Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study.
Ontology highlight
ABSTRACT:
SUBMITTER: Son KB
PROVIDER: S-EPMC8056004 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:OBJECTIVE:This study analysed utilisation of statins for new statin users and assessed market dynamics of statins in South Korea. DESIGN:This study is a retrospective cohort study. SETTING:The yearly claims data for statins were retrieved from the National Health Insurance Service-National Sample Cohort. MAIN OUTCOME MEASURE:We are interested in new statin users during 2003-2015 in Korea. Information on prescribed statins, including intensity of statins and entry of new and follow-on statins in the market, and healthcare institutions that prescribed the statins were also collected. In time series analysis, we estimated the effect of introduction of generics in the market, specifically for newly prescribed statin users. RESULTS:This 13-year longitudinal study of a sample cohort provided by the National Health Insurance Service found that the incidence of new statin user increase from 838.1/100 000 persons in 2003 to 1626.9/100 000 persons in 2015. Most new users were initiated on a monotherapy that was prescribed at primary healthcare institutions. However, the statin market for new users were quite dynamic in Korea. First, the most commonly prescribed statin changed several times during the study period. Second, the use of moderate-intensity statins increased from 57% in 2003 to 92% in 2015. In line with this result, we could not observe substantial differences in prescription of statins in groups having selected diseases history. Lastly, we found market invasion or switch of statins among new statin users, specifically at primary healthcare institutions. CONCLUSION:Similar to other countries, the incidence of new statin users has been increased in Korea. However, the statin market in Korea is quite dynamic compared with other countries. Interestingly, discounted price of originals after the introduction of generics immediately expand markets or substitute the market particularly in primary healthcare institutions in Korea.
| S-EPMC6430099 | biostudies-literature
Project description:We evaluated the survival rates and medical expenditure in patients with lung cancer using a nationwide claims database in South Korea. A retrospective observational cohort study design was used, and 2,919 lung cancer patients and their matched controls were included. Medical expenditures were analyzed with the Kaplan-Meier sample average method, and patients were categorized into 4 groups by operation and primary treatment method (i.e. Patients with operation: OP = surgery, OP+CTx/RTx = surgery with anti-cancer drugs or radiotherapy; Patients without operation: CTx/RTx = anti-cancer drugs or radiotherapy, Supportive treatment). The 5-year medical expenditure per case was highest in the OP+CTx/RTx group ($36,013), followed by the CTx/RTx ($23,134), OP ($22,686), and supportive treatment group ($3,700). Lung cancer-related anti-cancer drug therapy was the major cost driver, with an average 53% share across all patients. Generalized linear regression revealed that monthly medical expenditure in lung cancer patients, after adjustment for follow-up month, was approximately 3.1-4.3 times higher than that in the control group (cost ratio for OP = 3.116, OP+CTx/RTx = 3.566, CTx/RTx = 4.340, supportive treatment = 4.157). The monthly medical expenditure at end of life was estimated at $2,139 for all decedents, and approximately a quarter of patients had received chemotherapy in the last 3 months. In conclusion, this study presented the quantified treatment costs of lung cancer on various aspects compared with matched controls according to the treatment of choice. In this study, patients with operation incurred lower lifetime treatment costs than patients with CTx/RTx or supportive treatment, indicating that the economic burden of lung cancer was affected by treatment method. Further studies including both cancer stage and treatment modality are needed to confirm these results and to provide more information on the economic burden according to disease severity.
| S-EPMC6386401 | biostudies-literature
Project description:BackgroundThis study investigated the associations between exposure to ambient air pollutants and the incidence of osteoporosis using the Korean National Insurance Service-National Sample Cohort.MethodsThis nationwide, population-based, retrospective cohort study included 237,149 adults aged ≥40 years that did not have a diagnosis of osteoporosis at baseline between January 1, 2003, and December 31, 2015. Osteoporosis was defined as claim codes and prescriptions of bisphosphonates or selective estrogen receptor modulators at least twice annually. After matching values for PM10, NO2, CO, and SO2 during the 2002-2015 time period and PM2.5 in 2015 with residential areas, the incidence of osteoporosis was analyzed using a Cox proportional hazards regression model according to the quartile of average yearly concentrations of pollutants.ResultsOverall 22.2% of the study subjects, 52,601 (male: 5.6%, female: 37.6%) adults in total, were newly diagnosed with osteoporosis and treated. Exposure to PM10 was positively associated with incidence of osteoporosis (Q4: 1798 per 100,000 person-years vs. Q1: 1655 per 100,000 person-years). The adjusted hazard ratio (HR) with 95% confidence interval (CI) of Q4 in PM10 was 1.034 (1.009-1.062). The effect of PM10 on osteoporosis incidence was distinct in females (adjusted sub-HR: 1.065, 95% CI: 1.003-1.129), subjects aged < 65 years (adjusted sub-HR: 1.040, 95% CI: 1.010-1.072), and for residents in areas with low urbanization (adjusted sub-HR: 1.052, 95% CI: 1.019-1.087). However, there was no increase in osteoporosis based on exposure to NO2, CO, SO2, or PM2.5.ConclusionsLong-term exposure to PM10 was associated with newly diagnosed osteoporosis in Korean adults aged ≥40 years. This finding can aid in policy-making that is directed to control air pollution as a risk factor for bone health.
| S-EPMC8493748 | biostudies-literature
Project description:PurposeAlthough heart failure (HF) is recognized as a leading contributor to healthcare costs and a significant economic burden worldwide, studies of HF-related costs in South Korea are limited. This study aimed to estimate HF-related costs per Korean patient per year and per visit.Materials and methodsThis retrospective cohort study analyzed data obtained from six hospitals in South Korea. Patients with HF who experienced ?one hospitalization or ?two outpatient visits between January 1, 2013 and December 31, 2013 were included. Patients were followed up for 1 year [in Korean won (KRW)].ResultsAmong a total of 500 patients (mean age, 66.1 years; male sex, 54.4%), the mean 1-year HF-related cost per patient was KRW 2,607,173, which included both, outpatient care (KRW 952,863) and inpatient care (KRW 1,654,309). During the post-index period, 22.2% of patients had at least one hospitalization, and their 1-year costs per patient (KRW 8,530,290) were higher than those of patients who had only visited a hospital over a 12-month period (77.8%; KRW 917,029). Among 111 hospitalized patients, the 1-year costs were 1.7-fold greater in patients (n=52) who were admitted to the hospital via the emergency department (ED) than in those (n=59) who were not (KRW 11,040,453 vs. KRW 6,317,942; p<0.001).ConclusionThe majority of healthcare costs for HF patients in South Korea was related to hospitalization, especially admissions via the ED. Appropriate treatment strategies including modification of risk factors to prevent or decrease hospitalization are needed to reduce the economic burden on HF patients.
| S-EPMC5552648 | biostudies-literature
Project description:ObjectivesAlthough obesity is a risk factor for stroke, its impact on mortality in patients with stroke remains unclear. In this study, we aimed to evaluate the relationship between body mass index (BMI) and mortality due to ischaemic stroke among adults aged 20 years and above in Korea.DesignRetrospective cohort study.SettingA tertiary-hospital-based stroke registry linked to the death records.Participants3599 patients admitted for ischaemic stroke from January 2007 to June 2013.Outcome measuresThe HRs for all-cause and stroke-related mortality were calculated using Cox proportional hazards models. Progression from stroke-related mortality was assessed using the Fine-Grey competing risk model, treating other-cause mortality as a competing risk. Adjustments were made for age, gender, smoking status, Charlson comorbidity index, cardiovascular or non-cardiovascular comorbidities, stroke severity, severity related to other medical conditions, complications and enrolment year. We repeated the analysis with stratification based on age groups (less than 65 vs 65 years and above).ResultsFor stroke-related mortality, there was no significant difference among the four BMI groups. The risk of all-cause mortality was 36% higher in the underweight group than in the normal weight group (long-term HR=1.36, 95% CI: 1.04 to 1.79), whereas the mortality risk of the obese group was significantly lower (HR=0.66, 95%?CI: 0.54 to 0.81). Although this relationship was not estimated in the younger group, it was found that obesity had a protective effect on the all-cause mortality in the elderly (long-term HR=0.66, 95%?CI: 0.52 to 0.83).ConclusionsObesity is more likely to reduce mortality risk than normal weight, especially in elderly patients.
| S-EPMC6719766 | biostudies-literature
Project description:ObjectivesWe examined the relationship between duration (pack-year) of smoking and the risk of developing cerebral infarction in Korean men.DesignRetrospective cohort study.SettingNational Health Insurance Service-National Sample Cohort in Korea.ParticipantsOf 125 743 male participants from the National Health Insurance System undergoing medical health check-up in 2009, 114 377 were included in the final analysis.Primary and secondary outcome measuresDevelopment of cerebral infarction according to smoking duration after adjusting for age, body mass index, systolic blood pressure, fasting blood glucose, total cholesterol, γ-glutamyltransferase, estimated glomerular filtration rate, alcohol intake and physical activity.ResultsDuring 495 827.3 person-years of follow-up, 1450 incident cases of cerebral infarction developed between 2009 and 2013. The multivariate adjusted HRs (95% CI) for cerebral infarction between groups 2, 3 and 4 by duration of smoking were 1.02 (0.88 to 1.19), 1.36 (1.19 to 1.56) and 1.49 (1.28 to 1.74), respectively. In our secondary analysis by smoking status, the HR (95% CI) of former smokers showed a significant relationship in the unadjusted model but did not show statistically significant associations in the multivariate adjusted model. The HR (95% CI) of current smokers showed significant relationship in both the unadjusted and multivariate adjusted models (p for trend <0.001).ConclusionsThe study indicates that the prolonged duration of smoking (pack-year) increases the risk of cerebral infarction. Current smoking poses a higher risk for the development of cerebral infraction than former smoking among Korean men, indicating that current smoking cessation would be more protective.
| S-EPMC8054067 | biostudies-literature
Project description:ObjectivesThis study aimed to measure the burden of work-related upper limb amputation in Korea over a 10-year period and assess its trend.DesignEcological study.SettingNational level data in Korea between 2004 and 2013.Participants49 535 subjects who claimed Korea industrial accident compensation insurance due to upper limb amputation.Main outcome measuresThe disability-adjusted life years (DALYs) were calculated by sex, age and the site of amputation using annual incidence.ResultsThe burden of work-related upper limb amputations in Korea reached its peak in 2007 and decreased thereafter. Males showed a higher burden of disease. Finger amputations showed a decreasing trend from 2007, whereas arm amputations continued to show an increasing trend. An increasing trend was found among participants older than 50 years.ConclusionsThe decrease in the burden of finger amputations may be attributable to the lower incidence as a result of policy efforts. The increase in the burden of arm amputations was particularly noticeable among the elderly population over 50 years old. This could be attributable to the high proportion of the elderly population working in the manufacturing sector and the lack of policy efforts regarding major amputations in Korea. Future regulatory efforts are needed to prevent amputations.
| S-EPMC6886917 | biostudies-literature
Project description:Background: The coronavirus disease 2019 (COVID-19) pandemic has caused deaths and shortages in medical resources worldwide, making the prediction of patient prognosis and the identification of risk factors very important. Increasing age is already known as one of the main risk factors for poor outcomes, but the effect of body mass index (BMI) on COVID-19 outcomes in older patients has not yet been investigated. Aim: We aimed to determine the effect of BMI on the severity and mortality of COVID-19 among older patients in South Korea. Methods: Data from 1272 COVID-19 patients (≥60 years old) were collected by the Korea Centers for Disease Control and Prevention. The odds ratios (ORs) of severe infection and death in the BMI groups were analyzed by logistic regression adjusted for covariates.Results: The underweight group (BMI<18.5 kg/m2) had a higher OR for death (adjusted OR = 2.23, 95% confidence interval [95% CI] = 1.06-4.52) than the normal weight group (BMI, 18.5-22.9 kg/m2). Overweight (BMI, 23.0-24.9 kg/m2) was associated with lower risks of both severe infection (adjusted OR = 0.55, 95% CI = 0.31-0.94) and death (adjusted OR = 0.50, 95% CI = 0.27-0.91). Conclusions: Underweight was associated with an increased risk of death, and overweight was related to lower risks of severe infection and death in older COVID-19 patients in Korea. However, this study was limited by the lack of availability of some information, including smoking status.KEY MESSAGESUnderweight is an independent risk factor of death in older COVID-19 patients.Overweight patients have a lower risk of death and severe infection than normal-weight patients.
| S-EPMC8366651 | biostudies-literature
Project description:ObjectiveStrong concerns have been raised about whether the risk of ischemic stroke differs between conventional antipsychotics (CAPs) and atypical antipsychotics (AAPs). This study compared the risk of ischemic stroke in elderly patients taking CAPs and AAPs.MethodWe conducted a retrospective cohort study of 71,584 elderly patients who were newly prescribed the CAPs (haloperidol or chlorpromazine) and those prescribed the AAPs (risperidone, quetiapine, or olanzapine). We used the National Claims Database from the Health Insurance Review and Assessment Service (HIRA) from January 1, 2006 to December 31, 2009. Incident cases for ischemic stroke (ICD-10, I63) were identified. The hazard ratios (HR) for AAPs, CAPs, and for each antipsychotic were calculated using multivariable Cox regression models, with risperidone as a reference.ResultsAmong a total of 71,584 patients, 24,668 patients were on risperidone, 15,860 patients on quetiapine, 3,888 patients on olanzapine, 19,564 patients on haloperidol, and 7,604 patients on chlorpromazine. A substantially higher risk was observed with chlorpromazine (HR = 3.47, 95% CI, 1.97-5.38), which was followed by haloperidol (HR = 2.43, 95% CI, 1.18-3.14), quetiapine (HR = 1.23, 95% CI, 0.78-2.12), and olanzapine (HR = 1.12, 95% CI, 0.59-2.75). Patients who were prescribed chlorpromazine for longer than 150 days showed a higher risk (HR = 3.60, 95% CI, 1.83-6.02) than those who took it for a shorter period of time.ConclusionsA much greater risk of ischemic stroke was observed in patients who used chlorpromazine and haloperidol compared to risperidone. The evidence suggested that there is a strong need to exercise caution while prescribing these agents to the elderly in light of severe adverse events with atypical antipsychotics.
| S-EPMC4366389 | biostudies-literature
Project description:OBJECTIVES:This study examines the characteristics of studies that Health Canada uses to grant full marketing authorisation for products given a conditional approval between 1 January 1998 and 30 June 2017. DESIGN:Cohort study. DATA SOURCES:Journal articles listing drugs that fulfilled their conditions and received full marketing authorisation, Notice of Compliance database, Notice of Compliance with conditions website, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analysed, journal articles resulting from confirmatory studies. INTERVENTIONS:None. PRIMARY AND SECONDARY OUTCOME MEASURES:Characteristics of studies-study design (randomised controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women. RESULTS:Eleven companies confirmed 36 publications for 19 products (21 indications). Twenty-nine out of the 36 studies were randomised controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (IQR 44-61). The median number of men per study/trial was 184 (IQR 58-514) versus women 141 (IQR 46-263). CONCLUSIONS:Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts.
| S-EPMC5931291 | biostudies-literature