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
投稿 総説
日本における医薬品の価値情報文書の作成及びその活用
Value Dossierのモックアップ
鎌江 伊三夫古山 直樹Jovelle L. FERNANDEZ
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ジャーナル フリー

2022 年 53 巻 4 号 p. 322-338

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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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