Cost-Effectiveness Analysis of Increased Adalimumab Dose Intervals in Crohn's Disease Patients in Stable Remission: The Randomized Controlled LADI Trial J Crohns Colitis. 2023 Nov 24;17(11):1771-1780.doi: 10.1093/ecco-jcc/jjad101.
Fenna M Jansen 1, Reinier C A van Linschoten 2 3, Wietske Kievit 4, Lisa J T Smits 1, Renske W M Pauwels 2, Dirk J de Jong 1, Annemarie C de Vries 2, Paul J Boekema 5, Rachel L West 3, Alexander G L Bodelier 6, Ingrid A M Gisbertz 7, Frank H J Wolfhagen 8, Tessa E H Römkens 9, Maurice W M D Lutgens 10, Adriaan A van Bodegraven 11, Bas Oldenburg 12, Marieke J Pierik 13, Maurice G V M Russel 14, Nanne K de Boer 15, Rosalie C Mallant-Hent 16, Pieter C J Ter Borg 17, Andrea E van der Meulen-de Jong 18, Jeroen M Jansen 19, Sita V Jansen 20, Adrianus C I T L Tan 21, Frank Hoentjen 1 22, C Janneke van der Woude 2; LADI study group Desirée van Noord, Jildou Hoekstra, Johannes T Kamphuis, Moniek H P Gorter, Aura A J van Esch |
Author information 1Radboud University Medical Center, Department of Gastroenterology and Hepatology, Nijmegen, The Netherlands. 2Erasmus MC, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands. 3Franciscus Gasthuis & Vlietland, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands. 4Radboud University Medical Center, Radboud Institute for Health Science, Department for Health Evidence, Nijmegen, The Netherlands. 5Maxima Medical Center, Department of Gastroenterology and Hepatology, Eindhoven, The Netherlands. 6Amphia Hospital, Department of Gastroenterology and Hepatology, Breda, The Netherlands. 7Bernhoven Hospital, Department of Gastroenterology and Hepatology, Uden, The Netherlands. 8Albert Schweitzer Hospital, Department of Gastroenterology and Hepatology, Dordrecht, The Netherlands. 9Jeroen Bosch Hospital, Department of Gastroenterology and Hepatology, 's-Hertogenbosch, The Netherlands. 10Elisabeth Tweesteden Ziekenhuis, Department of Gastroenterology and Hepatology, Tilburg, The Netherlands. 11Zuyderland Medical Center, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Sittard-Geleen/Heerlen, The Netherlands. 12University Medical Center Utrecht, Department of Gastroenterology and Hepatology, Utrecht, The Netherlands. 13Maastricht University Medical Center+, Department of Gastroenterology and Hepatology, Maastricht, The Netherlands. 14Medisch Spectrum Twente, Department of Gastroenterology and Hepatology, Twente, The Netherlands. 15Amsterdam University Medical Center, Vrije University Amsterdam, Department of Gastroenterology and Hepatology, AGEM Research Institute, Amsterdam, The Netherlands. 16Flevoziekenhuis, Department of Gastroenterology and Hepatology, Almere, The Netherlands. 17Ikazia Hospital, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands. 18Leiden University Medical Center, Department of Gastroenterology and Hepatology, Leiden, The Netherlands. 19OLVG, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands. 20Reinier de Graaf Gasthuis, Department of Gastroenterology and Hepatology, Delft, The Netherlands. 21Canisius Wilhelmina Hospital, Department of Gastroenterology and Hepatology, Nijmegen, The Netherlands. 22Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Canada. Abstract Background and aims: We aimed to assess cost-effectiveness of increasing adalimumab dose intervals compared to the conventional dosing interval in patients with Crohn's disease [CD] in stable clinical and biochemical remission. Design: We conducted a pragmatic, open-label, randomized controlled non-inferiority trial, comparing increased adalimumab intervals with the 2-weekly interval in adult CD patients in clinical remission. Quality of life was measured with the EQ-5D-5L. Costs were measured from a societal perspective. Results are shown as differences and incremental net monetary benefit [iNMB] at relevant willingness to accept [WTA] levels. Results: We randomized 174 patients to the intervention [n = 113] and control [n = 61] groups. No difference was found in utility (difference: -0.017, 95% confidence interval [-0.044; 0.004]) and total costs (-€943, [-€2226; €1367]) over the 48-week study period between the two groups. Medication costs per patient were lower (-€2545, [-€2780; -€2192]) in the intervention group, but non-medication healthcare (+€474, [+€149; +€952]) and patient costs (+€365 [+€92; €1058]) were higher. Cost-utility analysis showed that the iNMB was €594 [-€2099; €2050], €69 [-€2908; €1965] and -€455 [-€4,096; €1984] at WTA levels of €20 000, €50 000 and €80 000, respectively. Increasing adalimumab dose intervals was more likely to be cost-effective at WTA levels below €53 960 per quality-adjusted life year. Above €53 960 continuing the conventional dose interval was more likely to be cost-effective. Conclusion: When the loss of a quality-adjusted life year is valued at less than €53 960, increasing the adalimumab dose interval is a cost-effective strategy in CD patients in stable clinical and biochemical remission. Clinical trial registration number: ClinicalTrials.gov, number NCT03172377. |
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