On 7 September 2021, the Australian Government announced two new Strategic Agreements with Medicines Australia and the Generic and Biosimilar Medicines Association (GBMA). The agreements will be in place from 1 July 2022 to 30 June 2027.
The agreements contain a comprehensive package of reforms that aim to ensure Australians gain access to transformative medical advancements developed around the world, while protecting the supply of medicines that Australians use daily. These agreements will further improve and safeguard access to new medicines in a range of ways including through:
- Equitable and sustainable access to the most effective medicines, including highly specialised, expensive and at times lifechanging medicines, through the Pharmaceutical Benefits Scheme (PBS).
- An Enhanced Consumer Engagement Process to facilitate enhanced consumer and patient engagement through the Pharmaceutical Benefits Advisory Committee (PBAC) assessment process.
- Continuous improvement of health technology assessment (HTA) processes for listing new medicines on the PBS to ensure they keep pace with the rapid advancement of health technology, remain world class and keep pace with rapid advances in medicine enabling them to be marketed and funded in Australia as they emerge.
- A new Medicines Supply Security Guarantee which will bolster medicine supply to Australian patients.
The Department of Health has developed the following fact sheets to expand on key elements of the agreements:
- Funding for new medicines
- Medicines Supply Security Guarantee
- HTA review
- Enhanced Consumer Engagement Framework
What these new agreements mean for Australians living with a rare disease
The new agreements detail commitments to supplying affordable medicines, earlier patient involvement in PBAC processes and the first independent review of Australia’s HTA system in almost 30 years. HTA encapsulates a range of processes and mechanisms that use scientific evidence to assess the quality, safety, efficacy and cost effectiveness of new medicines and technologies before they are made available in Australia (for example, medicines being funded under the PBS).
The HTA review will primarily be a technical review focused on HTA policy and methods. It will run parallel with the higher level review of the National Medicines Policy and be informed by submissions to the Parliamentary Inquiry (the Inquiry) into approval processes for new drugs and novel medical technologies in Australia that was conducted by the House of Representatives Standing Committee on Health, Aged Care and Sport. The HTA review will also be informed by any recommendations arising from the Inquiry. This is encouraging for the rare disease sector. We know one of the drivers for the Inquiry was the National Strategic Action Plan for Rare Diseases (the Action Plan). The rare disease sector strongly contributed to this Inquiry. It is pleasing to see the continued impact of this in these complementary reviews, and the continued emphasis on rare diseases. Rare diseases are specifically referenced in the Department of Health’s HTA review fact sheet. The detail within these new agreements generally align with priorities identified in the Action Plan. As the peak national body for Australians living with a rare disease, Rare Voices Australia (RVA) looks forward to utilizing our extensive HTA experience as we engage in the HTA review and contribute to the co-design of the Enhanced Consumers Engagement Process.