Aims: The study aimed to assess the budgetary impact (BI) of reimbursing varenicline in patients with chronic obstructive pulmonary disease (COPD), type-2 diabetes mellitus (t2-DM) or cardiovascular diseases (CVD). Methods: The BI was estimated comparing the current non-reimbursed scenario versus a projected reimbursed scenario using the Spanish National Health System (SNHS) perspective. A hybrid model was developed using epidemiological data and Markov chains to estimate smoking cessation rates with varenicline during a 5-year horizon. Costs of cessation were considered in the reimbursement scenario only. Efficacy, expressed as a 1-year continuous abstinence rate, was derived from clinical trials. Cost savings due to smoking cessation were extracted from local cost-of-illness studies. Results are shown as incremental cost savings. Univariate sensitivity analysis was also applied. Results: A total of 68,684 patients stopped smoking in the reimbursed scenario compared with 15,208 without reimbursement. In the reimbursed scenario, total savings accounted for €36.3 million, showing 14.6 million accumulated additional savings compared with the scenario without reimbursement. Sensitivity analyses showed results to be robust with monetary savings starting in the third year of modeling. Conclusion: Reimbursement of varenicline in smoking cessation is a cost-effective health policy in the SNHS in COPD, t2-DM or CVD, and could produce cost savings starting in the third year of implementation.

Keywords:
Varenicline, Chronic obstructive pulmonary disease, Cardiovascular diseases, Type-2 diabetes mellitus, Smoking cessation, Budgetary impact, Spanish National Health System
1.
World Health Organization. Geneva. http://www.who.int/tobacco/health_priority/en/index.html (accessed December 2014).
2.
Catalina Romero C, Sainz Gutiérrez JC, Quevedo Aguado L, Cortés Arcas MV, Pinto Blázquez JA, Gelpi Méndez JA, et al: [Prevalence of tobacco consumption among working population after the law 42/2010, Spain]. Rev Esp Salud Publica 2012;86:177-188.
3.
Banegas JR, Díez-Gañán L, Bañuelos-Marco B, González-Enríquez J, Villar-Álvarez F, Martín-Moreno JM, et al: [Smoking-attributable deaths in Spain, 2006]. Med Clin (Barc) 2011;136:97-102.
4.
Gutiérrez-Abejón E, Rejas-Gutiérrez J, Criado-Espegel P, Campo-Ortega EP, Breñas-Villalón MT, Martín-Sobrino N: [Smoking impact on mortality in Spain in 2012]. Med Clin (Barc) 2015;145:520-525.
5.
Instituto Nacional de Estadísticas (INE): Encuesta Nacional de Salud Española 2011/2012. http://www.msssi.gob.es/estadEstudios/ estadisticas/encuestaNacional/encuesta2011.htm (accessed September 2015).
6.
Rennard SI, Daughton DM: Smoking cessation. Clin Chest Med 2014;35:165-176.
7.
Rigotti NA: Smoking cessation in patients with respiratory disease: existing treatments and future directions. Lancet Respir Med 2013;1:241-250.
8.
Tashkin DP, Rennard S, Hays JT, Ma W, Lawrence D, Lee TC: Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. Chest 2011;139:591-599.
9.
Tashkin D, Kanner R, Bailey W, Buist S, Anderson P, Nides M, et al: Smoking cessation in patients with chronic obstructive pulmonary disease: a double-blind, placebo-controlled, randomised trial. Lancet 2001;357:1571-1575.
10.
Tønnesen P, Mikkelsen K, Bremann L: Nurse-conducted smoking cessation in patients with COPD using nicotine sublingual tablets and behavioral support. Chest 2006;130:334-342.
11.
Tonstad S, Lawrence D, Tsilkos K: Varenicline in Smokers with Diabetes. 20th Society for Research on Nicotine and Tobacco, February 5-8, 2014. Seattle, Washington, USA.
12.
Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S: Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation 2010;121:221-229.
13.
Tonstad S, Farsang C, Klaene G, Lewis K, Manolis A, Perruchoud AP, et al: Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study. Eur Heart J 2003;24:946-955.
14.
Cahill K, Stead LF, Lancaster T: Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev 2011;2:CD006103.
15.
Lock K, Wilson K, Murphy D, Riesco JA: A cost-effectiveness model of smoking cessation based on a randomised controlled trial of varenicline versus placebo in patients with chronic obstructive pulmonary disease. Expert Opin Pharmacother 2011;12:2613-2626.
16.
Wilson K, Hettle R, Marbaix S, Diaz Cerezo S, Ines M, Santoni L, et al: An economic evaluation based on a randomized placebo-controlled trial of varenicline in smokers with cardiovascular disease: results for Belgium, Spain, Portugal, and Italy. Eur J Prev Cardiol 2012;19:1173-1183.
17.
Fernández de Bobadilla Osorio J, Sánchez-Maestre C, Brosa Riestra M, Arroyo O, Sanz De Burgoa V, Wilson K: [Cost effectiveness analysis of varenicline (Champix) for the treatment of smoking in Spain]. An Med Interna 2008;25:342-348.
18.
Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, et al: Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med 2002;347:1087-1093.
19.
Jiménez-Ruiz CA, Riesco Miranda JA, Ramos Pinedo A, Barrueco Ferrero M, Solano Reina S, de Granda Orive JI, et al: [Recommendations for pharmacological tobacco cessation treatments: proposals for financing]. Arch Bronconeumol 2008;44:213-219.
20.
Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibáñez-Nolla J: The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice. Lung 2014;192:505-518.
21.
Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibánez-Nolla J: Effect of smoking status on healthcare costs and resource utilization in patients with type 2 diabetes in routine clinical practice: a retrospective nested case-control economic study. Eur Addict Res 2014;20:94-104.
22.
Sicras-Mainar A, Díaz-Cerezo S, de Burgoa VS, Navarro-Artieda R: Cost and clinical consequences of smoking cessation in outpatients after cardiovascular disease: a retrospective cohort study. Clinicoecon Outcomes Res 2013;5:419-427.
23.
Brosa M, Gisbert R, Rodríguez JM, Soto J: Principios, métodos y aplicaciones del análisis del impacto presupuestario en el sector sanitario. Pharmacoeconomics Spa Res Articl 2005;2:64-78.
24.
Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, et al: Budget impact analysis-principles of good practice: report of the ISPOR 2012 budget impact analysis good practice II task force. Value Health 2014;17:5-14.
25.
INE: National Institute of Statistics (INE) of Spain: Proyecciones de la Población Española. 2015. http://ww.ine.es/inebase/index.html (accessed September 2015).
26.
Soriano JB, Ancochea J, Miravitlles M, García-Río F, Duran-Tauleria E, Muñoz L, et al: Recent trends in COPD prevalence in Spain: a repeated cross-sectional survey 1997-2007. Eur Respir J 2010;36:758-765.
27.
de Miguel Diez J, Carrasco Garrido P, García Carballo M, Gil de Miguel A, Rejas Gutierrez J, Bellón Cano JM, et al: Determinants and predictors of the cost of COPD in primary care: a Spanish perspective. Int J Chron Obstruct Pulmon Dis 2008;3:701-712.
28.
Comité Nacional para la Prevención del Tabaquismo. 2008. http://www.cnpt.es/listado-recursos.asp?id_categoria=23&id_subcategoria=-1&pagina=8 (accessed December 2014).
29.
Soriguer F, Goday A, Bosch-Comas A, Bordiú E, Calle-Pascual A, Carmena R, et al: Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the [email protected] study. Diabetologia 2012;55:88-93.
30.
del Barrio JL, de Pedro-Cuesta J, Boix R, Acosta J, Bergareche A, Bermejo-Pareja F, et al: Dementia, stroke and Parkinson's disease in Spanish populations: a review of door-to-door prevalence surveys. Neuroepidemiology 2005;24:179-188.
31.
INE: Encuesta Nacional de Morbilidad Hospitalaria. 2012. http://www.ine.es/jaxi/menu.do?type=pcaxis&path=/t15/p414&file=inebase&L=0 (accessed December 2014).
32.
Blanes JI, Cairols MA, Marrugat J: Prevalence of peripheral artery disease and its associated risk factors in Spain: the ESTIME study. Int Angiol 2009;28:20-25.
33.
Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Reiner Z, et al: EUROASPIRE III. Management of cardiovascular risk factors in asymptomatic high-risk patients in general practice: cross-sectional survey in 12 European countries. Eur J Cardiovasc Prev Rehabil 2010;17:530-540.
34.
Getsios D, Marton JP, Revankar N, Ward AJ, Willke RJ, Rublee D, et al: Smoking cessation treatment and outcomes patterns simulation: a new framework for evaluating the potential health and economic impact of smoking cessation interventions. Pharmacoeconomics 2013;31:767-780.
35.
Krall EA, Garvey AJ, Garcia RI: Smoking relapse after 2 years of abstinence: findings from the VA normative aging study. Nicotine Tob Res 2002;4:95-100.
36.
Sicras Mainar A, Navarro Artieda R, Díaz Cerezo S, Martí Sánchez B, Sanz De Burgoa V: [Abstinence rates with varenicline compared to bupropion and nicotine replacement therapy for quitting smoking in primary care]. Aten Primaria 2011;43:482-489.
37.
Drug catalogue of the Consejo General de Colegios Oficiales de Farmacéuticos de España. http://www.portalfarma.com/Paginas/default.aspx (accessed October 2015).
38.
Guía de Deshabituación Tabáquica del Instituto Catalán de la Salud. http://www.ics.gencat.cat/3clics/main.php?page=GuiaPage&idGuia=1&lang=CAS (accessed September 2015).
39.
Tarifas de Asistencia Sanitaria Ambulatoria de la Comunidad de Madrid (B.O.C.M. 215 de 10 de septiembre de 2013).
40.
Wetter DW, Cofta-Gunn L, Fouladi RT, Cinciripini PM, Sui D, Gritz ER: Late relapse/sustained abstinence among former smokers: a longitudinal study. Prev Med 2004;39:1156-1163.
41.
Song F, Raftery J, Aveyard P, Hyde C, Barton P, Woolacott N: Cost-effectiveness of pharmacological interventions for smoking cessation: a literature review and a decision analytic analysis. Med Decis Making 2002;22(5 suppl):S26-S37.
42.
López-Bastida J, Oliva J, Antoñanzas F, García-Altés A, Gisbert R, Mar J, et al: Spanish recommendations on economic evaluation of health technologies. Eur J Health Econ 2010;11:513-520.
43.
Taylor DC, Chu P, Rosen VM, Baker CL, Thompson D: Budgetary impact of varenicline in smoking cessation in the United Kingdom. Value Health 2009;12:28-33.
44.
Fernández de Bobadilla J, Sánchez Maestre C, Brosa M, Arroyo O, Sanz de Burgoa V: Análisis del impacto presupuestario de vareniclina (Champix®) en el tratamiento del tabaquismo en España. Pharmacoeconomics Spa Res Articl 2008;5:39-47.
45.
Jiménez-Ruiz CA, Solano-Reina S, Signes-Costa J, de Higes-Martinez E, Granda-Orive JI, Lorza-Blasco JJ, et al: Budgetary impact analysis on funding smoking-cessation drugs in patients with COPD in Spain. Int J Chron Obstruct Pulmon Dis 2015;10:2027-2036.
46.
Cornuz J, Gilbert A, Pinget C, McDonald P, Slama K, Salto E, et al: Cost-effectiveness of pharmacotherapies for nicotine dependence in primary care settings: a multinational comparison. Tob Control 2006;15:152-159.
47.
Antoñanzas F, Portillo F: Evaluación económica del empleo de terapias farmacológicas para la cesación en el hábito tabáquico. Gac Sanit 2003;17:393-403.
48.
de Lucas Ramos P, Álvaro Alvarez D: Actualizaciones en la EPOC 2010. Monografías NEUMOMADRID, vol. XV. 2010. http://www.neumomadrid.org/descargas/monog_neumomadrid_xv.pdf (accessed December 2014).
49.
van Boven JF, Vemer P: Higher adherence during reimbursement of pharmacological smoking cessation treatments. Nicotine Tob Res 2016;18:56-63.
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