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1.
Value Health Reg Issues ; 21: 164-171, 2020 Jan 21.
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.

2.
Adv Ther ; 37(1): 457-476, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31808054

RESUMO

INTRODUCTION: The objective of the study was to evaluate the cost-effectiveness of glecaprevir/pibrentasvir versus other direct-acting antivirals (DAAs) for treating chronic hepatitis C virus (HCV) infections in Japan. METHODS: We developed a health state transition model to capture the natural history of HCV. A cost-effectiveness analysis of DAAs from the perspective of a public healthcare payer in Japan with a lifetime horizon over annual cycles was performed. Treatment attributes, baseline demographics, transition probabilities, health-state utilities, and costs data were extracted from publications. Costs and outcomes were discounted at 2% per annum. In the base case we focused on genotype 1 (GT1) treatment-naïve patients without cirrhosis. The scenario analysis examined a pan-genotype treatment in GT1-3 (i.e., portfolio), treatment-naïve, and treatment-experienced patients. The portfolio cost-effectiveness of DAAs was derived by calculating a weighted average of patient segments defined by treatment history, cirrhosis status, and genotype. RESULTS: The base case results indicated that glecaprevir/pibrentasvir was dominant (i.e., generating higher quality-adjusted life years [QALYs] and lower lifetime costs) compared to all other DAAs. The predicted lifetime risk of hepatocellular carcinoma was 3.66% for glecaprevir/pibrentasvir and sofosbuvir/ledipasvir, 4.99% for elbasvir/grazoprevir, and 5.27% for daclatasvir/asunaprevir/beclabuvir. In scenario analysis the glecaprevir/pibrentasvir (GLE/PIB) portfolio dominated the sofosbuvir (SOF)-based portfolio (namely sofosbuvir/ledipasvir in GT1-2 and sofosbuvir + ribavirin in GT3). The base case probabilistic sensitivity analysis (PSA) showed that glecaprevir/pibrentasvir was cost-effective in 93.4% of the simulations for a willingness-to-pay/QALY range of Japanese yen (JPY) 1.6-20 million. The PSA for the portfolio scenario indicated that the GLE/PIB portfolio was cost-effective in 100% of simulations until the willingness-to-pay/QALY reached JPY 5.2 million; this proportion decreased to 69.4% at a willingness-to-pay/QALY of JPY 20 million. Results were also robust in deterministic sensitivity analyses. CONCLUSION: In GT1 treatment-naïve non-cirrhotic patients GLE/PIB was a cost-effective strategy compared to other DAAs. When a pan-genotypic framework was used, the GLE/PIB portfolio dominated the SOF-based portfolio.

3.
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 , Quimioterapia Combinada , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Modelos Econômicos
4.
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 , 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 , Progressão da Doença , Quimioterapia Combinada , Fluorenos/economia , Fluorenos/uso terapêutico , Genótipo , Hepacivirus/genética , Humanos , Interferon-alfa/economia , Interferon-alfa/uso terapêutico , 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 , 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
5.
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 , Adulto , Quimioterapia Combinada , Feminino , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Ritonavir , Uracila/economia , Uracila/uso terapêutico
6.
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 , 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 , Quimioterapia Combinada , Feminino , Fibrose/economia , Fibrose/epidemiologia , Fluorenos/economia , Fluorenos/uso terapêutico , Genótipo , Humanos , Neoplasias Hepáticas/economia , Neoplasias Hepáticas/epidemiologia , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econométricos , 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
7.
Am J Manag Care ; 11 Spec No: SP14-20, 2005 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-15700905

RESUMO

OBJECTIVE: To determine the extent to which the strictness of the criteria used to control utilization of drugs not on a Medicaid preferred drug list (PDL) changes physician prescribing habits for non-Medicaid patients. STUDY DESIGN: Quasi-experimental design based on different timing of states' enactment of PDLs for cardiovascular medications. METHODS: A regression model was developed to analyze the effect that PDL implementation had on off-PDL product market share across 3 patient types (Medicaid, third-party insurance, and cash paying). The models included data from 2 states (Illinois and Louisiana) with different PDL prior-authorization criteria. The data allowed examination of different physician responses according to the proportion of Medicaid patients treated by the physician. The analysis also followed prescribing patterns longitudinally to determine whether the PDL-induced prescribing behaviors changed over time. RESULTS: There was a decrease of 9 percentage points (67.7%) and 6.2 percentage points (40.5%) in the Medicaid prescription share of restricted cardiovascular drugs post-PDL for Illinois and Louisiana, respectively. In the third-party insurance market, prescription shares of off-PDL drugs decreased 0.9 percentage points (6.8%) in Illinois and 1.3 percentage points (8.6%) in Louisiana. For physicians with a high percentage of prescriptions paid for by Medicaid, the share loss for off-PDL drugs was estimated to be more than 37% for the non-Medicaid portion of the practice. CONCLUSION: The effects of a Medicaid PDL on prescribing behavior extend beyond the Medicaid population. The health outcomes and economic consequences of these "spillover" effects are poorly understood and warrant further research.


Assuntos
Fármacos Cardiovasculares/provisão & distribução , Prescrições de Medicamentos , Uso de Medicamentos/tendências , Formulários Farmacêuticos como Assunto , Medicaid/legislação & jurisprudência , Padrões de Prática Médica/tendências , Afro-Americanos , Fármacos Cardiovasculares/economia , Fármacos Cardiovasculares/uso terapêutico , Uso de Medicamentos/economia , Pesquisa sobre Serviços de Saúde , Humanos , Illinois , Seguro Saúde , Louisiana , Mississippi , Modelos Econométricos , New York , Padrões de Prática Médica/economia , Análise de Regressão , Estados Unidos
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