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1.
J Med Econ ; 26(1): 1357-1367, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37819734

RESUMO

AIMS: Left atrial appendage closure (LAAC) has been demonstrated to be cost-saving relative to oral anticoagulants for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) in the United States and Europe. This study assessed the cost-effectiveness of LAAC with the Watchman device relative to warfarin and direct oral anticoagulants (DOACs) for stroke risk reduction in NVAF from a Japanese public healthcare payer perspective. METHODS: A Markov model was developed with 70-year-old patients using a lifetime time horizon. LAAC clinical inputs were from pooled, 5-year PROTECT AF and PREVAIL trials; warfarin and DOAC inputs were from published meta-analyses. Baseline stroke and bleeding risks were from the SALUTE trial on LAAC. Cost inputs were from the Japanese Medical Data Vision database. Probabilistic and one-way sensitivity analyses were performed. RESULTS: Over the lifetime time horizon, LAAC was less costly than warfarin (savings of JPY 1,878,335, equivalent to US $17,600) and DOACs (savings of JPY 1,198,096, equivalent to US $11,226). LAAC also provided 1.500 more incremental quality-adjusted life years (QALYs) than warfarin and 0.996 more than DOACs. In probabilistic sensitivity analysis, LAAC was cost-effective relative to warfarin and DOACs in 99.98% and 99.73% of simulations, respectively. LAAC dominated (had higher cumulative QALYs and was less costly than) warfarin and DOACs in 89.94% and 83.35% of simulations, respectively. CONCLUSIONS: Over a lifetime time horizon, LAAC is cost-saving relative to warfarin and DOACs for stroke risk reduction in NVAF patients in Japan and is associated with improved quality-of-life.


This study examined the cost-effectiveness of left atrial appendage closure (LAAC) compared to oral anticoagulants for stroke risk reduction among individuals with a specific type of irregular heart rhythm called non-valvular atrial fibrillation (NVAF). This study evaluated the cost-effectiveness of LAAC using the Watchman device in comparison to warfarin and direct oral anticoagulants (DOACs) from the perspective of Japan's public healthcare system. To investigate this, a computer-based model was developed involving 70-year-old patients over their lifetime. Data from notable studies such as the PROTECT AF and PREVAIL trials (covering 5 years) for LAAC and published meta-analyses for warfarin and DOACs were incorporated into the model. Baseline stroke and bleeding risks were derived from the SALUTE trial on LAAC. Cost inputs were based on data from the Japanese Medical Data Vision database. Additionally, we performed thorough cost-effectiveness analyses, including probabilistic and one-way sensitivity assessments. Our findings revealed that, over a lifetime, LAAC was more cost-effective than both warfarin and DOACs. Further, LAAC contributed an additional 1.500 quality-adjusted life years (QALYs) compared to warfarin and 0.996 QALYs compared to DOACs. In the long-term, adopting LAAC as an alternative to warfarin and DOACs is a cost-effective strategy for reducing stroke risk in NVAF patients in Japan. Moreover, it is associated with enhanced quality-of-life. These findings hold significant implications for informing decision-making in healthcare policies and clinical practices for NVAF patients.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Varfarina/uso terapêutico , Análise Custo-Benefício , Japão , Apêndice Atrial/cirurgia , Anticoagulantes/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/complicações , Resultado do Tratamento
2.
PLoS One ; 16(7): e0253547, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34228745

RESUMO

OBJECTIVES: The aim of this study was to examine the cost-effectiveness of branded and authorized generic (AG) celecoxib for chronic pain patients with osteoarthritis (OA), rheumatoid arthritis (RA), and low back pain (LBP), using real-world cost information for loxoprofen and pharmacotherapy for gastrointestinal bleeding. METHODS: This cost-effectiveness analysis was performed as a long-term simulation using the Markov model from the Japanese public healthcare payer's perspective. The analysis was conducted using loxoprofen with real-world weighted price by branded/generic distribution (hereinafter, loxoprofen with weighted price) as a comparator. In the model, we simulated the prognosis of patients with chronic pain by OA, RA, and LBP treated with loxoprofen or celecoxib, over a lifetime period. RESULTS: A cost-increase of 129,688 JPY (1,245.00 USD) for branded celecoxib and a cost-reduction of 6,268 JPY (60.17 USD) for AG celecoxib were recognized per patient in lifetime horizon, compared to loxoprofen with weighted price. No case was recognized to reverse the results of cost-saving by AG celecoxib in one-way sensitivity analysis. The incremental cost-effectiveness ratio of branded celecoxib attained 5,403,667 JPY/QALY (51,875.20 USD/QALY), compared to loxoprofen with the weighted price. CONCLUSION: The current cost-effectiveness analysis for AG celecoxib revealed its good value for costs, considering the patients' future risk of gastrointestinal injury; also, the impact on costs due to AG celecoxib against loxoprofen will be small. It implies that the disadvantage of AG celecoxib being slightly more expensive than generic loxoprofen could be offset by the good cost-effectiveness during the prognosis.


Assuntos
Celecoxib/administração & dosagem , Dor Crônica/tratamento farmacológico , Medicamentos Genéricos/administração & dosagem , Gastroenteropatias/epidemiologia , Fenilpropionatos/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Celecoxib/efeitos adversos , Celecoxib/economia , Dor Crônica/diagnóstico , Simulação por Computador , Redução de Custos/estatística & dados numéricos , Análise Custo-Benefício , Custos de Medicamentos , Medicamentos Genéricos/efeitos adversos , Medicamentos Genéricos/economia , Feminino , Gastroenteropatias/induzido quimicamente , Gastroenteropatias/economia , Humanos , Japão , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econômicos , Fenilpropionatos/efeitos adversos , Fenilpropionatos/economia , Anos de Vida Ajustados por Qualidade de Vida , Medição de Risco/estatística & dados numéricos
4.
J Med Econ ; 23(4): 317-322, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31944134

RESUMO

Background: In Japan, pharmacoeconomic requirements for list-price adjustment were institutionalized in April 2019 following provisional implementation of a new Health Technology Assessment (HTA) program 2016-2019. Since April 2019, submission of cost-effectiveness evidence to the Central Social Insurance Medical Council (Chuikyo) as part of the Japanese Ministry of Health, Labour, and Welfare has been mandatory for selected pharmaceuticals and medical devices.Methods: Based on a review of publications and commentaries since April 2019, together with views from a group of experts on key issues to be addressed, this report provides an update on recent HTA developments and key challenges still to be addressed.Results and Discussion: Japan's new HTA program is a first step toward development of a universal healthcare system that can be sustainable for many years into the future. Currently, Japan's HTA program requires provision of incremental cost-effectiveness ratios (ICERs) as evidence, with quality-adjusted life years as the preferred outcome measure. Prices can be adjusted both upward and downward according to the degree of the ICER estimate. Japan is the first country to have adopted an algorithmic method for "ICER-based" pricing; however, HTA measures that extend beyond a single ICER estimate are needed to take full advantage of HTA in the future. In particular, generation of evidence of value should support changes to the healthcare system so that incentives for innovation are not diminished while industry and government are not overburdened by the generation or assessment of evidence. There is a need to ensure scientifically sound HTA expertise across all sectors in Japan, and therefore enhancement of HTA literacy and capability among healthcare professionals, academia, government, and industry should be a priority.


Assuntos
Avaliação da Tecnologia Biomédica , Comércio , Análise Custo-Benefício , Japão , Medicamentos sob Prescrição/economia
5.
Value Health Reg Issues ; 21: 39-44, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31634795

RESUMO

Health technology assessment (HTA) has long been employed by many countries around the world, but its adoption in Asia has been slower. Only recently have a growing number of Asian countries started to implement HTA for pricing and reimbursement decisions. The objective of this article is to provide an overview of how HTA has been or is being implemented in Asia within the context of a country's existing-and often complex-coverage, reimbursement, and pricing schemes. Three countries at different stages of HTA implementation were selected as case studies: South Korea, where there is a young yet established HTA program; Japan, where a 3-year HTA pilot program has just concluded; and China, where HTA efforts are underway but have not been formally implemented. Not only do the experiences of these 3 countries well exemplify how the organization and scope of HTA can be customized to meet a country's unique healthcare needs, but they also provide the opportunity to outline some common key challenges that must be overcome to implement and develop HTA competencies and capabilities.


Assuntos
Programas Nacionais de Saúde/tendências , Avaliação da Tecnologia Biomédica/métodos , Ásia , Custos e Análise de Custo/tendências , Humanos , Avaliação da Tecnologia Biomédica/tendências
6.
Expert Rev Pharmacoecon Outcomes Res ; 18(3): 339-348, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29039214

RESUMO

BACKGROUND: Drug price setting is one of the key challenges faced by the Japanese health care system. This study aims to identify the determinants of drug price in Japan using the example of the rheumatoid arthritis (RA) treatment market. RESEARCH DESIGN AND METHODS: In order to compare prices across different products, we calculated prices per defined daily dose using WHO methodology. Price determinants were calculated both at launch and over time using IMS quarterly data on medicines approved for RA treatment in Japan from 2012 to 2015. Pharmaceutical pricing was modeled as a function of clinical and economic variables using regression analysis. RESULTS: For prices at the launch we found that differences in efficacy are not reflected in price differentials. We also report that the number of products within a molecule class had a negative effect on prices while originator drugs maintained higher prices. CONCLUSION: Although the existing pricing rules in Japan are very comprehensive they do not necessarily capture differences in product characteristics. The findings here support the notion that competitive forces are weak in highly regulated markets such as Japan.


Assuntos
Antirreumáticos/economia , Artrite Reumatoide/tratamento farmacológico , Comércio , Farmacoeconomia , Antirreumáticos/administração & dosagem , Artrite Reumatoide/economia , Custos de Medicamentos , Competição Econômica , Humanos , Japão , Análise de Regressão
7.
Int J Technol Assess Health Care ; 33(1): 121-127, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28560939

RESUMO

OBJECTIVES: Japanese authorities have announced a plan to introduce a health technology assessment (HTA) system in 2016. This study assessed the potential impact of such a policy on the price of the antivirologic drug simeprevir. METHODS: Taking the antivirologic drug simeprevir as an example, we compared the current Japanese price with hypothetical prices that might result if a U.K. (cost-utility) or German (efficiency frontier) style HTA assessment was in place. RESULTS: The simeprevir unit price under the current Japanese pricing scheme is 13,122 Japanese yen (equivalent to 109.35 U.S. dollars as of April 2015). Depending on the selection of comparators and the pricing method, and assuming that HTA will be used as a basis for price setting, the estimated prices of simeprevir vary up to four times higher than under the current Japanese pricing scheme. CONCLUSIONS: Although the analysis is based on only one drug, it cannot be taken for granted that a new HTA system would reduce public healthcare expenditure in Japan.


Assuntos
Antivirais/economia , Simeprevir/economia , Avaliação da Tecnologia Biomédica , Comércio , Gastos em Saúde , Humanos , Japão
8.
Hepatol Res ; 46(5): 423-33, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26440999

RESUMO

AIM: Standard of care for chronic hepatitis C in Japan is currently a pegylated interferon (IFN)-α + ribavirin (PR)-based regimen, notably associated with efficacy and tolerability issues. The advent of novel direct-acting antivirals (DAA) has provided more efficacious and better tolerated treatments. This study investigated the cost-effectiveness of the daclatasvir + asunaprevir (DCV + ASV) DAA regimen in patients infected with hepatitis C virus (HCV) genotype 1b who had previously not responded to or were ineligible for IFN-containing regimens. METHODS: A cost-utility analysis using an established Markov model compared DCV + ASV with simeprevir + PR (SMV + PR), telaprevir + PR (TVR + PR) and no treatment using Japanese-specific model inputs, with costs and utility values discounted at 2%. A cohort of patients was simulated until death and predicted quality-adjusted life-years (QALY) and costs were estimated. A subgroup analysis of patients with no DCV resistance was conducted. RESULTS: In all scenarios, DCV + ASV was predicted to be dominant over the comparator; namely, DCV + ASV was associated with increased QALY gains and decreased cost. In patients treated during the chronic hepatitis C stage, cost reductions were ¥1 057 288-2 619 206, and in patients treated during the compensated cirrhosis (CC) stage, reductions were ¥1 032 224-2 531 930. QALY gains were 0.749-2.609 and 0.874-3.043, respectively. Results improved when considering the subgroup of patients without DCV resistance. CONCLUSION: Cost-effectiveness conclusions are similar for patients treated in the chronic hepatitis C and CC disease stages, with DCV + ASV expected to be cost-saving versus standard of care in Japan for patients with HCV genotype 1b patients who have failed prior therapy or are IFN-ineligible/intolerant.

9.
PLoS One ; 10(11): e0141993, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26560127

RESUMO

BACKGROUND: Health technology assessment (HTA) has been continuously used for value-based healthcare decisions over the last decade. Healthcare databases represent an important source of information for HTA, which has seen a surge in use in Western countries. Although HTA agencies have been established in Asia-Pacific region, application and understanding of healthcare databases for HTA is rather limited. Thus, we reviewed existing databases to assess their potential for HTA in Thailand where HTA has been used officially and Japan where HTA is going to be officially introduced. METHOD: Existing healthcare databases in Thailand and Japan were compiled and reviewed. Databases' characteristics e.g. name of database, host, scope/objective, time/sample size, design, data collection method, population/sample, and variables were described. Databases were assessed for its potential HTA use in terms of safety/efficacy/effectiveness, social/ethical, organization/professional, economic, and epidemiological domains. Request route for each database was also provided. RESULTS: Forty databases- 20 from Thailand and 20 from Japan-were included. These comprised of national censuses, surveys, registries, administrative data, and claimed databases. All databases were potentially used for epidemiological studies. In addition, data on mortality, morbidity, disability, adverse events, quality of life, service/technology utilization, length of stay, and economics were also found in some databases. However, access to patient-level data was limited since information about the databases was not available on public sources. CONCLUSION: Our findings have shown that existing databases provided valuable information for HTA research with limitation on accessibility. Mutual dialogue on healthcare database development and usage for HTA among Asia-Pacific region is needed.


Assuntos
Bases de Dados Factuais/estatística & dados numéricos , Atenção à Saúde/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde/métodos , Avaliação da Tecnologia Biomédica/métodos , Atenção à Saúde/métodos , Humanos , Japão , Auditoria Médica/métodos , Auditoria Médica/estatística & dados numéricos , Saúde Pública/métodos , Saúde Pública/estatística & dados numéricos , Reprodutibilidade dos Testes , Tailândia
10.
Clin Ther ; 37(12): 2837-51, 2015 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-26608819

RESUMO

PURPOSE: The aim of this study was to evaluate the cost-effectiveness of apixaban compared with to warfarin, current standard of care, for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan. METHODS: A previously published lifetime Markov model was adapted to evaluate the cost-effectiveness of apixaban compared with warfarin in patients with NVAF in Japan. In the same model, the costs associated with each clinical event and background mortality were replaced with Japanese data. Whenever available, some of the utility parameters were derived from Japanese published literature. Lifetime horizon was selected to evaluate the value of the treatment benefit (stroke prevention) against potential risks (such as major bleedings) among patients with NVAF. Direct medical cost, long-term care cost, and quality-adjusted life years (QALYs) were calculated from the payers' perspective. FINDINGS: Compared with warfarin, treatment with apixaban was estimated to increase life expectancy by 0.231 year or 0.240 QALYs while treatment cost increased by ¥511,692 (US $5117 at an exchange rate of US $1 = ¥100). The incremental cost-effectiveness ratio was ¥2,135,743 per QALY (US $21,357 per QALY). On the basis of the results of the probabilistic sensitivity analysis, when the willingness-to-pay threshold was set at approximately ≥¥2,250,000 (US $22,500) per QALY, the probability of apixaban being cost-effective was ≥50%. Assuming a willingness-to-pay threshold of ¥5,000,000 (US $50,000) and ¥6,700,000 (US $67,000) in Japan, the probability of apixaban being cost-effective was 85% and 91%, respectively. CONCLUSION: Although most participants in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial used for the efficacy data of apixaban in the model were non-Japanese patients, the impact of the limitations on our results was considered small, and our results were deemed robust because of the additional effect in Japanese patients compared with that in the global population according to the subanalysis of Japanese patients in the trial. Therefore, based on an adaptation of a published Markov model, apixaban is a cost-effective alternative to warfarin in Japan for stroke prevention among patients with NVAF.


Assuntos
Anticoagulantes , Fibrilação Atrial/epidemiologia , Pirazóis , Piridonas , Acidente Vascular Cerebral , Varfarina , Idoso , Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Análise Custo-Benefício , Feminino , Humanos , Japão/epidemiologia , Pirazóis/economia , Pirazóis/uso terapêutico , Piridonas/economia , Piridonas/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Varfarina/economia , Varfarina/uso terapêutico
11.
Kobe J Med Sci ; 61(1): E9-18, 2015 Mar 24.
Artigo em Inglês | MEDLINE | ID: mdl-25868612

RESUMO

New schemes on the cost-effectiveness acceptability curve (CEAC) were developed, which can make the CEAC augmented to be more informative regarding the types of acceptance and statistical inference. Theoretical approaches have been undertaken to address two questions: 1) how the area under the curve (AUC) can be zoned by different types of acceptance displayed on the incremental cost-effectiveness plane, and 2) how the accepted dataset of incremental cost-effectiveness ratios (ICERs), which are generated by simulation runs, can be statistically associated with a threshold of ICER for acceptance. To address the first question, the AUC of a typically sigmoid-shaped CEAC was divided into three zones according to the three segmentations of the scattered plots accepted at South-east, North-east and South-west quadrants on the incremental cost-effectiveness plane. A solution for the second question was "a new CEAC of the mean" (mCEAC), which is defined by plotting a pair of the mean and its occurrence probability of ICER accepted at North-east quadrant on the incremental cost-effectiveness plane. All those schemes were graphically illustrated based on hypothetical examples using the bootstrapping simulation. Our new schemes on CEAC will provide decision makers with useful information on cost-effectiveness assessment beyond the standard presentation of CEAC.


Assuntos
Análise Custo-Benefício/métodos , Avaliação da Tecnologia Biomédica/métodos , Área Sob a Curva
12.
J Med Econ ; 17(8): 547-54, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24826807

RESUMO

OBJECTIVES: The value of a health technology can be measured in terms of cost and benefit on two-dimensional co-ordinates. This study is to quantitatively analyze the correlation and to conduct a regression on the X-Y plane constituted by cost and QALYs (quality-adjusted life years) associated with the first line treatment, the maintenance treatment, and the second line treatment for non-small cell lung cancer (NSCLC). METHODS: The cost-effectiveness data of the cost and QALYs were extracted, with respect to the three categories of the NSCLC treatment, from the CEA Registry at Tufts Medical Center, regarding the literature published from 2000-2011. As a result, 44 QALY-cost ratios were identified. RESULTS: Based on those extracted data, the correlation and regression analyses were performed by mathematical model using log and square-root functions. The plotted ratios stratified by the three stages for the NSCLC treatment were visually grouped into three clusters. There were statistically significant differences among the correlation coefficients of the cluster. In regression, the log model was found to be better fitted than the square-root model; formulating QALY = -1.12 + 0.16 log(Cost), -1.99 + 0.28 log(Cost), and -0.69 + 0.10 log(Cost) for the first line, the maintenance, and the second line treatment, respectively. Monetary units were standardized to 2008 US dollars. CONCLUSION: A good methodological potential was confirmed so as to assess the Incremental Cost Effectiveness Ratio (ICER) variations, considering stratification by multiple factors such as disease and treatment categories. This study has certain limitations, such as the small number of included articles and the stratification, not reflecting a factor of new genetic findings.


Assuntos
Antineoplásicos/economia , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Análise Custo-Benefício/métodos , Anos de Vida Ajustados por Qualidade de Vida , Antineoplásicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/economia , Feminino , Humanos , Masculino , Sistema de Registros , Análise de Regressão
13.
PLoS One ; 9(1): e86070, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24465875

RESUMO

BACKGROUND: The World Health Organization has called for global and regional assessments of the burden of hepatitis C (HCV) along with country-specific patient profiles to better inform healthcare policy. The present investigated the characteristics and burden of patients reporting a diagnosis of HCV infection in the US, France, Germany, Italy, Spain, the UK, urban China, and Japan using a consistent methodology of patient-reported surveys. METHODS: The 2010 5EU (N = 57,805), 2009 US (N = 75,000), 2008/2009 Japan (N = 37,683), and 2009/2010 urban China (N = 33,261) waves of the National Health and Wellness Survey were used as the data source. Within each country, patients with a self-reported diagnosis of HCV were compared with those who did not report a diagnosis of HCV on sociodemographics, health behaviors, comorbidities, and health outcomes (e.g., Short Form-12v2). The effect of HCV was examined using regression analysis applying sampling weights. RESULTS: The prevalence of HCV ranged from 0.26% (China) to 1.42% (Italy). Patients in Japan and Italy (61.60 and 61.02 years, respectively) were the oldest, while patients in the US were the most likely to be obese (39.31%) and have concomitant anxiety (38.43%) and depression (46.05%) compared with other countries. Pooling countries and adjusting for sociodemographics, health behaviors, and comorbidities, HCV was associated with significantly lower physical component summary scores (b = -2.51) and health utilities (b = -0.04) and greater overall work impairment (b = 8.79), physician visits (b = 2.91), and emergency department visits (b = 0.30) (all p<.05). The effects on health status were strongest in the US and UK while the effects on healthcare resource use were strongest in Japan. CONCLUSIONS: HCV was associated with a significant humanistic and economic burden. These results suggest that the manifestation of the HCV burden, and the profile of the patients themselves, varied dramatically by country. Successful disease management should be cognizant of region-specific unmet needs.


Assuntos
Efeitos Psicossociais da Doença , Conhecimentos, Atitudes e Prática em Saúde , Inquéritos Epidemiológicos/estatística & dados numéricos , Hepacivirus/fisiologia , Hepatite C Crônica/diagnóstico , Hepatite C Crônica/epidemiologia , Internacionalidade , Demografia , Eficiência , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Nível de Saúde , Hepatite C Crônica/economia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade
14.
Value Health Reg Issues ; 3: 136-145, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-29702919

RESUMO

OBJECTIVES: Japan has one of the highest endemic rates of hepatitis C virus (HCV) infection. Treatments in Japan are currently limited to interferon-alfa-based regimens, which are associated with tolerability and efficacy issues. A novel regimen combining two oral HCV therapies, daclatasvir and asunaprevir (DCV + ASV), has shown favorable results in Japanese patients with chronic genotype 1b HCV infection. Comparisons of clinical and economic outcomes associated with DCV + ASV treatment and current standards of care were investigated. METHODS: The MOdelling the NAtural histoRy and Cost-effectiveness of Hepatitis cost-effectiveness model projected outcomes in 1000 patients aged 70 years with either chronic hepatitis C or compensated cirrhosis over a lifetime simulation. Japanese-specific disease transition rates were used, and discounting was applied annually at a rate of 2%. Efficacy data for DCV + ASV and telaprevir triple therapy (telaprevir + pegylated interferon-alfa + ribavirin [TVR + pegIFN-α/RBV]) were obtained from a Japanese subgroup analysis found within a global meta-analysis: sustained virological response rates of 74%, 85%, and 87% were reported for null responders (NRs), partial responders (PRs), and interferon-alfa-ineligible/intolerant patients, respectively, treated with DCV + ASV, and rates of 42% and 59% were reported for NRs and PRs, respectively, treated with TVR + pegIFN-α/RBV. RESULTS: Initiating DCV + ASV treatment in patients in the chronic hepatitis C disease stage resulted in quality-adjusted life-year gains of 0.96 and 0.77 over TVR + pegIFN-α/RBV for NRs and PRs, respectively, and a gain of 2.61 in interferon-alfa-ineligible/intolerant patients over no treatment. Similarly, quality-adjusted life-year gains of 1.11, 0.90, and 3.05 were observed when initiating treatment in patients in the compensated cirrhosis stage. Cumulative lifetime events of decompensated cirrhosis, hepatocellular carcinoma, and liver-related mortality were reduced by up to 66, 115, and 128, respectively, with DCV + ASV treatment. CONCLUSIONS: There is a lack of successful therapies for patients with HCV who have previously failed to achieve sustained virological response or are ineligible for interferon-alfa-based therapies. Results demonstrate that the provision of an alternative, interferon-alfa-free regimen, such as DCV + ASV, offers significant value in terms of avoiding life-threatening liver complications and increasing patients' quality of life.

15.
Rinsho Ketsueki ; 53(3): 310-7, 2012 Mar.
Artigo em Japonês | MEDLINE | ID: mdl-22499047

RESUMO

The aim of this study was to assess the cost-effectiveness of azacitidine therapy for patients with myelodysplastic syndromes. A Markov model was developed to estimate the total additional direct cost and quality adjusted life years (QALYs) gained with azacitidine therapy versus best-supportive care in patients with high-risk MDS. The cost-effectiveness of azacitidine was evaluated with incremental cost-effectiveness ratio, which represents the additional cost per QALY gained from the more effective treatment. Azacitidine therapy was 1.83 million yen more costly per patient but yielded an additional 0.353 QALYs. The ICER (Increment of Cost-effectiveness Ratio) was 5.18 million yen per QALY. In conclusion, because the ICER was less than the threshold for acceptable cost-effectiveness in Japan, azacitidine therapy for MDS patient was assumed to be cost-effective.


Assuntos
Antimetabólitos Antineoplásicos/economia , Antimetabólitos Antineoplásicos/uso terapêutico , Azacitidina/economia , Azacitidina/uso terapêutico , Síndromes Mielodisplásicas/tratamento farmacológico , Síndromes Mielodisplásicas/economia , Análise Custo-Benefício , Humanos , Japão
16.
Am J Kidney Dis ; 60(2): 262-71, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22445709

RESUMO

BACKGROUND: Cinacalcet effectively reduces elevated levels of parathyroid hormone (PTH) in patients with secondary hyperparathyroidism (SHPT), even those with severe disease for whom parathyroidectomy can be the treatment of choice. The objective of this study was to estimate the cost-effectiveness of cinacalcet treatment in hemodialysis patients with severe SHPT in Japan. STUDY DESIGN: Cost-effectiveness analysis. SETTING & POPULATION: Patients with severe SHPT (intact PTH >500 pg/mL) who were receiving hemodialysis in Japan. MODEL, PERSPECTIVE, & TIMEFRAME: A Markov model was constructed from the health care system perspective in Japan. Patients were followed up over their lifetime. Dialysis costs were not included in the base case. INTERVENTION: Cinacalcet as an addition to conventional treatment compared to conventional treatment alone. In both arms, patients underwent parathyroidectomy if intact PTH level was >500 pg/mL for 6 months and they were eligible for surgery. OUTCOMES: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: ICERs for cinacalcet for those who were eligible for surgery and those who were not were $352,631/QALY gained and $21,613/QALY gained, respectively. Sensitivity and scenario analyses showed that results were fairly robust to variations in model parameters and assumptions. In the probabilistic sensitivity analysis, cinacalcet was cost-effective in only 0.9% of simulations for those eligible for surgery, but in more than 99.9% of simulations for those ineligible for surgery, if society would be willing to pay $50,000 per additional QALY. LIMITATIONS: Data for the long-term effect of cinacalcet on patient-level outcomes are limited. The model predicted rates for clinical events using data for the surrogate biochemical end points. CONCLUSIONS: The use of cinacalcet to treat severe SHPT is likely to be cost-effective for only those who cannot undergo parathyroid surgery for medical or personal reasons.


Assuntos
Hiperparatireoidismo Secundário/tratamento farmacológico , Naftalenos/economia , Naftalenos/uso terapêutico , Idoso , Cinacalcete , Análise Custo-Benefício , Custos e Análise de Custo , Feminino , Humanos , Hiperparatireoidismo Secundário/economia , Hiperparatireoidismo Secundário/etiologia , Japão , Falência Renal Crônica/complicações , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Método de Monte Carlo , Paratireoidectomia , Anos de Vida Ajustados por Qualidade de Vida , Diálise Renal
17.
Value Health ; 15(1 Suppl): S65-71, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22265070

RESUMO

OBJECTIVE: Viral hepatitis C (HCV) affects 170 million patients worldwide and 2 million patients in Japan. The objective of the current study was to examine the burden of HCV in Japan from a patient's perspective. METHODS: Using data from the 2008 and 2009 Japan National Health and Wellness Surveys, patients who reported an HCV diagnosis (n = 306) were compared with a propensity-score-matched control group (n = 306) on measures of quality of life (using the Medical Outcomes Study 12-Item Short Form Survey Instrument version 2), work productivity (using the Work Productivity and Activity Impairment questionnaire), and health-care resource use. All analyses applied sampling weights to project to the population. RESULTS: Prior to matching, patients with HCV had higher rates of hepatocellular carcinoma (4.88% vs. 0.02%) and cirrhosis (12.20% vs. 0.11%) than did subjects without HCV. The propensity-matching process eliminated differences between the two groups on demographics and patient characteristics. The postmatching analysis found significantly lower levels of quality of life for patients with HCV as measured by bodily pain (72.07 vs. 76.28), general health (44.64 vs. 48.61), and mental health (66.50 vs. 70.32) (all Ps < 0.05). Furthermore, compared with the matched group, the HCV group had significantly higher workplace absenteeism (8.59% vs. 4.12%), overall work impairment (26.08% vs. 17.32%), and health-care provider visits in the past 6 months (14.80 vs. 9.74). CONCLUSIONS: The results of this study suggest that HCV can be a substantial burden on patients in terms of quality of life in both physical and mental health measures. In addition, HCV can be a significant cost driver in terms of health-care use and lost productivity.


Assuntos
Efeitos Psicossociais da Doença , Hepatite C/economia , Qualidade de Vida , Absenteísmo , Adolescente , Adulto , Idoso , Carcinoma Hepatocelular/economia , Carcinoma Hepatocelular/etiologia , Eficiência , Feminino , Serviços de Saúde/estatística & dados numéricos , Nível de Saúde , Hepatite C/complicações , Humanos , Japão/epidemiologia , Cirrose Hepática/economia , Cirrose Hepática/etiologia , Neoplasias Hepáticas/economia , Neoplasias Hepáticas/etiologia , Masculino , Saúde Mental , Pessoa de Meia-Idade , Adulto Jovem
18.
Clin J Am Soc Nephrol ; 6(6): 1375-84, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21551021

RESUMO

BACKGROUND AND OBJECTIVES: Lanthanum carbonate (LC) is a nonaluminum, noncalcium phosphate binder that is effective for hyperphosphatemia in dialysis patients. However, its efficacy and cost-effectiveness as second-line therapy have not been fully examined. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We first conducted a multicenter, open-label, 16-week clinical trial to examine the effect of additive LC in 116 hemodialysis patients who had uncontrolled hyperphosphatemia with conventional phosphorus-lowering therapy alone. Based on these clinical data, a state transition model was developed to evaluate the benefits and costs associated with LC as second-line therapy. Reduced risks for cardiovascular morbidity and mortality among patients treated with LC arise through more of the population achieving the target phosphorus levels. Uncertainty was explored through sensitivity analysis. RESULTS: After 16 weeks of additive LC treatment, mean serum phosphorus levels decreased from 7.30 ± 0.90 to 5.71 ± 1.32 mg/dl, without significant changes in serum calcium or intact parathyroid hormone levels. A subsequent cost-effectiveness analysis showed that compared with conventional treatment, additive LC incurred an average additional lifetime cost of $22,054 per person and conferred an additional 0.632 quality-adjusted life years (QALYs). This resulted in an incremental cost-effectiveness ratio of $34,896 per QALY gained. Applying a cost-effectiveness threshold of $50,000 per QALY, a probabilistic sensitivity analysis showed that additive LC had a 97.4% probability of being cost-effective compared with conventional treatment. CONCLUSIONS: Our results indicate that the use of LC as second-line therapy would be cost-effective among hemodialysis patients with uncontrolled hyperphosphatemia in Japan.


Assuntos
Quelantes/economia , Quelantes/uso terapêutico , Custos de Medicamentos , Hiperfosfatemia/tratamento farmacológico , Falência Renal Crônica/terapia , Lantânio/economia , Lantânio/uso terapêutico , Fósforo/sangue , Diálise Renal , Adolescente , Adulto , Idoso , Análise de Variância , Biomarcadores/sangue , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/prevenção & controle , Análise Custo-Benefício , Feminino , Humanos , Hiperfosfatemia/sangue , Hiperfosfatemia/economia , Hiperfosfatemia/etiologia , Japão , Falência Renal Crônica/sangue , Falência Renal Crônica/complicações , Falência Renal Crônica/economia , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Diálise Renal/efeitos adversos , Diálise Renal/economia , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
19.
J Med Econ ; 14(2): 187-93, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21332273

RESUMO

OBJECTIVES: To investigate how the cost effectiveness of preventing HIV/AIDS varies across possible efficiency frontiers (EFs) by taking into account potentially relevant external factors, such as prevention stage, and how the EFs can be characterized using regression analysis given uncertainty of the QALY-cost estimates. METHODS: We reviewed cost-effectiveness estimates for the prevention and treatment of HIV/AIDS published from 2002-2007 and catalogued in the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. We constructed efficiency frontier (EF) curves by plotting QALYs against costs, using methods used by the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany. We stratified the QALY-cost ratios by prevention stage, country of study, and payer perspective, and estimated EF equations using log and square-root models. RESULTS: A total of 53 QALY-cost ratios were identified for HIV/AIDS in the Tufts CEA Registry. Plotted ratios stratified by prevention stage were visually grouped into a cluster consisting of primary/secondary prevention measures and a cluster consisting of tertiary measures. Correlation coefficients for each cluster were statistically significant. For each cluster, we derived two EF equations - one based on the log model, and one based on the square-root model. DISCUSSION: Our findings indicate that stratification of HIV/AIDS interventions by prevention stage can yield distinct EFs, and that the correlation and regression analyses are useful for parametrically characterizing EF equations. Our study has certain limitations, such as the small number of included articles and the potential for study populations to be non-representative of countries of interest. Nonetheless, our approach could help develop a deeper appreciation of cost effectiveness beyond the deterministic approach developed by IQWiG.


Assuntos
Infecções por HIV/economia , Infecções por HIV/prevenção & controle , Anos de Vida Ajustados por Qualidade de Vida , Análise de Regressão , Análise Custo-Benefício , Infecções por HIV/psicologia , Humanos , Modelos Estatísticos , Qualidade de Vida/psicologia , Estados Unidos
20.
Pharmacoeconomics ; 28(10): 831-8, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20831290

RESUMO

Asian healthcare systems are very diverse, representing cultures, political systems and economies from more than 30 countries with varying histories. Despite the diversity in the region, there has been enormous growth in health economics and outcomes research since the beginning of the 21st century. Whilst Japan has seen very limited use of health technology assessment (HTA), South Korea, Taiwan and Thailand have had remarkable success in establishing government agencies for HTA, employing HTA concepts from the UK National Institute for Health and Clinical Excellence (NICE). These three countries are driven by the following common factors: (i) a desire to establish universal healthcare insurance coverage in their respective nations; (ii) the need for rational allocation of scarce resources; (iii) a desire for government to provide leadership in HTA; and (iv) availability of HTA professionals and faculties through international networks. The HTA models introduced by these three countries are both similar to and different from those of HTA agencies in Europe, but might work well as examples for other countries in the region.


Assuntos
Atenção à Saúde/economia , Farmacoeconomia , Mecanismo de Reembolso/organização & administração , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/organização & administração , Custos e Análise de Custo , Humanos , Cobertura do Seguro/economia , Japão , Programas Nacionais de Saúde/economia , Desenvolvimento de Programas/economia , República da Coreia , Taiwan , Tailândia
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