Custo-efetividade dos stents recobertos por rapamicina em procedimentos percutâneos coronarianos no Brasil

Abstract

SummaryObjectives: 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% with SES and 78.8% 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.

Primary and secondary prevention interventions for cardiovascular disease in low-income and middle-income countries: a systematic review of economic evaluations

“…Four studies evaluated procedures including, PCI [ 51 ], stents [ 60 , 61 ] and ICD [ 62 ]. For stents, drug-eluting early generation and new generation stents were cost-effective compared to bare metal stents [ 61 ].…”

“…For stents, drug-eluting early generation and new generation stents were cost-effective compared to bare metal stents [ 61 ]. In Brazil, though stents were not cost-effective in preventing CVD events, a sensitivity analysis showed favourable ICERs in patients with diabetes and for small vessels needing revascularization [ 60 ]. Compared to standard heart failure (HF) therapy, ICD use in those aged 60 years with HF was not cost-effective in Brazil [ 62 ].…”

“…There was only one cost–benefit analysis [ 27 ]. Overall, among the 20 studies which did CEA, life years gained/saved was the predominant benefit measure [ 23 – 25 , 41 , 44 , 45 , 49 , 50 , 52 , 57 , 58 , 62 , 63 ], while the rest of the studies either used drop in blood pressure [ 33 , 34 , 37 , 39 ], avoided CVD [ 24 , 44 , 61 ] or restenosis [ 60 ] event as benefit measure. Out of 38 studies that mentioned their approach to defining an intervention as cost-effective or not, 7 employed the willingness to pay threshold, while the majority (n = 31) used the WHO’s Commission on Macroeconomics and Health (CMH) threshold using the respective countries’ GDP per capita.…”

Conflitos éticos e judiciais no emprego dos stents farmacológicos no Brasil: análise das principais controvérsias para incorporação dessa tecnologia nos sistemas de saúde público e privado no país

“…Ampliou-se, por conseguinte, o cenário de sua aplicação em cardiologia 9 , constituindo-se em alternativa segura e eficaz no tratamento da DAC, notadamente, por reduzir, de forma significativa, a frequência de ocorrência do fenômeno da reestenose. A questão dependente do alto valor monetário agregado desses dispositivos, no entanto, tem restringido a aplicação dessa tecnologia aos pacientes tratados com ICP no Brasil 10,11 .…”

Racional e desenho do registro Brasileiro para avaliação do stent coronário eluidor de biolimus A9 NoboriTM

“…No Brasil, como ainda não há reembolso por parte do Sistema Único de Saúde (SUS), estima-se que essa conversão seja da ordem de 30% a 40%, concentrada em pacientes tratados pela saúde suplementar. 3,6 Diversos registros de vigilância pós-comercialização, multicêntricos, nacionais e internacionais, foram idealizados e operacionalizados no último quinquênio, aferindo as taxas de segurança (ocorrência de trombose da prótese) e eficácia (necessidade de novo procedimento de revascularização da lesão-alvo) tardias de diversas marcas e modelos de stents farmacológicos, autorizados para utilização na prática clínica pelos departamentos de vigilância sanitária de cada país. 1,2,7 O registro do stent farmacológico Nobori TM (Terumo Corporation, Tóquio, Japão) foi idealizado para confirmar a segurança e a eficácia desse dispositivo de nova geração, que difere de outros stents por apresentar polímero biodegradável e eluição do fármaco antiproliferativo biolimus A9.…”