Building an appraisal framework for radiotherapy innovations in a value-based context: The ESTRO-Value-based radiation oncology categorisation system

Abstract

Aim: There is no consistent appraisal strategy for radiotherapy innovations supporting their clinical implementation or regulatory decision-making, thus hampering access to high-value care. This study presents the development of a categorisation system as a first step towards a value-based appraisal framework for radiotherapy innovations within the ESTRO Value-Based Radiation Oncology (VBRO) project. Methods: A mixed-method development process in four phases integrated qualitative and quantitative data in multiple rounds of revision, improvement and validation; and was supported by multidisciplinary stakeholders representing the European radiation oncology community. Results: Four distinct categories of radiotherapy interventions are defined: Drug-centred, Radiation-centred, Radiation-enabling and Operational radiation interventions. Innovations are categorised based on their primary aim, focussing on either patient-level or organisational level; their technological characteristics; and their radiotherapy-specific characteristics such as therapeutic ratio, biological or dosimetric properties or radiotherapy-drug combinations. To support categorisation choices, a sequence of decision-making questions was arranged in a decision algorithm and presented as a decision tree. The categories and categorisation algorithm were validated using qualitative and quantitative methods by representative stakeholders of the European radiation oncology community, by a bibliometrical data analysis, and finally by the VBRO steering committee. Conclusion: A correct definition of the different radiotherapy categories is essential to study their interrelation with optimum study design, outcomes, and magnitude of benefit, in view of optimising evidence generation and tailored appraisals. This categorisation system forms the basis to create a value-based appraisal framework within the ESTRO-VBRO project, aimed to support implementation and authorisation regulations for each category of radiotherapy innovation.