The cost-effectiveness of etanercept in patients with severe ankylosing spondylitis in the UK

Ara, Roberta; Reynolds, A. V.; Conway, Peter

doi:10.1093/rheumatology/kem133

Cited by 31 publications

(52 citation statements)

References 22 publications

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“…From a NHS perspective, the base-case cost per QALY gained was £23,097 for adalimumab over a 30-year horizon. Similar to the study by Ara et al, 161 the impact of alternative progression assumptions appeared to have limited impact on the ICER, with alternative scenario results ranging from between £23,802 (no BASFI progression on any treatment) and £23,812 per QALY (same BASFI progression on treatment). However, in contrast to Ara et al, 161 the ICERs appeared more sensitive to the alternative time horizons with estimates ranging between £47,083 (48 weeks), £26,332 (5 years) and £23,097 (30 years).…”

Section: Resultssupporting

confidence: 68%

“…Four of these studies were industry-funded assessments of the following anti-TNFs: infliximab (Kobelt et 161 funded by Wyeth pharmaceutical P.C.) and adalimumab (Botteman et al 162 funded by Abbott Laboratories).…”

Section: Results Of Review Of Existing Cost-effectiveness Evidencementioning

confidence: 99%

“…161 The Cost-Effectiveness of Etanercept in Patients with Severe Ankylosing Spondylitis in the UK Ara et al 161 estimated the cost-effectiveness of etanercept for the treatment of severe AS in the UK in accordance with BSR guidelines from a NHS/PSS perspective over a 25-year time horizon. Effectiveness data were derived from individual patient data from a large multicentre European RCT to inform the proportion and magnitude of initial response to treatment and associated changes in BASDAI and BASFI scores.…”

Section: Ara Et Almentioning

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: Resultssupporting

confidence: 68%

Section: Results Of Review Of Existing Cost-effectiveness Evidencementioning

confidence: 99%

Section: Ara Et Almentioning

confidence: 99%

See 1 more Smart Citation

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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“…Several cost analysis studies have implied cost-effectiveness of anti-TNF therapies in AS and PsA patients with moderate to severe disease. [133][134][135][136] However, there have been no headto-head pharmacoeconomic studies of etanercept in comparison with other biologic therapies or traditional DMARDS. Furthermore, it is very diffi cult to estimate cost-effectiveness of long-term therapies in chronic diseases, with short-term data often having to be mathematically modeled over a patient's lifetime.…”

Section: Patient Focused Perspectivesmentioning

confidence: 99%

“…In contrast, a mathematical model of long-term etanercept treatment of severe AS in the UK, compared to NSAID monotherapy, demonstrated cost-effectiveness with a cost of £22,700 per QALY gained. 134 A health economic model comparing methotrexate plus cyclosporin combination and lefl unomide therapies to etanercept in PsA patients demonstrated an estimated cost-effectiveness of etanercept between £28 000 and £38 000 per QALY. 138 In a mathematical model investigating the cost-effectiveness of both etanercept and infl iximab for the treatment of active PsA from a UK National Health Service perspective, only etanercept was found to be potentially cost-effective over a 10-year and lifetime horizon.…”

Section: Patient Focused Perspectivesmentioning

confidence: 99%

The Treatment of Ankylosing Spondylitis and Psoriatic Arthritis with Etanercept: A Comprehensive Review

Collamer

Battafarano

2009

Clinical Medicine. Therapeutics

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Etanercept is a dimeric recombinant soluble tumor necrosis factor (TNF) receptor protein utilized in the treatment of various infl ammatory diseases, including ankylosing spondylitis and psoriatic arthritis. Etanercept binds the proinfl ammatory cytokine TNF and blocks its interaction with soluble TNF receptors, thus decreasing the infl ammatory response. Several randomized controlled clinical trials have demonstrated the effi cacy, safety and tolerability of etanercept in the treatment of both ankylosing spondylitis and psoriatic arthritis. These trials have also shown signifi cant reductions in markers of systemic infl ammation and improvements in patient-reported quality of life measures. Inhibition of radiographic progression has been established in etanercept-treated psoriatic arthritis patients, and ankylosing spondylitis patients have demonstrated decreases in bony infl ammation; however, current data does not support a reduction in bone proliferation in ankylosing spondylitis patients. Concerns regarding long-term toxicity, effi cacy, and cost-effectiveness considerations persist and guidelines have been published to assist the clinician with appropriate patient selection for this biologic therapy. Current data indicates etanercept therapy has been a very successful and well-tolerated therapy for numerous ankylosing spondylitis and psoriatic arthritis patients and will likely continue to be a cornerstone therapy for treatment of these challenging diseases in the foreseeable future.

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The use of low-dose etanercept as an alternative therapy for treatment of ankylosing spondylitis: a case series

2011

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During recent decades, biological medications play a crucial role for treating rheumatologic disorders and thus are strongly recommended for initial treatment of ankylosing spondylitis. However, because of high cost of biological drugs, the use of these drugs has been limited. In current series, we tried to assess safety of low-dose etanercept as a common usable biological drug in patients with ankylosing spondylitis. In a case-series study, 4 men with ankylosing spondylitis were treated with low-dose etanercept (25 mg/2 weeks) plus methotrexate (10 mg/week). Safety was assessed by measuring rate of differences in severity of clinical manifestations and level of C-reactive protein (CRP). After the completion of treatment with low-dose etanercept, inflammatory low back pain and morning stiffness was reduced lower than 30 min in all patients. Only one patient had baseline high serum ESR and positive CRP that was changed to negative following treatment protocol. At one-year follow-up, all participants continued their regular treatment regimen with the etanercept survival rate 100%. Neither side effects related to drug nor clinical complications were observed within the follow-up period. Our findings suggest that low-dose etanercept (25 mg/2 weeks) has an acceptable safety and effectiveness profile in individuals with ankylosing spondylitis and can be good alternative instead of conventional therapy with etanercept (25 mg two times per week).

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The cost-effectiveness of etanercept in patients with severe ankylosing spondylitis in the UK

Abstract: This study demonstrates the potential cost-effectiveness of ETN plus NSAIDs compared with NSAIDs alone in patients with severe AS treated according to the BSR guidelines in the UK.

Cited by 31 publications

References 22 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

The Treatment of Ankylosing Spondylitis and Psoriatic Arthritis with Etanercept: A Comprehensive Review

The use of low-dose etanercept as an alternative therapy for treatment of ankylosing spondylitis: a case series

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