Cost-effectiveness of tiotropiumversussalmeterol: the POET-COPD trial

Abstract

The aim of this study was to perform a 1-yr trial-based cost-effectiveness analysis (CEA) of tiotropium versus salmeterol followed by a 5-yr model-based CEA.The within-trial CEA, including 7,250 patients with moderate to very severe chronic obstructive pulmonary disease (COPD), was performed alongside the 1-yr international randomised controlled Prevention of Exacerbations with Tiotropium (POET)-COPD trial comparing tiotropium with salmeterol regarding the effect on exacerbations. Main end-points of the trial-based analysis were costs, number of exacerbations and exacerbation days. The model-based analysis was conducted to extrapolate results to 5 yrs and to calculate quality-adjusted life years (QALYs).1-yr costs per patient from the German statutory health insurance (SHI) perspective and the societal perspective were J126 (95% uncertainty interval (UI) J55-195) and J170 (95% UI J77-260) higher for tiotropium, respectively. The annual number of exacerbations was 0.064 (95% UI 0.010-0.118) lower for tiotropium, leading to a reduction in exacerbation-related costs of J87 (95% UI J19-157). The incremental cost-effectiveness ratio was J1,961 per exacerbation avoided from the SHI perspective and J2,647 from the societal perspective. In the model-based analyses, the 5-yr costs per QALY were J3,488 from the SHI perspective and J8,141 from the societal perspective.Tiotropium reduced exacerbations and exacerbation-related costs, but increased total costs. Tiotropium can be considered cost-effective as the resulting cost-effectiveness ratios were below commonly accepted willingness-to-pay thresholds.KEYWORDS: Chronic obstructive pulmonary disease, costs, exacerbations, model, qualityadjusted life year, trial T he current international guidelines for the treatment of chronic obstructive pulmonary disease (COPD) recommend regular treatment with a long-acting anticholinergic drug (tiotropium) or a long-acting b-agonist (salmeterol, formoterol or indacaterol) for patients with moderate to very severe COPD [1]. These bronchodilators have been shown to improve symptoms, health-related quality of life and lung function, and reduce exacerbations and hospitalisations [2][3][4]. However, guidelines do not give a preference for either drug class. Until the publication of the Prevention of Exacerbations with Tiotropium (POET)-COPD trial, head-to-head comparisons were limited, had a short duration and/or were underpowered to detect a difference in COPD exacerbations [5,6]. The 1-yr POET-COPD trial was designed to compare the effects of tiotropium 18 mg once daily or salmeterol 50 mg twice daily on the occurrence of moderate or severe exacerbations in patients with moderate to very severe COPD and a history of least one exacerbation in the previous year [7]. This clinical trial demonstrated that tiotropium prolonged the time to first exacerbation (hazard ratio (HR) 0.83, 95% CI 0.77-0.90) and the time to first exacerbation leading to hospitalisation (HR 0.72, 95% CI 0.61-0.85), and reduced the total number of exacerbations (...

Systematic Review and Quality Appraisal of Cost-Effectiveness Analyses of Pharmacologic Maintenance Treatment for Chronic Obstructive Pulmonary Disease: Methodological Considerations and Recommendations

“…Tiotropium + UC2. UCEngland: +£796 (€917)Belgium: +€969(2011)England: +0.051 QALYsBelgium: +0.052 QALYsEngland: £15,567 (€17,936) /QALYBelgium: €18,617/QALYAdding tiotropium to UC is cost effective94Hoogendoorn et al 2013 (Germany) [17]Alongside 1-year RCT + 5-year model (CUA)1 and 5 yearsBoehringer Ingelheim1. Tiotropium2.…”

“…The remaining study reported higher QALY gains (0.42) [14]; however, the authors assumed an additional positive effect of tiotropium on cardiovascular outcomes (myocardial infarction, congestive heart failure) and used mapping to convert St George’s Respiratory Questionnaire (SGRQ) scores into utilities. One study compared tiotropium versus salmeterol based on the head-to-head POET-COPD clinical trial [17]. In this economic evaluation, 1-year trial-based cost effectiveness as well as model-based cost-effectiveness estimates (over 1-year and 5-year time horizons) were reported from both the societal and the payer’s perspective.…”

“…Reasons were not always explicitly stated, but the perspectives did not differ from their country’s recommendations or at least also included the recommended perspective [34]; 15 took a healthcare payer perspective (Supplementary Appendix Table A2). Four of these also applied a societal perspective [17, 18, 27, 30], two only used the societal perspective [15, 31] and another did not explicitly mention the perspective, but it seemed to have been undertaken from a healthcare perspective [28]. A total of 15 studies were modelling studies; the remaining three were performed alongside a clinical trial or used observational data, and all but two studies used efficacy data for their main effect estimate (QHES item 3).…”

“…A limitation of most of the included studies is that they did not describe the inclusion of comorbidities (Supplementary Appendix Table A3), with only five of the 18 studies clearly stating which comorbidities were present [17, 20, 21, 28, 32]. …”

Roflumilast in Kombination mit langwirksamen Bronchodilatatoren in der Versorgung von Patienten mit schwerer und sehr schwerer COPD

“…Für die Einordnung der Ergebnisse bezogen auf andere medikamentöse Therapieoptionen in Deutschland kann eine aktuell publizierte Kosten-Effektivitäts-analyse für LAMA (Tiotropium) versus LABA (Salmeterol) basierend auf den Daten der POET-Studie herangezogen werden. Die Modell-Berechnungen kommen mit 1961 € pro vermiedener Exazerbation aus Perspektive der GKV zu einem vergleichbaren Ergebnis (1852 €) [18]. Die Kosten pro gewonnenem QALY aus Sicht der GKV liegen bei der alleinigen Therapie mit Tiotropium niedrigerer (3488 €) als bei den Modellberechnungen für Roflumilast + LABA (19 457 €).…”