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. ⋯ 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.
Maureen P M H Rutten-van Mölken, Floortje E van Nooten, Marion Lindemann, Manfred Caeser, and Peter M A Calverley.
Institute for Medical Technology Assessment, Erasmus MC, Rotterdam, The Netherlands. m.rutten-vanmolken@erasmusmc.nl
Pharmacoeconomics. 2007 Jan 1;25(8):695-711.
RationaleRoflumilast 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.MethodsThe analysis was conducted alongside a 1-year, randomised, double-blind, placebo-controlled, multinational trial. The trial included 1514 COPD patients aged >or=40 years with a post-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted ResultsIn the total group, annual COPD-related costs from a societal perspective were euro1637 in the roflumilast group and euro1401 in the placebo group. From an NHS perspective, this was euro1418 and euro1242, respectively. The rate of moderate to severe COPD exacerbations per patient was low, and no statistically significant difference existed between roflumilast (0.96) and placebo (1.06). The net proportion of patients with a relevant improvement on SGRQ total score was higher in the roflumilast group (0.19) than in the placebo group (0.14), but the difference was not statistically significant. From a societal perspective, COPD-related costs were euro2356 per exacerbation avoided and euro4712 per net additional patient with a relevant improvement on the SGRQ. The probability that roflumilast was cost effective exceeded 70% at a willingness to pay of euro5000 to avoid an exacerbation. 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 euro804 per exacerbation avoided.ConclusionRoflumilast 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.