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      International Journal of COPD (submit here)

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      Budgetary impact analysis on funding smoking-cessation drugs in patients with COPD in Spain

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          Abstract

          The aim of the study was to assess the budgetary impact of funding smoking-cessation drugs in COPD patients in Spain. A hybrid model (cohort and Markov) was developed for a 5-year time horizon. Only approved cessation drugs (varenicline, bupropion, and nicotine replacement therapy) were considered. Irrespective of the drug, the model allowed for an initial cessation attempt, and up to three additional attempts in case of failure or smoking relapse during a 5-year period. Drug effectiveness was based on controlled clinical trials. National Health System perspective was applied; therefore, only medical resources were included. The pharmaceutical costs for smoking-cessation drugs, extra medical follow-up as a consequence of public reimbursement, and annual savings for health costs avoided due to stopping smoking were considered. The model estimated that 17,756 COPD patients would stop smoking if public funding was available, compared with 1,303 without reimbursement. In the reimbursement scenario, the savings accounted for a total of €48.0 million, compensating for expenditures on drugs and medical visits (€40.4 million). Accumulated total additional savings in 5 years (€4.3 million) compared with the scenario without reimbursement was shown. Sensitivity analyses supported the results robustness. Funding smoking-cessation drugs in COPD patients seems to be an efficient option and a National Health System drug reimbursement scheme would represent a cost-saving policy in Spain.

          Most cited references37

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          Spanish recommendations on economic evaluation of health technologies.

          The economic evaluation of health technologies has become a major tool in health policy in Europe for prioritizing the allocation of health resources and the approval of new technologies. The objective of this proposal was to develop guidelines for the economic evaluation of health technologies in Spain. A group of researchers specialized in economic evaluation of health technologies developed the document reported here, following the initiative of other countries in this framework, to provide recommendations for the standardization of methodology applicable to economic evaluation of health technologies in Spain. Recommendations appear under 17 headings or sections. In each case, the recommended requirements to be satisfied by economic evaluation of health technologies are provided. Each recommendation is followed by a commentary providing justification and compares and contrasts the proposals with other available alternatives. The economic evaluation of health technologies should have a role in assessing health technologies, providing useful information for decision making regarding their adoption, and they should be transparent and based on scientific evidence.
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            Evidence of real-world effectiveness of a telephone quitline for smokers.

            Telephone services that offer smoking-cessation counseling (quitlines) have proliferated in recent years, encouraged by positive results of clinical trials. The question remains, however, whether those results can be translated into real-world effectiveness. We embedded a randomized, controlled trial into the ongoing service of the California Smokers' Helpline. Callers were randomly assigned to a treatment group (1973 callers) or a control group (1309 callers). All participants received self-help materials. Those in the treatment group were assigned to receive up to seven counseling sessions; those in the control group could also receive counseling if they called back for it after randomization. Counseling was provided to 72.1 percent of those in the treatment group and 31.6 percent of those in the control group (mean, 3.0 sessions). The rates of abstinence for 1, 3, 6, and 12 months, according to an intention-to-treat analysis, were 23.7 percent, 17.9 percent, 12.8 percent, and 9.1 percent, respectively, for those in the treatment group and 16.5 percent, 12.1 percent, 8.6 percent, and 6.9 percent, respectively, for those in the control group (P<0.001). Analyses factoring out both the subgroup of control subjects who received counseling and the corresponding treatment subgroup indicate that counseling approximately doubled abstinence rates: rates of abstinence for 1, 3, 6, and 12 months were 20.7 percent, 15.9 percent, 11.7 percent, and 7.5 percent, respectively, in the remaining subjects in the treatment group and 9.6 percent, 6.7 percent, 5.2 percent, and 4.1 percent, respectively, in the remaining subjects in the control group (P<0.001). Therefore, the absolute difference in the rate of abstinence for 12 months between the remaining subjects in the treatment and control groups was 3.4 percent. The 12-month abstinence rates for those who made at least one attempt to quit were 23.3 percent in the treatment group and 18.4 percent in the control group (P<0.001). A telephone counseling protocol for smoking cessation, previously proven efficacious, was effective when translated to a real-world setting. Its success supports Public Health Service guidelines calling for greater availability of quitlines. Copyright 2002 Massachusetts Medical Society
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              Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial.

              Smoking is the most important risk factor for COPD and accelerates its progression. Despite the health implications, a large proportion of patients with COPD continue to smoke, so finding effective smoking cessation interventions for this population is paramount. To our knowledge, this is the first randomized clinical trial to compare the efficacy and safety of varenicline tartrate vs placebo in smokers with mild to moderate COPD. In a 27-center, double-blind, multinational study, 504 patients with mild to moderate COPD (postbronchodilator FEV1/FVC, <70%; FEV1 percent predicted normal value, ≥50%) and without known psychiatric disturbances were randomized to receive varenicline (n=250) or placebo (n=254) for 12 weeks, with a 40-week nontreatment follow-up. The primary end point was carbon monoxide-confirmed continuous abstinence rate (CAR) for weeks 9 to 12. A secondary end point was CAR for weeks 9 to 52. CAR for weeks 9 to 12 was significantly higher for patients in the varenicline group (42.3%) than for those in the placebo group (8.8%) (OR, 8.40; 95% CI, 4.99-14.14; P<.0001). CAR in the patients treated with varenicline remained significantly higher than in those treated with placebo through weeks 9 to 52 (18.6% vs 5.6%) (OR, 4.04; 95% CI, 2.13-7.67; P<.0001). Nausea, abnormal dreams, upper-respiratory tract infection, and insomnia were the most commonly reported adverse events (AEs) for patients in the varenicline group. Serious AEs were infrequent in both treatment groups. Two patients in the varenicline group and one patient in the placebo group died during the study. Reports of psychiatric AEs were similar for both treatment groups. Varenicline was more efficacious than placebo for smoking cessation in patients with mild to moderate COPD and demonstrated a safety profile consistent with that observed in previous trials. ClinicalTrials.gov; No.: NCT00285012; URL: www.clinicaltrials.gov.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2015
                24 September 2015
                : 10
                : 2027-2036
                Affiliations
                [1 ]Specialised Tobacco Unit, Community of Madrid, Hospital General Universitario Gregorio Marañón, Madrid, Spain
                [2 ]Tobacco Unit, Department of Pulmonary Medicine, Hospital General Universitario Gregorio Marañón, Madrid, Spain
                [3 ]Department of Pulmonary Medicine, Hospital Universitario San Juan, Alicante, Madrid, Spain
                [4 ]Department of Pulmonary Medicine, Hospital Universitario Fundación Alcorcón, Madrid, Spain
                [5 ]Department of Pulmonary Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain
                [6 ]Department of Pulmonary Medicine, Complejo Hospitalario de Navarra, Pamplona, Navarre, Spain
                [7 ]Department of Pulmonary Medicine, Hospital de San Pedro Alcántara, Cáceres, Spain
                [8 ]Drassanes Tobacco Unit, Hospital Universitari Vall-d’Hebron-Drassanes, The Jordi Gol University Institute for Research Primary Healthcare, Barcelona, Spain
                [9 ]Department of Pulmonary Medicine, Hospital Universitario de Salamanca, Biomedical Research Institute, Salamanca, Alcobendas, Madrid, Spain
                [10 ]Pharmacoeconomics & Outcomes Research Iberia, Sociedad Limitada Unificada, Alcobendas, Madrid, Spain
                [11 ]Department of Pharmacoeconomics and Health Outcomes Research, Pfizer, Sociedad Limitada Unificada, Alcobendas, Madrid, Spain
                Author notes
                Correspondence: Carlos A Jiménez-Ruiz, Specialized Tobacco Unit, Sub-directorate for Health Promotion and Disease Prevention, Directorate-General for Primary Care, Consejería de Sanidad, C/Santa Cruz de Marcenado, 9-2, 28015 Madrid, Spain, Tel +34 91 205 29 60, Fax +34 91 204 49 72, Email victorina@ 123456ctv.es
                Article
                copd-10-2027
                10.2147/COPD.S87597
                4590338
                26451100
                6d28c8cd-2b9e-48e7-9de0-07aeadfc7ce0
                © 2015 Jiménez-Ruiz et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Respiratory medicine
                pharmacotherapy,copd,smoking cessation,budgetary impact,health service
                Respiratory medicine
                pharmacotherapy, copd, smoking cessation, budgetary impact, health service

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