Australia HTA changes
Australia publishes recommendations for a new HTA roadmap to improve market access and faster patient uptake of new medicines by the end of 2024
There is consensus among patients, clinicians, industry and the government that the time to access new health technologies in Australia is too long and that HTA methods must be sustainable for future innovations in medical technology. The proposed HTA review by the Australian government is sought to develop recommendations to identify and improve current challenges associated with timing, safety and patients access to affordable medicines, as well as considering specific healthcare needs. The Department of Health has the intention to implement these recommendations by December 2024, this means imminent and substantial changes that manufacturers need to be aware of to navigate HTA in Australia successfully.
Key recommendations:
Consider a broader range of evidence for clinical evaluation: This includes using non-randomised and observational evidence, surrogate end points and therapies that target biomarkers. In addition, a framework will establish how PICO scoping could add value to HTA processes while considering what criteria are important to patients and clinicians.
Optimise real-world evidence with a new data-sharing infrastructure: Develop a new framework to optimise access, including enabling systems, pathways, and evaluation of real-world evidence. A dynamic data-sharing infrastructure will prioritise mapping Australian real-world data collection to meet HTA needs.
Streamline pathways for more timely access: The main principles for improving funding and pathways are:
· Improve the time to access by removing duplication/unnecessary steps
· Direct effort to where it is most needed
· Ensure consistency and certainty in HTA processes through unified stages and a triage mechanism (submissions will be directed to appropriate evaluation and appraisal)
· Improve equitable access to support continuous patient care
Improve pathways for listing medicines on the Pharmaceutical Benefits Scheme (PBS) using cost-minimisation: Reduce time to access by ensuring optimised assessment methods to list medicines on the PBS by using cost-minimisation analysis to create a streamlined pathway for therapies with high added therapeutic value.
Use practical approaches, like managed entry agreements, to handle uncertainty and risk: Support stakeholders in discussions and access so the approach does not become a barrier to more timely patient access. For example, managed entry agreements will have a revised policy providing flexibility to address uncertainties while supporting timely access. Moreover, a bridging fund program will be established to facilitate earlier temporary access to eligible therapies of high added therapeutic value that address high unmet needs.
Reassess health technologies regularly: Strengthen the existing aims and principles of the reassessment programs and improve decision-making regarding ongoing access to, and subsidisation of, health technologies. Publish a regular updated post-HTA pricing policy framework for stakeholder clarification and transparency.
Improve the post-submission process: Improve holistic understanding of the pricing, negotiation, and listing processes. Improve visibility and awareness of the processes and related policies affecting how stakeholders participate in the negotiation process. This aims to improve the timeliness and success rate of translating HTA recommendations into subsidised access to health technologies for patients.
The future outcomes resulting from these new recommendations will create adaptable polices for future technologies and address the lengthy time-to-access issues, only if manufacturers are up to date with new policies in order to take full advantage of them and successfully navigate HTA in Australia by December 2024.
Written by Alex Zaloumis
Decisive Dialogue 17th September 2024
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