Findings from New ‘Access to Medicines’ Report – Registration times for new medicines accelerating in Australia but broader reimbursed access behind international standards

Canberra, Monday 16 November 2020: A new report launched by Medicines Australia, assessing the timelines for registration and reimbursement of new medicines for Australian patients, against other OECD countries, shows faster registration by the Therapeutic Goods Administration (TGA) is being achieved, but broader access and reimbursement is behind international standards.

The Medicines Matter Report: Australia’s Access to Medicines 2014- 2019 analyses new and robust data into how Australia’s regulatory processes are faring (both registration and reimbursement) for the introduction of new molecular entities (NMEs), with first indications anywhere in the world, against other comparable OECD countries.

The report findings show significant improvements have been made with TGA registration timelines. Accelerated pathways and international collaborations are reducing timelines, on average, by 182 days. However, while 60 percent of new medicines are reimbursed in Australia within 12 months, this lags behind more than 60 percent of new medicines reimbursed within 6 months, on average, across the OECD countries assessed – highlighting an opportunity for greater attention and progress.

“Never before have innovative medicines been so integral to our nation’s health and also our economy,” states Elizabeth de Somer, CEO Medicines Australia. “It is imperative, particularly in these challenging times, we strive to keep up with the pace of transformation and therapeutic advancement for Australian patients, our community and our future.

The Medicines Matter Report involves a detailed and unique methodology, built by IQVIA, that standardises timelines for medicines registration (market authorisation) and also reimbursement across a variety of healthcare systems within comparable OECD countries including Australia.

“Pharmaceutical companies have broad and deep pipelines of innovative and advanced therapies – including gene and cell-based medicines. We recognise the breadth and complexity of these new and emerging medicines are not without many challenges,” continues Ms De Somer. “It is, however, essential we work collaboratively to ensure we have a contemporary and fit for purpose approach for the future so that patients benefit from these advancements as soon as possible.

“We believe Australia’s ability to retain a position as a ‘first wave’ country for registration and reimbursement of medicines is at risk. This not only impacts timely delivery of medicines to patients, but also how Australia is viewed and prioritised by established and emerging companies for the introduction of future innovative solutions to this country. Acting now is essential.”

TGA registration times have seen significant improvements: The introduction of the priority review and provisional registration pathways have significantly reduced evaluation and approval times: –

• Six medicines were designated for the Priority Review Pathway (2018 and 2019) and on average were processed 182 days quicker than medicines on the standard review pathway.
• International work sharing programs including Project Orbis and the Australia-Canada-Singapore- Switzerland Consortium (ACCSS) expedited the TGA process for seven medicines.

Further improvement is required with reimbursement timelines: In contrast, reimbursement timelines require attention, to ensure Australia tracks closer to its international counterparts: –

• Close to 60 percent of new medicines achieve reimbursement in Australia within 12 months from submission to the PBAC (2014 – 2019).
• In comparison, the majority of OECD countries achieve reimbursement, on average, with more than 60 percent of medicines within 6 months.
• In three top OECD countries, reimbursement is achieved for 60 percent of medicines within 3 months – setting an aspirational timeline for other nations to review and work towards.

Differences across therapy areas: The findings show differences in registration and reimbursement timelines across the therapeutic areas: –

• Oncology and cardiovascular medicines had some of the longest average timelines to listing (125-1144 days for oncology, 222 – 1007 for cardiovascular medicines).
• This is in contrast to asthma and arthritis which had some of the fastest timelines (asthma 142 -348 days, arthritis 152 -337 days).

“It’s time now to work in partnership and introduce progressive improvements to the regulatory and reimbursement processes working on a range of requirements – that recognise the full value of innovative medicines, builds active contribution and involvement  by consumers and establishes transparency and measurement of progress made,” concludes Ms De Somer.

For further information please contact Jamie Snashall on 0407 438 746 or Anne-Marie Sparrow on 0417 421 560.