PTU-127 The impact of surgery on health related quality of life in ulcerative colitis: Abstract PTU-127 Figure 1

Swinburn, P.; Elwick, Hannah; Bean, K; Curry, Alistair S; Patel, Saagar; Bodger, Keith; Lloyd, Adam

doi:10.1136/gutjnl-2012-302514c.127

Cited by 10 publications

(29 citation statements)

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“…The sensitivity analyses indicate that the model results are particularly sensitive to assumptions regarding HRQoL. The use of alternative utility estimates from Swinburn et al [32] results in a situation whereby colectomy moves from being the most effective option to the least effective option; this is largely driven by the lower post-colectomy utility value in this study. Under this scenario, the ICER for adalimumab versus conventional nonbiologic therapy (the next best non-dominated option) is estimated to be £79,714 per QALY gained, whilst the ICER for infliximab versus adalimumab is estimated to be £178,982 per QALY gained; golimumab is ruled out of the analysis due to simple dominance.…”

Section: Sensitivity Analysis Resultsmentioning

confidence: 80%

“…These direct analyses do not however consider the totality of the evidence base and are therefore of limited relevance to decision-making. The use of utilities from Swinburn et al [32] produces ICERs for adalimumab and infliximab which are less favourable than those generated using Woehl et al; [20] in this analysis, golimumab remains dominated. Within the analyses in which patients receiving anti-TNF-therapy remain in their last health state or remain in the remission state from week 60 onwards, the cost-effectiveness of infliximab and adalimumab is improved considerably.…”

Section: Sensitivity Analysis Resultsmentioning

confidence: 99%

“…Studies were considered potentially relevant if they reported EQ-5D estimates according to level of disease control, or if they reported valuations of post-surgery states. Of the 10 identified studies, two studies (Woehl et al [20] and Swinburn et al [32]), were UK-based and included large numbers of patients (n=180 and n=230, respectively). These studies also included the greatest coverage of the health states in the model.…”

Section: Hrqolmentioning

confidence: 99%

“…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). As neither Woehl nor Swinburn report on the impact of surgical complications on HRQoL, the disutility associated with chronic pouchitis was taken from Arseneau et al [21].…”

Section: Hrqolmentioning

confidence: 99%

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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: Sensitivity Analysis Resultsmentioning

confidence: 80%

Section: Sensitivity Analysis Resultsmentioning

confidence: 99%

Section: Hrqolmentioning

confidence: 99%

Section: Hrqolmentioning

confidence: 99%

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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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“…Nine sets of additional analyses were undertaken in each of the three modelled populations; these included correcting the mistake in the maintenance transition matrix for conventional management in the anti-TNF-naïve population, the use of alternative sources of HRQoL values i.e. using utilities for patients with UC in various health states (remission, response, moderate-to-severe UC and post-surgery), based on data reported by Woehl et al [40] and Swinburn et al [39], amending the surgery and post-surgical transition probabilities to better reflect clinical reality, removing assumptions regarding biologic treatment discontinuation, removing assumptions regarding the lower use of conventional therapies whilst patients are also receiving biologics, and improving the cost estimates used in the model to better reflect the costs borne by the NHS. The ERG also produced a preferred base case which combines most of these additional analyses.…”

Section: Additional Work Undertaken By the Evidence Review Groupmentioning

confidence: 99%

Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2015

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As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of vedolizumab (Takeda UK) to submit evidence of the clinical effectiveness and cost-effectiveness of vedolizumab for the treatment of patients with moderate-to-severe active ulcerative colitis (UC). The Evidence Review Group (ERG) produced a critical review of the evidence for the clinical effectiveness and cost-effectiveness of the technology, based upon the company's submission to NICE. The evidence was derived mainly from the GEMINI1 trial, which is a Phase III, multicentre, randomised, doubleblind, placebo-controlled trial designed to evaluate the efficacy and safety of vedolizumab as an induction and maintenance treatment in patients with moderate-to-severe active UC who had an inadequate response to, loss of response to, or intolerance to conventional therapy or anti-Tumour necrosis factor-alpha (TNF-). The clinical evidence showed that vedolizumab performed significantly better than placebo in both the induction and maintenance phases. In the post-hoc subgroup analyses, patients with or without prior anti-TNF-therapy, vedolizumab performed better then placebo (p-value not reported). In addition, a greater improvement in health-related quality of life was observed in patients treated with vedolizumab and the frequency and types of adverse events were similar between the vedolizumab and placebo group but the evidence was limited to shortterm follow-up. There were a number of limitations and uncertainties in the clinical evidence base which warrant caution in its interpretation. In particular, the post-hoc subgroup analyses and high dropout rates in the maintenance phase of the GEMINI1 trial. The company also presented a network meta-analysis of vedolizumab versus other biologics therapies indicated for moderate-to-severe UC. However, the ERG considered that the results presented may have underestimated the uncertainty in treatment effects since fixed effects models were Key Points for Decision Makers Vedolizumab appears to be more effective in both the induction and maintenance phase compared with placebo in patients with moderate-to-severe active ulcerative colitis who have had an inadequate response to, loss of response to, or intolerance to conventional therapy or TNF-inhibitor. However, the subgroup analyses for patients with or without prior TNF-inhibitor therapy were post-hoc and the study was not powered for these assessments.  The findings of the network meta-analysis of vedolizumab versus TNF-inhibitor are limited due to a number of uncertainties in treatment effects. In addition, there is currently no head-to-head randomised 3 controlled trial comparing vedolizumab to other biologic therapies indicated for moderate-to-severe ulcerative colitis.  The National Institute for Health and Care Excellence (NICE) Appraisal Committee recommended vedolizumab within its licence indication but only if the company provides vedolizumab with the discount agr...

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Cost-Effectiveness of Vedolizumab as a First-Line Advanced Therapy Versus Adalimumab Treatment Sequences for Ulcerative Colitis in Italy

Salcedo,

Hill-McManus,

Hardern

et al. 2024

PharmacoEconomics Open

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Background Today, there are many treatment options available for the management of ulcerative colitis, creating challenges in selecting the most efficacious and cost-effective treatment sequences. Treatments in the anti-tumor necrosis factor alpha (TNFα) therapeutic class, as well as vedolizumab, are widely used and endorsed as first-line options according to treatment guidelines. The aim of this study was to compare treatment sequences involving vedolizumab and the anti-TNFα treatment adalimumab in terms of cost-effectiveness in the treatment of moderately to severely active ulcerative colitis in Italy. Methods A cost-effectiveness model comparing treatment sequences within the Italian National Health Service in terms of costs and quality-adjusted life years (QALYs) with a lifetime horizon was developed. The analysis focused on the relative positioning of vedolizumab and adalimumab, leveraging the results of the landmark head-to-head VARSITY clinical trial as key inputs. The robustness of the results was investigated through a range of sensitivity and scenario analyses. ResultsThe strategy of vedolizumab as a first-line advanced therapy followed by adalimumab was associated with higher costs and health benefits compared with first-line adalimumab followed by vedolizumab. The incremental cost-effectiveness ratio was €16,146/QALY, which was found to be robust to changes to inputs associated with areas of high uncertainty. Conclusion This economic evaluation estimated a 94% probability that vedolizumab as a first-line advanced therapy is costeffective at a threshold of €33,004/QALY when compared with first-line adalimumab sequences. Using clinical trial evidence to inform the efficacy of second-line treatments estimated that the effectiveness of anti-TNFα treatments is not substantially reduced by vedolizumab exposure.

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PTU-127 The impact of surgery on health related quality of life in ulcerative colitis: Abstract PTU-127 Figure 1

Cited by 10 publications

References 1 publication

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

Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Cost-Effectiveness of Vedolizumab as a First-Line Advanced Therapy Versus Adalimumab Treatment Sequences for Ulcerative Colitis in Italy

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