OBJECTIVES: Previous cost-effectiveness analyses of oxaliplatin have been based on randomised trials whereas current Dutch policy requires evidence from daily practice. The objective of this study was to examine the real-world cost-effectiveness of oxaliplatin plus fluoropyrimidines (FL) versus FL-only as adjuvant treatment of stage III colon cancer. METHODS: A Markov model was developed to estimate lifetime cost and quality-adjusted life-years from a hospital perspective. The effectiveness of the oxaliplatin arm was modelled by combining published efficacy data from the pivotal clinical registration trial (MOSAIC trial) with real-world (RW) data from a Dutch population-based observational study. RW patients were categorised into "eligible" or "ineligible", depending on whether the patients fulfilled the MOSAIC trial eligibility criteria. Ineligible RW patients (18 %) had a poorer prognosis than eligible RW patients (82 %) and MOSAIC trial patients. The effectiveness of the comparator was modelled using MOSAIC trial results. All cost inputs were based on RW patients and reported in Euro 2012. Cost-effectiveness analyses were performed for four different scenarios: (1) cost-effectiveness analyses based on MOSAIC trial patients; (2) cost-effectiveness analyses using MOSAIC and eligible RW patients; (3) cost-effectiveness analyses using MOSAIC and both eligible and ineligible RW patients, assuming oxaliplatin had an equal effect in ineligible and eligible patients; (4) cost-effectiveness analyses using MOSAIC and both eligible and ineligible RW patients, assuming oxaliplatin had no effect amongst ineligibles. For each scenario, univariate and probabilistic sensitivity analyses were undertaken. RESULTS: MOSAIC trial patients and eligible RW patients treated with oxaliplatin had comparable 2-year disease-free survivals (79.5 vs. 78.4 %). Oxaliplatin showed an incremental QALY gain of 1.02, 1.13, 1.17 and 0.93 and incremental cost of <euro>9,961, <euro>11,055, <euro>9,814 and <euro>11,854 in scenarios 1-4, respectively. The corresponding incremental cost-effectiveness ratios (ICERs) were <euro>9,766, <euro>9,783, <euro>8,388 and <euro>12,746 in scenarios 1-4, respectively. In all scenarios, univariate and probabilistic sensitivity analyses indicated that the ICERs are acceptable and robust under a wide range of model assumptions. CONCLUSIONS: The ICERs of the different scenarios that resulted from combining MOSAIC trial data with data from Dutch daily practice all suggest that FL + oxaliplatin is cost-effective versus FL alone in the adjuvant treatment of colon cancer. This article illustrates how one could design and implement a real-world cost-effectiveness study to yield internally valid results that could also be generalisable.
RCT Entities:
OBJECTIVES: Previous cost-effectiveness analyses of oxaliplatin have been based on randomised trials whereas current Dutch policy requires evidence from daily practice. The objective of this study was to examine the real-world cost-effectiveness of oxaliplatin plus fluoropyrimidines (FL) versus FL-only as adjuvant treatment of stage III colon cancer. METHODS: A Markov model was developed to estimate lifetime cost and quality-adjusted life-years from a hospital perspective. The effectiveness of the oxaliplatin arm was modelled by combining published efficacy data from the pivotal clinical registration trial (MOSAIC trial) with real-world (RW) data from a Dutch population-based observational study. RW patients were categorised into "eligible" or "ineligible", depending on whether the patients fulfilled the MOSAIC trial eligibility criteria. Ineligible RW patients (18 %) had a poorer prognosis than eligible RW patients (82 %) and MOSAIC trial patients. The effectiveness of the comparator was modelled using MOSAIC trial results. All cost inputs were based on RW patients and reported in Euro 2012. Cost-effectiveness analyses were performed for four different scenarios: (1) cost-effectiveness analyses based on MOSAIC trial patients; (2) cost-effectiveness analyses using MOSAIC and eligible RW patients; (3) cost-effectiveness analyses using MOSAIC and both eligible and ineligible RW patients, assuming oxaliplatin had an equal effect in ineligible and eligible patients; (4) cost-effectiveness analyses using MOSAIC and both eligible and ineligible RW patients, assuming oxaliplatin had no effect amongst ineligibles. For each scenario, univariate and probabilistic sensitivity analyses were undertaken. RESULTS: MOSAIC trial patients and eligible RW patients treated with oxaliplatin had comparable 2-year disease-free survivals (79.5 vs. 78.4 %). Oxaliplatin showed an incremental QALY gain of 1.02, 1.13, 1.17 and 0.93 and incremental cost of <euro>9,961, <euro>11,055, <euro>9,814 and <euro>11,854 in scenarios 1-4, respectively. The corresponding incremental cost-effectiveness ratios (ICERs) were <euro>9,766, <euro>9,783, <euro>8,388 and <euro>12,746 in scenarios 1-4, respectively. In all scenarios, univariate and probabilistic sensitivity analyses indicated that the ICERs are acceptable and robust under a wide range of model assumptions. CONCLUSIONS: The ICERs of the different scenarios that resulted from combining MOSAIC trial data with data from Dutch daily practice all suggest that FL + oxaliplatin is cost-effective versus FL alone in the adjuvant treatment of colon cancer. This article illustrates how one could design and implement a real-world cost-effectiveness study to yield internally valid results that could also be generalisable.
Authors: Chantal W M van Gils; Miriam Koopman; Linda Mol; William K Redekop; Carin A Uyl-de Groot; Cornelis J A Punt Journal: Acta Oncol Date: 2011-11-28 Impact factor: 4.089
Authors: Samuel Aballéa; Jeremy V M Chancellor; Maria Raikou; Michael F Drummond; Milton C Weinstein; Sophia Jourdan; John Bridgewater Journal: Cancer Date: 2007-03-15 Impact factor: 6.860
Authors: J Ferlay; E Steliarova-Foucher; J Lortet-Tieulent; S Rosso; J W W Coebergh; H Comber; D Forman; F Bray Journal: Eur J Cancer Date: 2013-02-26 Impact factor: 9.162
Authors: C G Moertel; T R Fleming; J S Macdonald; D G Haller; J A Laurie; C M Tangen; J S Ungerleider; W A Emerson; D C Tormey; J H Glick; M H Veeder; J A Mailliard Journal: Ann Intern Med Date: 1995-03-01 Impact factor: 25.391
Authors: Jolien Tol; Miriam Koopman; Annemieke Cats; Cees J Rodenburg; Geert J M Creemers; Jolanda G Schrama; Frans L G Erdkamp; Allert H Vos; Cees J van Groeningen; Harm A M Sinnige; Dirk J Richel; Emile E Voest; Jeroen R Dijkstra; Marianne E Vink-Börger; Ninja F Antonini; Linda Mol; Johan H J M van Krieken; Otilia Dalesio; Cornelis J A Punt Journal: N Engl J Med Date: 2009-02-05 Impact factor: 91.245
Authors: N van der Linden; C W M van Gils; C P Pescott; J Buter; M R Vergeer; C A Uyl-de Groot Journal: Eur Arch Otorhinolaryngol Date: 2014-06-19 Impact factor: 2.503