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1.
Value Health Reg Issues ; 21: 164-171, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31978690

RESUMO

OBJECTIVES: The combination of pegylated-interferon and ribavirin (PegIFN+RBV) is currently the gold standard in treating chronic hepatitis C virus (HCV) patients in Malaysia and is reimbursed by the Malaysian authorities. This analysis evaluated the cost-effectiveness (CE) of the ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin (OBT/PTV/r+DSB±RBV) regimen as compared with the PegIFN+RBV or no treatment in chronic HCV Genotype 1 (GT1) treatment-naïve and treatment-experienced cirrhotic and noncirrhotic patients in Malaysia. METHODS: A Markov model based on previously published CE models of HCV was adapted for the Malaysian public healthcare payer perspective, based on good modeling practices. Treatment attributes included efficacy, regimen duration, and EQ-5D treatment-related health utility. Transitional probabilities and health state health utilities were derived from previous studies. Costs were derived from Malaysian data sources. Costs and outcomes were discounted at 3.0% per year. Deterministic and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainties around key variables. RESULTS: Based on the analysis, patients treated with the OBT/PTV/r+DSB±RBV showed less frequent progression to compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver-related deaths when compared with standard care (ie, PegIFN+RBV or no treatment). At a price of MYR 1846/day, the OBT/PTV/r+DSB±RBV regimen is cost-effective over PegIFN+RBV and yields better outcomes in terms of life-years (LYs) gained and quality-adjusted life-years (QALYs) at a higher cost, which is still well below the implied willingness to pay threshold of MYR 384 503/QALY. CONCLUSION: The OBT/PTV/r+DSB±RBV regimen is cost-effective for treatment naïve, treatment experienced, cirrhotic, and noncirrhotic GT1 chronic HCV patients in Malaysia.


Assuntos
Análise Custo-Benefício/métodos , Genótipo , Hepatite C/tratamento farmacológico , 2-Naftilamina , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/economia , Antivirais/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício/estatística & dados numéricos , Ciclopropanos/economia , Ciclopropanos/uso terapêutico , Hepatite C/epidemiologia , Humanos , Lactamas Macrocíclicas/economia , Lactamas Macrocíclicas/uso terapêutico , Malásia/epidemiologia , Prolina/análogos & derivados , Prolina/economia , Prolina/uso terapêutico , Ribavirina/economia , Ribavirina/uso terapêutico , Ritonavir/economia , Ritonavir/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Resultado do Tratamento , Uracila/análogos & derivados , Uracila/economia , Uracila/uso terapêutico , Valina
2.
Appl Health Econ Health Policy ; 16(5): 711-722, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30039348

RESUMO

BACKGROUND: Chronic Hepatitis C virus (cHCV) is a major health issue worldwide. New effective direct-acting anti-viral (DAA) drugs such as the combination sofosbuvir/velpatasvir, represent an important turning point, given the high sustained virologic response (SVR) rates associated with their use. OBJECTIVES: To estimate the cost and effects of two different treatment strategies based on sofosbuvir/velpatasvir. Strategy 1: treating all patients, including those in the early stages of fibrosis; Strategy 2: reserving treatments for patients at more advanced stages of disease (≥ F3). The analysis compares the incremental cost-effectiveness ratio (ICER) of Strategy 1 versus Strategy 2 in a cohort of HCV-infected patients and a cohort of hepatitis C virus (HCV)-human immunodeficiency virus (HIV) patients. METHODS: A Markov model simulating the natural history of the disease was built considering a 60-year time horizon and two cohorts of 1000 patients aged ≥ 35 years. Disease morbidity was classified according to the METAVIR classification. The robustness of the model was tested using deterministic and probabilistic sensitivity analyses (PSA). RESULTS: In both cohorts, Strategy 1 results in higher resource consumption and a greater number of quality-adjusted life-years (QALYs) compared with Strategy 2. The ICERs for the cohort of HCV patients and the cohort of co-infected HCV/HIV patients ranged between €15,555-74,804/QALY and €10,708-55,138/QALY, respectively, depending on the assumed cost of the treatment. In the PSA, the ICER distribution remained below the threshold of €30,000/QALY in 96 and 97% of the scenarios in the cohorts of HCV and HCV/HIV patients, respectively. CONCLUSIONS: Extending the treatment of HCV to patients at an early stage of HCV infection is estimated to be cost effective from the perspective of the Italian Healthcare System.


Assuntos
Antivirais/economia , Carbamatos/economia , Hepatite C Crônica/economia , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Sofosbuvir/economia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antivirais/administração & dosagem , Antivirais/uso terapêutico , Carbamatos/administração & dosagem , Carbamatos/uso terapêutico , Análise Custo-Benefício , Custos de Medicamentos/estatística & dados numéricos , Quimioterapia Combinada , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Hepatite C Crônica/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis/administração & dosagem , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Humanos , Itália , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Anos de Vida Ajustados por Qualidade de Vida , Sofosbuvir/administração & dosagem , Sofosbuvir/uso terapêutico , Adulto Jovem
3.
Cad. Saúde Pública (Online) ; 33(8): e00206516, Aug. 2017. tab
Artigo em Português | LILACS | ID: biblio-1039365

RESUMO

Resumo: O backlog na análise de pedidos de patentes é um problema que persiste desde a promulgação da Lei nº 9.279/1996, quando o Brasil passou a conceder patentes para medicamentos novamente. Os órgãos responsáveis pela concessão dessas patentes, Instituto Nacional da Propriedade Industrial (INPI) e Agência Nacional de Vigilância Sanitária (Anvisa), alegam motivos técnico-administrativos para justificar o atraso. No entanto, os impactos econômicos para a saúde devido à ineficiência do sistema de patentes brasileiro ainda foram pouco investigados. Assim sendo, este trabalho propõe uma metodologia para estimar o quanto as compras públicas de medicamentos são oneradas em função da morosidade na análise dos pedidos de patentes no país. Os resultados mostram que mais de R$ 14 milhões são gastos desnecessariamente anualmente pelo Governo Federal com apenas um medicamento antirretroviral por causa da extensão da vigência das patentes. Conclui-se que medidas governamentais de controle dessa situação são prementes no âmbito dos Três Poderes. Dentre elas, destacam-se a contratação de servidores para o INPI, análise dos projetos de lei que tramitam na Câmara dos Deputados e Senado Federal para a alteração da Lei da Propriedade Industrial, e julgamento das Ações Diretas de Inconstitucionalidade para a supressão do dispositivo legal que possibilita a extensão da vigência das patentes.


Abstract: The backlog in processing patent applications in Brazil has persisted since the enactment of Law 9,279/1996, when the country resumed granting patents on drugs. The agencies responsible for granting such patents, namely the Brazilian National Patent and Trademark Office (INPI) and the Brazilian National Health Surveillance Agency (Anvisa) cite technical and administrative reasons for the backlog. However, little research has focused on the economic impacts for health due to the inefficiency of the Brazilian patent system. The current study thus proposes a methodology to estimate the extent to which government procurement of medicines is burdened by the backlog in drug patent applications. According to the results, a total of more than BRL 14 million (USD 4.5 million) is spent unnecessarily per year by the Federal Government on just one antiretroviral drug due to the extension of the respective patent's life. Measures to resolve this situation are urgently needed in the three branches of government. These include hiring more staff for the INPI, analysis of bills of law under review in the two houses of the Brazilian Congress to amend the Industrial Property Law, and ruling on direct class action claims of unconstitutionality to suppress the legal mechanisms that allow extending the life of patents.


Resumen: El atraso en el procesamiento de solicitudes de patentes en Brasil ha persistido desde la promulgación de la Ley 9.279/1996, cuando el país reanudó la concesión de patentes sobre drogas. Los organismos encargados de otorgar las patentes, a saber, la Oficina Nacional de Patentes y Marcas (INPI) y la Agencia Nacional de Vigilancia Sanitaria (Anvisa), alegan motivos técnico-administrativos para justificar el retraso. Sin embargo, poca investigación se ha centrado en los impactos económicos para la salud debido a la ineficiencia del sistema brasileño de patentes. El presente estudio propone una metodología para estimar el grado en que la contratación pública de medicamentos está cargada con el atraso en las solicitudes de patente de medicamentos. De acuerdo con los resultados, el gobierno federal gasta innecesariamente un total de más de BRL 14 millones (USD 4.5 millones) por un solo medicamento antirretroviral debido a la extensión de la vida de la respectiva patente. Las medidas para resolver esta situación son urgentemente necesarias en las tres ramas del gobierno. Estos incluyen la contratación de más personal para la INPI, el análisis de los proyectos de ley en revisión en las dos cámaras del Congreso brasileño para enmendar la Ley de Propiedad Industrial, y la decisión sobre demandas de acción colectiva directa de inconstitucionalidad para suprimir los mecanismos legales que permiten extender la vida de las patentes.


Assuntos
Humanos , Patentes como Assunto/legislação & jurisprudência , Medicamentos Genéricos/economia , Indústria Farmacêutica/economia , Organofosfatos/economia , Sulfonamidas/economia , Brasil , Carbamatos/economia , Antirretrovirais/economia , Indústria Farmacêutica/legislação & jurisprudência , Acessibilidade aos Serviços de Saúde
4.
Value Health ; 19(4): 326-34, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27325324

RESUMO

BACKGROUND: Interferon-free hepatitis C treatment regimens are effective but very costly. The cost-effectiveness, budget, and public health impacts of current Medicaid treatment policies restricting treatment to patients with advanced disease remain unknown. OBJECTIVES: To evaluate the cost-effectiveness of current Medicaid policies restricting hepatitis C treatment to patients with advanced disease compared with a strategy providing unrestricted access to hepatitis C treatment, assess the budget and public health impact of each strategy, and estimate the feasibility and long-term effects of increased access to treatment for patients with hepatitis C. METHODS: Using a Markov model, we compared two strategies for 45- to 55-year-old Medicaid beneficiaries: 1) Current Practice-only advanced disease is treated before Medicare eligibility and 2) Full Access-both early-stage and advanced disease are treated before Medicare eligibility. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die each year. Morbidity was reduced after successful treatment. We calculated the incremental cost-effectiveness ratio and compared the costs and public health effects of each strategy from the perspective of Medicare alone as well as the Centers for Medicare & Medicaid Services perspective. We varied model inputs in one-way and probabilistic sensitivity analyses. RESULTS: Full Access was less costly and more effective than Current Practice for all cohorts and perspectives, with differences in cost ranging from $5,369 to $11,960 and in effectiveness from 0.82 to 3.01 quality-adjusted life-years. In a probabilistic sensitivity analysis, Full Access was cost saving in 93% of model iterations. Compared with Current Practice, Full Access averted 5,994 hepatocellular carcinoma cases and 121 liver transplants per 100,000 patients. CONCLUSIONS: Current Medicaid policies restricting hepatitis C treatment to patients with advanced disease are more costly and less effective than unrestricted, full-access strategies. Collaboration between state and federal payers may be needed to realize the full public health impact of recent innovations in hepatitis C treatment.


Assuntos
Antivirais/economia , Acessibilidade aos Serviços de Saúde/economia , Hepatite C/economia , Medicaid/economia , 2-Naftilamina , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/uso terapêutico , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Ciclopropanos , Combinação de Medicamentos , Feminino , Fluorenos/economia , Fluorenos/uso terapêutico , Inibidores da Protease de HIV/economia , Inibidores da Protease de HIV/uso terapêutico , Hepacivirus/genética , Hepatite C/tratamento farmacológico , Humanos , Lactamas Macrocíclicas , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Prolina/análogos & derivados , Ritonavir/economia , Ritonavir/uso terapêutico , Índice de Gravidade de Doença , Sofosbuvir , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Estados Unidos , Uracila/análogos & derivados , Uracila/economia , Uracila/uso terapêutico , Uridina Monofosfato/análogos & derivados , Uridina Monofosfato/economia , Uridina Monofosfato/uso terapêutico , Valina
5.
J Med Econ ; 19(12): 1144-1156, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27348464

RESUMO

OBJECTIVE: This study compared the cost-effectiveness of chronic hepatitis C virus (HCV) genotype 1b (GT1b) therapy ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) vs daclatasvir + asunaprevir (DCV/ASV) and no treatment in patients without cirrhosis. Cost-effectiveness analyses (CEAs) that compared OBV/PTV/r against DCV/ASV and sofosbuvir/ledipasvir (SOF/LDV) in Y93H mutation-negative, GT1b patients with and without cirrhosis were also included. METHODS: A health state transition model was developed to capture the natural history of HCV. A CEA over a lifetime horizon was performed from the perspective of the public healthcare payer in Japan. Costs, health utilities, and rates of disease progression were derived from published studies. Sustained virologic response (SVR) rates of OBV/PTV/r and DCV/ASV were extracted from Japanese clinical trials. Analyses were performed for treatment-naïve and -experienced patients. Alternative scenarios and input parameter uncertainty on the results were tested. RESULTS: OBV/PTV/r exhibited superior clinical outcomes vs comparators. For OBV/PTV/r, DCV/ASV, and no treatment, the lifetime risk of decompensated cirrhosis in treatment-naïve patients without cirrhosis was 0.4%, 1.4%, and 9.2%, and hepatocellular carcinoma was 6.5%, 11.4%, and 49.9%, respectively. Quality-adjusted life years (QALYs) were higher in treatment-naïve and -experienced patients without cirrhosis treated with OBV/PTV/r (16.41 and 16.22) vs DCV/ASV (15.83 and 15.66) or no treatment (11.34 and 11.23). In treatment-naïve and -experienced patients without cirrhosis, the incremental cost-effectiveness ratios (ICERs) of OBV/PTV/r vs DCV/ASV were JPY 1,684,751/QALY and JPY 1,836,596/QALY, respectively; OBV/PTV/r was dominant compared with no treatment. In scenario analysis, including GT1b patients with and without cirrhosis who were Y93H mutation-negative, the ICER of OBV/PTV/r vs DCV/ASV was below the Japanese willingness-to-pay threshold of JPY 5 million/QALY, while the ICER of SOF/LDV vs OBV/PTV/r was above this threshold; thus, OBV/PTV/r was cost-effective. CONCLUSION: OBV/PTV/r appears to be a cost-effective treatment for chronic HCV GT1b infection against DCV/ASV. OBV/PTV/r dominates no treatment in patients without cirrhosis.


Assuntos
Anilidas/economia , Anilidas/uso terapêutico , Antivirais/economia , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Genótipo , Hepacivirus/efeitos dos fármacos , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Ritonavir/economia , Ritonavir/uso terapêutico , Ciclopropanos , Quimioterapia Combinada , Feminino , Humanos , Japão , Lactamas Macrocíclicas , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Prolina/análogos & derivados , Sulfonamidas , Valina
6.
Adv Ther ; 33(8): 1316-30, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27342742

RESUMO

INTRODUCTION: New treatments for chronic hepatitis C virus (HCV) are highly effective in patients coinfected with human immunodeficiency virus (HIV). This study estimated the cost-effectiveness of treatments for genotype 1 (GT1) HCV in HIV-coinfected patients. METHODS: A Markov model based on HCV natural history was used. The base-case analysis included both treatment-naïve and -experienced patients. Alternatives were ombitasvir/paritaprevir/ritonavir, dasabuvir with or without ribavirin (3D ± R) for 12 or 24 weeks, sofosbuvir plus peginterferon and R (SOF + PR) for 12 weeks, SOF + R for 24 weeks, and no treatment (NT). A subgroup analysis restricted to treatment-naïve, non-cirrhotic patients compared 3D ± R for 12 weeks to SOF plus ledipasvir (LDV) for 12 weeks and NT. Transition probabilities, utilities, and costs were obtained from the published literature. Outcomes were measured over a lifetime horizon and included rates of compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma and liver-related death, total costs, life-years, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER). RESULTS: In the base-case, SOF + R was dominated by both SOF + PR and 3D ± R. Compared to SOF + PR, 3D ± R had an ICER of $45,581. The lifetime rates of liver morbidity and mortality were lower among those treated with 3D ± R compared to SOF + PR, SOF + R, or NT. In the subgroup analysis, 3D ± R was cost-effective compared to NT at a threshold of $50,000 per QALY (ICER $27,496). SOF/LDV had an ICER of $104,489 per QALY gained compared to 3D ± R. CONCLUSION: In the GT1 HCV population coinfected with HIV, 3D ± R was cost-effective compared to NT, SOF + R, and SOF + PR. In the treatment-naïve sub-population, 3D ± R was cost-effective compared to NT and SOF/LDV.


Assuntos
Antivirais/economia , Antivirais/uso terapêutico , Infecções por HIV/epidemiologia , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/epidemiologia , 2-Naftilamina , Adulto , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/administração & dosagem , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Carcinoma Hepatocelular/epidemiologia , Análise Custo-Benefício , Ciclopropanos , Progressão da Doença , Quimioterapia Combinada , Fluorenos/economia , Fluorenos/uso terapêutico , Genótipo , Hepacivirus/genética , Humanos , Interferon-alfa/economia , Interferon-alfa/uso terapêutico , Lactamas Macrocíclicas , Cirrose Hepática/epidemiologia , Neoplasias Hepáticas/epidemiologia , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Cadeias de Markov , Pessoa de Meia-Idade , Polietilenoglicóis/economia , Polietilenoglicóis/uso terapêutico , Prolina/análogos & derivados , Anos de Vida Ajustados por Qualidade de Vida , Proteínas Recombinantes/economia , Proteínas Recombinantes/uso terapêutico , Ribavirina/uso terapêutico , Ritonavir/economia , Ritonavir/uso terapêutico , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Estados Unidos , Uracila/análogos & derivados , Uracila/economia , Uracila/uso terapêutico , Valina
7.
J Med Econ ; 19(10): 983-94, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27172133

RESUMO

OBJECTIVES: To estimate clinical outcomes and cost-effectiveness of ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin (OMB/PTV/r + DSV ± RBV) compared with treatment regimens including pegylated interferon (PegIFN) for patients with chronic genotype 1 hepatitis C virus (HCV) infection. METHODS: An Excel spreadsheet Markov model tracking progression through stages of liver disease was developed. Costs and patient utilities for liver disease stages were taken from published studies. Rates of disease progression were based on studies of untreated HCV infection and long-term follow-up of those achieving sustained virologic response (SVR) after drug treatment. Impact of OMB/PTV/r + DSV ± RBV and other drug regimens on progression was estimated through SVR rates from clinical trials. Analyses were performed for treatment-naive and treatment-experienced patients. Impact of alternative scenarios and input parameter uncertainty on the results were tested. RESULTS: For genotype 1 treatment-naive HCV patients, for OMB/PTV/r + DSV ± RBV, PegIFN + ribavirin (PegIFN/RBV), sofosbuvir + PegIFN/RBV, telaprevir + PegIFN/RBV, boceprevir + PegIFN/RBV, lifetime risk of decompensated liver disease was 5.6%, 18.9%, 7.4%, 11.7%, and 14.9%; hepatocellular carcinoma was 5.4%, 9.2%, 5.7%, 7.0%, and 7.4%; and death from liver disease was 8.7%, 22.2%, 10.4%, 14.8%, and 17.6%, respectively. Estimates of the cost-effectiveness of OMB/PTV/r + DSV ± RBV for treatment-naive and treatment-experienced patients indicated that it dominated all other regimens except PegIFN/RBV. Compared with PegIFN/RBV, the incremental cost-effectiveness ratios were £13,864 and £10,258 per quality-adjusted life-year (QALY) for treatment-naive and treatment-experienced patients, respectively. The results were similar for alternative scenarios and uncertainty analyses. LIMITATIONS: A mixed-treatment comparison for SVR rates for the different treatment regimens was not feasible, because many regimens did not have comparator arms; instead SVR rates were based on those from recent trials. CONCLUSIONS: OMB/PTV/r + DSV ± RBV is a cost-effective oral treatment regimen for chronic genotype 1 HCV infection compared with standard treatment regimens and is estimated to reduce the lifetime risks of advanced liver disease.


Assuntos
Anilidas/economia , Anilidas/uso terapêutico , Antivirais/economia , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Hepacivirus/efeitos dos fármacos , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Uracila/análogos & derivados , 2-Naftilamina , Adulto , Ciclopropanos , Quimioterapia Combinada , Feminino , Humanos , Lactamas Macrocíclicas , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Prolina/análogos & derivados , Ritonavir , Uracila/economia , Uracila/uso terapêutico , Valina
8.
J Med Econ ; 19(8): 795-805, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27063573

RESUMO

OBJECTIVE: This study compared the cost-effectiveness of direct-acting antiviral therapies currently recommended for treating genotypes (GT) 1 and 4 chronic hepatitis C (CHC) patients in the US. METHODS: A cost-effectiveness analysis of treatments for CHC from a US payer's perspective over a lifelong time horizon was performed. A Markov model based on the natural history of CHC was used for a population that included treatment-naïve and -experienced patients. Treatment alternatives considered for GT1 included ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± R), sofosbuvir + ledipasvir (SOF/LDV), sofosbuvir + simeprevir (SOF + SMV), simeprevir + pegylated interferon/ribavirin (SMV + PR) and no treatment (NT). For GT4 treatments, ombitasvir/paritaprevir/ritonavir + ribavirin (2D + R), SOF/LDV and NT were compared. Transition probabilities, utilities and costs were obtained from published literature. Outcomes included rates of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC) and liver-related death (LrD), total costs, life-years and quality-adjusted life-years (QALYs). Costs and QALYs were used to calculate incremental cost-effectiveness ratios. RESULTS: In GT1 patients, 3D ± R and SOF-containing regimens have similar long-term outcomes; 3D ± R had the lowest lifetime risks of all liver disease outcomes: CC = 30.2%, DCC = 5.0 %, HCC = 6.8%, LT = 1.9% and LrD = 9.2%. In GT1 patients, 3D ± R had the lowest cost and the highest QALYs. As a result, 3D ± R dominated these treatment options. In GT4 patients, 2D + R had lower rates of liver morbidity and mortality, lower cost and more QALYs than SOF/LDV and NT. LIMITATIONS: While the results are based on input values, which were obtained from a variety of heterogeneous sources-including clinical trials, the findings were robust across a plausible range of input values, as demonstrated in probabilistic sensitivity analyses. CONCLUSIONS: Among currently recommended treatments for GT1 and GT4 in the US, 3D ± R (for GT1) and 2D + R (for GT4) have a favorable cost-effectiveness profile.


Assuntos
Antivirais/economia , Antivirais/uso terapêutico , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , 2-Naftilamina , Adulto , Idoso , Idoso de 80 Anos ou mais , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/administração & dosagem , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Carcinoma Hepatocelular/economia , Carcinoma Hepatocelular/epidemiologia , Análise Custo-Benefício , Ciclopropanos , Quimioterapia Combinada , Feminino , Fibrose/economia , Fibrose/epidemiologia , Fluorenos/economia , Fluorenos/uso terapêutico , Genótipo , Humanos , Lactamas Macrocíclicas , Neoplasias Hepáticas/economia , Neoplasias Hepáticas/epidemiologia , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econométricos , Prolina/análogos & derivados , Anos de Vida Ajustados por Qualidade de Vida , Ribavirina/economia , Ribavirina/uso terapêutico , Simeprevir , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Uracila/análogos & derivados , Uracila/economia , Uracila/uso terapêutico , Valina
9.
Surg Infect (Larchmt) ; 17(4): 427-35, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26891115

RESUMO

BACKGROUND: Surgical site infections (SSI) occur in 1.8%-9.2% of women undergoing cesarean section (CS) and lead to greater morbidity rates and increased treatment costs. The aim of the study was to evaluate the efficacy and cost-effectiveness of dialkylcarbamoyl chloride (DACC) impregnated dressings to prevent SSI in women subject to CS. METHODS: Randomized, controlled trial was conducted at the Mazovian Bródno Hospital, a tertiary care center performing approximately 1300 deliveries per year, between June 2014 and April 2015. Patients were randomly allocated to receive either DACC impregnated dressing or standard surgical dressing (SSD) following skin closure. In order to analyze cost-effectiveness of the selected dressings in the group of patients who developed SSI, the costs of ambulatory visits, additional hospitalization, nursing care, and systemic antibiotic therapy were assessed. Independent risk factors for SSI were determined by multivariable logistic regression. RESULTS: Five hundred and forty-three women undergoing elective or emergency CS were enrolled. The SSI rates in the DACC and SSD groups were 1.8% and 5.2%, respectively (p = 0.04). The total cost of SSI prophylaxis and treatment was greater in the control group as compared with the study group (5775 EUR vs. 1065 EUR, respectively). Independent risk factors for SSI included higher pre-pregnancy body mass index (adjusted odds ratio [aOR] = 1.08; [95% confidence interval [CI]: 1.0-1.2]; p < 0.05), smoking in pregnancy (aOR = 5.34; [95% CI: 1.6-15.4]; p < 0.01), and SSD application (aOR = 2.94; [95% CI: 1.1-9.3]; p < 0.05). CONCLUSION: The study confirmed the efficacy and cost-effectiveness of DACC impregnated dressings in SSI prevention among women undergoing CS.


Assuntos
Anti-Infecciosos/administração & dosagem , Cesárea/efeitos adversos , Curativos Oclusivos , Infecção da Ferida Cirúrgica/prevenção & controle , Adulto , Assistência Ambulatorial/economia , Anti-Infecciosos/economia , Antibioticoprofilaxia , Carbamatos/administração & dosagem , Carbamatos/economia , Cesárea/economia , Análise Custo-Benefício , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Gravidez , Método Simples-Cego , Deiscência da Ferida Operatória/economia , Deiscência da Ferida Operatória/etiologia , Infecção da Ferida Cirúrgica/economia , Resultado do Tratamento , Adulto Jovem
10.
Health Policy ; 104(1): 27-31, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22136812

RESUMO

In Germany, coverage decisions in the statutory health insurance (SHI) system are based on the principles of evidence-based medicine. Recently, an evidence assessment by the Institute for Quality and Efficiency in Health Care (IQWiG) of the oral antidiabetics of the glinide class showed that their long-term benefit is not proven. Accordingly, the responsible Federal Joint Committee (G-BA) decided to exclude glinides from prescription in the SHI system. This was, however, objected to by the Ministry of Health, which is charged with legal supervision. We use this case to illustrate the path from evidence assessments to coverage decisions in Germany against the background of the latest health reform, which has changed the legal requirements for evidence assessments and the ensuing coverage decisions.


Assuntos
Carbamatos/economia , Cicloexanos/economia , Diabetes Mellitus/tratamento farmacológico , Política de Saúde , Hipoglicemiantes/economia , Cobertura do Seguro , Fenilalanina/análogos & derivados , Piperidinas/economia , Medicamentos sob Prescrição/economia , Controle de Custos , Análise Custo-Benefício , Custos e Análise de Custo , Definição da Elegibilidade , Medicina Baseada em Evidências , Alemanha , Reforma dos Serviços de Saúde/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Humanos , Nateglinida , Programas Nacionais de Saúde , Fenilalanina/economia , Mecanismo de Reembolso , Avaliação da Tecnologia Biomédica
11.
Health Care Anal ; 11(4): 279-86, 2003 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-14769009

RESUMO

In 2001 the Italian Government defined Essential Assistance Levels (LEA), which can be considered as an important step forward in the health care system. The Italian health care system would provide payment of essential and uniform aid services in order to safeguard many values such as human dignity, personal health, equal assistance and good health practices. The Ministry of Health has worked to rationalize the National Formulary and to define evaluation methods for drugs in order to choose what to reimburse without penalizing the rights of the individual and society. This paper describes how this job of rationalization was done and tries to illustrate the choices made in Italy by the use of two meaningful examples (statins and rivastigmine).


Assuntos
Medicamentos Essenciais/economia , Formulários Farmacêuticos como Assunto/normas , Alocação de Recursos para a Atenção à Saúde/organização & administração , Programas Nacionais de Saúde/organização & administração , Fenilcarbamatos , Anticolesterolemiantes/economia , Atorvastatina , Carbamatos/economia , Inibidores da Colinesterase/economia , Custos de Medicamentos , Medicamentos Essenciais/provisão & distribuição , Custos de Cuidados de Saúde , Alocação de Recursos para a Atenção à Saúde/ética , Política de Saúde , Ácidos Heptanoicos/economia , Humanos , Reembolso de Seguro de Saúde , Itália , Assistência Médica/ética , Assistência Médica/organização & administração , Programas Nacionais de Saúde/ética , Pirróis/economia , Rivastigmina
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