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Cost Eff Resour Alloc. 2017 Sep 7;15:20. doi: 10.1186/s12962-017-0081-8. eCollection 2017.

Access criteria for anti-TNF agents in spondyloarthritis: influence on comparative 1-year cost-effectiveness estimates.

Author information

University of British Columbia, Vancouver, Canada.
Centre for Health Evaluation and Outcome Sciences, 588-1081, Burrard Street, Vancouver, BC V6Z 1Y6 Canada.
Sorbonne Universités, UPMC-GRC08, Pierre Louis Institute for Epidemiology and Public Health, Paris, France.
University Paris Diderot, Faculty of Medicine, Paris 07, Paris, France.
AP-HP, Rheumatology Department, Lariboisiere University Hospital, Paris, France.
Rheumatology Unit, Hôpital de la Cavale Blanche, 29609 Brest, France.
EA2216, INSERM ESPRI ERI29 Université de Brest LabEx IGO, Brest, France.
AP-HP, Rheumatology Department, Pitié Salpétrière University Hospital, Paris, France.



Anti-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.


We 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.


Anti-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).


Anti-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.


Anti-TNF; Biologics; Cost-effectiveness; Pharmaceutical policy; Spondyloarthritis

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