Cost effectiveness of adalimumab for the treatment of ankylosing spondylitis in the United Kingdom

Botteman, Marc; Hay, Joel W.; Luo, Michelle; Curry, Alistair S; Wong, Raymond M.H.; Hout, Ben A. van

doi:10.1093/rheumatology/kem031

Cited by 29 publications

(24 citation statements)

References 18 publications

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“…and adalimumab (Botteman et al 162 funded by Abbott Laboratories). The three studies published in 2007 are largely based on the economic analyses originally submitted by the manufacturers to NICE as part of the previous multiple TA (TA143).…”

Section: Results Of Review Of Existing Cost-effectiveness Evidencementioning

confidence: 99%

“…The ICERs for alternative time horizons ranged between £27,594 (2 years) and £22,704 (25 years). 162 evaluated the cost-effectiveness of adalimumab versus conventional therapy in patients with active AS from a NHS perspective over a 30-year time horizon. Effectiveness data were derived from pooled data from two Phase III studies in patients with an inadequate response to ≥ 1 NSAID.…”

Section: Resultsmentioning

confidence: 99%

“…Given the discrepancy between the results reported by McLeod et al 38 and the manufacturer's submissions [34][35][36][37] (largely reflected in the three industry-funded publications previously discussed in this section) [160][161][162] also submitted as part of TA143, 17 additional work was undertaken by NICE's Decision Support Unit (DSU) to reconcile the different models and to explore whether or not differences were a result of different parameter inputs or alternative structural assumptions.…”

Section: Additional National Institute For Health and Care Excellencementioning

confidence: 99%

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Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Corbett

Soares

Jhuti

et al. 2016

Health Technol Assess

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BackgroundTumour necrosis factor (TNF)-α inhibitors (anti-TNFs) are typically used when the inflammatory rheumatologic diseases ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-AxSpA) have not responded adequately to conventional therapy. Current National Institute for Health and Care Excellence (NICE) guidance recommends treatment with adalimumab, etanercept and golimumab in adults with active (severe) AS only if certain criteria are fulfilled but it does not recommend infliximab for AS. Anti-TNFs for patients with nr-AxSpA have not previously been appraised by NICE.ObjectiveTo determine the clinical effectiveness, safety and cost-effectiveness within the NHS of adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, within their licensed indications, for the treatment of severe active AS or severe nr-AxSpA (but with objective signs of inflammation).DesignSystematic review and economic model.Data sourcesFifteen databases were searched for relevant studies in July 2014.Review methodsClinical effectiveness data from randomised controlled trials (RCTs) were synthesised using Bayesian network meta-analysis methods. Results from other studies were summarised narratively. Only full economic evaluations that compared two or more options and considered both costs and consequences were included in the systematic review of cost-effectiveness studies. The differences in the approaches and assumptions used across the studies, and also those in the manufacturer’s submissions, were examined in order to explain any discrepancies in the findings and to identify key areas of uncertainty. A de novo decision model was developed with a generalised framework for evidence synthesis that pooled change in disease activity (BASDAI and BASDAI 50) and simultaneously synthesised information on function (BASFI) to determine the long-term quality-adjusted life-year and cost burden of the disease in the economic model. The decision model was developed in accordance with the NICE reference case. The model has a lifetime horizon (60 years) and considers costs from the perspective of the NHS and personal social services. Health effects were expressed in terms of quality-adjusted life-years.ResultsIn total, 28 eligible RCTs were identified and 26 were placebo controlled (mostly up to 12 weeks); 17 extended into open-label active treatment-only phases. Most RCTs were judged to have a low risk of bias overall. In both AS and nr-AxSpA populations, anti-TNFs produced clinically important benefits to patients in terms of improving function and reducing disease activity; for AS, the relative risks for ASAS 40 ranged from 2.53 to 3.42. The efficacy estimates were consistently slightly smaller for nr-AxSpA than for AS. Statistical (and clinical) heterogeneity was more apparent in the nr-AxSpA analyses than in the AS analyses; both the reliability of the nr-AxSpA meta-analysis results and their true relevance to patients seen in clinical practice are questionable. In AS, anti-TNFs are approximately equally effective. Effectiveness appears to be maintained over time, with around 50% of patients still responding at 2 years. Evidence for an effect of anti-TNFs delaying disease progression was limited; results from ongoing long-term studies should help to clarify this issue. Sequential treatment with anti-TNFs can be worthwhile but the drug survival response rates and benefits are reduced with second and third anti-TNFs. The de novo model, which addressed many of the issues of earlier evaluations, generated incremental cost-effectiveness ratios ranging from £19,240 to £66,529 depending on anti-TNF and modelling assumptions.ConclusionsIn both AS and nr-AxSpA populations anti-TNFs are clinically effective, although more so in AS than in nr-AxSpA. Anti-TNFs may be an effective use of NHS resources depending on which assumptions are considered appropriate.Future work recommendationsRandomised trials are needed to identify the nr-AxSpA population who will benefit the most from anti-TNFs.Study registrationThis study is registered as PROSPERO CRD42014010182.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Results Of Review Of Existing Cost-effectiveness Evidencementioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Additional National Institute For Health and Care Excellencementioning

confidence: 99%

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Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Corbett

Soares

Jhuti

et al. 2016

Health Technol Assess

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“…The economic evidence for the use of adalimumab in AS is limited to the models summarized in a NICE technology appraisal (NICE 2007) and one analysis investigating the cost efficacy of adalimumab for treatment of AS in the UK (Botteman et al 2007). The NICE technology appraisal includes a model from the manufacturer of adalimumab, and their own.…”

Section: Economic Evidencementioning

confidence: 99%

Adalimumab in ankylosing spondylitis: an evidence-based review of its place in therapy

Hennigan¹,

Ackermann²,

Kavanaugh

2007

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Introduction: Ankylosing spondylitis (AS) is an idiopathic chronic inflammatory disease that has prominent effects on the spine and peripheral joints. In addition, extraarticular manifestations such as enthesitis and acute anterior uveitis may be clinically important. In recent years, the therapy of AS has changed, largely due to the introduction of inhibitors of the proinflammatory cytokine tumor necrosis factor (TNF). Adalimumab, a human monoclonal antibody specifically for TNF, is the most recent of the TNF blocking agents that have been approved for the treatment of active, nonsteroidal antiinflammatory drug (NSAID)-refractory patients with AS.

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“…Four studies [28,[50][51][52] were submitted as part of NICE HTA guidance of adalimumab, etanercept, and infliximab for AS [53] and were further described in a systematic review [15]. The results from those studies showed that the ICERs of etanercept and adalimumab were roughly similar, falling below an assumed willingness-to-pay threshold of £30,000, while the ICER for infliximab was in the range of £40,000-50,000 per QALY.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of Golimumab in Ankylosing Spondylitis from the UK Payer Perspective

et al. 2017

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Introduction: Golimumab is a tumor necrosis factor-a (TNF-a) inhibitor for treatment of patients with severe, active ankylosing spondylitis. This study evaluated the cost-effectiveness of golimumab compared with conventional care and other TNF-a inhibitors in treatment of AS from the UK National Health Service perspective. Methods: A long-term Markov model (with initial decision tree) was developed to simulate the progression of a hypothetical cohort of patients with active AS over a lifetime. The effectiveness outcome was quality-adjusted life-years (QALYs). Utilities were estimated by mapping Bath Ankylosing Spondylitis Functional Index scores, and the primary response

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Cost effectiveness of adalimumab for the treatment of ankylosing spondylitis in the United Kingdom

Abstract: This analysis indicates that adalimumab, when used according to UK treatment guidelines, is cost-effective vs conventional therapy for treating AS patients.

Cited by 29 publications

References 18 publications

Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

Adalimumab in ankylosing spondylitis: an evidence-based review of its place in therapy

Cost-Effectiveness of Golimumab in Ankylosing Spondylitis from the UK Payer Perspective

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