RESUMO
PURPOSE: To study the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration. METHODS: We used a decision tree model to analyze the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration, from the Brazilian Public Health System (SUS) perspective. Ranibizumab and bevacizumab were administered to patients with the same treatment procedure, and the difference in treatment costs was calculated based on the cost of the drugs. Direct costs were estimated using the information provided by the Brazilian SUS. Effectiveness in terms of quality-adjusted life years (QALYs) was calculated based on the utility values for visual impairment. Incremental cost-effectiveness ratio was calculated by comparing both treatments. The analytical horizon was one year. RESULTS: The decision tree analysis showed that the difference in treatment effectiveness was 0.01 QALY. Incremental cost-effectiveness ratio showed that ranibizumab treatment required an incremental annual cost of more than R$ 2 million to generate 1 additional QALY, as compared to bevacizumab. CONCLUSIONS: From the Brazilian SUS perspective, bevacizumab is more cost-effective than ranibizumab for the treatment of neovascular age-related macular degeneration. Its use could allow potential annual savings in health budget.
Assuntos
Inibidores da Angiogênese/economia , Bevacizumab/economia , Ranibizumab/economia , Transtornos da Visão/tratamento farmacológico , Transtornos da Visão/economia , Inibidores da Angiogênese/administração & dosagem , Bevacizumab/administração & dosagem , Brasil , Análise Custo-Benefício , Custos de Medicamentos/estatística & dados numéricos , Custos de Cuidados de Saúde , Humanos , Programas Nacionais de Saúde , Anos de Vida Ajustados por Qualidade de Vida , Ranibizumab/administração & dosagem , Acuidade VisualRESUMO
ABSTRACT Purpose: To study the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration. Methods: We used a decision tree model to analyze the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration, from the Brazilian Public Health System (SUS) perspective. Ranibizumab and bevacizumab were administered to patients with the same treatment procedure, and the difference in treatment costs was calculated based on the cost of the drugs. Direct costs were estimated using the information provided by the Brazilian SUS. Effectiveness in terms of quality-adjusted life years (QALYs) was calculated based on the utility values for visual impairment. Incremental cost-effectiveness ratio was calculated by comparing both treatments. The analytical horizon was one year. Results: The decision tree analysis showed that the difference in treatment effectiveness was 0.01 QALY. Incremental cost-effectiveness ratio showed that ranibizumab treatment required an incremental annual cost of more than R$ 2 million to generate 1 additional QALY, as compared to bevacizumab. Conclusions: From the Brazilian SUS perspective, bevacizumab is more cost-effective than ranibizumab for the treatment of neovascular age-related macular degeneration. Its use could allow potential annual savings in health budget.
RESUMO Objetivo: Estudar o custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade neovascular. Métodos: Utilizamos um modelo de árvore de decisão para analisar a relação custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade, sob a perspectiva do Sistema Único de Saúde. O ranibizumabe e bevacizumabe foram administrados a pacientes com o mesmo procedimento de tratamento, e a diferença nos custos do tratamernto foi calculada com base no custo dos medicamentos. Os custos diretos foram estimados utilizando as informações fornecidas pelo SUS. A efetividade foi determinada em anos de vida ajustados pela qualidade (QALY) baseados em valores de utilidade em deficiênciavisual. A razãoincremental custo-efetividadefoicalculada comparando os dois tratamentos. O horizonte analítico foi de um ano. Resultados: A análise da árvore de decisão mostrou que a diferença na efetividade do tratamento foi de 0,01 QALY. A razão incremental de custo-efetividade mostrou que o tratamento com ranibizumabe exigiu um custo anual incremental de R$ 2 milhões para gerar um QALY adicional, em comparação ao bevacizumabe. Conclusões: Do ponto de vista do SUS, o bevacizumabe é mais custo-efetivo que o ranibizumabe no tratamento da degeneração macular relacionada à idade neovascular. O seu uso poderia gerar uma grande economia anual para o orçamento em saúde.
Assuntos
Humanos , Transtornos da Visão/economia , Transtornos da Visão/tratamento farmacológico , Inibidores da Angiogênese/economia , Bevacizumab/economia , Ranibizumab/economia , Brasil , Acuidade Visual , Custos de Cuidados de Saúde , Custos de Medicamentos/estatística & dados numéricos , Análise Custo-Benefício , Anos de Vida Ajustados por Qualidade de Vida , Inibidores da Angiogênese/administração & dosagem , Bevacizumab/administração & dosagem , Ranibizumab/administração & dosagem , Programas Nacionais de SaúdeRESUMO
BACKGROUND: Antiangiogenic therapy has proved to be an important therapeutic tool for many retinal vascular diseases; however, its availability is limited in developing countries. This study sought to describe the bevacizumab vial sharing process and to evaluate the impact of this repackaging system on the costs incurred in a Brazilian public hospital. METHOD: This retrospective study compared the number and costs of intravitreal antiangiogenic injections approved via court order in the first year of the study (2015) to the number and costs of the bevacizumab injections provided through the use of vial sharing in the second year of the study (2016). Vial sharing consists of the traditional process used to repackage bevacizumab; in this case, however, the drug samples used were the residual volume from the preparation of bevacizumab for oncology patients. The hospital adhered to the guidelines established by the Brazilian Health Surveillance Agency (ANVISA). RESULTS: In the first year of the study and using medication obtained through court orders, 550 intravitreal injections were performed in the ophthalmology ambulatory care center. Based on local pricing tables, the total cost of the medication was BRL$1,036,056.25 (USD$267,546.58), and the average cost of each application was BRL$1883.74 (USD$486.45). In the second year of the study, 1081 intravitreal applications were performed at the same hospital using doses obtained through bevacizumab vial sharing. The total cost was BRL$21,942.49 (USD$5663.30) and the per-unit cost was BRL$20.30, or USD$5.23 (a savings of 97.88%). CONCLUSION: This study found that bevacizumab vial sharing led to a significant reduction in public health care costs associated with antiangiogenic treatment and increased the availability of the drug to public health care patients. These results can be extrapolated to other types of drugs and health care systems.
Assuntos
Inibidores da Angiogênese/economia , Bevacizumab/economia , Custos de Medicamentos , Doenças Retinianas/tratamento farmacológico , Doenças Retinianas/economia , Idoso , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/uso terapêutico , Brasil , Análise Custo-Benefício , Feminino , Custos de Cuidados de Saúde , Humanos , Injeções Intravítreas/economia , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
The study's objective was to perform budget impact assessment for the incorporation of second-line intravitreal antiangiogenic therapy for diabatic macular edema in the scope of the Brazilian Unified National Health System (SUS) in Minas Gerais state, Brazil, discussing the incorporation's state budget feasibility. The budget impact assessment was performed as a deterministic method according to Ministry of Health guidelines. The study included patients with probable first-line treatment failure in a five-year timeline for all the technologies assessed. The analysis included the drugs bevacizumab (off-label use), ranibizumab, and aflibercept. The populations were calculated both by observed demand and epidemiological estimate. The following sensitivity analyses were performed: a scenario with slower technology diffusion, a scenario with the market entry of biosimilar versions of bevacizumab and ranibizumab, and a scenario disregarding inflation during the period. The incremental budget impacts according to observed and epidemiologically estimated demand, respectively, were BRL 69,493,906.95 to BRL 473,226,278.78 for bevacizumab; BRL 349,319,965.60 to BRL 2,378,732,103.09 for ranibizumab; and BRL 543,867,485.47 to BRL 3,703,524,490.16 for aflibercept. Bevacizumab proved to be the most financially feasible alternative in all the scenarios of estimates and sensitivity analyses. An increment of nearly 3% was estimated, compared to the 2016 budget (observed demand). The study showed that the incorporation is feasible in the SUS, Minas Gerais State, but subject to management priorities. Price discrepancies between products with similar efficacy is intriguing and provides fertile ground for future studies.
Os objetivos foram efetuar a análise do impacto orçamentário para a incorporação de segunda linha terapêutica com terapia antiangiogênica de aplicação intravítrea, para tratamento de edema macular diabético, no âmbito do Sistema Único de Saúde (SUS) em Minas Gerais, Brasil, discutindo sua viabilidade à luz do orçamento do estado. A análise do impacto orçamentário com método determinístico, segundo diretriz do Ministério da Saúde. Foram incluídos os pacientes com provável falha ao tratamento de primeira linha, num horizonte temporal de 5 anos para todas as tecnologias avaliadas. Incluíram-se na análise os medicamentos bevacizumabe (uso off-label), ranibizumabe e aflibercepte. As populações foram calculadas tanto por demanda aferida quanto por estimativa epidemiológica. Como análises de sensibilidade efetuaram-se: cenário com difusão de tecnologia mais lenta; cenário com a entrada de bevacizumabe e ranibizumabe biossimilares no mercado; cenário com a desconsideração da inflação no período. O impacto orçamentário incremental, de acordo com as estimativas de demanda aferida e epidemiológica, respectivamente, foi de R$ 69.493.906,95-R$ 473.226.278,78 para bevacizumabe; R$ 349.319.965,60-R$ 2.378.732.103,09 para ranibizumabe e R$543.867.485,47-R$ 3.703.524.490,16 para aflibercepte. Bevacizumabe foi a alternativa financeiramente mais viável em todos os cenários das estimativas e análises de sensibilidade. Estimou-se incremento próximo a 3%, comparando com o orçamento de 2016 (demanda aferida). Avalia-se que a incorporação é viável dentro do SUS em Minas Gerais, mas sujeita às prioridades da gestão. A discrepância de preços entre produtos de eficácia semelhante é intrigante e tema fértil para estudos futuros.
El objetivo fue efectuar un análisis del impacto presupuestario en la incorporación de una segunda línea terapéutica, con terapia antiangiogénica de aplicación intravítrea, para el tratamiento de edema macular diabético, en el ámbito del Sistema Único de Salud (SUS), en Minas Gerais, Brasil, discutiendo su viabilidad respecto al presupuesto del estado. Se realizó una análisis del impacto presupuestario con un método determinístico, según la directriz del Ministerio de Salud. Se incluyeron pacientes con probable fracaso al tratamiento de primera línea, en un horizonte temporal de 5 años para todas las tecnologías evaluadas. Se incluyeron en el análisis los medicamentos bevacizumab (uso off-label), ranibizumab y aflibercept. Las poblaciones se calcularon tanto por demanda evaluada, como por estimación epidemiológica. A modo de análisis de sensibilidad se planteó un escenario con una difusión de tecnología más lenta, un escenario con la entrada de bevacizumab y ranibizumab biosimilares en el mercado, y un escenario con la desconsideración de la inflación durante el período. El incremento del impacto presupuestario, de acuerdo con las estimativas de demanda evaluada y epidemiológica, respectivamente, fue BRL 69.493.906,95-BRL 473.226.278,78 en el caso del bevacizumab; BRL 349.319.965,60-BRL 2.378.732.103,09 en el de ranibizumab y BRL 543.867.485,47-BRL 3.703.524.490,16 en el aflibercept. El bevacizumab se mostró la alternativa financiera más viable en todos los escenarios de estimaciones y análisis de sensibilidad. Se estimó un incremento cercano al 3%, comparándolo con el presupuesto de 2016 (demanda evaluada). Se considera que la incorporación es viable dentro del SUS en Minas Gerais, pero sujeta a las prioridades de la gestión. La discrepancia de precios entre productos de eficacia semejante es intrigante y un tema fértil para estudios futuros.
Assuntos
Inibidores da Angiogênese/economia , Retinopatia Diabética/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Edema Macular/economia , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/economia , Bevacizumab/uso terapêutico , Brasil , Retinopatia Diabética/tratamento farmacológico , Humanos , Edema Macular/tratamento farmacológico , Ranibizumab/economia , Ranibizumab/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/economia , Proteínas Recombinantes de Fusão/uso terapêuticoRESUMO
Resumo: Os objetivos foram efetuar a análise do impacto orçamentário para a incorporação de segunda linha terapêutica com terapia antiangiogênica de aplicação intravítrea, para tratamento de edema macular diabético, no âmbito do Sistema Único de Saúde (SUS) em Minas Gerais, Brasil, discutindo sua viabilidade à luz do orçamento do estado. A análise do impacto orçamentário com método determinístico, segundo diretriz do Ministério da Saúde. Foram incluídos os pacientes com provável falha ao tratamento de primeira linha, num horizonte temporal de 5 anos para todas as tecnologias avaliadas. Incluíram-se na análise os medicamentos bevacizumabe (uso off-label), ranibizumabe e aflibercepte. As populações foram calculadas tanto por demanda aferida quanto por estimativa epidemiológica. Como análises de sensibilidade efetuaram-se: cenário com difusão de tecnologia mais lenta; cenário com a entrada de bevacizumabe e ranibizumabe biossimilares no mercado; cenário com a desconsideração da inflação no período. O impacto orçamentário incremental, de acordo com as estimativas de demanda aferida e epidemiológica, respectivamente, foi de R$ 69.493.906,95-R$ 473.226.278,78 para bevacizumabe; R$ 349.319.965,60-R$ 2.378.732.103,09 para ranibizumabe e R$543.867.485,47-R$ 3.703.524.490,16 para aflibercepte. Bevacizumabe foi a alternativa financeiramente mais viável em todos os cenários das estimativas e análises de sensibilidade. Estimou-se incremento próximo a 3%, comparando com o orçamento de 2016 (demanda aferida). Avalia-se que a incorporação é viável dentro do SUS em Minas Gerais, mas sujeita às prioridades da gestão. A discrepância de preços entre produtos de eficácia semelhante é intrigante e tema fértil para estudos futuros.
Abstract: The study's objective was to perform budget impact assessment for the incorporation of second-line intravitreal antiangiogenic therapy for diabatic macular edema in the scope of the Brazilian Unified National Health System (SUS) in Minas Gerais state, Brazil, discussing the incorporation's state budget feasibility. The budget impact assessment was performed as a deterministic method according to Ministry of Health guidelines. The study included patients with probable first-line treatment failure in a five-year timeline for all the technologies assessed. The analysis included the drugs bevacizumab (off-label use), ranibizumab, and aflibercept. The populations were calculated both by observed demand and epidemiological estimate. The following sensitivity analyses were performed: a scenario with slower technology diffusion, a scenario with the market entry of biosimilar versions of bevacizumab and ranibizumab, and a scenario disregarding inflation during the period. The incremental budget impacts according to observed and epidemiologically estimated demand, respectively, were BRL 69,493,906.95 to BRL 473,226,278.78 for bevacizumab; BRL 349,319,965.60 to BRL 2,378,732,103.09 for ranibizumab; and BRL 543,867,485.47 to BRL 3,703,524,490.16 for aflibercept. Bevacizumab proved to be the most financially feasible alternative in all the scenarios of estimates and sensitivity analyses. An increment of nearly 3% was estimated, compared to the 2016 budget (observed demand). The study showed that the incorporation is feasible in the SUS, Minas Gerais State, but subject to management priorities. Price discrepancies between products with similar efficacy is intriguing and provides fertile ground for future studies.
Resumen: El objetivo fue efectuar un análisis del impacto presupuestario en la incorporación de una segunda línea terapéutica, con terapia antiangiogénica de aplicación intravítrea, para el tratamiento de edema macular diabético, en el ámbito del Sistema Único de Salud (SUS), en Minas Gerais, Brasil, discutiendo su viabilidad respecto al presupuesto del estado. Se realizó una análisis del impacto presupuestario con un método determinístico, según la directriz del Ministerio de Salud. Se incluyeron pacientes con probable fracaso al tratamiento de primera línea, en un horizonte temporal de 5 años para todas las tecnologías evaluadas. Se incluyeron en el análisis los medicamentos bevacizumab (uso off-label), ranibizumab y aflibercept. Las poblaciones se calcularon tanto por demanda evaluada, como por estimación epidemiológica. A modo de análisis de sensibilidad se planteó un escenario con una difusión de tecnología más lenta, un escenario con la entrada de bevacizumab y ranibizumab biosimilares en el mercado, y un escenario con la desconsideración de la inflación durante el período. El incremento del impacto presupuestario, de acuerdo con las estimativas de demanda evaluada y epidemiológica, respectivamente, fue BRL 69.493.906,95-BRL 473.226.278,78 en el caso del bevacizumab; BRL 349.319.965,60-BRL 2.378.732.103,09 en el de ranibizumab y BRL 543.867.485,47-BRL 3.703.524.490,16 en el aflibercept. El bevacizumab se mostró la alternativa financiera más viable en todos los escenarios de estimaciones y análisis de sensibilidad. Se estimó un incremento cercano al 3%, comparándolo con el presupuesto de 2016 (demanda evaluada). Se considera que la incorporación es viable dentro del SUS en Minas Gerais, pero sujeta a las prioridades de la gestión. La discrepancia de precios entre productos de eficacia semejante es intrigante y un tema fértil para estudios futuros.
Assuntos
Humanos , Edema Macular/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Inibidores da Angiogênese/economia , Retinopatia Diabética/economia , Proteínas Recombinantes de Fusão/economia , Proteínas Recombinantes de Fusão/uso terapêutico , Brasil , Edema Macular/tratamento farmacológico , Inibidores da Angiogênese/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Bevacizumab/economia , Bevacizumab/uso terapêutico , Ranibizumab/economia , Ranibizumab/uso terapêuticoRESUMO
BACKGROUND: The last decade has seen the increasing use of biological medicines in combination with chemotherapy containing 5-fluorouracil/oxaliplatin or irinotecan for the treatment of metastatic colorectal cancer (mCRC). These combinations have resulted in increased progression-free survival (PFS) in patients with mCRC; however, there are remaining concerns over the extent of their effect on overall survival (OS). Published studies to date suggest no major differences between the three currently available monoclonal antibodies (MoAbs); however, there are differences in costs. In addition, there is rising litigation in Brazil in order to access these medicines as they are currently not reimbursed. OBJECTIVE: The aim was to investigate the comparative effectiveness and safety of three MoAbs (bevacizumab, cetuximab and panitumumab) associated with fluoropyrimidine-based chemotherapy regimens and compared to fluoropyrimidine-based chemotherapy alone in patients with mCRC, through an updated systematic review and meta-analysis of concurrent or non-concurrent observational cohort studies, to guide authorities and the judiciary. METHOD: A systematic review and meta-analysis was performed based on cohort studies published in databases up to November 2017. Effectiveness measures included OS, PFS, post-progression survival (PPS), Response Evaluation Criteria In Solid Tumors (RECIST), response rate, metastasectomy and safety. The methodological quality of the studies was also evaluated. RESULTS: A total of 21 observational cohort studies were included. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus no bevacizumab mainly around OS, PFS, PPS and the metastasectomy rate, but not for the disease control rates. However, there was an increase in treatment-related toxicities and concerns with the heterogeneity of the studies. CONCLUSION: The results pointed to an advantage in favor of bevacizumab for OS, PFS, PPS, and metastasectomy. Although this advantage may be considered clinically modest, bevacizumab represents a hope for increased survival and a chance of metastasectomy for patients with mCRC. However, there are serious adverse events associated with its use, especially severe hypertension and gastrointestinal perforation, that need to be considered.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Análise Custo-Benefício , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Bevacizumab/economia , Bevacizumab/uso terapêutico , Brasil , Cetuximab/economia , Cetuximab/uso terapêutico , Neoplasias Colorretais/mortalidade , Intervalo Livre de Doença , Honorários Farmacêuticos , Fluoruracila/economia , Fluoruracila/uso terapêutico , Humanos , Hipertensão/induzido quimicamente , Hipertensão/epidemiologia , Incidência , Perfuração Intestinal/induzido quimicamente , Perfuração Intestinal/epidemiologia , Irinotecano/economia , Irinotecano/uso terapêutico , Oxaliplatina/economia , Oxaliplatina/uso terapêutico , Panitumumabe/economia , Panitumumabe/uso terapêutico , Mecanismo de Reembolso/legislação & jurisprudência , Critérios de Avaliação de Resposta em Tumores SólidosRESUMO
BACKGROUND: The BEYOND trial found that the addition of bevacizumab (B) to paclitaxel-carboplatin (PC) chemotherapy provided a significant clinical benefit to Chinese patients with metastatic non-squamous non-small-cell lung cancer (NSCLC). This study aimed to evaluate the cost-effectiveness of adding B to first-line PC induction and continuation maintenance therapy from a Chinese perspective. METHODS: A Markov model was developed to estimate the cost and effectiveness of B + PC in the induction and maintenance therapy of patients with metastatic non-squamous NSCLC. Costs were calculated in the Chinese setting, and health outcomes derived from the BEYOND trial were measured as quality-adjusted life years (QALYs). A one-way sensitivity analysis was conducted to explore the impact of various parameters in the study. RESULTS: The B + PC treatment was more costly ($112,943.40 versus $32,171.43) and more effective (1.07 QALYs versus 0.80 QALYs) compared with the PC treatment. Adding B to the PC regimen for non-squamous NSCLC results in an incremental cost-effectiveness ratio of $299,155.44 per QALY, which exceeded the accepted societal willingness-to-pay threshold ($23,970.00) for China. In the sensitivity analysis, the duration of progression-free survival (PFS) for the B + PC group, the cost of the PFS state for B + PC group and the price of B were considered the most sensitive factors in the model. CONCLUSIONS: The addition of B to first-line PC induction and maintenance therapy was not determined to be a cost-effective strategy for metastatic non-squamous NSCLC in China, even when an assistance program was provided.
Assuntos
Antineoplásicos Imunológicos/administração & dosagem , Antineoplásicos Imunológicos/economia , Bevacizumab/administração & dosagem , Bevacizumab/economia , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Carboplatina/administração & dosagem , Carcinoma de Células Grandes/tratamento farmacológico , China , Análise Custo-Benefício , Humanos , Quimioterapia de Indução/economia , Quimioterapia de Indução/métodos , Quimioterapia de Manutenção/economia , Quimioterapia de Manutenção/métodos , Paclitaxel/administração & dosagemRESUMO
BACKGROUND: Metastatic colorectal cancer imposes a substantial burden on patients and society. Over the last years, progresses in the treatment have been made especially due to the introduction of monoclonal antibodies, such as bevacizumab which, on the other hand, has considerably increased the costs of treatment. We performed a cost-effectiveness analysis of bevacizumab plus XELOX in comparison with XELOX alone in metastatic colorectal cancer in first-line therapy, from the perspective of a public hospital school in Brazil. METHODS: This was a cost-effectiveness analysis performed by a decision tree and Markov models. Costs were expressed in local currency and outcomes were expressed in months of life gained. The model was constructed using the TreeAge Pro 2013® software. RESULTS: The incremental difference in years of life gained was 2.25 months, with an extra cost of 47,833.57 BRL, resulting in an incremental cost-effectiveness of 21,231.43 BRL per month of life gained. CONCLUSIONS: Although the XELOX plus bevacizumab regimen is a more expensive and more effective treatment than XELOX, it does not fit the reimbursement values fixed by the public healthcare system in Brazil.