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.
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.
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.
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.
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.
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.
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.
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.
【目的】治験薬の管理環境はその品質を確保するために厳格であり、温度逸脱時は煩雑な対応が求められることから、治験実施医療機関では厳重な保管環境を構築する必要がある。CubixxCT（以下、本機）は、温度データ自動サーバ送信、二重扉等開閉時の温度変化の少ない設計、24時間365日中央監視などを備えたInternet of ...Things（IoT）保管庫であるが、本機が山口大学医学部附属病院（以下、当院）の冷所治験薬の保管運用に適応できるかを評価した。併せて冷所治験薬保管に求める環境に関し、治験依頼者にニーズ調査を行ったので報告する。【方法】設定温度3.5℃、監視温度2.4-5.9℃、測定間隔1分間で本機を運用した。運用期間中の本機校正証明有効期間（2021年6月～2022年4月）における温度・開閉データを、サーバからWebでExcelデータにより収集し分析した。冷所治験薬の保管環境に関するニーズ調査は、2021年11月時点において当院で治験薬を冷所保管している治験依頼者15企業に対し、アンケート形式にて実施した。【結果・考察】分析対象期間において、保管治験総数8件、総開閉回数237回、最高温度4.5℃、最低温度2.6℃、平均温度3.20℃であり、温度逸脱アラートはなかった。開閉回数最高日（8回）も大きな温度変動はなく、更に開閉頻度3群の平均温度を比較したが、無開閉日3.20℃、低頻度開閉日（1-4回/日）3.18℃、高頻度開閉日（5-8回/日）3.37℃であり、高頻度開閉日でわずかに高い傾向が見られたが、本機は扉の開閉に対して安定した温度を維持できていた。なお、最高温度は全て霜取り機能作動中の夜間に記録されており、最低温度は持続的な温度低下を記録した期間が確認されたが許容範囲であった。ニーズ調査は12企業から回答を得た。治験依頼者が冷所保管に必要と考えるものとして「温度計の校正証明書」92％、「温度逸脱が発生しにくい構造」83％、「冷蔵庫のメンテナンス記録」75％、と高く、「24時間365日中央監視」等の必要度は低かった。なお必要度の高い項目への費用加算は積極的な検討対象ではなかったが、必要度の低い項目では完全な否定意見は半数以下であった。【結論】CubixxCTは扉の開閉による温度変動に強く、当院の冷所治験薬の保管に対し十分に適応を示した。冷所治験薬保管環境については、温度計校正証明書等の治験依頼者が求める必須的環境よりも、付加的環境に費用加算の交渉の余地がある。
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