Evaluation of changes in the clinical benefits of oncology drugs over time following reimbursement using the ASCO-VF and the ESMO-MCBS.

PURPOSE: This study aims to estimate changes in the value of oncology drugs over time from initial data of the reimbursement decisions to subsequent publications in Korea, using two value frameworks. METHODS: We retrieved primary publications assessed for reimbursement between 2007 and July 2021 from the decision documents of Health Insurance Review and Assessment and subsequent publications made available following reimbursement decision from ClinicalTrials.Gov and PubMed databases. Changes in the clinical benefit scores were assessed using the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). A paired t test was performed to test whether there was a difference in the scores between primary and subsequent publications. RESULTS: Of 73 anticancer product/indication pairs, 45 (61.6%) had subsequent publications, of which 62.5% were released within 1 year of reimbursement decision. The mean ESMO-MCBS and ASCO-VF Net Health Benefit scores increased from primary to subsequent publications, although the differences were not significant. The mean ASCO-VF bonus score significantly increased from 15.91 to 19.09 (p = 0.05). The ESMO-MCBS and bonus scores increased by 0.25 and 0.21, respectively, and the bonus score had a greater impact on the ESMO-MCBS score than the preliminary score did. CONCLUSION: The value of drugs demonstrated in subsequent publications varies considerably among oncology drugs, depending on uncertainty associated with the initial evidence and the availability of updated evidence. As decision-making in the face of uncertainty becomes more prevalent, the value frameworks can serve as simple screening tools for re-evaluation in these cases.

Current Status of the Pediatric Palliative Care Pilot Project in South Korea Based on the Experience of a Single Center.

Purpose: We evaluated the status of patients enrolled in South Korea's pediatric palliative care pilot project based on the experience of a single center. This study examined factors related to end-of-life services and differences in medical costs. Methods: The medical records of 120 patients referred by a pediatric palliative care team were analyzed retrospectively. Data from July 1 to February 28, 2022 were collected and analyzed using the chi-square test and the Mann-Whitney U test. Results: Volunteer programs and psychological support (100%), family support and education (99.2%), and financial support through institutional linkage (62.5%) were provided to the participants. In the deceased group, there were no significant differences in general characteristics, which included age, gender, primary disease, religion, duration of hospitalization in an intensive care unit (ICU) and non-intensive care unit (non-ICU). However, the ICU group had fewer opportunities to access individual pain and physical symptom management than the non-ICU group and there were limitations in linking with external resources. Medical expenses were significantly different for the ICU group, with a 3-times higher average cost than the non-ICU group. Conclusion: Although an individualized approach is needed for each patient in pediatric palliative care, psychosocial care is essential. In addition, if early intervention for end-of-life pediatric patients is available from a palliative care team, the cost burden of medical care for patients and their families should be minimal.

Economic Burden of Recurrence in Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer: A Retrospective Study Using Nationwide Claims Data of South Korea.

INTRODUCTION: Although many patients with early stage non-small cell lung cancer (NSCLC) experience recurrence despite complete resection, few studies have reported on the corresponding economic burden. This study aimed to understand the economic impact of recurrence by measuring healthcare costs and resource utilization in patients with recurrent stage IB-IIIA NSCLC. METHODS: Using Health Insurance Review and Assessment claims data from South Korea, we included patients who underwent complete resection for stage IB-IIIA NSCLC during the index period (January 1, 2012, to October 31, 2018). Patients who experienced recurrence were matched with those who did not using 1:1 propensity score (PS) matching. The mean healthcare costs and resource utilization were analyzed from the date of complete resection to the last claims for cancer treatment. A generalized linear model (GLM) was used to estimate the impact of covariates on healthcare costs. A difference-in-difference (DID) analysis was conducted to analyze the healthcare costs between the two groups before and after recurrence. RESULTS: Patients with recurrence incurred higher healthcare costs, particularly in outpatient settings. The cost of targeted therapy and immune checkpoint inhibitors primarily contributed to cost differences, and medication costs increased over time after complete resection. Patients with recurrence were also hospitalized more frequently (9.3 vs. 5.0, p < 0.0001) for a longer period (74 days vs. 42 days, p < 0.0001) than those without recurrence. GLM analysis showed that the total cost was 2.31-fold higher in patients with recurrence (95% confidence interval: 2.19-2.44). The DID analysis showed significantly increased total costs in patients with recurrence (ß = 26,269, p < 0.0001), which was mostly attributed to medication costs (ß = 17,951, p < 0.0001). CONCLUSION: Recurrence of completely resected NSCLC leads to a substantial increase in healthcare costs and resource utilization. The results of this study show the economic burden of recurrence, which may help future economic analyses and resource allocation.

[Usefulness of ¹8F-fluoro-2-deoxyglucose positron emission tomography in evaluation of gastric cancer stage].

BACKGROUND/AIMS: The usefulness of ¹8F-fluoro-2-deoxyglucose (FDG)-PET in detecting primary cancer, lymph node metastasis, and distant metastasis were studied in the gastric cancer patients. METHODS: The subjects were 392 gastric cancer patients who received FDG-PET and an abdominal CT test prior to surgery. The results of FDG-PET and CT were compared with the surgical and pathologic results. RESULTS: The primary site detection rate of FDG-PET was 74.4%, 50.3% in early gastric cancer and 92.0% in advanced gastric cancer. Detection rate was higher when tumors were larger than 3.5 cm, had deeper depth of invasion, and at a later stage (p<0.05, respectively). In multivariate analysis, tumor size, spread of tumor cells beyond the muscle layer (≥T2), and lymph node metastasis were statistically significant factors in primary site detection rate. The sensitivity, specificity, and positive predictive value of FDG-PET to lymph node metastasis were 59.6%, 88.8%, and 81.1% respectively, sensitivity being lower compared to CT while specificity and positive predictive value were higher. Sensitivity, specificity, and positive predictive value to distant metastasis were, respectively, 66.7%, 99.2%, and 88.0%, similar to CT. In 21 of the 392 patients (5.4%), synchronous double primary cancers were detected. CONCLUSIONS: In gastric cancer, usefullness of FDG-PET is limited to the advanced stage. Diagnostic value of this test was not superior to CT. However, FDG-PET may be useful in detecting synchronous double primary cancers.

Prospective assessment of risk of bacteremia following colorectal stent placement.

BACKGROUND: Colorectal stent insertion is an invasive endoscopic procedure. However, there are no reports regarding the incidence of bacteremia with colorectal stent. OBJECTIVE: This study was to evaluate the risk of bacteremia and infectious complications after stent insertion for colorectal obstruction. METHODS: Patients who underwent colorectal stent insertion were enrolled consecutively. Blood cultures were obtained before colorectal stent insertion and at 30 min after the procedure. Patients were monitored for 48 h after colorectal stent insertion to detect the development of infectious complications. Procedural data collected included location of obstruction, degree of bowel preparation, obstructive symptoms, and the time required for the procedure. RESULTS: Of 64 patients undergoing colorectal stent, four (6.3%) had a positive post-stent blood culture. All patients, including those with positive cultures, remained asymptomatic during the 48 h after the procedure. Site of obstruction, degree of bowel preparation, age, and underlying disease were not different between the two groups. Development of bacteremia was associated with long procedure time (p < 0.05). CONCLUSIONS: Colorectal stent insertion does not induce significant bacteremia in patients with colorectal obstruction. These findings suggest that the routine use of prophylactic antibiotics may not be necessary in colorectal stent insertion.

[Durability of sustained virologic response in chronic hepatitis C: analysis of factors related to relapse after sustained virologic response with peginterferon plus ribavirin combination therapy].

BACKGROUND/AIMS: Pegylated interferon plus ribavirin combination therapy has been the standard of therapy for patients with chronic hepatitis C. Although previous studies have reported long term durability after the sustained virologic response (SVR) with standard therapy for chronic hepatitis C, it is still unclear in Korea. The aim of this study was to evaluate the relapse rate and related factors after SVR to pegylated interferon therapy in Korean patients with chronic hepatitis C. METHODS: A total of 119 chronic hepatitis C patients were treated with pegylated interferon plus ribavirin, and 73 patients achieved SVR (61.3%). Among 73 patients who achieved SVR, 68 patients (genotype 1, n=40; genotype non-1, n=28) were evaluated for virological response after SVR. RESULTS: SVR rate in genotype 1 and genotype non-1 were 52.5%, and 65.1%, respectively. Relapse after SVR occurred in 5 patients (7.4%) with genotype 1, and the median time to relapse from SVR was 10 months. Univariate analysis revealed that the dose reduction of pegylated interferon (p=0.005) and cirrhosis (p=0.03) were significantly associated with relapse. CONCLUSIONS: These results suggested that the relapse could occur even after SVR achievement in Korean patients with chronic hepatitis C, and the dose reduction of pegylated interferon during treatment or having cirrhosis may increased the risk for relapse.