Reimbursement Coverage Decision Making for Digital Health Technologies in South Korea: Does It Fit the Value Framework Used in Traditional Medical Technologies?

OBJECTIVES: The introduction of digital health technologies (DHTs) that have the potential to improve health outcomes and lower the costs of healthcare services has seen an explosion in recent years. Indeed, the expectation that these innovative technologies can ultimately fill a gap in the patient-healthcare provider model of care with the hope of bending the continuously increasing healthcare expenditure curve has not yet been realized in many countries including South Korea (from herein referred to as Korea). We examine reimbursement coverage decision making status for DHTs in South Korea. METHODS: We examine the regulatory landscape, health technology assessment process, and reimbursement coverage determination for DHTs in Korea. RESULTS: We identified the specific challenges and opportunities for reimbursement coverage of DHTs. CONCLUSIONS: To ensure DHTs can be used effectively in medical practice, a more flexible and nontraditional approach to assessment, reimbursement, and payment determination is required.

Prognosis for non-small cell lung cancer patients with brain metastases.

PURPOSE: Brain metastasis has a poor prognosis in patients with advanced non-small cell lung cancer (NSCLC). In this study, we evaluated the prognosis of NSCLC patients with brain metastases. METHODS: We analyzed a total of 313 NSCLC patients with brain metastasis. We compared the prognoses between a group of less than four (group A) and a group of more than four or equal to four (≥4) (group B) brain metastases. RESULTS: The median survival time was 334 days (group A, 164 patients, 52.4%) and 234 days (group B, 149 patients, 47.6%). Univariate analysis showed that the number of metastases, age at diagnosis of brain metastasis, smoking history, histologic type, and former stage of primary lung cancer before brain metastasis, had a significant influence. In addition, treatment for primary lung cancer lesions and brain metastasis also affected the overall survival (p < .0001). However, there was no difference in the overall survival between the two groups in the multivariate analysis. CONCLUSION: Our results show that the number of brain metastases, classified by group A (<4) or group B (≥4) did not influence the overall survival of NSCLC patients. However, the overall survival in group A was better than in group B when analyzed, except for local brain treatment modalities in sub-group analysis, suggesting that non-optimized local treatment strategies might cause an unexpected prognosis result in this retrospective study. We suggest that more prospective studies might be needed for the optimal standard treatment for brain metastasis.

Prognosis in patients having chronic obstructive pulmonary disease with significant coronary artery lesion angina.

BACKGROUND/AIMS: Many studies have investigated angina and its relationship with chronic obstructive pulmonary disease (COPD). However, angina was diagnosed only by noninvasive tests or only by clinical symptoms in most of these studies. The aim of this study was to compare the prognosis, including rate of hospitalization and death from significant coronary artery lesion and nonsignificant coronary artery lesion angina, in patients with COPD. METHODS: Patients with COPD who underwent coronary angiography (CAG) due to angina were reviewed retrospectively at a tertiary referral hospital. COPD is defined as post-bronchodilator forced expiratory volume in 1 sec/forced vital capacity (FEV(1)/FVC) of < 70%. A significant coronary lesion is defined as at least 50% diameter stenosis of one major epicardial artery in CAG. RESULTS: In total, 113 patients were enrolled. Mean follow-up duration was 39 ± 21 months. Of the patients, 52 (46%) had mild COPD and 48 (42%) had moderate COPD. Sixty-nine (61%) patients had significant stenosis in CAG. The death rate in the follow-up period was 2.21 per 100 patient-years. No significant difference was observed among the all-cause mortality rate, admission rate, or intensive care unit admission rate in patients who had COPD with or without significant coronary artery disease. Pneumonia or acute exacerbation of COPD was the most common cause of admission. CONCLUSIONS: In patients having COPD with angina who underwent CAG, no significant difference was observed in mortality or admission events depending on the presence of a significant coronary artery lesion during the 2-year follow-up period.

The role of whole-body FDG PET/CT, Tc 99m MDP bone scintigraphy, and serum alkaline phosphatase in detecting bone metastasis in patients with newly diagnosed lung cancer.

Bone scan (BS) and serum alkaline phosphatase (ALP) concentration are used to detect bone metastasis in malignancy, although whole-body fluoro-D-glucose positron emission tomography computed tomography (FDG PET/CT) is being used increasingly. But BS is still used for the detection of metastatic bone lesion. So we compared the usefulness of PET/CT, BS, and serum ALP in detecting bone metastases in patients with newly diagnosed lung cancer. The medical record database was queried to identify all patients with a new diagnosis of lung cancer between January 2004 and December 2005, who had a PET/CT, BS, and serum ALP before treatment. We retrospectively reviewed all patients' records and radiological reports. One hundred eighty-two patients met the inclusion criteria. Bone metastases were confirmed in 30 patients. The sensitivity values were 93.3% for PET/CT, 93.3% for BS, 26.7% for serum ALP concentration, and 26.7% for BS complemented with serum ALP concentration. The respective specificity values were 94.1%, 44.1%, 94.1%, and 97.3%. The kappa statistic suggested a poor agreement among the three modalities. FDG PET/CT and BS had similar sensitivity, but PET/CT had better specificity and accuracy than BS. PET/CT is more useful than BS for evaluating bone metastasis. However, in the advanced stage, because of its high specificity, BS complemented with serum ALP is a cost-effective modality to avoid having to use PET/CT.

Clinical characteristics of a second small nodule(s) associated with cT1-2N0M0 non-small-cell lung cancer.

When a patient with cT(1-2)N(0)M(0) stage non-small-cell lung cancer (NSCLC) has a second small nodule(s), the treatment plan and prognosis depend largely on whether the nodule is benign or malignant. However, the incidence of malignancy of nodules associated with N(0) and M(0) NSCLC is unknown. Furthermore, predictive factors of malignancy have not been defined. Thus, we evaluated the nature of nodules that were less than 15 mm in diameter associated with stage T(1-2)N(0)M(0), and tried to identify clinical and radiologic factors predictive of malignancy. The study population consisted of 39 patients with T(1-2)N(0)M(0) NSCLC and a second nodule(s) less than 1.5 cm and who had received curative resection. Medical records and radiologic findings, including CT scans of the chest, were retrospectively reviewed. Nodules were finally diagnosed as benign in 85% and malignant in 15%. No significant differences in terms of gender, age, preoperative carcinoembryonic antigen (CEA) level, cell type, pathologic stages, shape, size, location and number of nodules, or the presence of calcification around nodules was observed between benign and malignant groups. We suggest that if primary NSCLC is resectable, an effort should be made to confirm the pathologic diagnosis of nodules. If histologic findings in nodules are not available, surgical resection should be actively considered, especially when nodules < 1.5 cm are associated with N(0) or M(0) NSCLCs.