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 Único de Saúde brasileiro. OBJETIVOS: Estimar o impacto da incorporação do stent farmacológico no orçamento do Sistema Único 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 Único 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 Único de Saúde é de 12,8% no cenário conservador e de 24,4% 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 Único de Saúde.
Universidade Federal de São Paulo – UNIFESP/EPM - São Paulo, SP
No ano de 2003, o Sistema Único de Saúde (SUS) financiou a realização de 30.666 angioplastias coronarianas com implante de
A incorporação do
O desenvolvimento do
As análises econômicas em saúde (como, por exemplo, custo-efetividade) são ferramentas eficientes de alocação de recursos para formuladores de políticas de saúde e financiadores do SUS, porém não são capazes de responder às questões específicas de financiamento para o objeto da análise. Por isso, além de maximizar a eficiência na alocação dos recursos, o financiador deverá analisar se a inclusão da nova tecnologia é compatível com seu orçamento. Existem modelos econômicos específicos para análise de impacto no orçamento, em que o financiador estima, a partir do número adicional de pessoas beneficiadas e da prevalência da doença em questão, qual será a necessidade de comprometimento de recursos para viabilizar a incorporação de uma nova tecnologia.
O objetivo desta análise é instrumentalizar os formuladores de políticas de saúde e gestores para tomada de decisão sobre a incorporação do
O modelo de análise de decisão do impacto no orçamento foi desenvolvido com dados obtidos a partir de análise crítica de ensaios clínicos randomizados multicêntricos2,3, meta-análise4, revisão sistemática5, dados de procedimentos cardiovasculares realizados no SUS, e dados de despesas disponíveis no DATASUS (base de dados da Central Nacional de Intervenções Cardiovasculares – CENIC da Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista – SBHCI), relatório de 2003. Foi realizado um painel de especialistas com membros da SBHCI para definir a realidade da prática cardiológica no Brasil.
As premissas do modelo de impacto no orçamento foram: taxa de conversão do
Utilizou-se o quantitativo de procedimentos de revascularização cirúrgica do miocárdio e angioplastia coronariana com implante de
Foram criados três cenários possíveis para estimar o impacto no orçamento do SUS com a incorporação do
A variação da conversão do
A estimativa de número de
O porcentual de reintervenções por reestenose no
As reintervenções por reestenose foram tratadas no modelo com 90% delas sendo abordadas com angioplastia coronariana e 10% com revascularização cirúrgica do miocárdio. Esse padrão de prática foi sugerido pelo painel de especialistas da SBHCI.
O preço do
Os valores utilizados para angioplastia coronariana e revascularização cirúrgica do miocárdio foram os reembolsados pelo SUS à rede credenciada (R$ 4.989,95 e R$ 6.484,84, respectivamente).
O impacto econômico da recomendação da SBHCI para uso de clopidogrel durante seis meses após o implante do
O cenário mais conservador, isto é, com menor incorporação de
O cenário intermediário com 40% de incorporação do
O cenário mais expressivo, com 50% de incorporação do
A análise de impacto no orçamento visa a auxiliar os tomadores de decisão do SUS na tarefa de avaliar criticamente a inclusão do
Os modelos econômicos em saúde utilizam dados de desfechos clínicos que são obtidos a partir da análise crítica da literatura. Os ensaios clínicos multicêntricos comparando
Os dados de custos e padrões da prática médica retrataram as características locais para que a estimativa do modelo econômico seja a mais acurada possível.
Existem algumas incertezas nas premissas que compõem os modelos econômicos em geral, conseqüentes à carência de dados e à variabilidade da prática médica local. Essas limitações são minimizadas com as análises de sensibilidade. No modelo de análise de impacto elaborado, determinamos a variação no porcentual de acesso da população ao
Seis marcas de
Resultado de pequeno estudo de seguimento tardio (de 18 meses a três anos após implante do
Meta-análise conduzida por Nordmann e cols.10 comparou os
O estudo BASKET-LATE9 e a meta-análise conduzida por Nordmann e cols.10 demonstraram a necessidade de reavaliar o tempo de início e manutenção do clopidogrel pós-implante de
A definição do tempo ideal de utilização do clopidogrel após o procedimento de implante de
Outro desdobramento possível da incorporação do
É provável que no subgrupo de diabéticos, em que a taxa de reestenose é maior que a média dos pacientes não-diabéticos14, a relação custo-efetividade seja mais atraente para a incorporação de
Com o rápido incremento do desenvolvimento tecnológico, especialmente na área cardiovascular, o processo de avaliação da incorporação de novas tecnologias se torna imprescindível, não somente por identificar as intervenções de valor para o sistema de saúde, mas também pela necessidade do processo de escolha entre as alternativas que reconhecidamente agregam valor ao sistema de saúde (
A discussão sobre a incorporação de novas tecnologias no SUS é uma oportunidade para a Sociedade Brasileira de Cardiologia fomentar o desenvolvimento de métodos que auxiliem os formuladores de políticas de saúde cardiovascular no processo de escolha entre as alternativas disponíveis, mensurando o benefício para cada unidade de custo e estimando o retorno para a sociedade da incorporação de novas modalidades diagnósticas e terapêuticas.
Denizar Vianna Araújo Av. Visconde de Albuquerque, 1400/501 22450-000 – Rio de Janeiro, RJ E-mail:
Artigo recebido em 10/09/06; artigo revisado recebido em 08/11/06; aceito em 24/11/06.
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% in the best scenario and 24.4% 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.
Universidade Federal de São Paulo – UNIFESP/EPM - São Paulo, SP - Brazil
In 2003, the Brazilian Unified Health System (SUS) financed 30,666 coronary angioplasties with stent placement and 19,909 myocardial revascularization surgeries with a total cost of approximately R$ 281 million.
The introduction of standard stents in the SUS, in 1999, represented a significant change in the interventional treatment of patients with ischemic cardiomyopathy. Until 1999, myocardial revascularization surgery represented the main type of interventional treatment. In the three subsequent years, the number of coronary angioplasty procedures increased by over 100%, with a significant decrease in the number of myocardial revascularization surgeries during this period. The benefits of treatment with standard stents were important although there were limitations in some subgroups, especially among patients with diabetes, who presented long lesions (>20 mm) and small caliber vessels (<3 mm), in which restenosis is significant in the first six months after the procedure.
The development of drug-eluting stents, still not available in the SUS, led to significantly lower rates of intra-stent restenosis in these subgroups of patients, but with an increase in initial cost of treatment. The dilemma that SUS faces is to match the budget restriction with the need to evaluate and integrate new cardiovascular technologies.
Health economic analyses (e.g. cost-effectiveness) are efficient resource allocation tools for policy makers and financiers of the Unified Health System; however, they are not able to answer the specific financing questions for the object of analysis. Therefore, in addition to maximizing efficiency in resource allocation, financiers shall analyze if the introduction of new technology is compatible with their budget. There are specific economic models for budget impact analysis, in which the financier estimates the amount of resources needed to absorb a new technology based on the additional number of patients benefited and the prevalence of the disease.
The objective of this analysis is to provide health policymakers and managers with tools for decision making on the introduction of drug-eluting stents as a procedure to be reimbursed by the SUS.
The model of decision analysis of the budget impact was developed with data obtained from a critical analysis of multicenter randomized clinical trials2,3, meta-analysis4, systematic review5, data on cardiovascular procedures performed by the SUS, data on expenses available at DATASUS, database of the
The assumptions of the budget impact model were: conversion rate of conventional to drug-eluting stents, number of stents/patients/procedures; percentage of reinterventions due to restenosis in standard stents; percentage of reinterventions due to restenosis in drug-eluting stents; prices of stents; values of AIH (Hospitalization Authorization) paid by the SUS to hospitals for procedures including angioplasty and myocardial revascularization surgery, price of post-procedure clopidogrel.
The number of myocardial revascularization surgery and coronary angioplasty procedures with placement of standard stents performed in 2003, by the SUS, was used to estimate the increase in budget in face of the hypothetical migration to the use of drug-eluting stents.
Three possible scenarios were created to estimate the impact on SUS budget after the introduction of drug-eluting stents. These different scenarios are the result of sensitivity analyses, where some concepts were modified within the variation found in the literature. Scenario 1 adopted a more conservative prospect; scenario 2 pictured an intermediate condition and scenario 3 presented the most expressive prospect for the introduction of drug-eluting stents.
The variation in conversion of standard stent to drug-eluting stent was 30%, 40% and 50%, according to the variations found in the guidelines of the National Institute for Clinical Excellence (NICE)6 and the
The estimate of the number of stents per patient in each procedure varied between 1.3 and 1.7. This estimate was obtained from the Final Report and Recommendations of the American Task Force about Drug-Eluting Stents8, the NICE guidelines and validation by a panel of specialists of SBHCI.
Reinterventions due to restenosis in standard stents varied between 20% and 15% and in drug-eluting stents it was 4%, according to data of a meta-analysis using a hierarchical Bayesian model to compare conventional and drug-eluting stents9. These reinterventions were treated in the model - 90% of them being by coronary angioplasty and 10% by surgical myocardial revascularization. This practice standard was suggested by the panel of specialists of the SBHCI.
The price of standard stents used in the analysis was the value paid by the SUS to accredited hospitals, that is, R$ 2,580.00. The price of drug-eluting stents was the amount reimbursed by the Medicare to the healthcare providers in the USA, at R$5,166.00, which characterized as the lowest value in the health systems surveyed (Canada, UK, France, Australia). The exchange rate was US$ 1 = R$ 2.87 on June 30, 2003.
The values used for coronary angioplasty and surgical myocardial revascularization were those reimbursed by the SUS to accredited health services - R$ 4,989.95 and R$ 6,484.84, respectively.
The economic impact of the SBHCI guideline for the use of clopidogrel for six months after placement of a drug-eluting stent and for one month after that of a standard stent was incorporated into the model. The price used for this medication was that listed in the Brasíndice minus 30%, which accounts for the retail marketing margin, with a final price of R$123.00.
The best scenario, i.e., the one with lower use of drug-eluting stents, forecasts a 30% migration from standard stent to drug-eluting stent. This scenario would represent an increase in the SUS budget by approximately 12.8% in the first year of the procedure. The additional cost of the drug, which is necessary to avoid intra-stent thrombosis in the first six months, would represent one-third 1/3 of total amount. The results of scenario 1 are shown in
The intermediate scenario with 40% inclusion of the drug-eluting stent represents an increase in the SUS budget by approximately 20.1% in the first year of the procedure. The increase by 10% in the number of patients who are eligible to receive drug-eluting stents caused a raise by approximately 35% in budget. The results of scenario 2 are shown in
The most dramatic scenario with 50% inclusion of drug-eluting stents would represent an increase by approximately 24.4% in the SUS budget in the first year of the procedure. In this change of scenario 2 to 3, the 10% increase in the number of patients who are illegible to receive drug-eluting stents caused an increase by only 18% in the budget. The results of scenario 3 are shown in
The analysis of budget impact aims to help decision makers at the SUS in their task of critically evaluating the inclusion of drug-eluting stents in treatment of patients who are eligible to receive this device.
Health economic models use data of clinical outcomes obtained from critical literature analysis. Multicenter clinical trials comparing drug-eluting stents
Data related to costs and clinical practice standards reflect the local features, so that the economic model be the most accurate possible.
There are some uncertainties in the assumptions that comprise the economic models in general due to scarcity of data and variability of local medical practice. Such limitations are minimized with sensitivity analyses. In the model of elaborated impact analysis, we determined the variation in the percentage of population access to drug-eluting stents and the percentage of reinterventions avoided in the 12 subsequent months, in order to help decision makers choose the possible scenarios. These variations explain the possible scenarios with increase by 12.8% to 24.4% in the budget in the first 12 months after the procedure.
Six brands of drug-eluting stents are authorized by the ANVISA (National Health Surveillance Agency) to be traded in Brazil in 2006, but only two (Cypher® and Taxus®) have long-term follow-up studies (more than three years). The definition of long-term performance of other brands requires the publication of randomized clinical trials with long-term follow-up.
The result of a small long-term follow-up trial (18 months to three years after placement of drug-eluting stents), with the purpose of analyzing cost-effectiveness of drug-eluting stents with rapamycin and paclitaxel versus standard stents (Study BASKET-LATE)10 showed that, in up to one year after discontinuation of clopidogrel, the group of patients with drug-eluting stents presented two to three times more events related to late thrombosis than the group of patients who received standard stents.
A meta-analysis conducted by Nordmann
The study BASKET-LATE and the meta-analysis conducted by Nordmann
The definition of ideal time of clopidogrel use after placement of drug-eluting stents is fundamental for the real estimate of the impact on the SUS budget, thus inferring that the medication shall be available to patients throughout the utilization period and with patient compliance to treatment. Our analysis evaluated a time period of six months as per the guideline of the SBHCI at that time. However, in view of the last publications mentioned above on late thrombosis after drug-eluting stent placement, the guidelines have been under re-evaluation to standardize a longer use of clopidogrel.
Another possible effect of the inclusion of drug-eluting stents in the SUS is the migration of myocardial revascularization surgery to this procedure. Myocardial revascularization surgery in Brazil presents mortality rates that are much higher than in other countries, in addition to a higher financial cost to the SUS. A study conducted by Godoy et al, in Brazil, found an overall mortality rate of 7.8% for myocardial revascularization surgery adjusted to age, sex and diagnostic groups, between 1999-200313. Migration of myocardial revascularization surgery to placement of drug-eluting stents was analyzed in a study conducted at the Mayo Clinic14. The authors concluded that up to 46% of patients who underwent myocardial revascularization surgery would be eligible for drug-eluting stents.
It is probable that in the subgroup of diabetic patients in whom the restenosis rate is higher than in non-diabetic individuals15, the cost-effectiveness ratio is more attractive for the inclusion of drug-eluting stents, with lower impact on the financier's budget.
With the fast technological development, especially in the cardiovascular field, the evaluation of inclusion of new technologies is essential not only to identify the interventions relevant to the health system, but also to choose the alternatives that actually aggregate value to the health system (
The discussion about the inclusion of new technologies in the SUS is an opportunity for the Brazilian Cardiology Society to foster the development of methods that help cardiovascular health policy makers in the process of choosing between the alternatives available, by measuring the benefits for each cost unit and the estimated return to society with the inclusion of new diagnostic and therapeutic models.
Denizar Vianna Araújo Av. Visconde de Albuquerque, 1400/501 22450-000 – Rio de Janeiro, RJ - Brazil E-mail:
Article received September 10, 2006; revised article received October 25, 2006; accepted November 24, 2006.