P194 Is there a difference in quality of life or costs between ulcerative colitis patients with a pouch or an ileostomy?

Valk, M. Van der; Mangen, Marie-Josée J.; Dijkstra, Gerard; Bodegraven, Adriaan A. van; Fidder, Herma H.; Jong, Djuna De; Pierik, Marie J.; Woude, Christien J. van der; Romberg‐Camps, Mariëlle; Clemens, Cees H.; Jansen, J. O.; Meeberg, P. van de; Mahmmod, Nofel; Ponsioen, Cyriel; Rogge-Wolf, Claudia; Vermeijden, Reinoud; Siersema, Peter; Oijen, M. van; Oldenburg, Bas

doi:10.1016/s1873-9946(12)60214-1

Cited by 3 publications

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“…These studies also included the greatest coverage of the health states in the model. Woehl et al [20] was selected for the base case analysis as the valuation for the surgery state (utility = 0.71 to 0.72) was most similar to, yet still lower than, the values reported in the post-surgery EQ-5D studies (range = 0.85 to 0.90) [33][34][35]. The valuation of the post-colectomy state within the Swinburn study [32] was considerably lower (utility = 0.59).…”

Section: Hrqolmentioning

confidence: 99%

A Model-Based Economic Evaluation of Biologic and Non-Biologic Options for the Treatment of Adults with Moderately-to-Severely Active Ulcerative Colitis after the Failure of Conventional Therapy

et al. 2016

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Background: Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. Medical management aims to induce and maintain remission, and to avoid UC complications and the necessity for surgical intervention. Colectomy removes the source of inflammation, but is associated with morbidity and mortality. Newer anti-tumour necrosis factor-(TNF-) therapies may improve medical outcomes albeit at an increased cost.Objective: To assess the incremental cost-effectiveness of infliximab, adalimumab and golimumab versus conventional therapy and surgery from a National Health Service (NHS) and Personal Social Services (PSS) perspective over a lifetime horizon.Methods: A Markov model was developed with health states defined according to whether the patient is alive or dead, current treatments received, history of colectomy and level of disease control.Transition probabilities were derived from network meta-analyses (NMAs) of trials of anti-TNFagents in the moderate-to-severe UC population. Health utilities, colectomy rates, surgical complications and resource use estimates were derived from literature. Unit costs were drawn from standard costing sources and literature and were valued at 2013/2014 prices.Results: For patients in whom surgery is an option, colectomy is expected to dominate all medical treatment options. For patients in whom colectomy is not an option, infliximab and golimumab are expected to be ruled out due to dominance, whilst the incremental cost-effectiveness ratio (ICER) for adalimumab versus conventional treatment is expected to be approximately £50,278 per qualityadjusted life year (QALY) gained. Conclusions:Based on the NMAs, the ICERs for anti-TNF-therapy versus conventional treatment or surgery are expected to be at best, in excess of £50,000 per QALY gained. The cost-effectiveness of withdrawing biologic therapy upon remission and re-treating relapse is unknown. KEY POINTS FOR DECISION-MAKERS• Colectomy is expected to be more effective and less expensive than medical treatments for ulcerative colitis.• For patients in whom colectomy is not an acceptable option, the ICERs for anti-TNFtherapy versus conventional treatment are in excess of £50,000 per QALY gained.• Using anti-TNF-therapy to induce remission, withdrawing therapy and re-treating upon relapse, may provide a more economically efficient approach, compared with continuous treatment in those achieving an induction response. The comparative effectiveness and costeffectiveness of this approach is however unclear.3

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Section: Hrqolmentioning

confidence: 99%

A Model-Based Economic Evaluation of Biologic and Non-Biologic Options for the Treatment of Adults with Moderately-to-Severely Active Ulcerative Colitis after the Failure of Conventional Therapy

et al. 2016

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“…[36] Similarly, although the utility scores were not reported based on the disease states specified in the model of Loftus et al, the authors were able to provide them with the means and standard errors of SG-calculated utility scores corresponding to the four CDAI states in their model. [33] In their base-case analysis, Archer et al preferred to selected the utility values from the abstract published in 2008 by Woehl et al, [42] because the valuation for the surgery state (0.71 to 0.72) was more consistent with the other post-surgery valuations identified [49][50][51] as compared with the Swinburn et al [43] study. [21] Archer et al note that the AbbVie submission could have mapped SF-6D utility estimates from the ULTRA2 trial onto the EQ-5D.…”

Section: Qol In the Identified Economic Evaluationsmentioning

confidence: 99%

Identifying Health Economic Considerations to Include in the Research Protocol of a Randomized Controlled Trial (the REDUCE-RISK Trial): Systematic Literature Review and Assessment

Neyt¹,

Christiaens²,

Aloi³

et al. 2021

JMIR Form Res

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Background The REDUCE-RISK trial was set up to compare the effectiveness of weekly subcutaneously administered methotrexate with daily oral azathioprine or 6-mercaptopurine in low-risk Crohn disease (CD) or subcutaneously administered adalimumab (ADA) in high-risk CD in a pediatric population (age 6-17 years). Objective The aim of this study is to perform a systematic review to provide input into the research protocol to gather the necessary information to improve the performance of an evidence-based economic evaluation when the trial is finished. Methods The Centre for Reviews and Dissemination (CRD) Health Technology Assessment (HTA) database, websites of HTA institutes, CRD’s National Health Service Economic Evaluation Database, MEDLINE (OVID), and Embase databases were consulted to retrieve (reviews of) relevant economic evaluations. Studies were eligible if they included a pediatric or adult population with inflammatory bowel diseases (CD and ulcerative colitis [UC]) treated with ADA (Humira). There were no restrictions on the comparator. Only economic evaluations expressing outcomes in life years gained or quality-adjusted life years gained were selected. Results A total of 12 primary studies were identified. None of these studies included a pediatric population because of a lack of supporting trials. The economic evaluations identified in our systematic review indicate that ADA is an appropriate intervention for inclusion in such a trial. From a health economic point of view, it is important to make an incremental analysis comparing such an intervention with standard care and not immediately versus another (expensive) biological treatment. Information on the impact of children’s school attendance and parents’ productivity is currently lacking in economic evaluations, and none of the underlying trials measured quality of life (QoL) using a generic utility instrument. Conclusions The review of the economic literature on ADA for the treatment of patients with CD supports the performance of a trial with biologicals in pediatric patients, including making a distinction according to disease severity. Conducting an economic literature review enabled us to decide which variables should be added to the research protocol from an economic point of view. Measurements for children’s and parents’ QoL (EuroQol 5-Dimension questionnaires), children’s school attendance, and parents’ productivity (WPAI-CD-CG questionnaire) were added to the research protocol. This will provide support for the calculation of the cost-effectiveness of the interventions evaluated in the REDUCE-RISK trial. Trial Registration ClinicalTrials.gov NCT02852694; https://clinicaltrials.gov/ct2/show/NCT02852694

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Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

Archer

Tappenden

Ren

et al. 2016

Health Technol Assess

143

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BackgroundUlcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients’ quality of life. The burden for the NHS is substantial.ObjectivesTo evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities.Data sourcesPeer-reviewed publications, European Public Assessment Reports and manufacturers’ submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals.Review methodsA systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model.ResultsTen randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade®, Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira®, AbbVie) or golimumab (GOL) (Simponi®, MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, in the induction phase, all biological treatments were associated with statistically significant beneficial effects relative to PBO, with the greatest effect associated with IFX. For patients in response following induction, all treatments except ADA and GOL 100 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although these were not significant. The greatest effects at 8–32 and 32–52 weeks were associated with 100 mg of GOL and 5 mg/kg of IFX, respectively. For patients in remission following induction, all treatments except ADA at 8–32 weeks and GOL 50 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although only the effect of ADA at 32–52 weeks was significant. The greatest effects were associated with GOL (at 8–32 weeks) and ADA (at 32–52 weeks). The economic analysis suggests that colectomy is expected to dominate drug therapies, but for some patients, colectomy may not be considered acceptable. In circumstances in which only drug options are considered, IFX and GOL are expected to be ruled out because of dominance, while the incremental cost-effectiveness ratio for ADA versus conventional treatment is approximately £50,300 per QALY gained.LimitationsThe health economic model is subject to several limitations: uncertainty associated with extrapolating trial data over a lifetime horizon, the model does not consider explicit sequential pathways of non-biological treatments, and evidence relating to complications of colectomy was identified through consideration of approaches used within previous models rather than a full systematic review.ConclusionsAdult patients receiving IFX, ADA or GOL were more likely to achieve clinical response and remission than those receiving PBO. Further data are required to conclusively demonstrate the effect of interventions on hospitalisation and surgical outcomes. The economic analysis indicates that colectomy is expected to dominate medical treatments for moderate to severe UC.Study registrationThis study is registered as PROSPERO CRD42013006883.FundingThe National Institute for Health Research Health Technology Assessment programme.

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P194 Is there a difference in quality of life or costs between ulcerative colitis patients with a pouch or an ileostomy?

Cited by 3 publications

References 0 publications

A Model-Based Economic Evaluation of Biologic and Non-Biologic Options for the Treatment of Adults with Moderately-to-Severely Active Ulcerative Colitis after the Failure of Conventional Therapy

A Model-Based Economic Evaluation of Biologic and Non-Biologic Options for the Treatment of Adults with Moderately-to-Severely Active Ulcerative Colitis after the Failure of Conventional Therapy

Identifying Health Economic Considerations to Include in the Research Protocol of a Randomized Controlled Trial (the REDUCE-RISK Trial): Systematic Literature Review and Assessment

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

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