Pharmaceutical and Medical Device Regulatory Science
Online ISSN : 2436-6226
Print ISSN : 1884-6076
Volume 53, Issue 4
Displaying 1-15 of 15 articles from this issue
  • Mock-up of Value Dossier
    Isao KAMAE, Naoki FURUYAMA, Jovelle L. FERNANDEZ
    2022 Volume 53 Issue 4 Pages 322-338
    Published: 2022
    Released on J-STAGE: September 08, 2022
    JOURNAL FREE ACCESS

    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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