Establishment of the Medicines Repurposing Program

About the Medicines Repurposing Program

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 the regulatory recognition and providing subsidy to patients for the new use.

The program creates a means for clinicians, health organisations, patient groups, researchers, pharmaceutical companies and other interested members of the public to inform the Department of Health and Aged Care of potential new therapeutic uses for existing medicines, with the ultimate aim to have this new use approved by the Therapeutic Goods Administration (TGA) and considered by the Pharmaceutical Benefits Advisory Committee (PBAC) for listings on the Pharmaceutical Benefits Scheme (PBS).

This initiative is supported by stakeholders and is part of Strategic Agreements 2022-2027 with the medicines industry. Medicines repurposing was included as an action item in the 2020 National Strategic Action Plan for Rare Diseases. Patient and clinical groups expressed strong interest in repurposing during the 2021 Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia.

During 2021 and 2022, the Department of Health and Aged Care collected stakeholder inputs through workshops, roundtables, and public consultations. Details of the public consultations along with feedback received from stakeholders are available on our Consultation Hub.

Following consultations, the MRP was developed by the Department of Health and Aged Care. The program was announced as part of a broader PBS reforms package in the Federal 2023-2024 Budget - Budget Paper No. 2: Budget Measures. The program currently has terminating funding for 4 years, until 30 June 2027.

The program is managed by the TGA, in collaboration with the Technology Assessment and Access Division (TAAD), who manage the PBS. Under legislation, a medicine cannot be listed on the PBS unless the PBAC makes a recommendation in favour of listing. The PBAC is an independent and expert body, comprising doctors, health professionals, health economists and consumer representatives. Similarly, the Government relies on advice from the PBAC before a change is made to an existing PBS listing, such as the addition of a new indication.

Importance of the program

Medicines repurposing involves identifying new therapeutic use(s) for older/existing medicines. It applies to a medicine that is already approved to treat a particular condition and is then found suitable to treat another condition. The new use would typically require regulatory approval and a positive recommendation from PBAC before it is subsidised for the new condition.

For many years, older prescription medicines have been used, through accepted clinical practice, for conditions without regulatory approval. However, this ‘off-label’ use, usually in an ad-hoc manner by individual prescribers, can lead to inequity of access for patients. Bringing ‘off-label’ use under regulatory oversight expands treatment options and increases prescriber consistency, benefiting more patients.

The concept of repurposing has gained significant attention in recent years. Identifying the right potential candidates, with the appropriate evidence to make new treatment options available for patients is critical to the program. Several overseas agencies are establishing similar programs to support clinicians, researchers, and non-commercial parties in identifying potential new uses for existing medicines.

For sponsors of older prescription medicines, lack of commercial value and costs associated with applications often present barriers to applying for approval of a new use. Other parties, such as academic institutions, researchers, and health organisations, may be aware of a medicine’s potential new use and benefit to patients, but may not be adequately resourced to bring these medicines forward for consideration independently. Through this program, the Department is addressing these barriers.

Identifying potential medicines

The MRP targets medicines for which a significant public health benefit has been identified but there is little or no commercial incentive for a sponsor to pursue regulatory approval and PBS listing to make this use more accessible. Persons and organisations who wish to nominate a new use of an existing medicine can complete a nomination form and submit their proposal to the TGA.

An organisation or individual can nominate more than one medicine, provided each meet the eligibility criteria, and are submitted in separate nomination forms.

If another nomination is received for the same medicine, the nominations will be packaged together for assessment and prioritisation as a single candidate through the program.

Learn more about the program’s eligibility criteria and prioritisation considerations.

Progressing potential medicines

A dedicated program team oversees the candidate nomination and prioritisation process to select the most promising candidate medicines, utilising advice from the Advisory Committee on Medicines (ACM). The ACM provides independent advice to assist with assessment and prioritisation of nominated candidate medicines.

The MRP works closely with stakeholders to identify potential candidate medicines, initiate discussions to facilitate expanding access for patients and address any potential barriers. As a new program, MRP will actively seek stakeholder inputs and feedback to improve and refine the program to ensure it achieves the intended goals. This collaborative approach gathers valuable insights to deliver a program that benefits patients. Over time, with stakeholder inputs and feedback, the program framework and processes may be refined to meet the goals of the program.

Contact

For any enquiries, please email mrp@health.gov.au