Abstract
BackgroundCertolizumab pegol, a PEGylated tumour necrosis factor (TNF)-inhibitor, improves the clinical signs and symptoms of rheumatoid arthritis (RA) when used in combination with methotrexate or as monotherapy. This study evaluatedthe cost-utility of certolizumab pegol versusTNF-inhibitors plus methotrexate in the treatment of moderate-to-severe RA in Spain.MethodsA Markov cohort health state transition model was developed to evaluate the cost-utility (costs and quality-adjusted life years [QALYs]) of certolizumab pegol versus other TNF-inhibitors licensed in Spain in 2009. Efficacy was measured using the American College of Rheumatology (ACR) responses at 6 months, based on adjusted indirect comparisons from published clinical trials. Utilities were derived from EQ-5D data from certolizumab pegol RA clinical trials. Clinical history and resource use data came from published literature. Unit costs were taken from Spanish databases or published data (cost year 2009). Base case analyses were conducted from the payer perspective, with a lifetime horizon, 3.5 % annual discounting rates for costs and outcomes, and 3 % inflation rate for 2009 onwards. One-way sensitivity analyses were conducted.ResultsThe average lifetime costs for certolizumab pegol, etanercept, adalimumab (every 2 weeks and weekly) and infliximab (3 mg/kg and 5 mg/kg) in combination with methotrexate were €140,971, €141,197, €139,148, €164,741, €136,961 and €152,561, respectively. The QALYs gained were 6.578, 6.462, 6.430 (for both adalimumab doses), 6.430, and 6.318 (for both infliximab doses), respectively. At a €30,000/QALY willingness-to-pay threshold, certolizumab pegol plus methotrexate dominated adalimumab weekly, etanercept, and infliximab 5 mg/kg, and was cost-effective versus adalimumab every 2 weeks and infliximab 3 mg/kg (all with methotrexate), with estimated ICERs of €12,346/QALY and €15,414/QALY, respectively. Certolizumab pegol monotherapy was more cost-effective versus adalimumab, and less expensive with similar health gains versus etanercept (6.416 QALYs vs 6.492). Univariate analysis showed ICERs to be sensitive to changes in time horizon, ACR response time point, baseline Heath Assessment Questionnaire (HAQ) score, and rate of HAQ-disability index deterioration after discontinuing treatment.ConclusionsThis analysis shows that certolizumab pegol is cost-effective compared with other TNF-inhibitors recommended in Spain for the treatment of RA.
Highlights
Certolizumab pegol, a PEGylated tumour necrosis factor (TNF)-inhibitor, improves the clinical signs and symptoms of rheumatoid arthritis (RA) when used in combination with methotrexate or as monotherapy
Biological disease-modifying antirheumatic drugs (DMARDs) include tumour necrosis factor (TNF) inhibitors, e.g. certolizumab pegol, adalimumab, golimumab, infliximab and etanercept, which target TNFα, a proinflammatory cytokine believed to play a major role in the pathogenesis of RA [5]
Other biological agents used in Spain are anakinra, abatacept and rituximab, which are used in patients with RA who do not respond to methotrexate and in patients with active RA despite treatment with TNF inhibitors [6, 7]
Summary
Certolizumab pegol, a PEGylated tumour necrosis factor (TNF)-inhibitor, improves the clinical signs and symptoms of rheumatoid arthritis (RA) when used in combination with methotrexate or as monotherapy. In line with national guidelines, methotrexate, a small-molecule DMARD, is the first treatment choice in Spain for more than 80 % of patients with RA [4]. Biological DMARDs include tumour necrosis factor (TNF) inhibitors, e.g. certolizumab pegol, adalimumab, golimumab, infliximab and etanercept, which target TNFα, a proinflammatory cytokine believed to play a major role in the pathogenesis of RA [5]. TNF inhibitors or tocilizumab, an antibody directed against the interleukin-6 receptor, administered alone or in combination with methotrexate, are the first treatment option after small-molecule DMARDs [6, 7]. A significant proportion of patients has an unsatisfactory response to these treatments and continues to experience episodes of disease activity while receiving therapy [8,9,10,11]
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