ESTRO 36 Abstract Book

S153 ESTRO 36 _______________________________________________________________________________________________

SP-0295 Radiotherapy costs: the good, the bad and the ugly L.Perrier 5 Cancer Centre Léon Bérard, Clinical Research and Innovation Direction, Lyon, France

Existing guidance on formulating the cost part of HE evaluation studies establishes an outline framework while giving researchers a high degree of freedom. The limited number of studies investigating the cost of EBRT do not systematically follow these published HE guidance leaving room for quality improvement in this increasingly influential research area. SP-0297 Method of development of ESMO Magnitude of Clinical Benefit applicable for radiotherapy? E.G.E. De Vries 1 , R. Sullivan 2 , N.I. Cherny 3 1 UMCG University Medical Center Groningen, Department of Medical Oncology, Groningen, The Netherlands 2 Institute of Cancer Policy, Kings Health Partners Integrated Cancer Centre- King's College London, London, United Kingdom 3 Shaare Zedek Medical Center, Cancer Pain and Palliative Medicine Service- Department of Medical Oncology, Jerusalem, Israel The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. Until recently, there was no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). An ESMO Task Force to guide the development of the grading scale was established in March 2013. A first- generation draft scale was developed and adapted through a ‘snowball’ method based upon previous work of Task Force members who had independently developed preliminary models of clinical benefit grading. The first- generation scale was sent for review by 276 members of the ESMO faculty and a team of 51 expert biostatisticians. The second-generation draft was formulated based on the feedback from faculty and biostatisticians and the conceptual work of Alberto Sobrero regarding the integration of both hazard ratio (HR), prognosis and absolute differences in data interpretation [J Clin Oncol 2009, Clin Cancer Res 2015]. The second-generation draft was applied in a wide range of contemporary and historical disease settings by members of the ESMO-MCBS Task Force, the ESMO Guidelines Committee and a range of invited experts. Results were scrutinized for face validity, coherence and consistency. Where deficiencies were observed or reported, targeted modifications were implemented and the process of field testing and review was repeated. This process was repeated through 13 redrafts of the scale preceding the current one (ESMO- MCBS v1.0). The final version and fielded testing results were reviewed by selected members of the ESMO faculty and the ESMO Executive Board. Version 1.0 appeared in 2015 (Cherny et al. Ann Oncol). This tool thus provides a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be

Abstract not received

OC-0296 A critical quality appraisal of studies estimating the cost of radiotherapy N. Defourny 1 , P. Dunscombe 2 , C. Grau 3 , Y. Lievens 4 , L. Perrier 5 1 ESTRO A.I.S.B.L., HERO, Brussels, Belgium 2 University of Calgary, Department of Oncology, Calgary, Canada 3 Aarhus University, Department of Clinical Medicine, Aarhus, Denmark 4 University Hospital Ghent, Radiation Oncologist, Ghent, Belgium 5 Cancer Centre Léon Bérard, Clinical Research and Innovation Direction, Lyon, France Purpose or Objective In the context of growing healthcare expenses combined with reduced economic growth, health economics (HE) studies are becoming paramount. Considerable interest in the domain is apparent when looking at the number of articles indexed with HE keywords. Nevertheless, a recent literature review has revealed very few articles calculating the cost of radiotherapy, and a large heterogeneity in the methodologies used. The aim of this complementary review is to report on existing guidance in HE and to critically assess guideline compliance in the A systematic literature review of cost computation studies in external photon beam radiation therapy (EBRT) from 1981-2015 was recently conducted by us. Building on this earlier work, existing HE guidelines have been reviewed and a list of relevant items for cost estimations has been compiled. The guidelines searched were ISPOR’s Good Practices For Outcome Research guidelines, HE evaluation quality appraisal instruments and National guidelines (EUnetHTA). A standardised framework focusing on recommendations on cost assessment was designed with the help of these guidelines. Fifty-two HE studies meeting criteria established in our earlier literature review were studied in-depth: cost assessment methods, descriptions of methodologies (e.g. sample size, time horizon, or discounting clearly mentioned), and relevant statistical analyses performed (e.g. selection bias treated, sensitivity analyses done) were all critically appraised within the framework. Results Guidance on HE analyses is often provided in the form of a checklist of items to be addressed. Direction on the cost type to estimate, the analysis to conduct, and methods for tackling uncertainty of data are outlined, e.g. ‘’identify relevant cost for each alternative and value the cost appropriately’’. Evaluation of the 52 studies against published HE recommendations revealed shortcomings in the cost assessment methodologies, the implications of that choice, and the calculation methods used. Among selected studies, heterogeneity was observed in the quantity and quality of the information disclosed. While documentation of cost items and sample size was found in 67% of the 52 articles, and the reference year of cost data was present in 85%, only 37% of the articles specified data sources used by the authors, 35% stated their discounting methods and just 8% mentioned the study’s time horizon. Descriptive statistics analyses were present in 35% of the studies and uncertainty treatment in 48%. Conclusion radiotherapy literature. Material and Methods