Presentation (CTI)

OBJECTIVES: PET/SPECT radiotracers can support earlier and more precise diagnosis, especially in conditions where accurate diagnosis drives therapeutic choice. We characterised pricing and reimbursement pathways for PET/SPECT radiotracers across nine European markets and identified structural barriers to patient access.
METHODS: We reviewed radiotracer pricing and reimbursement systems in Germany, France, the UK, Italy, Spain, the Netherlands, Belgium, Switzerland, and Denmark. For each market, we mapped ambulatory payment architecture, pricing and reimbursement processes for innovative radiotracers, and health technology assessment requirements. We also analysed reimbursement status of selected commercial tracers to identify payer evidence expectations.
RESULTS: Reimbursement architecture for PET/SPECT radiotracers varies across markets. Germany and Belgium provide separate reimbursement mechanisms for PET radiotracers, while most other healthcare systems bundle tracer costs within packaged imaging study fees. Within packaged payment systems, the degree to which codes differentiate tracers varies. In addition, in several markets, low-cost locally prepared tracers act as price anchors, creating unfavourable access conditions for commercially manufactured tracers. Across most systems, manufacturers lack a direct pathway to initiate reimbursement requests, relying instead on other stakeholders to drive coding and tariff requests. Where HTA is mandatory, authorities require evidence linking diagnostic performance to downstream clinical outcomes, which may be challenging for stand-alone diagnostic radiotracers.
CONCLUSIONS: Patient access to innovative PET/SPECT radiotracers is constrained by procedure-centred packaged payment systems that do not recognise the value of radiotracers, creating disincentives for adopting higher-cost high-value innovative radiotracers. Recent US Medicare reforms introducing separate payment for higher-cost diagnostic radiopharmaceuticals show that unbundling can improve access to innovative radiotracers. Policy reforms should consider separate or pass-through reimbursement, differentiated tariff descriptors, diagnostic-specific HTA frameworks, and recognition of the value of commercially produced tracers. Clinical societies and other relevant stakeholders should drive process reforms to ensure that diagnostic innovations can deliver their full value in clinical practice.