OBJECTIVE: The aim of the study was to assess the cost-effectiveness of almitrine in the treatment of severe, chronic obstructive pulmonary disease. METHODS: A retrospective approach was applied. Both costs and consequences of the therapy in two groups of patients, almitrine group and placebo group, were assessed. The pharmacoeconomic analysis was based on the results of a clinical trial entitled "Effects of sequential administration of almitrine bismesylate (100mg per day per os) in 120 patients with chronic obstructive pulmonary disease. One year, double blind study versus placebo". The effectiveness of the therapies was exemplified by significant changes in arterial oxygen partial pressure (D PaO2). The differences on Visual Analogue Scale for dyspnoea were also measured. Results of the trial demonstrated significant improvement in PaO2 during 12-months of treatment with almitrine compared to placebo. Direct medical costs of pharmacological treatment, hospitalisations, additional examinations and oxygen therapy were identified and calculated. The societal perspective and third-party-payer perspective were applied. RESULTS: The total cost per patient per year in the almitrine group amounted to 2 656 PLN and was 27 PLN lower than for the placebo group. The most important difference in cost components concerned costs of hospitalisations and oxygen therapy which were 47.4% and 34.5% lower in almitrine group (calculations made from societal perspective). Results of simulation assuming possibility of partial, subtotal or total reimbursement determined that savings due to this procedure might vary from 93 PLN per patient per year in the case of total reimbursement to 531 PLN per patient per year in the case of 50% reimbursement. CONCLUSION: Cost calculations together with clinical results determined that treatment with almitrine is a cost-effective alternative which leads to clinical improvement and constitutes effective use of resources both from the broad societal perspective and also from the third-party-payer perspective.