A program to support new clinical uses of existing medicines
The Medicines Repurposing Program (MRP, the program) aims to improve patient access to medicines in Australia by identifying new therapeutic uses for existing medicines and supporting sponsors in seeking the regulatory approval and subsidy of the new use.
The program focuses on medicines no longer under patent restrictions (off-patent medicines), although opportunities for repurposing medicines under patent restrictions (on-patent medicines) may also exist. The program offers fee waivers for the applications to register and seek subsidy for the new use to sponsors of these medicines.
Nominated medicines must first meet program eligibility criteria. After which, we assess them to determine suitability for repurposing and, if so, their priority for selection.
Eligibility criteria
To be eligible for consideration under the program, the nominated candidate medicine must be:
- a prescription medicine that is registered on the Australian Register of Therapeutic Goods (ARTG), and
- for a new, distinct indication (i.e., use is for a different medical condition or new patient group).
Medicines that do not meet the eligibility criteria will be excluded from the program.
Assessment and prioritisation
The program assesses medicines for eligibility, suitability and prioritises them for selection considering the factors below.
Feasibility for sponsors to participate in the program
The program liaises with existing sponsors of nominated medicines to determine if it is feasible for them to participate in the program, noting sponsor participation is critical for a candidate medicines progress through the program.
Existing formal evidence base
The program considers if there is a formal evidence base - such as medical literature supporting the new therapeutic use or regulatory approval by a comparable overseas regulator. At the time of nomination, the nominator should provide evidence supporting existing clinical use of the medicine for the proposed new use, where possible.
Constraints or barriers that may limit a medicine’s likelihood of repurposing success
When considering nominations, the program may engage with relevant stakeholders to assess the viability of certain candidates and discuss any other constraints and barriers, as well as potential ways to overcome these.
Advice from the Advisory Committee on Medicines (ACM) to inform prioritisation of candidate medicines
The program will seek advice from the ACM on the prioritisation of eligible candidate medicines to inform which medicines are selected for their potential to deliver on public health benefit, particularly unmet need. Feasibility to repurpose a medicine will also be considered, to best realise benefits to patients.
Decisions on nominated medicines
Each assessment results in one of the following outcomes:
- Selected for repurposing: The program offers the sponsor of selected medicine fee waivers for both the extension of indication and evaluation fees for submissions for listing on the Pharmaceutical Benefits Scheme (PBS). Selection for repurposing does not guarantee TGA approval of the new use (extension of indication) or PBS listing (subsidy). Applications will be evaluated as per standard pathways by the TGA and Pharmaceutical Benefits Advisory Committee (PBAC).
- Potentially suitable for repurposing: We assess the medicine as potentially suitable. Medicines satisfy the eligibility criteria but only some of the assessment criteria. For example, at the time of nomination; they may have limited formal evidence to support the new use, or repurposing is currently not feasible for the sponsor. These medicines may be considered for future selection. We will take no further action, unless the medicine is re-nominated, with new information indicating that the potential public health benefit and/or feasibility has changed. However, re-nomination does not guarantee future selection for repurposing.
- Unsuitable for repurposing: These medicines may, for example, have insufficient evidence demonstrating effectiveness in the proposed new use, or its public health benefit. In the event of any new development or significant change, you can re-nominate the medicine, with additional new evidence. However, re-nomination does not guarantee any specific outcome.
We will publish numbers of eligible medicines considered and details of medicines selected for repurposing. Details of medicines not selected for repurposing will not be published. As the selection process involves multiple processes with variable timeframes, an overall timeframe, from nomination to selection, is unable to be provided.
Learn more about the program
We held two webinars in March 2024. You can view the presentation slides (please note that the content presented at both webinars was the same):
Establishment of the Medicines Repurposing Program
For any enquiries, or to discuss potential nominations, email mrp@health.gov.au