Cost-Effectiveness of Drug-Eluting vs. Bare-Metal Stents in Patients with Coronary Artery Disease from the Korean National Health Insurance Database

PURPOSE: The aim of this study was to evaluate the cost-effectiveness of the use of drug-eluting stents (DESs), as compared with bare-metal stents (BMSs) in Korea. MATERIALS AND METHODS: A retrospective cohort study was conducted between January 2000 and December 2007. Subjects were stent-treated for the first time between 2004 and 2005, with four years of follow-up (2004-2007) (n=43674). The incremental cost-effectiveness ratio (ICER) was used to calculate the costs of DESs compared with BMSs among patients with coronary artery disease (CAD). Cost-effectiveness was assessed with effectiveness defined as a reduction in major adverse cardiac events after six months and after one, two, three, and four years. RESULTS: The total costs of a DESs were 674108 Korean won (KRW) higher than that of a BMSs at the end of the follow-up; 13635 thousand KRW per patient treated with DESs and 12960 thousand KRW per patient treated with BMSs. The ICER was 256315 per KRW/death avoided and 293090 per KRW/re-stenting avoided among the CAD patients at the end of the follow-up. CONCLUSION: The ICER for the high-risk patients was lower than that for the low-risk patients. The use of DESs is clinically more useful than the use of BMSs for CAD and myocardial infarction patients, especially for those considered to be high-risk patients in Korea.

Use of Drug-eluting Stents Versus Bare-metal Stents in Korea: A Cost-minimization Analysis Using Population Data / 예방의학회지

OBJECTIVES: The goal of this study was to perform an economic analysis of a primary stenting with drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with acute myocardial infarction (AMI) admitted through an emergency room (ER) visit in Korea using population-based data. METHODS: We employed a cost-minimization method using a decision analytic model with a two-year time period. Model probabilities and costs were obtained from a published systematic review and population-based data from which a retrospective database analysis of the national reimbursement database of Health Insurance Review and Assessment covering 2006 through 2010 was performed. Uncertainty was evaluated using one-way sensitivity analyses and probabilistic sensitivity analyses. RESULTS: Among 513 979 cases with AMI during 2007 and 2008, 24 742 cases underwent stenting procedures and 20 320 patients admitted through an ER visit with primary stenting were identified in the base model. The transition probabilities of DES-to-DES, DES-to-BMS, DES-to-coronary artery bypass graft, and DES-to-balloon were 59.7%, 0.6%, 4.3%, and 35.3%, respectively, among these patients. The average two-year costs of DES and BMS in 2011 Korean won were 11 065 528 won/person and 9 647 647 won/person, respectively. DES resulted in higher costs than BMS by 1 417 882 won/person. The model was highly sensitive to the probability and costs of having no revascularization. CONCLUSIONS: Primary stenting with BMS for AMI with an ER visit was shown to be a cost-saving procedure compared with DES in Korea. Caution is needed when applying this finding to patients with a higher level of severity in health status.

Análise de custo-efetividade dos stents farmacológicos e não farmacológicos na doença coronariana / Analysis of the cost-effectiveness of drug-eluting and bare-metal stents in coronary disease

FUNDAMENTO: Na literatura nacional há escassez de análises de custo-efetividade, comparando stents farmacológicos (SF) versus não farmacológicos (SNF), no seguimento tardio. OBJETIVO: Estimar a Razão de Custo-Efetividade Incremental (RCEI) entre SF e SNF na coronariopatia uniarterial. MÉTODOS: 217 pacientes (130 SF e 87 SNF), com 48 meses de seguimento (média=26). Desfecho primário: custo por re-estenose evitada, sendo efetividade definida como redução de eventos maiores. O modelo analítico de decisão foi baseado no estudo de Polanczyk et al. Os custos diretos foram aqueles utilizados diretamente nas intervenções. RESULTADOS: A amostra foi homogênea para idade e sexo. O SF foi mais utilizado em diabéticos: 59 (45,4 por cento) vs 16 (18,4 por cento)(p<0,0001) e com história de DAC: 53 (40,7 por cento) vs 13 (14,9 por cento)(p<0,0001). O SNF foi utilizado em lesões mais simples, porém com pior função ventricular. Os SF foram implantados preferencialmente nas lesões proximais: (p=0,0428) e os SNF no 1/3 médio (p=0,0001). Sobrevida livre de eventos: SF=118 (90,8 por cento) vs SNF=74 (85,0 por cento) (p=0,19); Angina: SF=9 (6,9 por cento) vs SNF=9 (10,3 por cento) (NS): Reestenose clínica: SF=3 (2,3 por cento) vs SNF=10 (10,3 por cento) (p=0,0253). Óbitos cardíacos: 2 (1,5 por cento) no SF e 3 (3,5 por cento) no SNF (NS). Custos: a árvore de decisão foi modelada na reestenose. O benefício líquido para SF necessitou de incremento de R$7.238,16. A RCEI foi R$131.647,84 por reestenose evitada (acima do limiar da OMS). CONCLUSÕES: O SF abordou lesões mais complexas. Os resultados clínicos foram similares. A reestenose foi maior no SNF. O SF foi uma estratégia não custo-efetiva.

BACKGROUND: There is a scarcity of cost-effectiveness analyses in the national literature comparing drug-eluting stents (DES) with bare-metal stents (BMS), at late follow-up. OBJECTIVE: To estimate the Incremental Cost-Effectiveness Ratio (ICER) between DES and BMS in uniarterial coronariopathy. METHODS: 217 patients (130 DES and 87 BMS), with 48 months of follow-up (mean = 26 months) were assessed. Primary outcome: cost per prevented restenosis, with effectiveness being defined as the decrease in major events. The analytical model of decision was based on the study by Polanczyk et al. The direct costs were those used directly in the interventions. RESULTS: The sample was homogenous for age and sex. The DES was more used in diabetic patients: 59 (45.4 percent) vs 16 (18.4 percent)(p<0.0001) and with a history of coronary artery disease (CAD): 53 (40.7 percent) vs 13 (14.9 percent)(p<0.0001). The BMS was more used in simple lesions, but with worse ventricular function. The DES were implanted preferentially in proximal lesions: (p=0.0428) and the BMS in the mid-third (p=0.0001). Event-free survival: DES = 118 (90.8 percent) vs BMS=74 (85.0 percent) (p=0.19); Angina: DES=9 (6.9 percent) vs BMS=9 (10.3 percent) (NS): Clinical restenosis: DES=3 (2.3 percent) vs BMS=10 (10.3 percent) (p=0.0253). Cardiac deaths: 2 (1.5 percent) in DES and 3 (3.5 percent) in BMS (NS). Costs: the tree of decision was modeled based on restenosis. The net benefit for the DES needed an increment of R$7,238.16. The ICER was R$131,647.84 per prevented restenosis (above the WHO threshold). CONCLUSIONS: The DES was used in more complex lesions. The clinical results were similar. The restenosis rate was higher in the BMS group. The DES was a non-cost-effective strategy.

Avaliação do custo efetividade dos stents farmacológicos em comparação aos stents convencionais: resultados clínicos e de custos a médio e longo prazo / Assessing the cost effectiveness of drug eluting stents compared to bare metal stents: clinical results and costs in the medium and long term

Fundamentos: Os resultados tardios com os stents farmacológicos são melhores do que com stents convencionais, principalmente no que se refere à reestenose. Entretanto, no "mundo real", os stents farmacológicos são implantados em pacientes de maior complexidade, o que teoricamente já diminui a diferença dos resultados. Objetivos: Comparar resultados da utilização de stents com paclitaxel (Grupo I) em pacientes complexos com stents convencionais (Grupo II) implantados em pacientes menos graves. A partir dos resultados realizar análise para estimar a razão de custo-efetividade nos dois grupos. Métodos: Foram analisados 220 pacientes prospectivamente durante aproximadamente dois anos (média de 17 meses): 111 do Grupo 1 (GI) e 109 do Grupo II (GII). Foram avaliadas a sobrevida e a sobrevida livre de eventos através do método de Kaplan-Meier. Usando-se os critérios da Organização Mundial de Saúde, calculou-se a razão custo-efetividade incremental (RCEI) para cada reestenose evitada. O escore de propensão foi usado para reduzir diferenças entre os dois grupos. Resultados: Foi observado predomínio do sexo masculino nos dois grupos (n=174 66,8%), mas sem diferenças entre eles. Também não houve diferenças em relação à idade, que variou de 42 anos a 91 anos (65,9 anos). As diferenças que ocorreram, com maior incidência no GI foram: diabetes: GI=60 (50,4%) e GII=19 (17,4%), p=0,0001; história familiar para doença arterial coronariana (DAC): GI=43 (38,7%) e GII=24 (22,1%), p=0,007; infarto prévio: GI=54 (48,6%) e GII=31 (28,4%), p=0,002; cirurgia de revascularização prévia: GI=24 (21,7%) e GII=6 (5,5%), p=0,0005; angioplastia prévia: GI=28 (25,2%) e GII=17 (15,5%), p=0,077; síndromes coronarianas agudas: GI=48 (43,3%) e GII=35 (32,0%), p=0,088. Os pacientes triarteriais foram mais presentes no GI=21 (18,9%) do que no GII=11 (10,1%), p=0,029. No entanto, os pacientes do GII apresentaram mais frequentemente função normal do VE: GI=51 (45,9%) e GII=85 (77,9%), p=0,0001...

Background: Long term outcomes for drug eluting stents are better than those for bare metal stents, especially for restenosis. However, drug eluting stents are usually implanted in more complex patients, theoretically lessening the difference in the outcomes. Objetives: To compare the outcomes of paclitaxel stents (GI) in complex patients and bare metal stents (GII), in less complex patients. Methods: For some two years (mean: 17 months), 220 patients were analyzed prospectively: 111 in GI and 109 in GII. Their general survival and cardiovascular event-free survival rates were assessed through the Kaplan-Meier method. Using the criteria of the World Health Organization (WHO), the incremental cost-effectiveness ratio (ICER) was calculated for each restenosis avoided. Propensity scores was used to reduce selection bias by equating both groups based on these covariates. Results: Men predominated in both groups (n=174 66.8%), with no differences between them, including age, ranging from 42 to 91 years (65.9 years). The main differences, with higher rates in GI, were diabetes: GI=60 (50.4%) and GII=19 (17.4%), p=0.0001; family history: GI=43 (38.7%) and GII=24 (22.1%), p=0.007; previous acute myocardial infarction: GI=54 (48.6%) and GII=31 (28.4%), p=0.002; previous coronary artery bypass graft: GI=24 (21.7%) and GII=6 (5.5%), p=0.0005; previous angioplasty: GI=28 (25.2%) and GII=17 (15.5%), p=0.077; acute coronary syndrome: GI=48 (43.3%) and GII=35 (32.0%), p=0.088. Multivessel patients were more frequent in GI=21 (18.9%) than in GII=11 (10.1%), p=0.029. However, the GII patients presented normal left ventricle functions more frequently: GI=51 (45.9%) and GII=85 (77.9%), p=0.0001. There were no differences between the groups for the number of lesions treated and number of arteries per patient. The bare metal stent group presented simpler lesions: Type A GI=43 (25.6%); GII=65 (45.5%), p=0.0002; Type B: B1 GI=50 (29.7%) and GII=35 (24.5%), p=0.30...

Análise de impacto do stent farmacológico no orçamento do sistema único de saúde / Impact analysis of drug-eluting stent in the unified health system budget

FUNDAMENTO: Stents farmacológicos representam opção adicional para o tratamento da doença arterial coronariana. Essa tecnologia representa importante inovação, para a qual pode ser necessário financiamento adicional, no curto prazo, para permitir incorporação no Sistema Unico de Saúde brasileiro. OBJETIVOS: Estimar o impacto da incorporação do stent farmacológico no orçamento do Sistema Unico de Saúde, no primeiro ano de utilização. MÉTODOS: Foi elaborado um modelo de impacto no orçamento para prever o impacto econômico da incorporação dos stents farmacológicos no orçamento do Sistema Unico de Saúde. Foram coletados dados de custo e procedimentos locais de várias fontes, mais especificamente: dados de volume de procedimentos, custos hospitalares, custos dos stents, custos de medicamentos e número de stents utilizados por procedimentos uni e multivasculares. RESULTADOS: Os resultados no primeiro ano indicam que o impacto no Sistema Unico de Saúde é de 12,8 por cento no cenário conservador e de 24,4 por cento no pior cenário, representando aumento de R$ 24 milhões a R$ 44 milhões no orçamento total projetado. CONCLUSÃO: O uso de stent farmacológico tem custo adicional comparativamente ao uso de stent convencional, no primeiro ano de utilização, no Sistema Unico de Saúde.

BACKGROUND: Drug-eluting stents represent an additional option to treat coronary artery disease. This technology represents a major breakthrough that may require additional funding in the short-term to enable its inclusion in procedures of the Unified Health System. OBJECTIVE: To estimate the impact on the Unified Health System budget in the first year of use of drug-eluting stents. METHODS: A Budget Impact Model was designed to predict the economic impact of the inclusion of drug-eluting stents in the Unified Health System budget. Data about costs and local procedures were collected in multiple sources, specifically procedure volume data, hospital costs, cost of stents, drug costs and number of stents used in single and multi-vessel procedures. RESULTS: The results in the first year indicate that the impact on the Unified Health System is of 12.8 percent in the best scenario and 24.4 percent in the worst scenario, representing an increase by R$ 24 to 44 million in the total projected budget. CONCLUSION: Drug-eluting stents have an additional cost compared with standard stents in the first year of use in the Unified Health System.

Custo-efetividade dos stents recobertos por rapamicina em procedimentos percutâneos coronarianos no Brasil / Cost-effectiveness of sirolimus-eluting stents in percutaneous coronary interventions in Brazil

OBJETIVOS: Comparar as relações de custo-efetividade do stent recoberto (SR) por rapamicina com o stent convencional (SC), sob duas perspectivas: medicina suplementar e sistema público (SUS). MÉTODOS: Modelo de decisão analítico com três estratégias de tratamento de lesão coronariana: intervenção coronária percutânea (icP) com SC; com SR com rapamicina e SC seguido de SR para manejo de reestenose sintomática. Os desfechos foram: sobrevida livre de eventos em um ano e expectativa de vida. As árvores de decisão foram construídas com resultados de registros e ensaios clínicos publicados. RESULTADOS: A sobrevida em um ano livre de reestenose foi de 92,7 por cento com SR e de 78,8 por cento com SC. A expectativa de vida estimada das estratégias foi muito semelhante, entre 18,5 e 19 anos. Sob a perspectiva não-pública, a diferença de custo no primeiro ano entre SC e SR foi de R$ 3.816, com relação de custo-efetividade incremental de R$ 27.403 por evento evitado em um ano. Sob a perspectiva do SUS, o custo por evento evitado em um ano foi de R$ 47.529. Na análise de sensibilidade, foram preditores relevantes a probabilidade de reestenose, a redução de risco esperada com SR, o custo do stent e o custo do manejo da reestenose. Os dados por anos de vida demonstraram relações de custo-efetividade bastante elevadas na simulação de Monte Carlo. CONCLUSÃO: As relações de custo-efetividade do SR por rapamicina foram elevadas em modelo brasileiro. O uso de SR foi mais favorável em pacientes de alto risco de reestenose, com elevado custo do manejo de reestenose e sob a perspectiva não-pública.

OBJECTIVES: To compare the cost-effectiveness ratios of sirolimus-eluting stents (SES) with bare-metal stents (BMS) under two perspectives: the "supplementary medical system" (health plans and private patients) and the public health (SUS) system. METHODS: A decision-analytic model using three different therapeutic strategies for coronary lesions: percutaneous coronary intervention (PCI) with BMS; with SES; or with BMS followed by SES to treat symptomatic restenosis. Study endpoints were one-year event-free survival and life expectancy. Decision trees were constructed using the results of published registries and clinical trials. RESULTS: One-year restenosis-free survival was 92.7 percent with SES and 78.8 percent with BMS. Estimated life expectancy was very similar for all the strategies, ranging from 18.5 to 19 years. Under a nonpublic perspective, the cost difference in the first year between BMS and SES was R$3,816, with an incremental cost-effectiveness ratio of R$27,403 per event avoided in one year. Under the SUS perspective, the cost per event avoided in one year was R$47,529. In the sensitivity analysis, probability of restenosis, risk reduction expected with SES, the price of the stent and cost of treating restenosis were all important predictors. In the Monte Carlo simulation, data per years of life saved showed very high cost-effectiveness ratios. CONCLUSION: In the Brazilian model, the cost-effectiveness ratios for SES were elevated. The use of SES was more favorable for patients with high risk of restenosis, as it is associated with elevated costs in restenosis management of and under a nonpublic perspective.