordois, BA, MSc, Director, HEOR and Value Demonstration, BioCryst Pharmaceuticals, Leeds, United Kingdom

Health technology assessment (HTA) has a long-standing history in Australia. As one of the first countries to implement HTA processes for new medicines, it has been mandatory since 1993 for sponsors to provide an economic evaluation in submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the independent statutory body advising the Government on drug reimbursement decisions.

The recently completed HTA Policy and Methods Review (“the Review”) marks the first independent review of Australia’s HTA system in nearly 30 years. It was initiated in October 2022 as part of the current 5-year Strategic Agreement between Medicines Australia (the national research-based pharmaceutical industry association) and the Federal Government. The Agreement recognized the shared goals of: (a) reducing the time for Australians to access new health technologies and (b) maintaining the attractiveness of Australia as a first-launch country by ensuring its HTA processes keep pace with advances in health technology and minimize barriers to access.

The Review’s terms of reference covered HTA policy and methods and funding and approval pathways, for medicines, vaccines, highly specialized therapies (eg, cell and gene therapies), other linked health technologies (eg, pathology tests), and foreseeable changes in healthcare. The goal was to develop a comprehensive set of recommendations to Government that are implementable and sustainable; give all Australians equitable, timely, safe and affordable access to high-quality medicines; adopt a person-centered approach to HTA; and ensure HTA policy and methods are suitable for emerging technologies.

An extensive and detailed consultation process to inform the Review—open to all stakeholders—generated 253 submissions across 2 public consultations, “deep-dive” discussions with 116 participants, 1 in-person and 3 online workshops, and 7 commissioned research papers from expert HTA groups. Importantly, the Review was also informed by a rigorous comparative analysis of international HTA systems.

The final report, published September 10, 2024, provides 50 detailed recommendations across a wide range of areas, including improving access to new health technologies, tackling inequity, and making HTA processes simpler for consumer and clinician participation. The recommendations broadly fall into 7 categories—a nonexhaustive summary is provided below.

1. Create more equitable access for First Nations people and pediatrics

2. Streamline pathways for more timely access

• Reform HTA and funding processes to be fit-for-purpose, unified, and consistent.
• Improve reimbursement pathways (eg, streamline cost-minimization submissions, more support for medicines with added therapeutic value, consider alternative modeling approaches).
• Restructure the vaccines application pathway.
• Improve the time to access life-saving drugs for ultra-rare diseases.
• Create performance targets to measure the impact of HTA reforms, jointly owned by government and industry.

3. Develop policies, methods, and processes to translate HTA recommendations into patient access

• Design a framework that supports different funding mechanisms for high-cost/high-impact health technologies.
• Improve the clarity of post-HTA negotiations.
• Periodically review reimbursed technologies.
• Develop practical approaches to manage uncertainty (eg, revised framework for managed entry agreements, bridging fund to facilitate earlier access to therapies of high therapeutic value).
• Incentivize the development of technologies addressing antimicrobial resistance.

4. Improve transparency and stakeholder involvement

• Improve the transparency and communication of HTA pathways, processes, and decisions (eg, plain language summaries, website improvements).
• Ensure wider stakeholder involvement in HTA by developing an engagement framework, offering support to consumers and requesting information from sponsors on engagements.
• Develop an explicit “qualitative values” framework for HTA committees.

5. Enhance real-world evidence for HTA

• Develop a framework to ensure timely access to data, an effective data infrastructure, cross-jurisdictional data sharing, and best-practice methods for data standardization and analysis.

6. Implement methods for confident decision making

• Create a framework to govern how PICO scoping and engagement can support HTA.
• Update guidance on integrating consumer input into HTA processes.
• Develop guidance to assess nonrandomized and observational evidence, surrogate end points, and therapies targeting biomarkers.
• Recommendations for economic evaluation (eg, discount rate reductions for some technologies, comparator selection).

7. Support HTA architecture

• Develop processes to identify areas of high unmet clinical need and bring forward submissions of technologies addressing these areas.
• Establish a national horizon scanning function to improve stakeholder engagement.
  

To deliver these recommendations, the Review supports developing the capacity and capability of the HTA system and establishing mechanisms for further reviews. The Review reference committee believes that implementing these recommendations will substantially reduce medicine approval times, provide more timely and equitable access to new treatments, and enable greater involvement of those impacted by HTA decisions.