There has been a significant increase in the development of drugs that can be used in multiple conditions. However, there are no evaluation frameworks to assess the safety, clinical efficacy and value for money of multi-use drugs for government funding and hence assessments for reimbursements are done on per use or per indication basis. This is inefficient and resource intensive, leading to significant delays in patient access for new and innovative medicines. My PhD project aims to develop a methodological framework for evaluating multi-use drugs and explore different funding mechanisms to ensure they are available to patients in a timely manner. As medicines rarely have the same level of effectiveness across different diseases and conditions, ensuring the medicine with its clinical benefits is worth the proposed price in all uses is a key focus of the project. 

Available Research Projects

What is the overlap between the Federal and State government in consideration of medicines for funding decisions? What bearing do two factors have on funding decisions – patient engagement and high unmet medical need?”

Project Description:

Although the federal government’s Pharmaceutical Benefits Schedule (PBS) provides subsidised medicines for all Australians, many drugs have not been considered by the Pharmaceutical Benefits Advisory Committee (PBAC) for reimbursement. There are many reasons for this: the long-term clinical benefit of the drug may be uncertain, the drug may be too costly for its clinical benefit, or if the target patient population is small, pharmaceutical companies may not even bother lodging an application for reimbursement. Even if a medicine is reimbursed by the PBS, it is usually restricted to a very narrow patient population (known as an indication) where the PBAC can be certain the medicine represents good value for money. In these cases, decision makers in state health departments and hospitals, such as the South Australian Medicines Evaluation Panel (SAMEP), must decide whether they will fund medicines for uses outside the PBS indication.

While the safety, clinical benefit, cost-effectiveness and budget impact of a medicine is typically what is assessed for reimbursement, recently decision-making bodies have considered other factors, namely patient engagement and high unmet clinical need, when determining their final decision. We are interested in the impact of these two factors on the final decision (to recommend for reimbursement or not). This will help decision making bodies with the reimbursement of medicines where the level of conventional benefit (i.e. safety, clinical effectiveness and cost-effectiveness) is uncertain.

Reviewing policy documents, this research project involves:

• Reviewing drug indication pairs that were considered by SAMEP and subsequently the PBAC.
• Identifying funding approval conditions or restrictions placed on drug-indication pairs by SAMEP or PBAC.
• Reviewing patient or patient group engagement to the decision-making bodies for each drug-indication pair.
• Determining how often high unmet clinical need (i.e. no other treatment options) informed funding decisions.

For details on additional projects view the following booklet: School of Public Health Student Projects. Please email to discuss availability.