医薬品医療機器レギュラトリーサイエンス
Online ISSN : 2436-6226
Print ISSN : 1884-6076
最新号
選択された号の論文の15件中1~15を表示しています
特集 Decentralized Clinical Trialを巡る最近の動きと関連規制
今月のTopic 規制
今月のTopic 基礎・臨床試験
今月のTopic 製造・品質管理
今月のTopic 再生医療
投稿 総説
  • Value Dossierのモックアップ
    鎌江 伊三夫, 古山 直樹, Jovelle L. FERNANDEZ
    2022 年 53 巻 4 号 p. 322-338
    発行日: 2022年
    公開日: 2022/09/08
    ジャーナル 認証あり

    Cost-effectiveness is an important indicator of the value of medicines, and is helpful when considering the acceptability of reimbursement decisions, or to set or adjust the prices of medicines in various countries. However, a multifaceted approach is needed to assess the value of medicines, and suitable criteria have so far been discussed mainly by international academic societies, taking into account the policies of individual countries. Here, we propose and explain the contents, composition, and preparation of the Pharmaceutical Value Information Document (abbreviated as value dossier), which has not yet been fully recognized in Japan. We take the case of a proton pump inhibitor as an example. The value dossier is expected to be a useful tool to clarify the value of medicines in actual clinical practice based on real-world evidence.

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財団Information 報告書
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