Treatment of Inflammatory Bowel Disease with Biologics in Japan: A Single-Center, Retrospective Pharmacoeconomic Study.

Biologics are essential for treating inflammatory bowel disease (IBD); however, only a few studies have validated cost-effective treatment options and patient factors for biologic use using real-world data from Japanese patients with IBD. Here, we aimed to provide pharmacoeconomic evidence to support clinical decisions for IBD treatment using biologics. We assessed 183 cases (127 patients) of IBD treated with biologics between November 2004 and September 2021. Data on patient background, treatment other than biologics, treatment-related medical costs, and effectiveness index (ratio of the C-reactive protein-negative period to drug survival time) were analyzed using univariate and multivariate logistic regression analyses. Drug survival was determined using Kaplan-Meier survival curve analysis. The outcomes were to validate a novel assessment index and elucidate the following aspects using this index: the effectiveness-cost relationship of long-term biologic use in IBD and cost-effectiveness-associated patient factors. Body mass index ≥25 kg/m2 and duration of hypoalbuminemia during drug survival correlated significantly with the therapeutic effectiveness of biologics. There were no significant differences in surgical, granulocyte apheresis, or adverse-event costs per drug survival time. Biologic costs were significantly higher in the group showing lower effectiveness than in the group showing higher effectiveness. These findings hold major pharmacoeconomic implications for not only improving therapeutic outcomes through the amelioration of low albumin levels and obesity but also potentially reducing healthcare expenditure related to the use of biotherapeutics. To our knowledge, this is the first pharmacoeconomic study based on real-world data from Japanese patients with IBD receiving long-term biologic therapy.

[Profile of Generic Drugs Associated with the Discontinuation of the Supply].

A consistent and uninterrupted supply of pharmaceuticals is essential for optimal pharmacotherapy. However, some cases of supply disruptions and recalls have been reported. In particular, the withdrawal of some drugs from the market was occurred in recent year. Nevertheless, the characteristics of these drugs were unknown. The aim of this study was to analyze the ratio of generic drugs and the profile of generic drugs that have been withdrawn from the market. Data were collected from a drug information database for the period between April 2017 and March 2022 and analyzed for characteristics, such as price, number of suppliers, and reasons for withdrawal. The results showed a 1.4-fold increase in the number of drugs discontinued in 2021 compared with that in 2017, with 78.6% of the drugs discontinued being generic drugs. The proportion of discontinued generic drugs costing less than 10 yen (29.2%) was higher than those remaining on the market (15.0%). Additionally, the proportion of withdrawn generic drugs sold by four or more suppliers (67.6%) was higher than those that remained in the market (38.4%). In most cases (78.8%), the reasons for the discontinuation of these generic drugs were not disclosed. This study showed that most drugs withdrawn in Japan during the study period were generic drugs, characterized by low prices or many suppliers. Our study contributes to the understanding of the instability in the pharmaceutical supply chain in Japan.

Influence of filtering on the effective concentration and sterility of a 2% cyclosporine ophthalmic solution: a quality improvement perspective.

BACKGROUND: Pharmaceutical companies do not sell formulations for all diseases; thus, healthcare workers have to treat some diseases by concocting in-hospital preparations. An example is the high-concentration 2% cyclosporine A (CyA) ophthalmic solution. Utilizing a filter in sterility operations is a general practice for concocting in-hospital preparations, as is the case for preparing a 2% CyA ophthalmic solution. However, whether filtering is appropriate concerning the active ingredient content and bacterial contamination according to the post-preparing quality control of a 2% CyA ophthalmic solution is yet to be verified. METHODS: We conducted particle size, preparation concentration, and bacterial contamination studies to clarify aforementioned questions. First, we measured the particle size of CyA through a laser diffraction particle size distribution. Next, we measured the concentration after preparation with or without a 0.45-µm filter operation using an electrochemiluminescence immunoassay. Finally, bacterial contamination tests were conducted using an automated blood culture system to prepare a 2% CyA ophthalmic solution without a 0.45 µm filtering. Regarding the pore size of the filter in this study, it was set to 0.45 µm with reference to the book (the 6th edition) with recipes for the preparation of in-hospital preparations edited by the Japanese Society of Hospital Pharmacists. RESULTS: CyA had various particle sizes; approximately 30% of the total particles exceeded 0.45 µm. The mean ± standard deviation of filtered and non-filtered CyA concentrations in ophthalmic solutions were 346.51 ± 170.76 and 499.74 ± 76.95ng/mL, respectively (p = 0.011). Regarding bacterial contamination tests, aerobes and anaerobes microorganisms were not detected in 14 days of culture. CONCLUSIONS: Due to the results of this study, the concentration of CyA may be reduced by using a 0.45-µm filter during the preparation of CyA ophthalmic solutions, and furthermore that the use of a 0.45-µm filter may not contribute to sterility when preparing CyA ophthalmic solutions.

Pharmacoeconomic study of biologics for psoriasis treatment based on real-world drug survival.

The efficacy of biologics in psoriasis treatment is clinically proven; however, biologics are expensive. In this study, we assessed the real-world cost-effectiveness of biologics for psoriasis treatment by evaluating the relationship between biologic drug survival (DS) and total medical-treatment costs from a pharmacoeconomic viewpoint. Furthermore, the effects of patient factors on cost-effectiveness were investigated. We retrospectively reviewed the medical records of 135 cases who received either a tumor necrosis factor-alpha (TNF-α) monoclonal antibody (TNF-mab), interleukin (IL)-17 mab, or IL23p19-mab for psoriasis from January 2010 to June 2020 at Yamaguchi University Hospital. We compared the monthly medical-treatment costs according to biologic classification and found that costs of medical services, tests, and external preparations required for the treatment process were significantly higher in the TNF-mab group than in the other groups, and the total medical costs associated with TNF-mab treatment were significantly higher than those of IL17-mab treatment. The total monthly cost of medical care was lower in the long-term DS group than in the short-term group. The number of prescriptions for external preparations, comprising Vitamin D3 and corticosteroid, was significantly higher in the long-term DS group than in the short-term group; in the TNF-mab group, the proportion of patients without smoking habits was significantly higher in the long-term group as well. Our study indicated that when costly biologics are used for psoriasis treatment, the maintenance of long-term DS and appropriate patient guidance might improve the quality of medical care, thus allowing cost-effective medical care.

[Standardization of Hypnotic Agents for Prevention of Falls: A Pharmacoeconomic Study].

To reduce the number of falls caused by hypnotic agents, the standardization of insomnia treatment was carried out at Yamaguchi University Hospital from April 2019. There were concerns that medical costs would increase due to the selected medicines-suvorexant and eszopiclone-being more expensive than conventional benzodiazepines. In this study, the standardization of insomnia treatment was evaluated by pharmacoeconomics. The costs of the hypnotic agents was considered, as was the cost of examination/treatment following falls. Effectiveness was evaluated as the incidence of falls within 24 hours of taking hypnotic agents. This analysis took the public healthcare payer's perspective. Propensity score matching based on patient background, showed that, per hospitalization the medicine costs of the recommended group increased by 1,020 yen, however, the examination/treatment costs following falls decreased by 487 yen when compared with the non-recommended group. Overall, the recommended group incurred costs of 533 yen more per hospitalization for patients prescribed hypnotic agents compared to the non-recommended group, but the incidence of falls for the recommended group was significantly lower than that in the non-recommended group (1.9% vs. 6.3%; p<0.01). These results suggest that in order to prevent the incidence of falls by 1 case, it is necessary to increase costs by 12,086 yen which is the subthreshold cost for switching to the recommended medicine as standardization. The selection of recommended medicines may be a cost-effectiveness option compared with non-recommended medicines.