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PURPOSE: We aimed to elicit scientific evidence on the cost-effectiveness of two catechol-O-methyltransferase inhibitors (COMT-i) versus no COMT-i in patients with advanced Parkinson's disease. METHODS: A mixed model of the decision tree and a Markov model with three health states by OFF-time level (<25%, ≥25%, and death) was constructed to compare opicapone (OPC), entacapone (ENT), and no COMT-i over a lifetime. A hypothetical cohort of 10,000 patients was created and simulated based on the characteristics of the BIPARK trial subjects. FINDINGS: Two COMT-i (OPC and ENT) were identified as a cost-effective option compared to no COMT-i. Probabilistic sensitivity analysis showed that over 90% of the simulations proved the robust cost-effectiveness of COMT-i. When the time horizon as the most influential factor decreases to a 5- and 10-year period, COMT-i can be a cost-saving option. Although ENT may be the preferred option over OPC economically because of its lower price, OPC can be acceptable if the drug price is reduced by 17%. IMPLICATIONS: Add-on treatment with COMT-i in patients with PD receiving levodopa/carbidopa appears to be cost-saving compared with not using COMT-i. In the future, it is necessary to evaluate the economic evaluation of COMT-i based on long-term real-world evidence.
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Background: The global coronavirus disease 2019 (COVID-19) pandemic has placed patients with end-stage kidney disease (ESKD) at heightened risk owing to their vulnerability to infections. Our study focused on patients with ESKD, examining COVID-19 incidence, hospitalization, and mortality in relation to their renal replacement therapy (RRT) type and identifying factors influencing COVID-19 hospitalization. Methods: We conducted a retrospective cohort study using health insurance claims data from the Health Insurance Review and Assessment Service for patients with ESKD between July 2017 and June 2022. COVID-19 data for the general population were sourced from the Korea Disease Control and Prevention Agency. Results: Patients undergoing hemodialysis (HD) constituted 90.7% of the cohort, followed by kidney transplantation (KT) recipients and peritoneal dialysis (PD). After adjusting for every 10,000 individuals, KT recipients exhibited the highest COVID-19 incidence, followed by those undergoing HD and PD, whereas the general population showed a higher infection rate of 43.64. Patients undergoing HD had the highest hospitalization rates, followed by KT recipients and those undergoing PD. The mortality rate per 10,000 individuals was highest in HD, followed by PD, the general population, and KT. Multivariate analysis indicated that age, RRT duration, residence in a nursing hospital, and comorbidities were associated with COVID-19 hospitalization. Conclusion: Among RRT modalities, KT recipients displayed the highest COVID-19 incidence, whereas those undergoing HD exhibited the highest hospitalization and mortality rates. This study contributes to our understanding of infectious diseases in patients on RRT and aids in preparedness for future infectious disease outbreaks.
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As the importance of utilizing real-world data (RWD)/real-world evidence (RWE) for supporting regulatory scientific decision-making continues to grow, experiences and inputs from experts become crucial for developing a systematic and practice-oriented plan for the use of fit-for-purpose RWD/RWE. This study aimed to survey relevant experts from government agencies, industries, and academia to identify prerequisites for the drug life cycle in Korea. The questionnaire comprised the following: (A) the definition and categories of RWD/RWE, (B) the suitability and feasibility of using RWD/RWE at each authorization stage by the types of RWD, and (C) the challenges and solutions for the use of RWD/RWE. A total of 46 respondents completed the online survey, with 89.1% of them having prior experience with RWD/RWE usage. A majority of respondents agreed that RWD can be obtained from various sources. Among these sources, the registry was the most suitable source. It is suitable to compensate for the limitations of randomized control trials and ensure quality in data collection. Though there was consensus among the respondents for the use of RWD/RWE in post-marketing surveillance, the use of such data in new drug application (NDA) was disagreeable. Respondents considered it necessary to write a protocol in advance for RWD collection and RWE generation, for all RWD types. In conclusion, this study examined the perceptions of experts for RWD/RWE use at each approval stage of drugs. The results suggest that guidelines for the fit-for-purpose use of RWD/RWE should be developed via careful deliberation among experts in the future.
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Pharmaceutical Preparations , Humans , Consensus , Registries , Republic of Korea , Surveys and QuestionnairesABSTRACT
INTRODUCTION: The most notable challenge facing hemophilia A treatment is the development of inhibitors against factor VIII, resulting in increased clinical and socioeconomic burdens due to the need for expensive bypassing agents (BPAs). Although immune tolerance induction (ITI) is currently the primary approach for inhibiting and reducing the inhibitors, the lengthy duration of ITI necessitates the continued use of BPA to manage bleeding episodes. In this study, we aimed to obtain real-world evidence on the clinical and economic aspects and associated burdens experienced by patients with hemophilia A with inhibitors undergoing ITI in Korea. METHODS: Claims data from January 1, 2007, to December 31, 2020, were used in this study. The study cohort comprised patients with hemophilia A undergoing ITI, who were categorized into three groups: successful, failed, or continuation of ITI. We evaluated clinical and economic burdens, including monthly healthcare visits, medication costs, and total medical expenses. RESULTS: The study involved 33 cases of ITI across 32 patients. Excluding seven continuation cases where success could not be determined at the observation point, the estimated success rate of ITI was 80.8 %. The median duration of ITI for all patients was 25.7 months. While no significant disparities were noted in the ITI duration between successful and unsuccessful cases (24.51 vs. 25.66 months), substantial discrepancies were observed in the duration of BPA usage (11.10 vs. 25.66 months) and the number of prescribed BPAs (1.79 vs. 2.97). CONCLUSION: Successful ITI reduced both clinical and economic burdens, resulting in decreased monthly medication expenses and overall medical costs.
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Hemophilia A , Immune Tolerance , Humans , Hemophilia A/economics , Hemophilia A/immunology , Hemophilia A/drug therapy , Republic of Korea , Male , Child , Adult , Adolescent , Child, Preschool , Factor VIII/therapeutic use , Factor VIII/immunology , Factor VIII/economics , Cost of Illness , Young Adult , Female , Infant , Health Care CostsABSTRACT
The prevalence of attention-deficit/hyperactivity disorder (ADHD) is steadily increasing across Korea. We analyzed ADHD patients with ADHD medications (Rx) characteristics and treatment patterns compared to patients without Rx and identified the differences between pediatric-/adult- and active-/transient-patients with Rx. Using a nationwide claims dataset from 2020 to 2021, we conducted a prevalence-based cross-sectional study and analyzed the recent patients' characteristics and patterns among ADHD patients. Among 132â 017 ADHD patients with Rx, differences from 20â 312 without Rx across all characteristics except sex. We found significant differences in characteristics and treatment patterns between pediatric-/adult- and active-/transient-patients with Rx. Age-specific sex ratios notably diverged in pediatric patients (61.2%), but remained similar in adults, revealing significant psychiatric comorbidities differences. Active-patients peaked at 6-11â years (41.4%), while transient-patients at 18-30â years (36.1%). Predominantly, methylphenidate (89.7%), atomoxetine (27.8%), and clonidine (2.8%) were prescribed, with 85% experiencing treatment changes within methylphenidate formulations. In pediatric patients, extended-release methylphenidate was preferred (56.1%), adults favored oral delivery system methylphenidate (71.5%), and active-patients had higher treatment rates than transient-patients across all patterns, with low monotherapy rates. This study provides epidemiologic insights into recent characteristics and treatment patterns of ADHD patients with Rx in Korea, providing valuable evidence for identifying those actively receiving ADHD treatment in future healthcare policy decisions.
Subject(s)
Atomoxetine Hydrochloride , Attention Deficit Disorder with Hyperactivity , Central Nervous System Stimulants , Databases, Factual , Methylphenidate , Humans , Attention Deficit Disorder with Hyperactivity/drug therapy , Attention Deficit Disorder with Hyperactivity/epidemiology , Republic of Korea/epidemiology , Male , Female , Child , Adult , Adolescent , Cross-Sectional Studies , Atomoxetine Hydrochloride/therapeutic use , Young Adult , Methylphenidate/therapeutic use , Central Nervous System Stimulants/therapeutic use , Practice Patterns, Physicians'/trends , Practice Patterns, Physicians'/statistics & numerical data , Child, Preschool , Clonidine/therapeutic use , Middle Aged , PrevalenceABSTRACT
BACKGROUND: Although clinical benefits of intravascular imaging-guided percutaneous coronary intervention (PCI) in patients with complex coronary artery lesions have been observed in previous trials, the cost-effectiveness of this strategy is uncertain. METHODS: RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance vs Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) was conducted in Korea between May 2018 and May 2021. This prespecified cost-effectiveness substudy was conducted using Markov model that simulated 3 states: (1) post-PCI, (2) spontaneous myocardial infarction, and (3) death. A simulated cohort was derived from the intention-to-treat population, and input parameters were extracted from either the trial data or previous publications. Cost-effectiveness was evaluated using time horizon of 3 years (within trial) and lifetime. The primary outcome was incremental cost-effectiveness ratio (ICER), an indicator of incremental cost on additional quality-adjusted life years (QALYs) gained, in intravascular imaging-guided PCI compared with angiography-guided PCI. The current analysis was performed using the Korean health care sector perspective with reporting the results in US dollar (1200 Korean Won, â©=1 dollar, $). Willingness to pay threshold was $35 000 per QALY gained. RESULTS: A total of 1639 patients were included in the trial. During 3-year follow-up, medical costs ($8661 versus $7236; incremental cost, $1426) and QALY (2.34 versus 2.31; incremental QALY, 0.025) were both higher in intravascular imaging-guided PCI than angiography-guided PCI, resulting incremental cost-effectiveness ratio of $57 040 per QALY gained within trial data. Conversely, lifetime simulation showed total cumulative medical cost was reversed between the 2 groups ($40 455 versus $49 519; incremental cost, -$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis. CONCLUSIONS: The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.
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Cost-Effectiveness Analysis , Percutaneous Coronary Intervention , Humans , Cost-Benefit Analysis , Quality of Life , Coronary Vessels/diagnostic imagingABSTRACT
Importance: Complete revascularization by non-infarct-related artery (IRA) percutaneous coronary intervention (PCI) in patients with acute myocardial infarction is standard practice to improve patient prognosis. However, it is unclear whether a fractional flow reserve (FFR)-guided or angiography-guided treatment strategy for non-IRA PCI would be more cost-effective. Objective: To evaluate the cost-effectiveness of FFR-guided compared with angiography-guided PCI in patients with acute myocardial infarction and multivessel disease. Design, Setting, and Participants: In this prespecified cost-effectiveness analysis of the FRAME-AMI randomized clinical trial, patients were randomly allocated to either FFR-guided or angiography-guided PCI for non-IRA lesions between August 19, 2016, and December 24, 2020. Patients were aged 19 years or older, had ST-segment elevation myocardial infarction (STEMI) or non-STEMI and underwent successful primary or urgent PCI, and had at least 1 non-IRA lesion (diameter stenosis >50% in a major epicardial coronary artery or major side branch with a vessel diameter of ≥2.0 mm). Data analysis was performed on August 27, 2023. Intervention: Fractional flow reserve-guided vs angiography-guided PCI for non-IRA lesions. Main Outcomes and Measures: The model simulated death, myocardial infarction, and repeat revascularization. Future medical costs and benefits were discounted by 4.5% per year. The main outcomes were quality-adjusted life-years (QALYs), direct medical costs, incremental cost-effectiveness ratio (ICER), and incremental net monetary benefit (INB) of FFR-guided PCI compared with angiography-guided PCI. State-transition Markov models were applied to the Korean, US, and European health care systems using medical cost (presented in US dollars), utilities data, and transition probabilities from meta-analysis of previous trials. Results: The FRAME-AMI trial randomized 562 patients, with a mean (SD) age of 63.3 (11.4) years. Most patients were men (474 [84.3%]). Fractional flow reserve-guided PCI increased QALYs by 0.06 compared with angiography-guided PCI. The total cumulative cost per patient was estimated as $1208 less for FFR-guided compared with angiography-guided PCI. The ICER was -$19â¯484 and the INB was $3378, indicating that FFR-guided PCI was more cost-effective for patients with acute myocardial infarction and multivessel disease. Probabilistic sensitivity analysis showed consistent results and the likelihood iteration of cost-effectiveness in FFR-guided PCI was 97%. When transition probabilities from the pairwise meta-analysis of the FLOWER-MI and FRAME-AMI trials were used, FFR-guided PCI was more cost-effective than angiography-guided PCI in the Korean, US, and European health care systems, with an INB of $3910, $8557, and $2210, respectively. In probabilistic sensitivity analysis, the likelihood iteration of cost-effectiveness with FFR-guided PCI was 85%, 82%, and 31% for the Korean, US, and European health care systems, respectively. Conclusions and Relevance: This cost-effectiveness analysis suggests that FFR-guided PCI for non-IRA lesions saved medical costs and increased quality of life better than angiography-guided PCI for patients with acute myocardial infarction and multivessel disease. Fractional flow reserve-guided PCI should be considered in determining the treatment strategy for non-IRA stenoses in these patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02715518.
Subject(s)
Fractional Flow Reserve, Myocardial , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Male , Humans , Female , Cost-Benefit Analysis , Cost-Effectiveness Analysis , Quality of Life , Myocardial Infarction/therapy , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND AND AIM: Serotonin affects the balance and integrity of the gut microbiome; however, studies have confirmed the influence of selective serotonin reuptake inhibitors (SSRIs) on irritable bowel syndrome (IBS). We evaluated the association between SSRI use and subsequent IBS occurrence in a real-world setting. METHODS: A multivariate Cox proportional hazard model was adopted, and the National Health Insurance Service cohort claims database between 2010 and 2019 was used. Non-SSRI users were selected using the propensity score matching method. Subgroup analyses were performed using the point of use, cumulative dose, and duration of SSRI use. Additional analysis was performed using a control group without psychiatric medications. RESULTS: We included 2901 SSRI users and 2727 non-SSRI users. After adjusting covariates, the risk of developing IBS in SSRI users was 1.54 times that in non-SSRI users (95% confidence interval [CI]: 1.01-2.33). The hazard ratio (HR) of the recent, heavy, and short-term user groups were 3.19 (95% CI: 2.03-4.99), 2.22 (95% CI: 1.50-3.29), and 4.83 (95% CI: 3.02-7.73), respectively, compared with that of non-users. In patients without a history of psychiatric medications, the risk of IBS incidence after SSRI use increased significantly (HR: 1.61, 95% CI: 1.06-2.42), whereas HR was insignificant in patients with a history of psychiatric medications (HR: 1.25, 95% CI: 0.98-1.60). CONCLUSIONS: The risk of subsequent IBS occurrence following SSRI use was high in patients who initially took a heavy SSRI dose and those who did not have a history of psychiatric drug use.
Subject(s)
Irritable Bowel Syndrome , Selective Serotonin Reuptake Inhibitors , Humans , Selective Serotonin Reuptake Inhibitors/adverse effects , Retrospective Studies , Irritable Bowel Syndrome/chemically induced , Irritable Bowel Syndrome/epidemiology , Irritable Bowel Syndrome/drug therapy , Incidence , Proportional Hazards ModelsABSTRACT
BACKGROUND: With the outbreak of COVID-19, school closures and quarantines following social distancing have brought significant changes to children's lifestyles. Therefore, we aimed to compare the population-adjusted incidence of febrile seizures(FS) and epilepsy before and after the COVID-19 outbreak in Korea and to assess the effects of the COVID-19 outbreak on the incidence by region and age group. METHODS: A retrospective cohort study was conducted using nationwide claims data and covid data from January 2019 to December 2020. The incidence of diseases and difference in incidence before (Jan 20 to Dec 30, 2019) and after (Jan 20 to Dec 30, 2020) the COVID-19 outbreak was measured using rate ratio. An Interrupted time series analysis was used to identify the effect of COVID-19 on trends of FS and epilepsy. Subgroup analysis by age, sex, insurance, and risk of coronavirus by area were conducted. RESULTS: Following the onset of the pandemic, the number of newly diagnosed FS cases decreased sharply by 69 % (24,182 to 7238), whereas the incidence of epilepsy, increased to 1.02 times (30,286-29,312), when adjusted in proportion to the population. Notably, a greater decrease in the incidence of FS were found in the regions with high-risk of coronavirus. A result of segmented regression analysis proved the decrease was significant and made immediately after the pandemic started(p < 0.001). In contrast to the incidence of FS, that of epilepsy did not exhibit a significant month-to-month change during the baseline period, immediately after the pandemic started, and during the pandemic. CONCLUSIONS: The COVID-19 outbreak and resulting social distancing measures reduced the incidence of febrile seizure immediately rather than gradually. Unlike in the case of acute febrile seizure, the COVID-19 pandemic had no effect on the incidence of chronic epilepsy.
Subject(s)
COVID-19 , Epilepsy , Seizures, Febrile , Child , Humans , COVID-19/epidemiology , Epilepsy/epidemiology , Incidence , Interrupted Time Series Analysis , Pandemics , Retrospective Studies , Seizures, Febrile/epidemiologyABSTRACT
BACKGROUND: People with hearing impairment have many problems with healthcare use, which is associated with health literacy. Research on health literacy is less focused on people with hearing impairments. This research aimed to explore the levels of health literacy in people with hearing impairment, find the barriers to health literacy, and summarize methods for improving health literacy. METHODS: A systematic review was conducted using three databases (PubMed, Cochrane, and Embase) to search the relevant articles and analyze them. The studies were selected using pre-defined inclusion/exclusion criteria in two steps: first, selection by examining the title and abstract; and second, after reading the study in full. The Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) was used to assess the quality of the articles. RESULTS: Twenty-nine studies were synthesized qualitatively. Individuals with hearing impairment were found to have lower health literacy, when compared to those without impairment, which can lead to a higher medical cost. Most of the people with hearing impairment faced barriers to obtaining health-related information and found it difficult to communicate with healthcare providers. To improve their health literacy, it is essential to explore new ways of accessing health information and improving the relationship between patients and healthcare providers. CONCLUSIONS: Our findings show that people with hearing impairment have lower health literacy than those without. This suggests that developing new technology and policies for people with hearing impairment is necessary not to mention promoting provision of information via sign language. TRIAL REGISTRATION: OSF: https://doi.org/10.17605/OSF.IO/V6UGW . PROSPERO ID: CRD42023395556.
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INTRODUCTION: Oral branched-chain amino acids (BCAAs) might benefit patients with advanced liver disease. We assess its effects on prognosis compared with control from the meta-analysis. METHODS: Study end points were development of hepatic encephalopathy (HE), hepatocellular carcinoma (HCC), mortality, and overall liver-related events (LREs). Risk ratios (RRs) and hazard ratios (HRs) were calculated using random effects model and heterogeneity using I 2 statistic. RESULTS: Twenty-eight studies were included in this meta-analysis; 1,578 and 1,727 patients in oral BCAAs and control groups, respectively. From studies using RRs as outcome measures, oral BCAAs were better in preventing HE and LRE than controls, with RRs 0.684 (95% confidence interval [CI] 0.497-0.941; P = 0.019) and 0.788 (95% CI 0.585-0.810; P < 0.001), respectively. Oral BCAAs had marginal effect on preventing HCC compared with control, with RR 0.791 (95% CI 0.619-1.011; P = 0.061); no significant difference in mortality was detected. From studies using HRs as outcome measures, oral BCAAs were superior to control in preventing LRE with adjusted HR 0.497 (95% CI 0.321-0.770; P = 0.002). In subgroups undergoing HCC resection, oral BCAAs had beneficial effect in preventing HE (RR 0.716, 95% CI 0.514-0.996; P = 0.047) and LRE (RR 0.716, 95% CI 0.595-0.860; P < 0.001). DISCUSSION: Oral BCAAs could afford clinical benefits in reducing HE and LRE risks, especially among patients undergoing HCC resection.
Subject(s)
Carcinoma, Hepatocellular , Hepatic Encephalopathy , Liver Neoplasms , Humans , Carcinoma, Hepatocellular/prevention & control , Carcinoma, Hepatocellular/surgery , Liver Neoplasms/surgery , Hepatic Encephalopathy/etiology , Hepatic Encephalopathy/prevention & control , Amino Acids, Branched-Chain/therapeutic use , Prognosis , Dietary SupplementsABSTRACT
PURPOSE: Netarsudil is a Rho kinase inhibitor and the first new class of clinically useful ocular hypotensive agents. In this study, we conducted a systematic literature review and meta-analysis to summarize and synthesize the available evidence on the efficacy and safety of fixed-dose combination (FDC) therapy with netarsudil/latanoprost in patients with glaucoma. METHODS: We identified relevant studies in PubMed, Ovid Medline, Embase, and Cochrane Central until April 2021. The quality of the studies and the level of evidence were assessed using the Risk of Bias tool. Efficacy was measured as the mean difference in reducing intraocular pressure (IOP), and safety was assessed by the risk of conjunctival hyperemia (CH) due to FDC therapy, netarsudil monotherapy, or latanoprost monotherapy. RESULTS: Four studies met the predefined eligibility criteria and were included in the meta-analysis. The mean difference in the reduction in IOP after 2 weeks and 4 to 6 weeks of drug administration was -2.41 mmHg (95% confidence interval [CI], -2.95 to -1.87) and -1.77 mmHg (95% CI, -2.31 to -1.87), respectively, in patients receiving FDC therapy versus those receiving latanoprost monotherapy. On the other hand, latanoprost monotherapy had a greater effect in reducing IOP than netarsudil monotherapy after 4 to 6 weeks of administration (mean difference, 0.95 mmHg; 95% CI, 0.43 to 1.47). The risk of CH was significantly higher with both FDC therapy and netarsudil monotherapy compared to latanoprost monotherapy in week 12, where the relative ratio was 3.01 (95% CI, 1.95 to 4.66) and 2.33 (95% CI, 1.54 to 3.54), each. CONCLUSIONS: Netarsudil/latanoprost FDC therapy has a significantly greater effect on reducing IOP than latanoprost alone. The symptoms of CH were mostly mild, and only a few glaucoma patients discontinued the medication owing to CH in earlier clinical trials. Therefore, it would be beneficial to consider the administration of netarsudil/latanoprost FDC therapy in patients with glaucoma.
Subject(s)
Glaucoma, Open-Angle , Glaucoma , Ocular Hypertension , Prostaglandins F, Synthetic , Antihypertensive Agents/therapeutic use , Benzoates , Glaucoma, Open-Angle/drug therapy , Humans , Intraocular Pressure , Latanoprost , Ocular Hypertension/drug therapy , Prostaglandins F, Synthetic/therapeutic use , Timolol , Treatment Outcome , beta-Alanine/analogs & derivatives , rho-Associated KinasesABSTRACT
BACKGROUND: Patients with decompensated cirrhosis are well known to experience morbidity and mortality. AIM: We assessed clinical characteristics, health-care utilization, and economic burden according to the type, number, and combination of decompensation-related complications. METHODS: We used recent nationally representative sample data from 2016 to 2018, covering approximately 13% of hospitalized patients in South Korea annually. Decompensation-related complications included ascites, hepatic encephalopathy (HE), gastroesophageal variceal (GEV) bleeding, and hepatorenal syndrome (HRS). RESULTS: Among 14 601 patients with decompensated cirrhosis, 11 201 (76.7%) experienced ≥ 1 decompensation-related complications, and approximately three-quarters underwent hospitalization. The most prevalent decompensation-related complications were ascites (54.8%), GEV bleeding (33.2%), HE (27.4%), and HRS (3.6%). Patients with GEV bleeding exhibited the highest hospitalization rate (95.7%), and patients with HE or HRS underwent hospitalization for 4 weeks/year due to decompensated cirrhosis. Hospitalization costs were 1.9 times higher in patients with HRS than in those with ascites alone ($9022 vs $4673; P < 0.01). Once patients developed decompensation-related complications, 41.3% had ≥ 2 types of decompensation-related complications. As the number of decompensation-related complications increased from 0 to ≥ 3, health-care utilization and economic burden significantly increased in a stepwise manner; patients with ascites, GEV bleeding, and HE visited medical institutions 2.2 times more (11 vs 5/year; P < 0.01) and incurred 6.4 times greater medical expenditure ($11 060 vs $1728/year; P < 0.01) than those with ascites only. CONCLUSION: A substantial proportion of patients had multiple decompensation-related complications and socioeconomic burdens for decompensated cirrhosis considering admission rate, hospital stay, and costs increased markedly, depending on the number of decompensation-related complications.
Subject(s)
Hepatic Encephalopathy , Hepatorenal Syndrome , Humans , Ascites/epidemiology , Ascites/etiology , Ascites/therapy , Liver Cirrhosis/complications , Liver Cirrhosis/epidemiology , Liver Cirrhosis/therapy , Financial Stress , Hepatic Encephalopathy/epidemiology , Hepatic Encephalopathy/etiology , Hepatic Encephalopathy/therapy , Hepatorenal Syndrome/epidemiology , Hepatorenal Syndrome/etiology , Hepatorenal Syndrome/therapy , Hemorrhage , Patient Acceptance of Health CareABSTRACT
BACKGROUND: Due to stringent reimbursement criteria, significant numbers of patients with compensated cirrhosis (CC) and low-level viremia [LLV; serum hepatitis B virus (HBV)-DNA levels of 20-2000 IU/mL] remain untreated especially in the East Asian countries, despite potential risk of disease progression. We analyzed cost-effectiveness to assess rationales for antiviral therapy (AVT) for this population. METHODS: We compared cost and effectiveness (quality-adjusted life years, QALYs) in a virtual cohort including 10,000 54-year-old CC-LLV patients receiving AVT (Scenario I) versus no treatment (Scenario II). A Markov model, including seven HBV-related conditions, was used. Values for transition probabilities and costs were mostly obtained from recent real-world South Korean data. RESULTS: As per a simulation of a base-case analysis, AVT reduced costs by $639 USD and yielded 0.108 QALYs per patient for 5 years among CC-LLV patients compared to no treatment. Thus, AVT is a cost-saving option with lower costs and better effectiveness than no treatment. If 10,000 patients received AVT, 815 incident cases of hepatocellular carcinoma (HCC) and 630 HBV-related deaths could be averted in 5 years compared to no treatment. In case of 10-year observation, AVT was consistently dominant. Even when the transition probabilities from CC-LLV vs. maintained virological response to HCC were same, fluctuation of results also lied within willingness-to-pay in South Korea. In the probabilistic sensitivity analysis with the willingness-to-pay threshold, the probability of AVT cost-effectiveness was 100%. CONCLUSION: The extended application of AVT in CC-LLV patients may contribute positively to individual clinical benefits and national healthcare budgets.
Subject(s)
Carcinoma, Hepatocellular , Hepatitis B, Chronic , Liver Neoplasms , Antiviral Agents , Carcinoma, Hepatocellular/pathology , Cost-Benefit Analysis , DNA, Viral , Hepatitis B virus/genetics , Hepatitis B, Chronic/complications , Hepatitis B, Chronic/drug therapy , Hepatitis B, Chronic/pathology , Humans , Liver Cirrhosis/pathology , Liver Neoplasms/pathology , Middle AgedABSTRACT
BACKGROUND: Long-term levodopa administration for treating Parkinson's disease (PD) may shorten the duration of effect and cause dyskinesias, inducing the need for catechol-O-methyltransferase (COMT) inhibitors as adjuvant therapy. OBJECTIVE: We provide pooled scientific evidence highlighting the efficacy and safety of opicapone, a newly approved COMT inhibitor, as an adjuvant to levodopa. METHODS: We searched Ovid Medline, Embase, and Cochrane databases for relevant reports. Efficacy and safety were evaluated as off-time reduction and risk ratio (RR) of dyskinesia, respectively. Data were independently extracted using predefined criteria. Selected placebo-controlled trials were divided into double-blind and open-label periods. Using a random-effects model, the mean difference (MD) of the off-time reduction (efficacy), RR for the occurrence of dyskinesia, and on-time without/with troublesome dyskinesia (TD; safety assessment) were compared between opicapone and placebo groups. RESULTS: Five studies from three randomized controlled trials were included, and a meta-analysis was performed with 407 patients receiving opicapone 50âmg and 402 patients receiving placebo. Compared with the placebo, opicapone (50âmg) reduced off-time by 49.91âmin during the double-blind period (95% confidence intervals [CIs]â=â-71.39, -28.43; I2â=â0%). The RR of dyskinesia was 3.43 times greater in the opicapone 50 mg group than in the placebo group (95% CIâ=â2.14, 5.51; Iâ=â0%). Compared with the placebo, opicapone increased the on-time without TD by 44.62âmin (95% CIâ=â22.60, 66.64; I2â=â0%); the on-time increase with TD did not differ between treatments. CONCLUSION: Opicapone can play a positive role as an adjuvant to levodopa in patients with PD by reducing off-time and prolonging on-time without PD.
Subject(s)
Dyskinesias , Parkinson Disease , Antiparkinson Agents/adverse effects , Catechol O-Methyltransferase , Catechol O-Methyltransferase Inhibitors/adverse effects , Dyskinesias/drug therapy , Dyskinesias/etiology , Humans , Levodopa/adverse effects , Oxadiazoles , Parkinson Disease/drug therapy , Randomized Controlled Trials as TopicABSTRACT
Hepatitis C virus (HCV) infection is the second most common cause of chronic liver disease in South Korea, with a prevalence ranging from 0.6% to 0.8%, and HCV infection incidence increases with age. The anti-HCV antibody test, which is cheaper than the HCV RNA assay, is widely used to screen for HCV infections; however, the underdiagnosis of HCV is a major barrier to the elimination of HCV infections. Although several risk factors have been associated with HCV infections, including intravenous drug use, blood transfusions, and hemodialysis, most patients with HCV infections present with no identifiable risk factors. Universal screening for HCV in adults has been suggested to improve the detection of HCV infections. We reviewed the cost-effectiveness of HCV screening and the methodologies used to perform screening. Recent studies have suggested that universal HCV screening and treatment using direct-acting antivirals represent cost-effective approaches to the prevention and treatment of HCV infection. However, the optimal timing and frequency of HCV screening remain unclear, and further studies are necessary to determine the best approaches for the elimination of HCV infections.
Subject(s)
Hepatitis C, Chronic , Hepatitis C , Adult , Antiviral Agents/therapeutic use , Cost-Benefit Analysis , Hepacivirus/genetics , Hepatitis C/drug therapy , Hepatitis C, Chronic/diagnosis , Hepatitis C, Chronic/drug therapy , HumansABSTRACT
Background: There are limited studies on the cost-effectiveness of fractional flow reserve (FFR)-based percutaneous coronary intervention (PCI) over angiography-based PCI. Objectives: The current study sought to evaluate long-term cost-effectiveness of FFR-based PCI compared to angiography-based PCI. Methods: A cost-effectiveness analysis was conducted using a nationwide cohort that consisted of patients with stable or unstable angina from the National Health Insurance Service (NHIS) and Health Insurance Review and Assessment (HIRA) database in Korea. The cost-effectiveness analysis was also performed by using a decision and Markov model with key values from the United States and the United Kingdom health care systems. Incremental cost-effectiveness ratio (ICER), an indicator of incremental cost on additional quality-adjusted life-years gained by FFR-based PCI, was evaluated. Results: In the NHIS-HIRA data, FFR-based PCI was used during the index PCI in 5,116 patients (3.8%) among 134,613 eligible patients. FFR-based PCI showed significantly lower risk of all-cause death (5.8% vs 7.7%, P = 0.001) and spontaneous myocardial infarction (1.6% vs 2.2%, P = 0.022) than the angiography-based PCI at 4 years. In the NHIS-HIRA data, FFR-based PCI gained 0.039 quality-adjusted life-years at a lower cost ($303) than angiography-based PCI, yielding an ICER of -$7,748 during the 4-year follow-up. FFR-based PCI was dominant in the health care system of Korea (ICER = -$7,309), United States (ICER = -$31,267), and United Kingdom (ICER = -$1,341) during a 10-year time horizon. These results were consistently shown in probabilistic sensitivity analyses. Conclusions: In the current cohort, FFR-based PCI was associated with higher quality of life at a lower cost than angiography-based PCI. FFR-based PCI was cost-effective in patients with stable or unstable angina undergoing PCI.
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BACKGROUND: Frequent exposure to antibiotic treatments may increase the risk of antibiotic resistance, which may threaten the effectiveness of future antibiotic treatments. Thus, it is important to identify the preventable risks in terms of antibiotic use. This study assessed the association between major depressive disorder (MDD) and antibiotic use by comparing the likelihood and extent of antibiotic use between patients with and without MDD. METHODS: This retrospective cross-sectional study utilized the National Patients Sample data from the 2017 Health Insurance Review and Assessment Service. We analyzed 16,950 patients with MDD, defined as those with at least two claims records stating a primary diagnosis of MDD (International Classification of Diseases, 10th revision codes F32-33) and 67,800 patients without MDD (1:4 propensity-score matched control group). Antibiotic use was compared between the patients with and without MDD based on three variables: the presence of antibiotic prescriptions, total prescription days of antibiotics per year, and total medication costs of antibiotics per year. RESULTS: The adjusted odds ratio obtained by multivariate regression analysis for the presence of prescription of antibiotics was 1.31 (95% confidence interval [CI]: 1.25-1.36). In the negative binomial model, the number of prescription days was 1.25 times (95% CI: 1.23-1.28) higher in patients with MDD than in those without MDD. Generalized linear model analysis showed a 1.39-fold (95% CI: 1.36-1.43) higher cost of antibiotic prescription in patients with MDD than in those without MDD. CONCLUSIONS: Our results suggest a potential association between MDD and the prescription of antibiotics, implying that patients with MDD are relatively vulnerable to infections. It is important to prevent as well as closely monitor the occurrence of infections when managing patients with MDD.
Subject(s)
Depressive Disorder, Major , Anti-Bacterial Agents/therapeutic use , Cross-Sectional Studies , Depression , Depressive Disorder, Major/complications , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/epidemiology , Humans , National Health Programs , Retrospective StudiesABSTRACT
BACKGROUND AND PURPOSE: Guillain-Barré syndrome (GBS) is rare, but its symptoms are severe and they occasionally lead to long-term disability. Country-specific epidemiological evidence is useful for detecting potential problems at the population level. This study investigated the epidemiological and economic characteristics of GBS in South Korea. METHODS: The Korean National Health Insurance Service claims data from 2010 to 2016 were used to identify incident cases as newly hospitalized patients with a primary diagnosis of GBS (the 10th revision of the International Classification Disease code of G61.0). New cases were defined as patients not having claim records for GBS within one year prior to the hospital admission for GBS. RESULTS: The incidence rate increased by 45.6% between 2010 and 2016, from 1.28 to 1.82 per 100,000 population. All age groups other than <20 years showed increasing trends. The incidence rate was highest in those aged 65 years to 74 years. Approximately 72% of the incident GBS cases had antecedent infection within 42 days before GBS was diagnosed. Children younger than 10 years constituted the highest proportion of antecedent infections (93.7%). The average length of stay per GBS hospitalization was 33.5 days. Patients had an average of 7.48 outpatient visits for GBS treatment per year. The economic burden from a societal perspective of treating GBS during the first year was USD 16,428. CONCLUSIONS: The increasing incidence trend and substantial economic burden of GBS strongly advocate the development of effective strategies for preventing and managing GBS.
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INTRODUCTION: Antiviral therapy (AVT) for chronic hepatitis B (CHB) can prevent liver disease progression. Because of its stringent reimbursement criteria, significant numbers of patients with untreated minimally active (UMA)-CHB exist, although they are still subject to disease progression. We thus performed a cost-effectiveness analysis to assess the rationale for AVT for UMA-CHB. METHODS: We compared cost and effectiveness (quality-adjusted life years, QALYs) in virtual UMA-CHB cohorts of 10,000 50-year-olds receiving AVT (scenario 1) vs no treatment (scenario 2) for 10 years. A Markov model, including 7 health states of CHB-related disease progression, was used. Values for transition probabilities and costs were mostly obtained from recent South Korean data. RESULTS: The simulation of AVT vs no treatment predicted $2,201 incremental costs and 0.175 incremental QALYs per patient for 10 years, with an incremental cost-effectiveness ratio (ICER) of $12,607/QALY, suggesting cost-effectiveness of AVT. In sum, if 10,000 patients received AVT, 720 incident hepatocellular carcinoma and 465 CHB-related more deaths could be averted in 10 years relative to no treatment. When the simulated analysis period was extended to 20 years, AVT was also highly cost-effective with an ICER of $2,036/QALY. Although hepatocellular carcinoma-related mortality was a major factor influencing ICER, its fluctuation can be accepted within willingness to pay of $33,000 in South Korea. According to probabilistic sensitivity analysis with the threshold of willingness to pay, the probability of AVT cost-effectiveness was 83.3%. DISCUSSION: Long-term AVT for patients with UMA-CHB may contribute positively toward individual clinical benefit and national health care budget.