A Comparative Analysis of Anticancer Drug Appraisals Including Managed Entry Agreements in South Korea and England.

OBJECTIVES: This study aimed to compare appraisal decisions about anticancer drugs between the health technology assessment (HTA) agencies in Korea and England, and investigate whether the decisions and supporting evidence are comparable. METHODS: This study identified 49 anticancer drugs listed by the Korean Ministry of Health and Welfare between January 2014 and December 2019. Of those, 46 anticancer drugs for 58 indications were included for analysis. Official appraisal documents from both countries for 58 drug-indication pairs were compared and assessed in terms of clinical and economic evidence. Evidence items and their groups for analysis were predefined. RESULTS: Three-quarters of cases were recommended with managed entry agreements (MEAs) in England and three-fifths in Korea. Finance-based MEA types were most common in both countries. Korean and English authorities made consistent decisions in 48 cases (83%) when classifying decisions as 'recommended' and 'not recommended', while the degree of agreement lowered to 16 cases (28%) when subdividing decisions according to MEA types. When the evidence base was identical, their decisions were more likely to be consistent. Regarding clinical evidence, while the majority of cases referred to the same pivotal studies, differences between the committees' recognized comparators and the appraisal date caused discrepancies in decisions. Economic evidence, including incremental cost-effectiveness ratio (ICER) estimates, was identical in only 12 cases (21%), which contributed to discrepancies. CONCLUSION: England relies on economic evaluation, with increasing use of data collection agreements, in contrast with Korea's new procedure exempting companies from providing economic evaluation. While there is possibility for international cooperation in the assessment of clinical evidence, transferability issues exist, particularly with regard to economic evidence.

Association between cost-sharing and drug prescribing in Korean elderly veterans with chronic diseases: A real-world claims data study.

This study aimed to investigate the relationship between cost-sharing and drug prescribing and its appropriateness in Korean elderly veterans with chronic conditions. This is a cross-sectional study using real-world claims data. Veterans with primary hypertension or dyslipidemia were compared with two controls with higher levels of cost-sharing. Study subjects (age ≥65 years) were selected through stratified random sampling and matching the individual attributes. The primary outcome was the annual amount of drugs prescribed per patient, and the secondary outcomes included several other measures investigating multifaceted aspects of drug prescribing, medical institution utilization behavior, and prescribing appropriateness. Gamma regression models or logistic regression models were employed. Veterans were prescribed 59%~74% more drugs (exp (ß) = 1.59 [95% confidence interval [CI] = 1.55-1.64] ~ 1.74 [1.70-1.79]) compared to the National Health Insurance (NHI) patients. This was attributed mainly to longer prescribing days (44%) and slightly more prescriptions (6%~7%) than NHI patients. Veterans spent 14%~15% higher medication costs. Veterans were less likely to visit multiple medical institutions by estimates of 0.77 (0.76-0.79) ~ 0.80 (0.79-0.82). Similar but smaller differences were observed between veterans and medical aid (MedAid) patients. The veteran patients showed a more than 50% increased risk of therapeutic duplication than the other two controls (adjusted odds ratio [ORs] = 1.47 [1.37-1.57] ~ 1.61 [1.50-1.72]). Inappropriate drug prescribing was also more common in veterans than the two controls (adjusted ORs = 1.20 [1.11-1.31] ~ 1.32 [1.22-1.43]). In Korean elderly veterans with chronic illnesses, a level of cost-sharing was associated with having more prescribed medicines, and increased inappropriate prescribing.

Relationship between continuity of care and clinical outcomes in patients with dyslipidemia in Korea: a real world claims database study.

Dyslipidemia is a risk factor for atherosclerotic cardiovascular disease and requires proactive management. This study aimed to investigate the association between care continuity and the outcomes of patients with dyslipidemia. We conducted a retrospective cohort study on patients with dyslipidemia by employing the Korea National Health Insurance claims database during the period 2007-2018. The Continuity of Care Index (COCI) was used to measure continuity of care. We considered incidence of atherosclerotic cardiovascular disease as a primary outcome. A Cox's proportional hazards regression model was used to quantify risks of primary outcome. There were 236,486 patients newly diagnosed with dyslipidemia in 2008 who were categorized into the high and low COC groups depending on their COCI. The adjusted hazard ratio for the primary outcome was 1.09 times higher (95% confidence interval: 1.06-1.12) in the low COC group than in the high COC group. The study shows that improved continuity of care for newly-diagnosed dyslipidemic patients might reduce the risk of atherosclerotic cardiovascular disease.

Assessment of the effects of methodological choice in continuity of care research: a real-world example with dyslipidaemia cohort.

OBJECTIVE: To determine if the choice of methodological elements affects the results in continuity of care studies. DESIGN: This is a retrospective cohort study. The association between continuity of care and clinical outcome was investigated using the Continuity of Care Index. The association was explored in 12 scenarios based on four definitions of the relative timing of continuity and outcome measurements in three populations (three Ps × four Ts). SETTING: National Health Insurance claims from all primary and secondary care facilities in South Korea between 2007 and 2015. PARTICIPANTS: Participants were patients diagnosed with dyslipidaemia, made ≥2 ambulatory visits and were newly prescribed with ≥1 antihyperlipidaemic agent at an ambulatory setting in 2008. Three study populations were defined based on the number of ambulatory visits: 10 084 patients in population 1 (P1), 8454 in population 2 (P2) and 4754 in population 3 (P3). MAIN OUTCOME MEASURE: Hospitalisation related to one of the four atherosclerotic cardiovascular diseases, including myocardial infarction, stable or unstable angina, ischaemic stroke and transient ischaemic attack. RESULTS: Concurrent measure of continuity and outcome (T1) showed a significantly higher risk of hospitalisation (adjusted HRs: 2.73-3.07, p<0.0001) in the low continuity of care group, whereas T2, which measured continuity until the outcome occurred, showed no risk difference between the continuity of care groups. T3, which measured continuity as a time-varying variable, had adjusted HRs of 1.31-1.55 (p<0.05), and T4, measuring continuity for a predefined period and measuring outcomes in the remaining period, had adjusted HRs of 1.34-1.46 (p<0.05) in the low continuity of care. Within each temporal relationship, the effect estimates became more substantial as the inclusion criteria became stricter. CONCLUSIONS: The study design in continuity of care studies should be planned carefully because the results are sensitive to the temporal relationship between continuity and outcome and the population selection criteria.

Effects of a price cut reform on the cost and utilization of antidiabetic drugs in Korea: a national health insurance database study.

BACKGROUND: Despite the potential widespread application and a significant need, the policy effectiveness of prescribed medications price controls has not been studied extensively. We aimed to explore the effects of a price cut introduced in April 1st of 2012 on the cost and utilization of antidiabetics in South Korea. METHODS: We identified approximately four million outpatients who filed at least one diabetes-related claim during the index period (January 2010 to December 2012) using the National Health Insurance claims data. We performed interrupted time series analyses for cost and utilization of "overall," "reduced price," and "constant price" antidiabetics between January 2009 and June 2013, and measured the growth rate for incidents of medical and surgical procedures for diabetes-induced complications. RESULTS: The segmented regression suggests that spending on overall and reduced price antidiabetics would drop by 6 and 23%, respectively; spending on constant price antidiabetics would rise by 16% in a year after the new pricing compared to if the policy were not in existence. There were a few immediate changes in utilization, and its trend indicated a significant decrease in reduced price antidiabetics and an increase in constant price antidiabetics. Incidents of medical and surgical procedures relating to diabetic complications were unaffected. CONCLUSIONS: The Korean price cut program contained costs by immediately reducing the cost of pharmaceuticals without any major signals associated with compromised clinical conditions in diabetic patients.

Awareness and attitude of the public toward personalized medicine in Korea.

OBJECTIVES: As personalized medicine (PM) is expected to greatly improve health outcomes, efforts have recently been made for its clinical implementation in Korea. We aimed to evaluate public awareness and attitude regarding PM. METHODS: We performed a self-administered questionnaire survey to 703 adults, who participated in the survey on a voluntary basis. The primary outcome measures included public knowledge, attitude, and acceptance of PM. We conducted multinomial multivariate logistic analysis for outcome variables with three response categories and performed multivariate logistic regression analyses for dichotomous outcome variables. RESULTS: Only 28% of participants had knowledge that genetic factors can contribute to inter-individual variations in drug response and the definition of PM (199 out of 702). Higher family income was correlated with greater knowledge concerning PM (OR = 3.76, p = 0.034). A majority of respondents preferred integrated pharmacogenomic testing over drug-specific testing and agreed to inclusion of pharmacogenomic testing in the national health examination (64% and 77%, respectively), but only 51% were willing to pay for it. DISCUSSION: Our results identify the urgent need for public education as well as the potential health disparities in access to PM. This study helps to frame policies for implementing PM in clinical practice.

International experience in controlling pharmaceutical expenditure: influencing patients and providers and regulating industry - a systematic review.

OBJECTIVE: To review international policies to control expenditure on pharmaceuticals by influencing the behaviour of patients and providers and regulating the pharmaceutical industry. METHOD: Systematic review of experimental and quasi-experimental studies. Published studies were identified with an electronic search strategy using MEDLINE and EMBASE from 1980 to May 2012. Studies were eligible if they assessed the effect of policies aimed at influencing the behaviour of patients and providers, and regulating the pharmaceutical industry. Outcome measures included pharmaceutical expenditure, prices or utilization; other resource use relating to pharmaceuticals; and health outcomes and patients' or providers' behaviour relating to pharmaceutical use. Quality assessment criteria for each study design were developed based on the standard criteria recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group. The review includes studies based on randomized controlled trials and rigorous quasi-experimental designs (interrupted time-series and controlled before-and-after studies). Studies were excluded if they were conducted within a single hospital or practice; related to pharmaceutical care services or disease management; had less than 6 months of follow-up period (or less than 12 months overall for interrupted time series); if data in controlled before-and-after studies were not collected contemporaneously or if no rationale was stated for the choice of control group; or if relevant and interpretable data were not presented. RESULTS: A total of 255 studies met the inclusion criteria for this review. The majority of the studies relating to patients evaluated cost sharing interventions such as user charges (52 studies). User charges do reduce utilization of pharmaceuticals, and reduce public expenditure by shifting costs to patients. But they reduce the use of essential as well as non-essential drugs, and without adequate exemptions they affect vulnerable groups disproportionately. The majority of studies relating to doctors evaluated the effects of educational approaches (78 studies), reimbursement restrictions (48 studies) and incentive systems (22 studies). Evidence on these policies is of mixed quality. It appears possible to influence prescribing modestly, through various means, but it is essential that messages to prescribers are based on good evidence of effectiveness and cost-effectiveness. Twenty-nine studies related to industry regulation, and they were of mixed quality. Evidence from studies of reference pricing suggests that this may result in cost savings. These are, however, achieved not by companies reducing or restraining prices, or by reductions in the overall volume of prescriptions, but by some shifts in use and shifting costs to patients, with consequent adverse effects on the equity of access to medicines. Other price and profit controls remain almost completely lacking in evaluative evidence. CONCLUSIONS: It may be that the undesirable consequences of policies influencing patients, particularly user charges, can outweigh the benefits. To influence demand for pharmaceuticals, it is more appropriate to influence prescribing doctors and although interventions to improve prescribing practice have been developed, they often achieve relatively modest benefits and sometimes at high cost. Good evaluative evidence related to industry regulation is scarce despite its policy importance.

Sociodemographic factors influencing the use of injections in South Korean outpatient care.

PURPOSE: This study explored the relationship between sociodemographic factors and injection utilization in South Korea. METHODS: We conducted a retrospective cross-sectional analysis using 2009 prescription claims for Korean National Health Insurance beneficiaries. We analyzed the utilization, costs, and proportion of injections in the insured market for oral-injection dual-dose-form ingredients (DFIs). We included outpatients who were prescribed DFIs with no age limits. Descriptive analysis and multivariate logistic regression were performed to evaluate the predictive factors of injection use. RESULTS: Injections accounted for about 5% of outpatient utilization and costs of the study drugs. The odds of having injections were 1.3-1.6 times higher among those patients who are 70 years and older compared with those in the 20s, in smaller-sized hospitals and clinics than that in larger, and among medical institutions in rural areas than those in the capital area. The odds of having injections were increased stepwise for the age groups of 30-69 years. Injections were more likely to be prescribed for systematic hormonal preparations and drugs for the musculoskeletal system. CONCLUSIONS: The use of injections was higher among older groups, among smaller medical institutions, and among institutions in rural areas in Korean outpatient care. The difference between prescribing defined daily doses and prescribing rate for injections of the audit reports implies that Korean doctors prescribed injections often, but small doses for momentary effects in outpatient settings. Further studies are required to uncover the underlying causes of the high prevalence of injection use in older or rural populations and smaller institutions.

The effects of new pricing and copayment schemes for pharmaceuticals in South Korea.

OBJECTIVES: This study examined the effect of new Korean pricing and copayment schemes for pharmaceuticals (1) on per patient drug expenditure, utilisation and unit prices of overall pharmaceuticals; (2) on the utilisation of essential medications and (3) on the utilisation of less costly alternatives to the study medication. METHODS: Interrupted time series analysis using retrospective observational data. RESULTS: The increasing trend of per patient drug expenditure fell gradually after the introduction of a new copayment scheme. The segmented regression model suggested that per patient drug expenditure might decrease by about 12% 1 year after the copayment increase, compared with the absence of such a policy, with few changes in overall utilisation and unit prices. The level of savings was much smaller when the new price scheme was included, while the effects of a price cut were inconclusive due to the short time period before an additional policy change. Based on the segmented regression models, we estimate that the number of patients filling their antihyperlipidemics prescriptions decreased by 18% in the corresponding period. Those prescribed generic and brand-named antihyperlipidemics declined by around 16 and 19%, respectively, indicating little evidence of generic substitution resulting from the copayment increase. Few changes were found in the use of antihypertensives. CONCLUSIONS: The policies under consideration appear to contain costs not by the intended mechanisms, such as substituting generics for brand name products, but by reducing patients' access to costly therapies regardless of clinical necessity. Thus, concerns were raised about potentially compromising overall health and loss of equity in pharmaceutical utilisation.