Innovation in radiotherapy: How to prove its value for money? Yolande Lievens, MD, PhD Radiation Oncology Ghent University Hospital & Ghent University, Belgium Co-Chair ESTRO-HERO project ESTRO President © 2010 Universitair Ziekenhuis Gent ESTRO’s vision 2020 Every cancer patient in Europe will have access to state of the art radiation therapy, as part of a multi-disciplinary approach where treatment is individualised for the specific patient’s cancer, taking account of the patient’s personal circumstances optimize local tumour control minimize normal tissue toxicity improved therapeutic ratio TCP - Tumour Control Probability NTCP - Normal Tissue Complication Probability Nahum AE. Comput Math Methods Med. 2012 the value of innovation - breast conventional RT intensity-modulated RT 90% 95% 95% 100% 102% 100% 98% 105% 110% 112% Donovan et al, R&O 2007 the value of innovation - breast P<0.0001 Desquamation (Gr. 2-4) Breast IMRT Pain (Gr. 2-3) p=0.0018 (global) P<0.001 (breast) p=0.002 p=0.0019 (global) p=0.0028 (breast) Quality of Life (EORTC – global/breast) “Dosimetric inhomogeneity independently predicted for (chronic) pain and should be minimized to the greatest extent possible.” Pignol et al, J Clin Oncol 2008 Mak et al, IJROBP 2014 the value of innovation - lung conventional RT intensity-modulated RT 90% 95% 95% 100% 102% 100% 98% 105% 110% 112% SBRT 66Gy/22Gy vs 3D-CRT 70Gy/2Gy no statistically significant difference, Phase II, low patient numbers Nyman et al, R&O 2016 the value of innovation - lung conventional RT intensity-modulated RT 90% 95% 95% 100% 102% 98% 100% 105% 110% 112% radiotherapy all patients Palma et al, JCO 2010 ? Tier 1: health status ✔ Tier 2: process of recovery ✔? Tier 3: sustainability of health • survival • degree of health/recovery ✔ • time to recovery/to return to normal activities • disutility of care /treatment process ✔ • sustainability of health/recovery; nature of recurrences • long-term consequences of therapy ? Adapted from Porter ME. NEJM 2010 changing radiation technology changing imaging modalities changing patient population changing disease presentation changing surgical techniques changing systemic treatment technology and techniques outcome acute and long-term toxicity randomised data are difficult and insufficient time investment by HC provider emerging Financing premarket CEA – BIA? Effectiveness? Cost calculation? Performance & safety extent clinical use market introduction early development launch diffusing established obsolete t demonstrate value / medical practice time Lievens et al, Acta Oncol 2015 the development trap “ Developing evidence for comparative effectiveness with no reimbursement is difficult, but the absence of evidence makes justifying reimbursement difficult. “ Smith et al, IJROBP 2016 Sullivan et al, Lancet Oncol 2011 late side effects! Mak et al, Eur Res J 2016 blended evidence generation Source: Redesigning clinical effectiveness paradigm. Institute of Medicine, 2010. the right treatment for the right patient Widder et al, IJROBP 2016 no reimbursement for SBRT ! what is the (level 1) evidence? the cost? the value for money? the budgetary impact? Coverage with Evidence Generation in Belgium Collaboration National Institute for Health & Disability Insurance Health Care Knowledge Centre Belgian Radiation Oncology professionals real-life data collection = feasible! 18/24 centres participate Hulstaert et al, Report 198 KCE 2013 Lievens et al, J Thor Oncol 2015 16000 14000 Free breathing - center A 12000 Free breathing - center B Cost (€) 10000 Free breathing - center C Free breathing - center D 8000 Free breathing - center E Free breathing - center F 6000 Gating - center G 4000 Gating - center H Tracking - center I 2000 Tracking or Free breathing - center J 0 3 4-6 N of fractions 7-10 average cost SBRT: 6,221€ Hulstaert et al, Report 198 KCE 2013 prospective real-life data collection = feasible 44% oligoM+ (≤ 3 Mets) 56% primary 40 2198 cases in 3 years Primary lung (peripheral) lesion Primary (para-) spinal lesion 642 1210 143 Primary lung lesion (central lesion and/or lesion > 5cm) Primary prostate lesion Hepatic metastases (Para-)spinal metastases 118 33 6 6 Lung metastases A pragmatic observational basket study to evaluate radical radiotherapy for oligo-metastatic cancer patients. a collaborative ESTRO-EORTC initiative a pragmatic observational basket study WP 1 ≤ 5 M a + s b l u a i t t i a v WP 2 b e l e R f T o r WP 3 Common Data Elements collected across diseases + tumor type-specific data collection Follow-up to death or lost to follow-up minimum criteria ! all cancer types a pragmatic observational basket study SBRT oligo SBRT oligo follow-up of common + pathology-specific data survival and local control acute and late radiotherapy side effects QoL, PROMs and economic data Mak et al, Eur Res J 2016 innovative radiotherapy more accurate, more effective long-term horizon for capturing outcome and costs, immediate investments development trap calls for an innovative view on evidence generation, costing and financing NEEDS optimal radiotherapy utilisation in European countries AVAILABILITY equipment & staffing guidelines reimbursement in Europe ACTIVITY-BASED COSTING ECONOMIC EVALUATION of radiotherapy treatments and techniques in Europe cost and productivity at the national level within European countries HERO-project Lievens & Grau. R&O 2012 Thank you for your attention!
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