TY - JOUR
T1 - Cost-effectiveness and cost-utility of optimized mercaptopurine treatment versus placebo in ulcerative colitis patients
T2 - The randomized controlled OPTIC trial
AU - Lowenberg, Mark
AU - van Barreveld, Marit
AU - Volkers, Adriaan
AU - van Gennep, Sara
AU - Duijvestein, Marjolijn
AU - van Bodegraven, Adriaan A.
AU - Hulshoff, Melanie S.
AU - Jansen, Jeroen M.
AU - van Asseldonk, Dirk
AU - West, Rachel
AU - D'Haens, Geert
AU - de Boer, Nanne
AU - Dijkgraaf, Marcel G. W.
PY - 2024/11
Y1 - 2024/11
N2 - Background and aims: We assessed the cost-effectiveness and cost-utility of therapeutic drug monitoring (TDM)-guided mercaptopurine treatment compared with placebo in ulcerative colitis (UC) patients failing 5-aminosalicylates. Methods: Data were gathered alongside the randomized controlled OPTIC trial (EudraCT: 2015-005260-41). The evaluation was performed from a health care and societal perspective as cost-effectiveness and cost-utility analyses with a time horizon of one year. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses and productivity loss were assessed. The main outcomes were the extra costs per additional patient who achieved clinical remission and endoscopic improvement at 52 weeks (responders) and extra costs per quality-adjusted life-year (QALY) gained. Results: In total, 59 patients were randomized to the intervention (n = 29) and control (n = 30) group. Non-significant differences in costs were €63 (−€1267 to €1434; P = 0.93) in favour of placebo from a health care perspective and −€742 (−€3683 to €2016; P = 0.64) in favour of mercaptopurine from a societal perspective. The higher proportion of responders and a non-significant QALY difference of 0.0475 (−0.024–0.117) (P = 0.184) favouring patients on mercaptopurine treatment resulted in €165 extra costs per additional responder and €1326 extra costs per QALY gained from a health care perspective. From a societal perspective, dominance over placebo was observed with cost savings of €1937 per additional responder and €15,621 per QALY gained. The probability of optimised mercaptopurine treatment being cost-effective was 0.80 at a willingness to pay per additional QALY of €20,000. Conclusions: TDM-based mercaptopurine treatment in UC patients failing 5-aminosalicylates is a cost-effective strategy from a societal perspective.
AB - Background and aims: We assessed the cost-effectiveness and cost-utility of therapeutic drug monitoring (TDM)-guided mercaptopurine treatment compared with placebo in ulcerative colitis (UC) patients failing 5-aminosalicylates. Methods: Data were gathered alongside the randomized controlled OPTIC trial (EudraCT: 2015-005260-41). The evaluation was performed from a health care and societal perspective as cost-effectiveness and cost-utility analyses with a time horizon of one year. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses and productivity loss were assessed. The main outcomes were the extra costs per additional patient who achieved clinical remission and endoscopic improvement at 52 weeks (responders) and extra costs per quality-adjusted life-year (QALY) gained. Results: In total, 59 patients were randomized to the intervention (n = 29) and control (n = 30) group. Non-significant differences in costs were €63 (−€1267 to €1434; P = 0.93) in favour of placebo from a health care perspective and −€742 (−€3683 to €2016; P = 0.64) in favour of mercaptopurine from a societal perspective. The higher proportion of responders and a non-significant QALY difference of 0.0475 (−0.024–0.117) (P = 0.184) favouring patients on mercaptopurine treatment resulted in €165 extra costs per additional responder and €1326 extra costs per QALY gained from a health care perspective. From a societal perspective, dominance over placebo was observed with cost savings of €1937 per additional responder and €15,621 per QALY gained. The probability of optimised mercaptopurine treatment being cost-effective was 0.80 at a willingness to pay per additional QALY of €20,000. Conclusions: TDM-based mercaptopurine treatment in UC patients failing 5-aminosalicylates is a cost-effective strategy from a societal perspective.
KW - 6-mercaptopurine
KW - costs
KW - IBD
KW - inflammatory bowel disease
KW - of therapeutic drug monitoring
KW - TDM
KW - thiopurines
KW - INFLAMMATORY-BOWEL-DISEASE
U2 - 10.1002/ueg2.12661
DO - 10.1002/ueg2.12661
M3 - Article
SN - 2050-6406
VL - 12
SP - 1256
EP - 1265
JO - United European Gastroenterology Journal
JF - United European Gastroenterology Journal
IS - 9
ER -