Although faster registration by the Therapeutic Goods Administration (TGA) is being achieved, broader access and reimbursement is behind international standards when assessing timelines for registration and reimbursement of new medicines for Australian patients against other OECD countries.
The newly launched, The Medicines Matter Report: Australia’s Access to Medicines 2014- 2019, by Medicines Australia 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% of new medicines are reimbursed in Australia within 12 months, this lags behind more than 60% of new medicines reimbursed within six 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,” says 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 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.”
For the full report, visit:
Medicines Matter: Australia’s Access to Medicines 2014-2019