Background/Aims: Despite the advent of advanced therapies, cases of so-called “difficult-to-treat” (D2T) ulcerative colitis (UC) persist. This study aims to clarify the epidemiological and clinical characteristics of patients with D2T UC. Methods: We conducted a nested case-control study using the Medical Data Vision Claims Database in patients with UC who began an advanced therapy (biologics, advanced small molecules, calcineurin inhibitors) from January 2018 through April 2023. D2T UC patients were defined as having 2 or more switches of advanced therapies, or as undergoing surgery for UC, within 2 years after the first advanced therapy. Results: Four hundred and one (16.7%) and 1,996 patients (83.3%) met the definitions of patients with D2T UC and non-D2T UC, respectively. After 1:1 matching by index year, 355 patients per group were included in the analysis. Multivariate logistic regression analyses, including sensitivity analyses based on follow-up period after the first advanced therapy, showed that a prescribed corticosteroid dose of ≥ 30 mg/day during the 6-month baseline period was associated with D2T UC. In D2T UC patients, median duration of the first advanced therapy was 99 days, and median number of advanced therapies per year was 1.7. The first advanced therapy was continued for 2 years in 78% of patients with non-D2T UC. Conclusions The proportion of D2T UC patients among UC patients starting advanced therapy was 16.7%. The factor most associated with D2T UC was the need for a corticosteroid dose ≥ 30 mg/day during the 6 months before initiation of advanced therapy.

“Appropriate/Rational allocation for limited healthcare resources”, which was the fundamental concept of the health economics, had not been widely accepted/disseminated for the general public in Japan. Although vast majority agreed with the existence of healthcare budget constraint, it had not been widely recognized that “physical” healthcare resources, such as healthcare professional and/or healthcare facilities, were also limited and restricted, until current COVID-19 ERA. The HTA （Health Technology Assessment） concept could be used for COVID-19 related resource allocation issues, such as prioritization of the vaccination. Kohli et al. conducted cost-utility analysis of various treatment strategy for the hypothetical vaccine in the US setting. They proved that vaccination for elderly and stuffs for health care/long term care facilities were cost-effective （dominant and USD 20,000/QALY, respectively）, while we need to take into account relatively low incidence rate of COVID-19 in Japan.However, current framework of the HTA with narrower perspective, could not capture entire value of the preventive intervention against COVID-19. Appleby et al. argued that broader perspective, under which external impacts, outside of healthcare area, would be incorporated, would be needed for appropriate decision making.Faced with COVID-19 pandemic, importance of re-defining （or expanding） the value of intervention would be widely recognized and further conceptual research should be warranted.

OBJECTIVE: The pharmacological effects of generic (GE) donepezil are the same as Aricept, its brand-name counterpart. However, little is known as to whether these two drugs provide the same quality of life (QOL). The study subjects were patients with Alzheimer's disease who were taking donepezil hydrochloride tablets, and were selected by visiting either the local pharmacies or the patients' homes. We chose the brand-name drug Aricept and its GE form donepezil to investigate, from a long-term caregiver's perspective, the influence of both drugs on the patients' QOL. METHODS: An EuroQol-5 Dimension (EQ-5D) was used to assess the QOL of patients with Alzheimer's disease, before and after various Aricept and/or donepezil regimens. Patients were divided into four groups: first time users of Aricept (n=43), first time users of GE donepezil (n=45), users refilling previous prescriptions of Aricept (n=51), and users switching from Aricept to GE donepezil (n=51). RESULTS: The average change in the EQ-5D utility indices rose significantly in the patients starting a new regimen of Aricept and its GE drug. The patients continuing an existing regimen of Aricept showed no significant differences, even after Aricept was switched to a GE drug. CONCLUSION: The QOL of patients starting a new regimen of Aricept and its GE drug improved. The QOL was maintained upon switching to the GE drug form.
Alzheimer Disease* ; Drugs, Generic ; Humans ; Pharmacies ; Prescriptions ; Quality of Life* ; Tablets

The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) as a measuring unit was developed along with an increased concern about drug utilization studies in Europe in the 1960s. Its use was recommended by the WHO Regional Office of Europe on 1981, then by the WHO Headquarters in Geneva in 1996. It is maintained by the WHO Collaborating Centre on Drug Statistics Methodology in Olso (http://www.whocc.no/) and widely used in Europe. However, it is rarely used in other parts of the world. This paper aims to inform the Japanese public about the ATC/ DDD system towards a more rational use of drugs in Japan. It attempts to answer the five Ws on ATC/ DDD, i.e., “What is ATC/DDD?”; “Why is ATC/DDD used?”; “When was ATC/DDD established?”; “Who decide ATC/DDD and how?”; and “Where is ATC/DDD used?”