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‘Visionary’ review suggests quicker approval of new medicines
New subsidised medication approvals would be streamlined and access made easier for vulnerable populations, under a new health technology plan.
Approvals for medicines and vaccines must be quicker and the Therapeutic Goods Administration (TGA) approval and product registration processes should be undertaken simultaneously to save time, according to a new independent review.
The Health Technology Assessment (HTA) Review was handed down earlier this month, making a suite of recommendations to policies and methods, funding and approval pathways, and health technologies.
Its final report found that 90% of worthy products could be Pharmaceutical Benefits Scheme (PBS) listed within six months of TGA registration, compared to the current timeframe of 22 months.
The proposed reforms could see new vaccines ‘subsidised faster’, within 18–22 weeks, and ‘life-saving medications for people with ultra-rare diseases’ subsidised within just four weeks.
The review’s key recommendations include:
- creating equity for Aboriginal and Torres Strait Islander communities
- improving access to medicines for children
- streamlining approval processes for vaccines.
The Federal Government says it will now ‘carefully consider’ the recommendations and will establish an implementation group to guide the HTA reform process and provide regular updates.
Dr Michael Tam, RACGP Expert Committee – Quality Care member, said there will always be balance needed between patient access to medications and medicine safety.
‘Australia’s system for assessment for drugs and devices was perhaps designed more from the perspective of new pharmaceuticals … and from that perspective it has largely worked well,’ he told
newsGP.
‘There is always a tension between the rigor of the analysis and access … and what we have in Australia is a system that has worked well.’
Dr Tam said there is also a need to increase transparency around the approvals process, as well as increased access to care for all Australians.
‘There is a benefit to an equity lens to improve access for Aboriginal and Torres Strait Islander peoples, children and others who may be disadvantaged from a socio-economic perspective,’ he said.
According to the report, estimates show the PBS and Repatriation Schedule of Pharmaceutical Benefits spends $167 per person for Aboriginal and Torres Strait Islander patients, compared to $427 per person for non-Indigenous Australians.
‘These figures bring into sharp focus the issues First Nations people face in gaining equitable access to medicines,’ the report said.
‘Stakeholders also reported that many medicines that are integral to the health and wellbeing of First Nations people are not listed on the PBS.
‘The review recommends reforming HTA mechanisms to appropriately engage First Nations people in decision-making processes so that their priorities and perspectives are integrated across the HTA continuum.’
The review also calls for better access to PBS-listed medicines for children and adolescents, saying there are gaps in medicines approved to treat paediatric patients, in part due to challenges undertaking research in this group.
The report highlights examples of age-inclusive approaches including where the Pharmaceutical Benefits Advisory Committee has ‘omitted age from PBS restrictions, allowing broader access for children than that approved by the TGA’.
It went on to call for consideration of in-scope strategies to improve access to medicines for children.
Dr Corin Miller, a New South Wales GP with a special interest in paediatrics, said children frequently experience difficulty accessing medications for very common conditions, such as asthma and ADHD.
She told
newsGP these barriers include a lack of PBS approval, where sponsors have not sought a medication’s approval for use in children, and additional red tape preventing GPs initiating or prescribing common medications.
Dr Miller said off-label prescribing is common in paediatrics, saying that changes to formal approvals processes which increase access to medications for children would be welcome.
The review recommends the National Immunisation Program adopt streamlined approval processes which are ‘proportionate with the level of risk and complexity’.
It recommends better coordination between the Australian Technical Advisory Group on Immunisation and other stakeholders, suggesting processes include ‘proactive consideration of how new products or potential changes to the vaccine program could impact disease burden’.
However, Dr Tam said, in a practical sense, medication indications change over time and sponsors are less likely to invest time and money in seeking PBS approvals for subsequent indications, especially where medicines or devices may be ‘off patent’.
Such delays, or indefinite absence, of PBS approvals for subsequent indications are common, particularly in patient groups where clinical trials may lag behind, highlighting the need for better alignment of approved PBS indications with clinical guidelines and practice.
Federal Health and Aged Care Minister Mark Butler labelled the report ‘visionary’ and said value for money remains paramount.
‘The goal is faster access to the best therapies, at a cost that patients and the community can afford,’ he said.
‘With health technologies, the opportunity cost of a dollar spent needlessly or on the wrong therapy is enormous.
‘Good reform must be jointly owned. Landing it will take time and the collective effort of governments, experts, patients and industry.’
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