• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.14 no.1
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• pp.151-166
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• 2019

New drug development requires 10 to 15 years of long time and more than $ 1 billion in funding, ranging from basic research${\rightarrow}$preclinical medicine${\rightarrow}$clinical medicine${\rightarrow}$product approval${\rightarrow}$sales. Many new drug development bio-venture companies will continue to pursue new drug development with funds secured through listing on the securities market. This study focuses on the impact of the listing on the market of bio-venture companies in the development of new drugs. It is necessary to determine whether the increase in registered patent, preclinical, clinical and technology transfer contracts at the time of listing (D) The results of this study are as follows. We also analyzed whether the registered patent, preclinical, and clinical effects had significant effect on technology transfer contracts at two years after listing and listing. The results of the analysis are as follows. First, Korea's new drug development bio-venture firms increased their registered patents but did not increase their pre-clinical, clinical and technology transfer contracts. Second, at the time of listing and two years after listing, pre-employment has a significant effect on Korea's technology transfer contracts and has a significant effect on overseas technology transfer contracts. However, registered patents and clinics have significant influence on technology transfer contracts. Korea 's new drug development bio-venture firms showed patent increase despite the stock market listing, but pre-clinical, clinical and technology transfer contracts did not increase. In order to strengthen technological commercialization of new drug development bio-venture companies in the future, it is required to establish R & D strategy for efficient use of IPO subscription funds, open innovation through strengthening industry-academia-partnerships, and more sophisticated preclinical and clinical strategy establishment.

• Korean Journal of Clinical Pharmacy
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• v.25 no.2
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• pp.120-129
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• 2015

Objectives: Drug utilization review program in Korea has provided 'drug combinations to avoid (DCA)' alerts to physicians and pharmacists to prevent potential adverse drug events or inappropriate drug use. Seven hundred and six DCA pairs have been announced officially by the Ministry of Food and Drug Safety (MFDS) by March, 2015. Some DCA pairs could be grouped based on the drug interaction mechanism and its consequences. This study aimed to investigate the drug-drug interaction (DDI) pairs, which may be potential DCAs, generated by the drug class-drug class interaction method. Methods: Eleven additive/synergistic and one antagonistic drug class-drug class interaction groups were identified. By combining drugs of two interacting drug class groups, numerous DDI pairs were made. The status and severity of DDI pairs were examined using Lexicomp and Micromedex. Also, the DCA listing rate was calculated. Results: Among 258 DDI pairs generated by the drug class-drug class interaction method, only 142 pairs were identified as official DCA pairs by the MFDS. One hundred and four pairs were identified as potential DCA pairs to be listed. QT prolonging agents-QT prolonging agents, triptans-ergot alkaloids, tricyclic antidepressants-monoamine oxidase inhibitors, and dopamine agonists-dopamine antagonists were identified as drug class-drug class interaction groups which have less than 50 % DCA listing rate. Conclusion: To improve the clinicians' adaptability to DCA alerts, the list of DCA pairs needs to be continuously updated.

• Journal of Preventive Medicine and Public Health
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• v.41 no.2
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• pp.69-73
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• 2008

To curb a rapid increase in expenditures for pharmaceuticals, the Korean government introduced a positive list system and a negotiation process for drug prices at the end of 2006. Economic evaluation of pharmaceuticals has begun to have a pivotal role in the listing and pricing of drugs for the Korean National Health Insurance. There are some points to discuss regarding the use of economic evaluation in the listing and pricing in the context of the Korean system. First, the listing and pricing processes have been fragmented, evoking complaints from pharmaceutical companies and delaying the access of new drugs to patients. Second, there is a concern that the positive list system may limit the range and availability of drugs for patients to choose for treatment. Third, the time schedule for de-listing of existing drugs may not be realistic. Fourth, it is not always easy to provide reliable evidence of cost-effectiveness due to a lack of materials. Fifth, there is no consensus on the range of the ICER (incremental cost-effectiveness ratio) acceptable to the Korean society. In conclusion, in the near future, it will be necessary to evaluate the achievements that the economic evaluation has provided to the Korean society.

• 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.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1995.04a
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• pp.21-27
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• 1995

This document collects Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) guidance documents, citations to the primary literature, and other published and unpublished documents relevant to development and approval of drug/device combinations collected by the CDRH Division of Cardiovascular, Respiratory and Neurological Devices (DCRND). Since the Master Bibliography number represents an accession number, an alphabetical (by author) listing appears at the end of the document, Any citation marked with a, is on file in the DCRND offices, 340B, in the Piccard Building (HFZ-450), 1390 Piccard Avenue, Rockville, MD 20850.

• YAKHAK HOEJI
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• v.54 no.4
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• pp.309-315
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• 2010

The Positive List System was newly introduced in South Korea as of January 2007. This study aims to survey and compare perception of and attitudes toward the Positive List System in the process of new drug listing that health professionals and pharmaceutical companies have. 50 professionals and 52 companies answered the questionnaire regarding health policy environments, policy decision/enforcement process, policy effects and satisfaction related to introducing the Positive List System. SAS 9.1 was used for statistical analyses. The results showed that participants had the general sympathy with health policy environments for the introduction of the Positive List System into South Korea. However, the response rates of policy decision/enforcement process and effects were negative and these tendencies were more striking in pharmaceutical companies. As for policy satisfaction, participants marked positive responses more than negative ones. It is necessary to remedy and supplement problems with policy decision/enforcement policy and effects revealed in this study and to improve the Positive List System through gathering opinions among groups and organization concerned.

• Journal of Pharmaceutical Investigation
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• v.38 no.3
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• pp.207-215
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• 2008

Drug approval-patent linkage is the practice of linking drug marketing approval to the patent status of the originator's product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term unless by consent of the patent owner. Article 18.9.5 of Korea-US Free Trade Agreement requires that Korea introduce the linkage system in drug marketing approval. However, Korea is unfamiliar with the linkage system. In addition, there have been lots of arguments over the impacts of this system on Korean pharmaceutical industry and pharmaceutical market in the future. This report investigated the linkage systems of the US and Canada. The US and Canada have implemented drug approval-patent linkage system since 1984 and 1993, respectively. Both countries have patent lists for drug approvalpatent linkage on which originators are required to list patents on substance, product, and use of their drugs. Generic or follow-on drug applicants must contain a certification regarding each patent listed that relates to the referenced drug. If the patent holder files suit for patent infringement within 45 days of notice of application, drug approval is not allowed for several months - 30 months in the US and 24 months in Canada. Both countries have amended their systems after having experienced unexpected results such as listing improper and additional patents, multiple patent litigations and delayed generic entries. After reviewing the US and Canada's experiences, we suggested three principles needed in implementing the system: protecting patent holder's right; promoting generic drug development and marketing; monitoring the process and the effect of the system.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.124-130
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• 2018

Objective: This study examined the Risk Sharing Agreement (RSA) on pharmaceutical pricing system in Korean national health insurance. Through RSA, the insurer was able to maintain the principles in the price listing process while managing the budget effectively and improving patient access to new drugs. Despite these positive effects, there are still issues raised by some stakeholders, such as lack of transparency in the listing process and doubts about its effectiveness. Therefore, we investigated the impacts of RSA on national health insurance financing and patient access to analyze the effects of RSA. Methods: The impact of RSA was investigated by analyzing the health insurance claims data for 2014~2016. The degree of improvement in patient access was determined by the decreased amount of patients' payment. Results: Results showed that the financial impact of RSA was not significant and patients' access to the new drug greatly improved. Conclusion: These results show that RSA is a good system for improving patient access to new drugs without additional expense on insurance.

• The Korean Journal of Applied Statistics
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• v.31 no.2
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• pp.303-313
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• 2018

This study considers time series models to forecast drug expenditures in national health insurance. We adopt autoregressive error model (ARE) and transfer function model (TFM) with segmented level and trends (before and after 2012) in order to reflect drug price reduction in 2012. The ARE has only a segmented deterministic term to increase the forecasting performance, while the TFM explains a causality mechanism of drug expenditure with closely related exogenous variables. The mechanism is developed by cross-correlations of drug expenditures and exogenous variables. In both models, the level change appears significant and the number of drug users and ratio of elderly patients variables are significant in the TFM. The ARE tends to produce relatively low forecasts that have been influenced by a drug price reduction; however, the TFM does relatively high forecasts that have appropriately reflected the effects of exogenous variables. The ARIMA model without the exogenous variables produce the highest forecasts.

• Health Policy and Management
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• v.19 no.4
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• pp.98-120
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• 2009

The purpose of this study is to elicit preference for drug listing decision criteria and to estimate the ICER threshold in South Korea using the discrete choice experiment (DCE) method. To collect the data, a DCE survey was administered to a subject sample either educated in the principle concepts of pharmacoeconomics or were decision makers within that field. Subjects chose between alternative drug profiles differing in four attributes: ICER, uncertainty, budget impact and severity of disease. The orthogonal and balanced designs were determined through computer algorithm to take the optimal set of drug profiles. The survey employed 15 hypothetical choice sets. A random effect probit model was used to analyze the relative importance of attributes and the probabilities of a recommendation response. Parameter estimates from the models indicated that three attributes (ICER, Impact, Severity of disease) influenced respondents' choice significantly(p${\pm}$0.001). In addition, each parameter displayed an expected sign. The Lower the ICER, the higher the probability of choosing that alternative. Respondents also preferred low levels of uncertainty and smaller impact on health service budget. They were also more likely to choose drugs for serious diseases rather than mild or moderate ones. Uncertainty however is not statistically significant. The ICER threshold, at which the probability of a recommendation was 0.5, was 29,000,000 KW/QALY in expert group and 46,500,000 KW/QALY in industry group. We also found that those in our sample were willing to accept high ICER to get medication for severe diseases. This study demonstrates that the cost-effectiveness, budget impact and severity of disease are the main reimbursement decision criteria in South Korea, and that DCE can be a useful tool in analyzing the decision making process where a variety of factors are considered and prioritized.