+1 Recommend
1 collections

      Therapeutics and Clinical Risk Management (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on reporting of clinical studies, outcomes and safety in all therapeutic areas and surgical intervention areas. Sign up for email alerts here.

      34,006 Monthly downloads/views I 2.755 Impact Factor I 4.5 CiteScore I 1.0 Source Normalized Impact per Paper (SNIP) I 0.598 Scimago Journal & Country Rank (SJR)

      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Treatment cost of narcolepsy with cataplexy in Central Europe


      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.



          Narcolepsy is a lifelong, rare neurological sleep disorder characterized by chronic, excessive attacks of daytime sleepiness. This disease is often extremely incapacitating, interfering with every aspect of life, in work and social settings.


          The purpose of this study is to specify the treatment costs of patients in Central Europe (Czech Republic), while the attention is mainly paid to the drugs that were fully or partially covered by public health insurance. Furthermore, concomitant therapy is also evaluated, since it incurs a certain financial burden for patients and their family members. On the basis of the calculated costs, impact on the public budget is evaluated.

          Patients and methods

          This study monitors the direct costs of the drugs for 13 patients, who represent ~1.3% of the total number of diagnosed patients in the Czech Republic, and evaluates the costs associated with their treatment during the period from January 9, 2011 to April 23, 2013.


          Most of the treatment costs (~80%) were covered by publicly available sources. This finding is also true for the concomitant therapy of comorbidities. Additional payments for the drugs constitute about 20% of the total costs.

          Most cited references15

          • Record: found
          • Abstract: found
          • Article: not found

          Socio-economic Aspects of Alzheimer's Disease.

          Social development, better living conditions and medical advances lead to the fact that more people have the opportunity to live longer than in the past. The aging population is a characteristic feature of demographic trends in developed countries. This trend is closely linked with the issue of increasing number of diseases in old age and increasing government expenditure on health and social care. The most frequently mentioned diseases in old age include dementia. The cause may lie in all kinds of diseases, the most common are Alzheimer's disease and cerebrovascular disease. Now the care of current 35 million patients with dementia costs over $ 600 billion per year, it is approximately one percent of global Gross Domestic Product. This review discusses the recent issues and questions in the area of social and economic aspects of Alzheimer's disease. It focuses in detail on the national strategies in the approach to Alzheimer's disease, the anticipated problems concerning the insufficient number of social workers and necessary expenses of state budgets in the future. The situation in the area of health insurance companies' expenditures is illustrated in the context of the analysis of long-term care systems, in the chosen countries within the European Union.
            • Record: found
            • Abstract: found
            • Article: not found

            A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy.

            MSG Xyrem (2002)
            To evaluate and compare the efficacy and safety of three doses of sodium oxybate and placebo for the treatment of narcolepsy symptoms. A multicenter, double blind, placebo-controlled trial. N/A. Study subjects were 136 narcolepsy patients with 3 to 249 (median 21) cataplexy attacks weekly. Prior to baseline measures, subjects discontinued anticataplectic medications. Stable doses of stimulants were permitted. Subjects were randomized in blinded fashion to receive 3, 6, or 9 g doses of sodium oxybate or placebo taken in equally divided doses upon retiring to bed and 2.5-4 hours later for 4 weeks. Disease symptoms and adverse events were recorded in daily diaries. The primary measure of efficacy was the change from baseline in weekly cataplexy attacks. Secondary measures included daytime sleepiness using the Epworth Sleepiness Scale (ESS), inadvertent daytime naps/sleep attacks and nighttime awakenings. Investigators assessed changes in disease severity using Clinical Global Impression of Change (CGI-c). Compared to placebo, weekly cataplexy attacks were decreased by sodium oxybate at the 6 g dose (p=0.0529) and significantly at the 9 g dose (p=0.0008). The ESS was reduced at all doses, becoming significant at the 9 g dose (p=0.0001). The CGI-c demonstrated a dose-related improvement, significant at the 9 g dose (p=0.0002). The frequency of inadvertent naps/sleep attacks and the nighttime awakenings showed similar dose-response trends, becoming significant at the 9 g dose (p=0.0122 and p=0.0035, respectively). Sodium oxybate was generally well-tolerated at all three doses. Nausea, headache, dizziness and enuresis were the most commonly reported adverse events. Sodium oxybate significantly improved symptoms in patients with narcolepsy and was well tolerated.
              • Record: found
              • Abstract: found
              • Article: not found

              EFNS guidelines on management of narcolepsy.

              Management of narcolepsy with or without cataplexy relies on several classes of drugs, namely stimulants for excessive daytime sleepiness and irresistible episodes of sleep, antidepressants for cataplexy and hypnosedative drugs for disturbed nocturnal sleep. In addition, behavioral measures can be of notable value. Guidelines on the management of narcolepsy have already been published. However contemporary guidelines are necessary given the growing use of modafinil to treat excessive daytime sleepiness in Europe within the last 5-10 years, and the decreasing need for amphetamines and amphetamine-like stimulants; the extensive use of new antidepressants in the treatment of cataplexy, apart from consistent randomized placebo-controlled clinical trials; and the present re-emergence of gamma-hydroxybutyrate under the name sodium oxybate, as a treatment of all major symptoms of narcolepsy. A task force composed of the leading specialists of narcolepsy in Europe has been appointed. This task force conducted an extensive review of pharmacological and behavioral trials available in the literature. All trials were analyzed according to their class evidence. Recommendations concerning the treatment of each single symptom of narcolepsy as well as general recommendations were made. Modafinil is the first-line pharmacological treatment of excessive daytime sleepiness and irresistible episodes of sleep in association with behavioral measures. However, based on several large randomized controlled trials showing the activity of sodium oxybate, not only on cataplexy but also on excessive daytime sleepiness and irresistible episodes of sleep, there is a growing practice in the USA to use it for the later indications. Given the availability of modafinil and methylphenidate, and the forseen registration of sodium oxybate for narcolepsy (including excessive daytime sleepiness, cataplexy, disturbed nocturnal sleep) in Europe, the place of other compounds will become fairly limited. Since its recent registration cataplexy sodium oxybate has now become the first-line treatment of cataplexy. Second-line treatments are antidepressants, either tricyclics or newer antidepressants, the later being increasingly used these past years despite few or no randomized placebo-controlled clinical trials. As for disturbed nocturnal sleep the best option is still hypnotics until sodium oxybate is registered for narcolepsy. The treatments used for narcolepsy, either pharmacological or behavioral, are diverse. However the quality of the published clinical evidences supporting them varies widely and studies comparing the efficacy of different substances are lacking. Several treatments are used on an empirical basis, specially antidepressants for cataplexy, due to the fact that these medications are already used widely in depressed patients, leaving little motivation from the manufacturers to investigate efficacy in relatively rare indications. Others, in particular the more recently developed substances, such as modafinil or sodium oxybate, are evaluated in large randomized placebo-controlled trials. Our objective was to reinforce the use of those drugs evaluated in randomized placebo-controlled trials and to reach a consensus, as much as possible, on the use of other available medications.

                Author and article information

                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                18 November 2016
                : 12
                : 1709-1715
                [1 ]Department of Economics, Faculty of Informatics and Management
                [2 ]Department of Chemistry, Faculty of Science, University of Hradec Králové
                [3 ]Biomedical Research Center, University Hospital Hradec Králové
                [4 ]Department of Applied Linguistics, Faculty of Informatics and Management
                [5 ]Faculty of Informatics and Management, University of Hradec Králové, Hradec Králové, Czech Republic
                Author notes
                Correspondence: Kamil Kuča, Biomedical Research Centre, University Hospital Hradec Králové, Sokolska 581, 500 05 Hradec Kralove, Czech Republic, Tel +420 603 289 166, Email kamil.kuca@ 123456fnhk.cz
                © 2016 Maresova et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Original Research

                cataplexy,cost,narcolepsy,orphan drug,rare disease,sodium oxybate
                cataplexy, cost, narcolepsy, orphan drug, rare disease, sodium oxybate


                Comment on this article