Drugs In South Korea Research Articles

Detection of l-Methamphetamine and l-Amphetamine as Selegiline Metabolites.

Selegiline (SE) is a selective, irreversible monoamine oxidase-B inhibitor, used for reducing symptoms in early-stage Parkinson's disease. The metabolites of SE include l-methamphetamine, l-amphetamine and desmethylselegiline (DSE). The stereoisomers of SE metabolites, d-methamphetamine and d-amphetamine are highly addictive psychostimulants and some of the most abused drugs in South Korea. In order to differentiate medical SE users form illicit methamphetamine abusers, it is important to distinguish between the l-isomers and d-isomers in urine samples. A 52-year-old male, seemingly under the influence of intoxication and demonstrating abnormal behavior, was reported to the police. The initial urine test using a methamphetamine detection kit demonstrated a positive result. Given the initial results, the police officer requested a further analysis of the urine sample. The urine sample was screened using headspace-solid phase microextraction-gas chromatography-mass spectrometry (HS-SPME-GC-MS). Both methamphetamine and amphetamine were detected, in addition to SE and DSE. To quantitate methamphetamine and amphetamine by HS-SPME-GC-MS, we performed a standard addition method due to the matrix effect of the case sample. Consistent with previous studies, our results indicated that the ratio of amphetamine to methamphetamine was 0.27, which was in the range of SE ingestion. Furthermore, we confirmed l-methamphetamine and l-amphetamine by chiral derivatization using (R)-(-)-α-methoxy-α-(trifluoromethyl) phenylacetyl chloride.

The current state of patient access to new drugs in South Korea under the positive list system: evaluation of the changes since the new review pathways

ABSTRACT Objective: This study aims to provide an up-to-date analysis of the current state of patient access to new drugs in South Korea, focusing on the effect of new review pathways for reimbursement. Methods: We analyzed patients’ access to new drugs, listing rate and lead time until listing from marketing authorization. New pathways were defined as ‘price negotiation waiver,’ ‘risk-sharing agreements,’ and ‘pharmacoeconomic evaluation exemption.’ Results: The listing rate for drugs increased after the introduction of the new pathways (93.7% vs. 77.9%, p < 0.001). Before the new pathways, the median lead time for listing was 21.0 months (95% CI: 16.9–25.0), while afterward it was shortened to 10.9 months (95% CI: 10.2–11.7) (p < 0.001). Conclusion: Although it has strengthened national health insurance coverage by positively impacting the rate and lead time, the lead time for the oncology and orphan drugs is substantially longer as compared to other drugs. Expanding the eligibility criteria to include non-life-threatening but rare or intractable diseases, and resolving the system’s operational issues are still necessary.

Patient Accessibility and Budget Impact of Orphan Drugs in South Korea: Long-Term and Real-World Data Analysis (2007-2019).

This study aimed to identify orphan drug accessibility and impact on pharmaceutical budgets in South Korea by analyzing the status of orphan drug designation, approval, reimbursement, and pharmaceutical expenditure. We analyzed the dataset on orphan drugs designated, approved, and reimbursed from 2007 to 2019 based on long-term real-world data. The designated and approved orphan drugs were 165 and 156, respectively, and 88 out of 156 approved products were reimbursed. Total expenditure on orphan drugs increased annually to account for about 1.44% of total pharmaceutical expenditure in 2018. Orphan drug expenditure per patient increased on average by 8.7% per year. The average annual cost of orphan drugs was USD 27,000–USD 47,000, with the maximum value of USD 260,000–USD 560,000. As there are a number of orphan drugs that have not yet been reimbursable after approval, a reimbursement policy should be established that considers the characteristics of orphan drugs. Since the rapid increase in orphan drug expenditure can be a potential threat to the insurance budget, budget management should also be considered. In conclusion, it is necessary to take preemptive measures to manage the health insurance budget efficiently while improving patient accessibility to orphan drugs.

Generic atorvastatin and rosuvastatin in the South Korean market: time of introduction in relation to manufacturer characteristics

ABSTRACT Background: The competition for and market dynamics of generic medicines can be understood by analyzing manufacturers’ behavior. In this study, we analyzed the various types of generic atorvastatin and rosuvastatin that were introduced onto the South Korean market from 2002 to 2018 and their corresponding manufacturers. Methods: Based on publicly available data, we selected drugs containing atorvastatin and rosuvastatin as active ingredients for the analysis. We calculated the time between the date of marketing approval for the first generic and that of the remaining generics. Then, we categorized manufacturers that marketed generics into first movers and latecomers. Results: We confirmed that many manufacturers have marketed generic drugs in South Korea and that manufacturers can be categorized as first movers and latecomers. Interestingly, latecomers account for a large portion of the manufacturers of generics, and they have entered the market steadily, even after the market matured with a number of manufacturers. Additionally, the characteristics of the manufacturers were closely related to manufacturers’ behaviors in the market. Conclusions: The order-of-entry effect, which is commonly observed in other markets, is marginal in the South Korean market, and this phenomenon is mainly explained by the rare price competition among generic manufacturers.

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System.

This study reviews and evaluates the national drug formulary system used to improve patient access to new drugs by making reimbursement decisions for new drugs as part of the South Korean national health insurance system. The national health insurance utilizes three methods for improving patient access to costly drugs: risk-sharing agreements, designation of essential drugs, and a waiver of cost-effectiveness analysis. Patients want reimbursement for new drugs to be processed quickly to improve their access to these drugs, whereas payers are careful about listing them given the associated financial burden and the uncertainty in cost-effectiveness. However, pharmaceutical companies are advocating for drug prices above certain thresholds to maintain global pricing strategies, cover the costs of drug development, and fund future investments into research and development. The South Korean government is expected to develop policies that will improve patient access to drugs with unmet needs for broadening health insurance coverage. Simultaneously, the designing of post-listing management methods is warranted for effectively managing the financial resources of the national health insurance system.

Eliciting societal preferences of reimbursement decision criteria for anti cancer drugs in South Korea

ABSTRACTIntroduction: In order to look beyond the cost-effectiveness analysis, this study used a multi-criteria decision analysis (MCDA), which reflects societal values with regard to reimbursement decisions. This study aims to elicit societal preferences of the reimbursement decision criteria for anti cancer drugs from public and healthcare professionals.Methods: Eight criteria were defined based on a literature review and focus group sessions: disease severity, disease population size, pediatrics targets, unmet needs, innovation, clinical benefits, cost-effectiveness, and budget impacts. Using quota sampling and purposive sampling, 300 participants from the Korean public and 30 healthcare professionals were selected for the survey. Preferences were elicited using an analytic hierarchy process.Results: Both groups rated clinical benefits the highest, followed by cost-effectiveness and disease severity, but differed with regard to disease population size and unmet needs. Innovation was the least preferred criteria.Conclusions: Clinical benefits and other social values should be reflected appropriately with cost-effectiveness in healthcare coverage. MCDA can be used to assess decision priorities for complicated health policy decisions, including reimbursement decisions. It is a promising method for making logical and transparent drug reimbursement decisions that consider a broad range of factors, which are perceived as important by relevant stakeholders.

Simultaneous Determination of Sildenafil, Tadalafil, and Vardenafil in Pharmaceutical Preparations by High-Temperature Gas Chromatography/Mass Spectrometry

Sildenafil (SD), tadalafil (TD), and vardenafil (VD) are drugs used to treat erectile dysfunction (ED). Pharmaceutical counterfeiting-related SD, TD, and VD compounds are becoming a critical problem due to their harmful side-effects. Especially, SD and TD are two major counterfeit ED drugs in South Korea. In this study, a new high-temperature gas chromatography/mass spectrometry (HTGC/MS) method was developed for the rapid determination of SD, TD, and VD in pharmaceutical preparations. A HT GC column was introduced for the rapid analysis of high molecular weight and high boiling point compounds. High-speed centrifugation led to shortened time for results. Calibration curves were linear (R2 ≥ 0.9972) over the concentration ranges of 12.5–100 µg mg−1 for TD and VD, and 25–175 µg mg−1 for SD. The intra- and inter-day precisions were within 7.5 %, while the intra- and inter-day accuracies ranged from –3.0 to 8.0 %. The limits of quantification were 0.7 µg mg−1 (SD and TD) and 0.13 µg mg−1 (VD). The recoveries were in the range of 87.3–102.4 %. The developed method was rapid and accurate both for routine quantitative measurement of SD, TD, and VD in pharmaceutical preparations as well as screening their suspected counterfeit compounds.

PHP17 - The impact of new Drug pricing policy on market competition among off-patent Drugs in South Korea

PHP17 - The impact of new Drug pricing policy on market competition among off-patent Drugs in South Korea

PCN235 - Off-Label Use of Anticancer Drugs In South Korea

PCN235 - Off-Label Use of Anticancer Drugs In South Korea

Pitfalls in Reimbursement Decisions for Oncology Drugs in South Korea: Need for Addressing the Ethical Dimensions in Technology Assessment

This study aimed to discover to what extent ethical issues are considered in the reimbursement decision process based on health technology assessment (HTA) in Korea, especially for oncology medications. Public summary documents (PSDs) published by the Health Insurance Review and Assessment Service (HIRA) were analyzed for empirical and normative factors. For external comparison, PSDs presented by corresponding institutions of Australia and the United Kingdom were employed. Furthermore, the opinions of eight expert oncologists were obtained regarding the accountability of the evidence in PSDs. Among 7 oncology drugs, there were differences in the final decisions and empirical factors considered, such as selected comparators and interpretation of evidence between the PSDs from the three institutions. From an ethical viewpoint, the following matters were deficient in the HTA decision-making process for oncology drugs: clear and reasonable standards; identifying and evaluating ethical values; and public accountability for reasonableness about decisions and due process.

The Factors Contributing to Expenditures on Over-the-Counter Drugs in South Korea

ObjectivesTo determine the factors contributing to the use of over-the-counter (OTC) drugs and to examine the relationship between the purchase of OTC drugs and the utilization of health care services in South Korea. MethodsThis study used data from the 2008 Korea Health Panel Survey. The respondents were classified according to the purpose of the OTC drug use. The first group (n = 364) included respondents who had purchased OTC drugs for self-medication, and the second group (n = 955) included respondents who had taken OTC drugs for nutrition for more than 3 months. Logistic regression analyses were conducted to identify the factors contributing to the purchase of OTC drugs. ResultsThe self-medication group was more likely to be older and to have a chronic disease. In addition, the purchase of OTC drugs was related to the utilization of other health care services. The more outpatient services at clinics were used, the more the respondents tended to purchase OTC drugs for self-medication and nutrition. As hospital outpatient visits increased, however, the purchase of OTC drugs for self-medication decreased and the purchase of OTC drugs for nutrition increased. ConclusionsThis study shows that age and chronic disease are the major factors related to using OTC drugs for self-medication for long-term periods. Furthermore, this study suggests that the use of outpatient services is one of the factors associated with purchasing OTC drugs. Considering the potential adverse effects of OTC drugs, communication between physicians and patients should be encouraged at outpatient visits.

PHP67 Review of the Currently Listed Drugs in South Korea

PHP67 Review of the Currently Listed Drugs in South Korea

A Comparative Analysis of the Impact of a Positive List System on New Chemical Entity Drugs and Incrementally Modified Drugs in South Korea

Background Medical costs in South Korea have risen, in part due to increased demand and consumption of pharmaceutical products by an aging population and also because of the introduction of newer, more expensive drugs. In an effort to stabilize the financing of health insurance and alleviate the financial burden on individuals, the government implemented a policy changing the national health insurance drug-listing system from a negative list system to a positive list system (PLS). Objectives The goal of this study was to compare differences in drug-listing rates for new chemical entities (NCEs) and incrementally modified drugs (IMDs) after South Korea introduced the PLS in December 2006. Parameters significantly affecting NCE and IMD listings were also identified. Methods New drug-listing data for 2007 and 2008 were obtained from the databases of the Health Insurance Review Agency and the Ministry of Health and Welfare. Descriptive analyses on the reimbursement rate and logistic regression analysis were conducted. Statistical significance was tested for all results, and P < 0.05 was considered statistically significant. Results A total of 150 reimbursement applications (79 for NCEs, 71 for IMDs) were examined for this study. The overall drug-listing rate was lower than before the introduction of the PLS. Drug reimbursement rates for NCEs (50.6%) were lower than those for IMDs (74.6%) ( P = 0.0025). However, the price negotiation rate was 85.0% for NCEs compared with 73.6% for IMDs ( P = 0.1847). The time required for both reimbursement and drug pricing was significantly longer for NCE than for IMD listings ( P < 0.05). Cost-effectiveness and budget impact were 2 significant variables affecting the listing of NCEs. However, no significant variable was identified for IMDs. Conclusions The PLS challenges the drug-listing system by decreasing the drug-listing rate and lengthening the period for reimbursement determinations. These effects were more pronounced for NCE listings than for IMD listings.