Budget impact analysis of a bioprosthetic valve with a novel tissue versus mechanical aortic valve replacement in patients older than 65 years with aortic stenosis in Saudi Arabia.

AIMS: A budget impact analysis (BIA) comparing bioprosthetic valves with RESILIA tissue and mechanical valves in aortic stenosis (AS) patients > 65 years in the public and private sectors of Saudi Arabia. MATERIALS AND METHODS: A decision-tree with a partitioned survival model was adapted to estimate the financial consequences of either a RESILIA tissue valve or a mechanical valve in aortic valve replacement (AVR) procedures up to 5 years. The budget impact of resource consumption for both valve types was compared and included disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments. One-way sensitivity analyses (OWSA) were performed on cost and probability inputs. RESULTS: RESILIA tissue valves versus mechanical valves are overall budget saving commencing in Year 1 and savings gradually increase year-on-year. The higher costs of the initial procedure, reoperation, and additional monitoring (echocardiogram tests and visits) associated with RESILIA tissue valves are offset by savings in warfarin use, disabling strokes, major bleeding, and anticoagulation complications. The cost per initial procedure per patient is SAR795 higher for a RESILIA tissue valve reflecting the higher valve acquisition cost, which is partially offset by a shorter hospital stay. The OWSA suggests that total procedure costs of each valve, including the hospital stay, are the main cost drivers in the model. LIMITATIONS: The variability of cost inputs and the presence of multiple payers with multiple costing data is a key challenge in Saudi Arabia. Budget impact results may, therefore, change if repeated per AVR center and may also be impacted by the long-term durability of RESILIA tissue valves. CONCLUSIONS: An AVR in patients > 65 years with a RESILIA tissue valve is budget-saving from the first year in Saudi Arabia. Patients, payers, providers and policymakers may benefit economically from increased implantation of RESILIA tissue valves.

Cost-effectiveness analysis of the SAPIEN 3 transcatheter aortic valve implant in patients with symptomatic severe aortic stenosis.

INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implant has become a widely accepted treatment for inoperable patients with aortic stenosis and patients at high surgical risk. Its indications have recently been expanded to include patients at intermediate and low surgical risk. Our aim was to evaluate the efficiency of SAPIEN 3 vs conservative medical treatment (CMT) or surgical aortic valve replacement (SAVR) in symptomatic inoperable patients at high or intermediate risk. METHODS: We conducted a cost-effectiveness analysis of SAPIEN 3 vs SAVR/CMT, using a Markov model (monthly cycles) with 8 states defined by the New York Heart Association and a time horizon of 15 years, including major complications and management after hospital discharge, from the perspective of the National Health System. Effectiveness parameters were based on the PARTNER trials. Costs related to the procedure, hospitalization, complications, and follow-up were included (euros in 2019). An annual discount rate of 3% was applied to both costs and benefits. Deterministic and probabilistic sensitivity analyses (Monte Carlo) were performed. RESULTS: Compared with SAVR (high and intermediate risk) and CMT (inoperable), SAPIEN 3 showed better clinical results in the 3 populations and lower hospital stay. Incremental cost-utility ratios (€/quality-adjusted life years gained) were 5471 (high risk), 8119 (intermediate risk) and 9948 (inoperable), respectively. In the probabilistic analysis, SAPIEN 3 was cost-effective in more than 75% of the simulations in the 3 profiles. CONCLUSIONS: In our health system, SAPIEN 3 facilitates efficient management of severe aortic stenosis in inoperable and high- and intermediate-risk patients.

Tasas de abstinencia de vareniclina frente a bupropión y terapia sustitutiva con nicotina en la cesación del tabaco en atención primaria / Abstinence rates with varenicline compared to bupropion and nicotine replacement therapy for quitting smoking in Primary Care

Objetivo: Determinar las tasas de abstinencia continua conseguidas con vareniclina, bupropión y terapia de sustitución nicotínica (TSN) en la cesación del consumo de tabaco en 2 unidades externas de apoyo a atención primaria (AP).DiseñoEstudio observacional, multicéntrico, longitudinal, a partir de la revisión retrospectiva de registros médicos.EmplazamientoSeis centros de AP.ParticipantesSe incluyeron pacientes > 18 años que iniciaron tratamiento de cesación del hábito tabáquico entre 1/01/2006 y 31/12/2008 con vareniclina, bupropión o TSN.Mediciones principalesPrincipales medidas: sociodemográficas, comorbilidad, efectividad (abstinencia continua) y tolerabilidad farmacológica. Se evaluó la abstinencia a los 6 y 12 meses de seguimiento. Análisis estadístico: modelos de regresión logística y curva de supervivencia de Kaplan-Meier.ResultadosSe incluyeron 957 pacientes fumadores, tratados con TSN (53,0%), bupropión (25,1%) y vareniclina (21,9%). Su media de edad era 47,6 (DE: 11,3) años, y el 58,6% eran hombres. Un 32,0% acudieron por dependencia física y el tiempo medio de fumadores fue de 19,5 (DE: 6,7) años. A los 6 meses, la abstinencia continua con vareniclina fue del 61,2% (IC: 54,6-67,8%), con bupropión del 56,9% (IC: 50,6-63,2%) y con TSN del 52,3% (IC: 48,0-56,6%); p=0,003. A los 12 meses, fue del 57,4% (IC: 50,7-64,1%), 52,9% (IC: 46,6-59,2%) y 47,1% (IC: 42,8-51,4%), respectivamente, p=0,002.ConclusionesLos resultados tras un año de seguimiento sugieren que vareniclina es una alternativa adecuada frente al bupropión y la TSN en la cesación del tabaco en el ámbito de la AP(AU)

Objective: The objective of this study was to estimate the continuous abstinence rates of varenicline, bupropion and nicotine replacement therapy (NRT) in smoking cessation in 2 Primary Care (PC) External Support Units.DesignObservational, multicentre, longitudinal study using a retrospective review of medical records.SettingSix Primary Care Centres.ParticipantsPatients > 18 years, who began smoking cessation treatment between 1/01/2006 and 1/12/2008 with varenicline, bupropion or NRT were included in the analysis.ContinuationPatient follow-up was conducted from time-baseline (day 1) and assessed at 6 and 12 months. Main variables: comorbidities, effectiveness (continuous abstinence) and pharmacological tolerability. Statistical analysis: logistic regression models and Kaplan-Maier survival curves; P<.05.ResultsA total of 957 smokers treated with NRT (53.0%), bupropion (25.1%) and varenicline (21.9%) were included in the analysis. Mean age: 47.6 (11.3) years; 58.6% men. 32.0% of smokers attended due to physical dependence. Average duration of smoking: 19.5 (6.7) years. At 6 months, 61.2% (95% CI: 54.6-67.8%) of participants in the varenicline group continuously abstained from smoking compared with 56.9% (95% CI: 50.6-63.2%) in the bupropion group, and 52.3% (95% CI: 48.0-56.6%) in the NRT group; P=.003. At 12 months, the rate of continuous abstinence was 57.4% (95% CI: 50.7-64.1%) in the varenicline group compared with 52.9% (95% CI: 46.6-59.2%) in the bupropion group and 47.1% (95% CI: 42.8-51.4%) in the NRT group; P=.002.ConclusionOne year-follow up results suggest that varenicline is an appropriate alternative compared with bupropion and NRT on smoking cessation in the PC setting(AU)

[Abstinence rates with varenicline compared to bupropion and nicotine replacement therapy for quitting smoking in primary care]. / Tasas de abstinencia de vareniclina frente a bupropión y terapia sustitutiva con nicotina en la cesación del tabaco en atención primaria.

OBJECTIVE: The objective of this study was to estimate the continuous abstinence rates of varenicline, bupropion and nicotine replacement therapy (NRT) in smoking cessation in 2 Primary Care (PC) External Support Units. DESIGN: Observational, multicentre, longitudinal study using a retrospective review of medical records. SETTING: Six Primary Care Centres. PARTICIPANTS: Patients > 18 years, who began smoking cessation treatment between 1/01/2006 and 1/12/2008 with varenicline, bupropion or NRT were included in the analysis. CONTINUATION: Patient follow-up was conducted from time-baseline (day 1) and assessed at 6 and 12 months. MAIN VARIABLES: comorbidities, effectiveness (continuous abstinence) and pharmacological tolerability. STATISTICAL ANALYSIS: logistic regression models and Kaplan-Maier survival curves; P<.05. RESULTS: A total of 957 smokers treated with NRT (53.0%), bupropion (25.1%) and varenicline (21.9%) were included in the analysis. Mean age: 47.6 (11.3) years; 58.6% men. 32.0% of smokers attended due to physical dependence. Average duration of smoking: 19.5 (6.7) years. At 6 months, 61.2% (95% CI: 54.6-67.8%) of participants in the varenicline group continuously abstained from smoking compared with 56.9% (95% CI: 50.6-63.2%) in the bupropion group, and 52.3% (95% CI: 48.0-56.6%) in the NRT group; P=.003. At 12 months, the rate of continuous abstinence was 57.4% (95% CI: 50.7-64.1%) in the varenicline group compared with 52.9% (95% CI: 46.6-59.2%) in the bupropion group and 47.1% (95% CI: 42.8-51.4%) in the NRT group; P=.002. CONCLUSION: One year-follow up results suggest that varenicline is an appropriate alternative compared with bupropion and NRT on smoking cessation in the PC setting.