Maureen P.M.H. Rutten-van Molken (Institute for Medical Technology Assessment, Erasmus MC, Rotterdam, The Netherlands) Floortje E. van Nooten (Institute for Medical Technology Assessment, Erasmus MC, Rotterdam, The Netherlands) Marion Lindemann (ALTANA Pharma AG, Konstanz, Germany) Manfred Caeser (ALTANA Pharma AG, Konstanz, Germany) Peter M.A. Calverley (Division of Infection and Immunity, Department of Medicine, Clinical Sciences, University Hospital Aintree, Liverpool, UK)
Abstract
Rationale: Roflumilast is an oral, once-daily phosphodiesterase IV (PDE4) inhibitor under investigation for chronic obstructive pulmonary disease (COPD). This study investigated the cost effectiveness of roflumilast in patients with severe to very severe COPD from the perspective of the UK society and UK NHS. Methods: The analysis was conducted alongside a 1-year, randomised, double-blind, placebo-controlled, multinational trial. The trial included 1514 COPD patients aged >=40 years with a post-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted <=50% who were randomised to receive either roflumilast 500mug once daily (n = 761) or placebo (n = 753). Patients in both treatment groups were allowed to receive active treatment with a short-acting bronchodilator (salbutamol or anticholinergic) as needed. About 62% of patients in both groups were using an inhaled corticosteroid at trial entry. They were allowed to continue this on a stable dosage. Direct healthcare and productivity costs were calculated. Resource utilisation was recorded at every scheduled visit in health economics case report forms (HE-CRFs). Trial-wide resource use was combined with UK unit cost (2004 values). Roflumilast was assumed to cost Results: In the total group, annual COPD-related costs from a societal perspective were In a subgroup of patients with very severe COPD (n = 223), the placebo group had a high exacerbation rate (1.7 per patient per year) whereas roflumilast recipients showed 35% fewer exacerbations (1.1 per patient per year). This resulted in roflumilast dominating placebo. In a subgroup of patients with high healthcare utilisation prior to the study (n = 549) roflumilast recipients showed 19% fewer exacerbations than those receiving placebo, which translated into an ICER of Conclusion: Roflumilast increased the overall treatment costs of COPD, although the increase was partly offset by reductions in other forms of healthcare use. Roflumilast has the potential to be cost saving in patients with very severe COPD, due to a statistically significant reduction of exacerbations.
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Article provided by Wolters Kluwer Health | Adis in its journal PharmacoEconomics.
Volume (Year): 25 (2007) Issue (Month): 8 () Pages: 695-711 Download reference. The following formats are available: HTML,
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