Abstract
BackgroundAnti-tumor necrosis factor (anti-TNF) agents are an effective, but costly, treatment for spondyloarthritis (SpA). Worldwide, multiple sets of access criteria aim to restrict anti-TNF therapy to patients with specific clinical characteristics, yet the influence of access criteria on anti-TNF cost-effectiveness is unknown. Our objective was to use data from the DESIR cohort, a prospective study of early SpA patients in France, to determine whether the French anti-TNF access criteria are the most cost-effective in that setting relative to other potential restrictions.MethodsWe used data from the DESIR cohort to create five study populations of patients meeting anti-TNF access criteria from Canada, France, Germany, United Kingdom, and Hong Kong, respectively. For each study population, we calculated the costs and quality-adjusted life years (QALYs) over 1 year of patients treated and not treated with anti-TNF therapy. To control for differences between anti-TNF users and non-users, we used linear regression models to derive adjusted mean costs and QALYs. We calculated incremental cost-effectiveness ratios (ICERs) representing the incremental cost per additional QALY gained by treating with an anti-TNF within each of the five study populations, using bootstrapping to explore the range of uncertainty in costs and QALYs. A series of sensitivity analyses was conducted, including one to simulate the effect of a 24-week stopping rule for anti-TNF non-responders.ResultsAnti-TNF access criteria from France were satisfied by the largest proportion of DESIR patients (27.8%), followed by Germany (25.1%), Canada (23.8%), the UK (12.1%) and Hong Kong (8.6%). Confidence intervals around incremental costs and QALYs in the basecase analysis were overlapping, indicating that anti-TNF cost-effectiveness estimates derived from each subset were similar. In the sensitivity analysis that examined the effect of excluding costs accumulated past 24 weeks by anti-TNF non-responders, the incremental cost per QALY was reduced by approximately 25% relative to the basecase analysis (France: €857,992 vs. €1,105,859; Canada: € 626,459 vs. €818,186; Germany: € 422,568 vs. €545,808); UK €578,899 vs. €766,217; Hong Kong €335,418 vs. €456,850).ConclusionsAnti-TNF cost-effectiveness is strongly affected by treatment continuation among non-responders. Access criteria could improve anti-TNF cost-effectiveness by defining patients likely to respond.
Highlights
Anti-tumor necrosis factor agents are an effective, but costly, treatment for spondyloarthritis (SpA)
The clinical data include many of the parameters commonly cited in access criteria for antiTNF agents [4], including diagnosis; disease activity according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Physician Global Assessment (PhGA); X-ray, magnetic resonance imaging (MRI), and computerized tomography (CT) findings; acute phase reactants (e.g., C-reactive protein (CRP)); and treatment history
The criteria sets from the United Kingdom (UK) and Hong Kong both required a diagnosis of ankylosing spondylitis (AS), while those from Canada, France, and Germany were inclusive of nr-axSpA patients
Summary
Anti-tumor necrosis factor (anti-TNF) agents are an effective, but costly, treatment for spondyloarthritis (SpA). Many criteria sets that allow anti-TNF use by nraxSpA patients require them to have sacroiilitis or spinal inflammation visible on MRI and/or elevated acute-phase reactants, such as C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), while others do not incorporate these additional markers. The variation in these criteria sets means that patient access to anti-TNF therapy is more difficult in some settings than others. The burden of SpA in terms of disease activity and impairment to be comparable among AS and nr-axSpA patients [9,10,11], indicating the need to treat both populations
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