AUSTRALIAN patients are facing significant delays in accessing new medicines, according to Amgen's latest Australian Patient Access Gap (PAG) report.
On average, it takes 591 days from the time a medicine is registered with the Therapeutic Goods Administration (TGA) to when it is available on the Pharmaceutical Benefits Scheme (PBS).
In contrast, patients in Japan wait 101 days, Germany 121 days, and the UK 167 days.
The report calls for urgent reforms to shorten this delay, suggesting a goal of reimbursing new medicines within three months of regulatory approval, which could improve access to life-saving treatments.
Key factors contributing to these delays include multiple resubmissions to the Pharmaceutical Benefits Advisory Committee (PBAC), complex approval processes, limited resources, regulatory barriers, and negotiation delays.
The report also found that drugs requiring cost-effectiveness analysis (CEA) faced longer delays compared to those with cost-minimisation analysis (CMA).
The average time for CEA medicines was 638 days, while CMA medicines took 488 days.
The report also notes that 38% of medicine and population pairings were recommended on the first submission, with a higher success rate for CMA medicines (77%) compared to CEA medicines (19%).
These hurdles extend the time it takes for innovative therapies to reach patients.
The average time for a PBAC recommendation to a PBS listing was 6.6 months.
Amgen emphasised that streamlining these processes are crucial to ensuring timely access to new medicines for Australian patients. JG
The above article was sent to subscribers in Pharmacy Daily's issue from 20 Aug 24
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 20 Aug 24
