News

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Can medicine repurposing help GPs?

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The Therapeutic Goods Administration (TGA) has commenced a new Medicines Repurposing Program (MRP) in a bid to expand treatment options, calling for suggested medicines to be nominated.
 
The MRP will identify new therapeutic uses for existing medicines registered on the Australian Register of Therapeutic Goods (ARTG), with the aim of facilitating and encouraging ARTG registration and consideration by the Pharmaceutical Benefits Advisory Committee for listing on the PBS. 
 
Bond University Professor of General Practice Mark Morgan is Chair of the RACGP Expert Committee – Quality Care (REC–QC). He told newsGP while the program could be valuable for GPs, there are details to consider.
 
‘Medicine repurposing is an opportunity for an expansion of prescribing criteria for existing medicines,’ he told newsGP.
 
‘The idea is to actively identify target medicines and support the often-challenging process of getting these medicines accessible for patients.
 
‘It is important that any medicines assessed for this extended use have strong evidence of benefit over harm, and that we have sufficient knowledge about the way the medicine should be used, including precautions.’
 
Medicines repurposing was included as an action item in the Australian Government’s 2020 National Strategic Action Plan for Rare Diseases, as well as part of recommendations from a 2021 Parliamentary Inquiry into approval processes for access to new drugs and medical technologies.
 
Following various public consultations, the MRP was announced as part of a broader PBS reform package in last year’s Federal Budget, with $10.1 million allocated over four years from 2023–24 for the TGA to help medicine sponsors repurpose certain medicines by expanding approval for their use.
 
Individuals and organisations can propose new uses for existing medicines, supported by accepted clinical practice and/or publicly available literature, and the program is seeking nominations with ‘a clear public health benefit substantiated by evidence of established clinical practice’. 
 
Dr Gary Deed, who also sits on the REC–QC and is Chair of RACGP Specific Interests Diabetes, encourages GPs to nominate medicines to be repurposed as part of the program, he said there is a caveat.
 
‘There can be influential forces from sponsors encouraging a select opinion leader to nominate a particular product or indication,’ he told newsGP.
 
‘That is why it is important to consult the health societies as well, plus have clear lines of conflicts of interest declared.
 
‘The fact that TGA indications are updated still is not articulated with the PBS access – this is a different process and often GPs and the public don’t understand the difference.’
 
According to the TGA, repurposing of older medicines is ‘the process of identifying potential new therapeutic uses or “indications” for older medicines through new research and evidence’.
 
This includes indications where benefits to public health have been identified, for example when the medication is: 

• already approved in other jurisdictions
• for a less common disease
• already accepted clinical practice although ‘off-label’
• likely to be less commercially profitable.

The TGA states that while older prescription medicines have been used for conditions without regulatory approval for many years under ‘accepted clinical practice’, this example of off-label use can lead to inequitable access for patients.
 
In response, the MRP proposes to move off-label use under regulatory oversight to expand treatment options and improve prescriber consistency.
 
Dr Deed warned this is something for GPs to be aware of when it comes to prescribing.
 
‘It may not always offset off-label prescribing, as this is determined by PBS access or restrictions, not always the TGA listing,’ he said.
 
‘But it may improve evidence-based therapy being implemented into clinical practice, as currently guidelines emerge, but [the] TGA and PBS can be slow to update.’
 
Professor Morgan adds that medication no longer under patent restriction is another consideration.
 
‘The proposal is necessary when likely profits are insufficient for pharmaceutical companies to push for the changed criteria, for example off-patent drugs,’ he said.
 
Echoing the REC–QC Chair, Dr Deed agrees that overall, the MRP could be beneficial to GPs and the wider healthcare system, but he also holds some concerns.
 
‘It may allow faster access to significant emerging evidence of the clinical utility of existing medications, but it needs to be balanced against the extra costs to the health system by faster access,’ he said.
 
‘But having said that, the PBS is the filter to apply economic modelling around the further subsidised access.’
 
The TGA will assess nominations for the MRP in batches on a rolling basis to allow review of eligible medicines at the Advisory Committee on Medicines (ACM) meetings, with the first batch of nominations accepted until Wednesday 17 April. More information is available on the TGA website.
 
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medicines repurposing program off-patent medication PBAC TGA treatment access

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