• 한국임상약학회지
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• 제31권1호
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• pp.1-11
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• 2021

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion: The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

• 한국임상약학회지
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• 제28권1호
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• pp.40-50
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• 2018

Objective: This study presented the analysis period, the complexity of combined therapy and comparator choice as the key limitations in the economic evaluation of new drugs, and discussed programs for coping with these limitations. Methods: This study evaluated the post-evaluation, risk-sharing agreement, extra funding program, and flexible incremental cost-effectiveness ratio (ICER) threshold as actions or programs that would increase accessibility to costly new drugs. The study also presented the cases of other countries. The application of the post-evaluation was considered to deal with high uncertainty regarding new drugs. Results: The risk-sharing agreement was introduced in European countries as well as South Korea and has been responsible for the shift from using the financial schemes to outcome-based schemes. The drug funding program has had troubled in securing stable extra funds. The application of higher ICER in the economic evaluation of expensive and innovative oncology drugs was criticized because of the inequity between oncology patients and patients with other diseases. Conclusion: Therefore, introducing and applying actions that would increase the accessibility to costly new drugs in South Korea have been deemed necessary after careful reviews and discussions with various stakeholders (insurer, policy makers, pharmaceutical companies and patients).

• 한국임상약학회지
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• 제28권2호
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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.

• East Asian Economic Review
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• 제24권2호
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• pp.127-164
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• 2020

We perform an econometric assessment of the role that pharmaceutical innovation-the introduction and use of new drugs-has played in improving the health of Koreans, by investigating whether diseases for which more new drugs were launched had larger subsequent increases in longevity and smaller subsequent increases in hospitalization. Drugs launched during 1993-2012 are estimated to have increased mean age at death from all diseases by 1.71 years between 1995 and 2015 and 1.09 years between 2005 and 2015. We also estimate that new drugs increased the five-year relative survival rate from all cancers combined by 23.2 percentage points-78.5% of the total increase-between 1993-1995 and 2011-2015, and that new drugs launched during 2008-2010 reduced the number of hospital days in 2017 by 13.0 million. If the drugs launched during 2003-2012 had had no effect on other medical expenditure in 2015, the cost per life-year gained would not have exceeded 6332 USD. Therefore, even if we ignore the effect of new drugs on hospital utilization, the drugs launched during 2003-2012 were very cost-effective, overall. When reduced hospital utilization is accounted for, the evidence indicates that, in the long run, pharmaceutical innovation was cost-saving as well as life-year saving.

• 한국임상약학회지
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• 제30권3호
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• pp.177-184
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• 2020

Background & objective: The Korean government has expanded its benefit coverage to enhance patients' access to orphan drugs and cancer medicines. However, the number of new drugs whose indications were not applied to reimbursement in health insurance was increased. This study aimed to understand the perspectives of experts and various stakeholders on the introduction of a new funding program for cancer treatment and orphan drugs. Methods: We conducted email surveys comprising 19 questions, from September 9 to 26, 2016. We distributed questionnaires to members of the Pharmaceutical Benefit Appraisal Committee and Cancer Assessment Committee. We also conducted a qualitative study through group interviews with stakeholders, including pharmaceutical companies and some patient groups for diseases. Results: A total of 35 survey respondents recommended the introduction of a funding program for orphan drugs, whereas 66% recommended the launch of funding for anticancer drugs. In addition, most pharmaceutical companies and patient groups recommended the introduction of new funding programs targeting patients with cancer and rare diseases. However, some participants asserted that it would be more appropriate to modify the existing reimbursement scheme than launch new funding. Conclusion: This study concluded that introducing new funding needs a social consensus to relieve financial hardships at the patient level.

• Journal of Pharmaceutical Investigation
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• 제39권4호
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• pp.299-307
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• 2009

Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

• The Korean Journal of Physiology and Pharmacology
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• 제16권1호
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• pp.1-9
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• 2012

Because the average human life span has recently increased, the number of patients who are diagnosed with neurodegenerative diseases has escalated. Recent advances in stem cell research have given us access to unlimited numbers of multi-potent or pluripotent cells for screening for new drugs for neurodegenerative diseases. Neural stem cells (NSCs) are a good model with which to screen effective drugs that increase neurogenesis. Recent technologies for human embryonic stem cells (ESCs) or induced pluripotent stem cells (iPSCs) can provide human cells that harbour specific neurodegenerative disease. This article discusses the use of NSCs, ESCs and iPSCs for neurodegenerative drug screening and toxicity evaluation. In addition, we introduce drugs or natural products that are recently identified to affect the stem cell fate to generate neurons or glia.

• Journal of Preventive Medicine and Public Health
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• 제41권2호
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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 Applied Biological Chemistry
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• 제66권
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• pp.29-38
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• 2023

Recent studies have highlighted the link between diseases and inflammation across our lifespan. Our sedentary lifestyle, high-calorie diet, chronic stress, chronic infections, and exposure to pollutants and xenobiotics, collectively intensify the course and recurrence of infections and inflammation in our bodies, promoting the prevalence of chronic diseases and aging. Given such phenomena and considering additional factors such as the frequency of prescription, and easy access to over-the-counter drugs, the need for anti-inflammatory therapeutics is ever-increasing. However, the readily available anti-inflammatory treatment option comes with a greater risk of side effects or high cost (biologics). Therefore in this growing competition of discovering and developing new potent anti-inflammatory drugs, we focused on utilizing the established knowledge of traditional medicine to find lead compounds. Since lead optimization is an indispensable step toward drug development, we applied this concept for the production of potent anti-inflammatory compounds achieved by structural modification of flavonoids. The derivative obtained through acetylation of myricetin, 3,3',4',5,5',7-hexaacetate myricetin, showed a greater inhibitory effect in the production of pro-inflammatory mediators such as nitric oxide, Prostaglandin E₂, and pro-inflammatory cytokines like interleukin-6, interleukin1β, in lipopolysaccharide-stimulated RAW264.7 mouse macrophage cells compared to myricetin. The increased potency of inhibition was in conjunction with an increased inhibitory effect on inducible nitric oxide synthase and cyclooxygenase-2 proteins. Through such measures, this study supports lead optimization for well-established lead compounds from traditional medicine using a simpler and greener chemistry approach for the purpose of designing and developing potent anti-inflammatory therapeutics with possibly fewer side effects and increased bioavailability.

• Natural Product Sciences
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• 제8권1호
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• pp.1-15
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• 2002

An International Cooperative Biodiversity Group (ICBG) program based at the University of Illinois at Chicago initiated its activities in 1998, with the following specific objectives: (a) inventory and conservation of of plants of Cuc Phuong National Park in Vietnam and of medicinal plants of Laos; (b) drug discovery (and development) based on plants of Vietnam and Laos; and (c) economic development of communities participating in the ICBG project both in Vietnam and Laos. Member-institutions and an industrial partner of this ICBG are bound by a Memorandum of Agreement that recognizes property and intellectual property rights, prior informed consent for access to genetic resources and to indigenous knowledge, the sharing of benefits that may arise from the drug discovery effort, and the provision of short-term and long-term benefits to host country institutions and communities. The drug discovery effort is targeted to the search for agents for therapies against malaria (antimalarial assay of plant extracts, using Plasmodium falciparum clones), AIDS (anti-HIV-l activity using HOG.R5 reporter cell line (through transactivation of the green fluorescent protein/GFP gene), cancer (screening of plant extracts in 6 human tumor cell lines - KB, Col-2, LU-l, LNCaP, HUVEC, hTert-RPEl), tuberculosis (screening of extracts in the microplate Alamar Blue assay against Mycobacterium tuberculosis $H_{37}Ra\;and\;H_{37}Rv),$ all performed at UIC, and CNS-related diseases (with special focus on Alzheimer's disease, pain and rheumatoid arthritis, and asthma), peformed at Glaxo Smith Kline (UK). Source plants were selected based on two approaches: biodiversity-based (plants of Cuc Phuong National Park) and ethnobotany-based (medicinal plants of Cuc Phuong National Park in Vietnam and medicinal plants of Laos). At mc, as of July, 2001, active leads had been identified in the anti-HIV, anticancer, antimalarial, and anti- TB assay, after the screening of more than 800 extracts. At least 25 biologically active compounds have been isolated, 13 of which are new with anti-HIV activity, and 3 also new with antimalarial activity. At GSK of 21 plant samples with a history of use to treat CNS-related diseases tested to date, a number showed activity against one or more of the CNS assay targets used, but no new compounds have been isolated. The results of the drug discovery effort to date indicate that tropical plant diversity of Vietnam and Laos unquestionably harbors biologically active chemical entities, which, through further research, may eventually yield candidates for drug development. Although the substantial monetary benefit of the drug discovery process (royalties) is a long way off, the UIC ICBG program provides direct and real-term benefits to host country institutions and communities.