Abstract

ObjectiveTo assess the cost-effectiveness of tofacitinib-containing treatment sequences versus sequences containing only standard biological therapies in patients with moderate-to-severe rheumatoid arthritis (RA) after the failure of conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR population) and in patients previously treated with methotrexate (MTX) who show an inadequate response to second-line therapy with any tumour necrosis factor inhibitor (TNFi-IR population).MethodsA patient-level microsimulation model estimated, from the perspective of the Spanish Public NHS, lifetime costs and quality-adjusted life years (QALY) for treatment sequences starting with tofacitinib (5 mg twice daily) followed by biological therapies versus sequences of biological treatments only. Concomitant treatment with MTX was considered. Model’s parameters comprised demographic and clinical inputs (initial Health Assessment Questionnaire [HAQ] score and clinical response to short- and long-term treatment). Efficacy was measured by means of HAQ score changes using mixed treatment comparisons and data from long-term extension (LTE) trials. Serious adverse events (SAEs) data were derived from the literature. Total cost estimation (€, 2018) included drug acquisition, parenteral administration, disease progression and SAE management.ResultsIn the csDMARD-IR population, sequences starting with tofacitinib proved dominant options (more QALYs and lower costs) versus the corresponding sequences without tofacitinib. In the TNFi-IR population, first-line treatment with tofacitinib+MTX followed by scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX proved dominant versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX; and tofacitinib+MTX➔scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX was less effective but remained a cost-saving option.ConclusionsInclusion of tofacitinib seems a dominant strategy in moderate-to-severe RA patients after csDMARDs failure. Tofacitinib, as initial third-line therapy, proved a cost-saving strategy (€− 337,489/QALY foregone) in moderate-to-severe TNFi-IR RA patients.Key points• Therapeutical approach in rheumatoid arthritis (RA) consisted in sequences of several therapies during patient lifetime.• Treatment sequences initiating with tofacitinib followed by biological drugs provided higher health effects in csDMARDs-IR population, compared with sequences containing only biological drugs.• In both csDMARD-IR and TNFi-IR RA populations, initiating treatment with tofacitinib was associated to lower treatment costs for the Spanish National Health System.

Highlights

  • Rheumatoid arthritis (RA) is a chronic and progressive autoimmune disease associated with long-term morbidity, increased mortality [1] and a decline in patients’ quality of life [2].A recent study showed that the prevalence of rheumatoid arthritis (RA) in Spain is to 0.9% [3]

  • EFP, ex-factory price; MTX, methotrexate *Reference price **Lowest price of the biosimilar products available on Spanish market. This analysis assessed the efficiency of several treatment sequences, consisting of the administration of tofacitinib (5 mg BID) and subsequent lines of biological DMARDs (bDMARDs) in two different populations, compared with alternative sequences which did not consider the administration of tofacitinib (Table 4)

  • In the other scenario, the sequence with tofacitinib would provide 13.75 quality-adjusted life years (QALY) compared with the 13.62 QALYs in the alternative sequence

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Summary

Introduction

Rheumatoid arthritis (RA) is a chronic and progressive autoimmune disease associated with long-term morbidity, increased mortality [1] and a decline in patients’ quality of life [2]. A recent study showed that the prevalence of RA in Spain is to 0.9% [3]. RA generates a significant cost for the Spanish National Health System (NHS). In 2001, RA-derived costs exceeded 2.25 billion euros, with healthcare costs, mainly associated to the disease-derived disability, representing 70% of the total [4]. RA treatment guidelines recommend methotrexate (MTX) or other synthetic disease-modifying antirheumatic drugs (csDMARDs) as the first therapeutic option. If the therapeutic objective is not achieved with csDMARDs, start treatment with advanced therapies, as biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is recommended [5]

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