Tight control for Crohn's disease with adalimumab-based treatment is cost-effective: an economic assessment of the CALM trial
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
31285357
PubMed Central
PMC7063396
DOI
10.1136/gutjnl-2019-318256
PII: gutjnl-2019-318256
Knihovny.cz E-resources
- Keywords
- Crohn’s disease, TNF-alpha, cost-effectiveness, economic evaluation,
- MeSH
- Adalimumab therapeutic use MeSH
- Cost-Benefit Analysis MeSH
- Anti-Inflammatory Agents therapeutic use MeSH
- Biomarkers metabolism MeSH
- C-Reactive Protein metabolism MeSH
- Crohn Disease drug therapy metabolism MeSH
- Hospitalization MeSH
- Quality-Adjusted Life Years MeSH
- Leukocyte L1 Antigen Complex metabolism MeSH
- Humans MeSH
- Symptom Assessment MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- United Kingdom MeSH
- Names of Substances
- Adalimumab MeSH
- Anti-Inflammatory Agents MeSH
- Biomarkers MeSH
- C-Reactive Protein MeSH
- Leukocyte L1 Antigen Complex MeSH
OBJECTIVE: To evaluate the cost-effectiveness of an inflammatory biomarker and clinical symptom directed tight control strategy (TC) compared with symptom-based clinical management (CM) in patients with Crohn's disease (CD) naïve to immunosuppressants and biologics using a UK public payer perspective. DESIGN: A regression model estimated weekly CD Activity Index (CDAI)-based transition matrices (remission: CDAI <150, moderate: CDAI ≥150 to <300, severe: CDAI ≥300 to <450, very severe: CDAI ≥450) based on the Effect of Tight Control Management on Crohn's Disease (CALM) trial. A regression predicted hospitalisations. Health utilities and costs were applied to health states. Work productivity was monetised and included in sensitivity analyses. Remission rate, CD-related hospitalisations, adalimumab injections, other direct medical costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated. RESULTS: Over 48 weeks, TC was associated with a higher clinical remission (CDAI <150) rate (58.2% vs 46.8%), fewer CD-related hospitalisations (0.124 vs 0.297 events per patient) and more injections of adalimumab (40 mg sc) (mean 31.0 vs 24.7) than CM. TC was associated with 0.032 higher QALYs and £593 higher total medical costs. The ICER was £18 656 per QALY. The ICER was cost-effective in 57.9% of simulations. TC became dominant, meaning less costly but more effective, when work productivity was included. CONCLUSION: A TC strategy as used in the CALM trial is cost-effective compared with CM. Incorporating costs related to work productivity increases the economic value of TC. Cross-national inferences from this analysis should be made with caution given differences in healthcare systems. TRIAL REGISTRATION NUMBER: NCT01235689; Results.
AbbVie Inc North Chicago Illinois USA
Department of Gastroenterology University Hospitals Leuven Leuven Belgium
Department of Internal Medicine 4 Medical University of Vienna Vienna Austria
Department of Medicine 4 Medical University Vienna Vienna Austria
Gastroenterology AMC Amsterdam The Netherlands
Gastroenterology Department Bezmialem Vakıf University Istanbul Turkey
Gastroenterology Imelda General Hospital Bonheiden Belgium
Gastroenterology John Radcliffe Hospital Oxford UK
Inflammatory Bowel Disease Unit University of Calgary Calgary Alberta Canada
Internal Medicine and Gastroenterology Catholic University Rome Italy
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NCT01235689
