• Title/Summary/Keyword: Benefit assessment

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Evidence-Based Benefit-Risk Assessment of Medication (근거에 기반한 의약품의 유익성-위해성 평가)

  • Lee, Eui-Kyung
    • The Journal of Health Technology Assessment
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    • v.1 no.1
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    • pp.22-26
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    • 2013
  • Objectives: Balancing benefits and risks through the drug life cycle has been discussed for many decades. The objective of this study was to review the processes and tools currently proposed for benefit-risk assessment of medicinal drugs. It aimed to establish scientific and efficient drug safety management system based on the synthetic analysis of benefit-risk evidence. Methods: We conducted a review of exiting literatures published by regulatory agencies or initiatives. Not only quantitative methodologies but also qualitative method were compared to understand their key characteristics for the benefit and risk assessment of drugs. Results: Recently, benefit-risk assessments have more structured approaches to decision making as part of regulatory science. Regulatory agencies such as European Medicines Agency, FDA have prepared plans to apply benefit-risk assessment to regulatory decision making. Also many initiatives such as IMI (Innovative Medicine Initiative) have conducted research and published reports about benefit-risk assessment. For benefit-risk assessment, four kinds of methods are necessary. Frameworks such as BRAT (Benefit Risk Action Team) framework, PrOACT-URL provide guidance for the whole process of decision-making. Metrics are measurements of risk benefit. The estimation techniques are methods to synthesis and combine evidences from various sources. The utility survey techniques are necessary to explicit preferences of various outcome from stakeholders. Conclusion: There is the lack of widely accepted, validated model for benefit-risk assessment. Nor there is an agreement among academia, industry, and government on methods for the quantitative valuation. It is also limited by available evidence and underlying assumptions. Nevertheless, benefit-risk assessment is fundamental to improve transparency, consistency and predictability for decision making through the structured systematic approaches.

Pesticide Risk and Benefit Assessment

  • Birtley, Robin D.N.
    • Korean Journal of Weed Science
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    • v.13 no.4
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    • pp.195-202
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    • 1993
  • The benefits of pesticides in improving the food quantity and quality requirements for an increasing world population are significant, and they can be described in agronomic, economic and social terms. The risks are assessed from the hazards which are likely to occur in practice ; the hazards are defined by the toxicity of the pesticide to non-target organisms at various exposure levels. There are ways of reducing the risks (mainly by reducing exposure in practice) and improving the benefits of pesticides ; these are known as risk management and benefit management respectively. The overall risk-benefit assessment is facilitated if each component can be expressed in financial terms, but it must be made nationally or locally on a sound technical basis against the prevailing agronomic, socio-economic and political circumstances. Paraquat is used to illustrate the risk-benefit assessment process in general terms, and the conclusion is that the benefits greatly outweigh the risks. It is important to keep the risks of pesticides in perspective with those associated with other naturally occurring chemicals in our diet and with other everyday aspects of life. In an overall context, the pesticide risk is small.

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Impact of Selective Health Benefit on Medical Expenditure and Provider Behavior: Case of Gastric Cancer Surgery (선별급여 도입이 위암수술의 건강보험 진료비 및 진료행태에 미치는 영향)

  • Cho, Su-Jin;Ko, Jung-Ae;Choi, Yeonmi
    • Health Policy and Management
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    • v.26 no.1
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    • pp.63-70
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    • 2016
  • Background: Selective health benefit was introduced for decreasing economic burden of patients. Medical devices with economic uncertainty have been covered as selective health benefit by National Health Insurance since December 2013. We aimed to analyze impact of selective health benefit to medical expenditure and provider behavior focused on electrosurgery (ultrasonic shears, electrothermal bipolar vessel sealers) for gastric cancer patients covered since December 2014. Methods: We used the National Health Insurance claims data of 2,698 patients underwent gastric cancer surgery between August 2014 and March 2015. Medical cost and patient sharing per inpatient day were analyzed to verify that covering electrosurgery increased medical expenditure and changed provider behavior from open surgery to endoscopic or laparoscopic surgery. Additionally, we analyzed the claim rate of medical device or goods relating gastric endoscopic and laparoscopic surgery. Results: Medical cost and patient sharing per inpatient day were increased after covering electosurgery as selective health benefit (39,724/1,421 won). However, there were no medical expenditure increases after adjusting claim of electosurgery and patient sharing was decreased 1,057 won especially. The coverage of selective health benefit did not increase the claim rate of medical device or goods related endoscopic or laparoscopic surgery, either. Conclusion: Covering electosurgery decreased patient economic burden and did not change of provider behavior. Expanding selective health benefit is needed to decrease economic burden of severe patients. Further study should evaluate the long term effect with accumulated data.

Formal Fire Safety Assessment on Passenger Ships: Application of Cost-Benefit Analysis and Decision-Making Approach (여객선의 공식 화재안전 평가: 비용-이득 및 의사결정 평가)

  • Kim, Soo Woong
    • Journal of the Korean Society of Mechanical Technology
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    • v.13 no.2
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    • pp.21-29
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    • 2011
  • This paper examines the applicability of formal safety assessment to the passenger ships. This is followed by an analysis of passenger ship characteristics and a proposed formal safety assessment methodology. Five interlocking steps are described to construct a safety model including novel risk assessment, cost-benefit analysis and decision-making approaches. A case study is carried out in order to demonstrate the proposed methodology. Further development in formal safety assessment in the context of passenger ship safety is finally discussed in detail.

New Drug Listing Process and Reimbursement Standard Management (약제의 신규등재 절차와 급여기준 관리)

  • Yoon Kyeong Bai;Mi-Young You
    • Journal of Digestive Cancer Research
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    • v.11 no.2
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    • pp.104-107
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    • 2023
  • The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services. To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug's clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

Design and Application of an Analysis-frame Linking EIA and CBA (환경영향평가와 비용편익분석의 연계를 위한 분석 틀 설계 및 적용)

  • Ahn, So-Eun;Kim, Ji-Young
    • Journal of Environmental Impact Assessment
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    • v.20 no.4
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    • pp.565-574
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    • 2011
  • This paper aims to design a policy-assessment tool liking the Environmental Impact Assessment(EIA) and the Cost Benefit Analysis (CBA). As a step towards the incorporation of environmental and economic considerations, the approach used herein takes the form of integrating quantitative information on environmental benefits and costs associated with implementing the project into the existing framework of the EIA. Our case study is an project appraisal of a solar energy plant. It is confirmed that the technique is operational, however, there are certain limitations for a complete assessment. The difficulty mainly originated from the omission of important information from each step of the valuation process. Alternatively stated, some environmental services are not identified, nor quantified, and nor monetized in the process. More case studies are warranted in the future along with elaboration in methodology of techniques. In addition, the construction of a database on environmental values will be required to accumulate reliable and systematized data. These are the necessary conditions to improving quality in application of techniques as well as providing comprehensive and balanced information to decision makers.

A study on the Dynamic Cost-Benefit Analysis with System Dynamics: Modeling and Economic Feasibility (시스템 다이내믹스 기법을 활용한 동태적 비용편익분석 모델구축과 사업성 평가에 관한 연구)

  • 최남희;전재호
    • Korean System Dynamics Review
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    • v.3 no.2
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    • pp.113-140
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    • 2002
  • The cost-benefit analysis is a technique for assisting with decision about the use of society's scare resources. There exists no detailed assessment like cost-benefit analysis. But recently, many policy analysts criticized the merit of cost-benefit analysis. As it is, it can be said that partial or approximate estimates of benefit and cost may be more dangerous than helpful. The purpose of this study is to overcome the limit of traditional cost-benefit analysis. For this purpose, we use the system dynamics approach for setting up new cost-benefit analysis, which we named that ‘Dynamics Cost-Benefit Analysis'. The usefulness of ‘Dynamics Cost-Benefit Analysis' is as follows; finding structural causal relationship between cost factors and benefit factors, understanding the long-term behavior of systems economic feasibility. In this study, we apply 'Dynamic Cost-Benefit Analysis' to case that is construction investment of funeral house by local government sector.

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Analysis of Economical efficiency for renewable energy in Steam Power Plant (신재생에너지 적용에 따른 화력발전 경제성분석)

  • Choi, Kyoung-Sik
    • Journal of Environmental Impact Assessment
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    • v.23 no.1
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    • pp.11-17
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    • 2014
  • Since the Renewable Portfolio Standard (RPS) would be started in 2012, the use of renewable energy should be 11% of total energy use including bio-fuel in 2030. The economic efficiency for renewable energy in B power plant was considered with the bio-diesel, wind power and solar power. The Net Present Value (NPV) and Benefit/Cost Ratio(BC) were used for the economic efficiency with the cost and benefit analysis. In case of bio-diesel, the cost resulted from the fuel conversion and the benefit would be created with trade and environmental improvement. With regard to wind power and solar power, the construction cost would be required and benefit factors would be same as the bio-diesel. The wind power was the best of economic efficiency of renewable energy as the results of NPV and BC ratio. Whereas, the market of wind power was very popular and the techniques of wind power has been developing rapidly.

A Study on the Standards of Volatile Organic Compounds in Indoor Air of Office (사무실 실내공기중 휘발성유기화합물의 기준설정에 관한 연구)

  • Kim, Yoon-Shin;Lee, Cheol-Min;Roh, Young-Man;Lee, So-Dam;Sohn, Jong-Ryeul;Kim, Seok-Won
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.16 no.4
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    • pp.413-427
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    • 2006
  • It is necessary to study and develop guidelines for providing comfort and health indoor air quality for office workers since air-tight envelope system of current office building may cause poor indoor air quality. The purpose of this study is to propose guideline for volatile organic compounds in office base on the field study, human health risk assessment and cost-benefit analysis. The field study was conducted to survey the concentrations of volatile organic compounds in indoor air of 69 offices from June to September, 2005 in Seoul and Gyeonggi-do. The rate of excess to guideline of volatile organic compounds in indoor air of new apartment on the Ministry of Environment in Korea(MOE) was surveyed 37.6% for benzene, 6.8% for toluene, and 1.5% for ethylbenzene. As the result of human health risk assessment, mean cancer risk did not exceed 10-6 which is guideline of US.EPA. Also, total hazard index did not exceed 1 which is guideline of US.EPA. Through the cost-benefit analysis of angle on the social-economics to verify the necessary to establish the standards of volatile organic compounds for improvement and development of indoor air quality in office, the present value of benefit was higher than the present value of cost. With the above considerations in mind, it is suggested that the field study for indoor air quality in offices should be expanded and human health risk assessment and cost-benefit analysis be performed th offer scientific data for decision-making of policy for improvement and management of indoor air quality in office.

Hazard and Risk Assessment and Cost and Benefit Analysis for Revising Permissible Exposure Limits in the Occupational Safety and Health Act of Korea (산업안전보건법 허용기준 대상물질의 허용기준 개정을 위한 유해성·위험성 평가 및 사회적 비용·편익 분석)

  • Kim, Ki Youn;Oh, Sung Eop;Hong, Mun Ki;Lee, Kwon Seob
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.25 no.2
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    • pp.134-145
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    • 2015
  • Objectives: An objective of this study was to perform a risk assessment and social cost-benefit analysis for revising permissible exposure limits for seven substances: Nickel(Insoluble inorganic compounds), benzene, carbon disulfide, formaldehyde, cadmium(as compounds), trichloroethylene, touluene-2,4-diisocyanate. Materials and Methods: The research methods were divided into risk and hazard assessment and cost-benefit analysis. The risk and hazard assessment for the seven substances consists of four steps: An overview of GHS MSDS(1st), review of document of ACGIH's TLVs (2nd), comparison between international occupational exposure limits and domestic permissible exposure limits(3rd), and analysis of excess workplace and excess rate for occupational exposure limits based on previous work environment measurement data(4th). Total cost was estimated using cost of local exhaust ventilation, number of excess workplace and penalties for exceeding a permissible exposure limit. On the other hand, total benefit was calculated using the reduction rate of occupational disease, number of workplaces treating each substance and industrial accident compensation. Finally, the net benefit was calculated by subtracting total cost from total benefit. Results: All the substances investigated in this study were classified by CMR(Carcinogens, Mutagens or Reproductive toxicants) and their international occupational exposure limits were stricter than the domestic permissible exposure limits. As a result of excess rate analysis, trichloroethylene was the highest at 11%, whereas nickel was the lowest at 0.5%. The excess rates of all substances except for trichloroethylene were observed at less than 10%. Among the seven substances, the total cost was highest for trichloroethylene and lowest for carbon disulfide. The benefits for the seven substances were higher than costs estimated based on strengthening current permissible exposure limits. Thus, revising the permissible exposure limits of the seven substances was determined to be acceptable from a social perspective. Conclusions: The final revised permissible exposure limits suggested for the seven substances are as follows: $0.2mg/m^3$ for nickel, 0.5 ppm(TWA) and 2.5 ppm(STEL) for benzene, 1 ppm(TWA) for carbon disulfide, $0.01mg/m^3$(TWA) for cadmium, 10 ppm(TWA) and 25 ppm(STEL) for trichloroethylene, 0.3 ppm(TWA) for formaldehyde, and 0.005 ppm(TWA) and 0.02 ppm(STEL) for toluene diisocynate(isomers).