Background: Theranostic radiopharmaceuticals are emerging as next generation medical technologies for addressing complex health challenges, and their successful listing on Medicare and/or the Pharmaceutical Benefits Scheme (PBS) offers significant benefit to Australia.
Aim: This study aims to identify the barriers, facilitators, and strategies affecting theranostic radiopharmaceutical access in Australia from various stakeholder perspectives.
Method: Between October 2025 to March 2026, twelve semi-structured interviews were conducted with healthcare professionals, Health Technology Assessment (HTA) and policy representatives, pharmaceutical industry representatives, and cancer patient organisation. Interviews were transcribed verbatim and analysed via inductive thematic approach using NVivo 14. Subgroup analysis was performed to compare perspectives across stakeholder groups.
Results: A total of 482 codes were identified, with each classified as a barrier, facilitator, or strategy. Five overarching themes emerged: 1) Investment and Innovation; 2) Theranostic Workforce and Capability; 3) Supply Chain and Sovereign Capability; 4) Regulation and Contextual Conditions; and 5) Reimbursement, Access, and Patient Value. Across the 13 sub-themes, the largest concentration of barriers related to the fragility of isotope supply and the legal/commercial conflict surrounding [¹⁷⁷Lu]lutetium, illustrating how supply insecurity and market uncertainty can disrupt clinical access and investment. The largest strategy cluster concerned regulatory and reimbursement reform, particularly the need to improve existing HTA processes and strengthen negotiation and coordination between government and industry. Collectively, the findings indicate that access to radiotheranostics is influenced not only by evidence of clinical effectiveness and cost-effectiveness, but also by their distinctive mechanisms of action, specialised supply chain requirements, and complex operational and service-delivery characteristics. These qualitative findings will inform the development of a fit-for-purpose HTA value framework for radiotheranostics that captures their clinical, economic and societal value.
Conclusion: This study enhances understanding of the systemic factors shaping theranostic radiopharmaceutical access, with the aim of improving patient access and delivery in Australia.