Infliximab versus ciclosporin in steroid resistant acute severe ulcerative colitis: a model-based cost-utility analysis of data from CONSTRUCT pragmatic trial

Mohammed Fasihul Alam; Mirella Longo; David Cohen; Sam Groves; Laith Alrubaiy; Hayley A Hutchings; Alan Watkins; Shaji Sebastain; John G Williams

doi:10.1186/s12913-023-09233-w

Infliximab versus ciclosporin in steroid resistant acute severe ulcerative colitis: a model-based cost-utility analysis of data from CONSTRUCT pragmatic trial

BMC Health Serv Res. 2023 Mar 8;23(1):226. doi: 10.1186/s12913-023-09233-w.

Authors

Mohammed Fasihul Alam¹, Mirella Longo², David Cohen³, Sam Groves⁴, Laith Alrubaiy⁵, Hayley A Hutchings⁵, Alan Watkins⁵, Shaji Sebastain⁶, John G Williams⁵

Affiliations

¹ Department of Public Health, College of Health Sciences, QU-Health, Qatar University, PO Box 2713, Doha, Qatar. malam@qu.edu.qa.
² Marie Curie Palliative Care Research Centre, Cardiff University, 8th Floor Neuadd Meirionnydd, Heath Park Way, Cardiff, CF14 4YS, UK.
³ Faculty of Health, Sport and Professional Practice, University of South Wales, Lower Glyntaff, Pontypridd, CF37 1DL, UK.
⁴ Swansea Centre for Health Economics, College of Health and Human Sciences, Swansea University, Singleton Park, Swansea, SA2 8PP, UK.
⁵ Swansea University Medical School, Swansea University, Singleton Park, Swansea, SA2 8PP, UK.
⁶ IBD Unit, Hull University Teaching Hospitals NHS Trust, Hull, UK.

Abstract

Background: There is limited evidence in the literature on the long-term effectiveness and cost-effectiveness of treatments for Acute Severe Ulcerative Colitis (ASUC). The study aimed to perform decision analytic model-based long-term cost-utility analysis (CUA) of infliximab versus ciclosporin for steroid-resistant ASUC investigated in CONSTRUCT pragmatic trial.

Methods: A decision tree (DT) model was developed using two-year health effect, resource use and costs data from CONSTRUCT trial to estimate relative cost-effectiveness of two competing drugs from the United Kingdom (UK) National Health Services (NHS) perspective. Using short-term trial data, a Markov model (MM) was then developed and evaluated over further 18 years. Both DT and MM were combined to investigate cost-effectiveness of infliximab versus ciclosporin for ASUC patients over 20-year time horizon, with a rigorous multiple deterministic and probabilistic sensitivity analyses to address uncertainty in results.

Results: The decision tree mirrored trial-based results. Beyond 2-year trial follow-up, Markov model predicted a decrease in colectomy rate, but it remained slightly higher for ciclosporin. NHS costs and quality adjusted life years (QALYs) over base-case 20 year time horizon were £26,793 and 9.816 for ciclosporin and £34,185 and 9.106 for infliximab, suggesting ciclosporin dominates infliximab. Ciclosporin had 95% probability of being cost-effective at a willingness-to-pay (WTP) threshold value up to £20,000.

Conclusion: Using data from a pragmatic RCT, the cost-effectiveness models produced incremental net health benefit in favour of ciclosporin relative to infliximab. Results from long-term modelling indicated that ciclosporin remains dominant compared with infliximab for the treatment of NHS ASUC patients, however, these need to be interpreted cautiously.

Trial registration: CONSTRUCT Trial registration number ISRCTN22663589; EudraCT number: 2008- 001968-36 (Date 27/08/2008).

Keywords: Ciclosporin; Cost-effectiveness; Decision tree; Infliximab; Markov model; Ulcerative colitis.

Publication types

Pragmatic Clinical Trial

MeSH terms

Colitis, Ulcerative* / drug therapy
Cost-Benefit Analysis
Cyclosporine* / therapeutic use
Humans
Immunosuppressive Agents / therapeutic use
Infliximab / therapeutic use
Quality-Adjusted Life Years
Steroids

Substances

Cyclosporine
Immunosuppressive Agents
Infliximab
Steroids