Application of an economic evaluation approach to making regulatory decisions regarding access to medicines: advantages, challenges and recommendations.

Initially patients require a prescription to access most new medicines. Some medicines may later be reclassified, allowing patients to access them without a prescription. Currently, Australian Therapeutic Goods Administration guidelines regarding reclassification decisions focus on patient risk rather than on potential benefits to patient health and the healthcare system. We conducted two extensive case studies demonstrating an economic evaluation approach to medicine reclassification in Australia, which were presented at various conferences and to key stakeholders. This article discusses the advantages and challenges of using an economic evaluation approach to inform medicine reclassification decisions. Advantages identified include systematically and transparently synthesising evidence from multiple sources; predicting the overall expected impact of reclassification on health outcomes and costs before it occurs; considering a broader range of risks and benefits; aggregation of health impacts into a single measure (quality-adjusted life years); identification of drivers of uncertainty; insight into the effects of different regulatory decisions; and improved consistency of evidence. Challenges include data availability and quality, estimating behavioural changes, model complexity, the lack of an incremental cost-effectiveness ratio threshold, and funding of economic analyses. We recommend that regulatory decision makers use an economic evaluation approach to help inform reclassification decisions, although economic evaluation results should be considered as part of the broader body of evidence. Ultimately, the use of an economic evaluation approach will contribute to helping decision makers maximise population health outcomes in an efficient way. What is known about the topic? In the past, decisions regarding medicine reclassification have generally been made using a deliberative approach focusing on patient risk. However, there are also potential benefits to patient health and effects on the healthcare system. Increasing awareness of these benefits have led to the development of alternative approaches to decision making, including an economic evaluation approach. What does this paper add? This article discusses the advantages and challenges of using an economic evaluation approach to inform medicine reclassification decisions compared with alternative approaches. What are the implications for practitioners? Economic evaluation results should be considered as part of the broader body of evidence regarding the types of health impacts, the extent of the available evidence, who will be affected, and the role of medical practitioners and pharmacists in mitigating any risks. However, awareness of the advantages and challenges of this approach in advance will help mitigate some of the challenges and increase acceptance of the economic evaluation results by decision makers and stakeholders.