What is the issue:
Australians currently wait an average of 391 days1 for a proven innovative medicine to be listed on the PBS and takes far longer than most developed countries.
Why is it important:
Australia must remain a ‘first wave’ country for launching new medicines, vaccines and technologies so Australians have access to world-class medicines when they need them. In the 3 top OECD countries, reimbursement of 60% of medicines is achieved within 3 months2. In Australia, only 20% of medicines are reimbursed in that time.
- The Government should adopt the recommendations in The New Frontier – Delivering Better Health for all Australians Report3 tabled in Nov. 2021 by the House of Representatives (HOR) Inquiry into access to new drugs and novel medical technologies.
- Use the Health Technology Assessment (HTA) Review outlined in the 2022-2027 Strategic Agreement between the Commonwealth and Medicines Australia for genuine reform to ensure Australians have access to new and emerging innovations. This Review is recognised as one of the most significant reforms for medicines access seen in the last 30 years. In parallel, ensure the National Medicines Policy (NMP) Review provides a framework that supports the intentions of the HTA Reform and the recommendations from the “New Frontier” report.
Medicines Australia signed its Strategic Agreement 2022-2027 with the Australian Government in September 2021. The Agreement contains a series of investment and savings measures focused on supporting innovation by lessening price reduction impacts on new medicines but significantly increasing price reductions on older products. It also incorporates a reform agenda with policy improvements designed to create faster access to medicines including
The first HTA review in 30 years. Topics of focus include enabling faster access to innovative medicines, comparator selection, methods for evaluating rare diseases, use of real world evidence and managing uncertainty. Recommendations will be implemented by July 2024.
It is important to note this level of policy commitment is unheard of in Strategic Agreement history, which have previously been focused on pricing issues. This demonstrates goodwill by the Government to improve the broader health ecosystem. The HTA Review and the NMP Review, provide the Government with an unprecedented opportunity to harness improved access times to affordable medicines for all Australians.
Medicines Australia’s Position
Issue: Reimbursement Access
Medicines Australia research highlights that reimbursement is lagging behind other comparable countries. For example, in Australia 60% of new medicines achieve reimbursement within 12 months; while in Japan, Germany, and Austria, 60% of new medicines achieve reimbursement within 3 months6.
- Australia’s average time to reimbursement from registration is 391 days. This is in contrast to the 20 OECD countries average of 351 days4.
- It takes, on average, 1.70 submissions that include a full economic evaluation of any type, to obtain a PBAC recommendation.
- 75% of industry submissions to the Parliamentary (HOR) Inquiry highlight the need to improve HTA processes in line with international best practice5.
The HOR inquiry tabled its report in Nov 2021 with 31 recommendations6 of which 20 specifically address reimbursement issues. Medicines Australia fully supports these recommendations and will work with the Government to ensure they are implemented as quickly as is practicable.
Medicines Australia Recommendations:
Our vision is to make a real difference to the health of all Australians by ensuring they have access to world-class medicines when they need them. This can be achieved in a number of ways including:
- Ensure timely implementation of the HOR inquiry recommendations, including
- Establishment of a Centre for Precision Medicine and Rare Diseases within the Department of Health (Rec 1)
- HTA process for cell and gene therapies be simplified to establish a clear and certain pathway for such therapies (Rec 2)
- Better coordination with international HTA bodies (Rec 16)
- Clinical trials harmonisation (Recs 22-26)
- Patient voice integration in HTA process (Rec 28)
- Expanded stakeholder involvement in decision making; before, during and after HTA consideration, should be factored into an improved process, including improvements to opportunities for public consultation, consumer input to decision makers and stakeholder research.
- Through the HTA Review, modernise and improve HTA evaluation processes in line with international best practice HTA and better capture the impact of the social and economic contribution of medicines, such as patient reported outcomes, productivity and community.
- Reinstate annual dialogue between industry (represented by Medicines Australia) and the Reimbursement Committees to consider and create opportunities to resolve issues of relevance for a contemporary HTA process.
- Ensure the NMP Review provides a framework that supports the intentions of the HTA Reform and the HOR Inquiry recommendations.
McKell Institute (2018), “Our Health Our Wealth: The Impact of Ill Health on Retirement Savings in Australia” accessed via https://medicinesaustralia.com.au/wp-content/uploads/sites/52/2018/09/Our-Health-Our-Wealth-full-report.pdf
- Medicines Australia Medicines Matter – Australia’s Access to Medicines 2014-2019, pg. 18
- Medicines Australia Medicines Matter – Australia’s Access to Medicines 2014-2019, pg. 7
- https://parlinfo.aph.gov.au/parlInfo/download/committees/reportrep/024755/toc_pdf/TheNewFrontier-DeliveringbetterhealthforallAustralians. pdf;fileType=application%2Fpdf
- Medicines Australia, “A presentation to Medicines Australia members on House of Representatives-Standing Committee on Health, Aged Care & Sport Inquiry into approval processes for new drugs and novel medical technologies in Australia”, 4 March 2021