EU HTA 規制の準備:オランダの視点からの洞察
Anne Willemsen1,2, Maureen Rutten-van Mölken3, Riam Al Dulaimi1
1Zorginstituut Nederland, 1112 Diemen, ZA, The Netherlands.
Journal of market access & health policy
|August 27, 2025
まとめ
医療技術評価に関する欧州規則は 国内プロセスに影響を及ぼします オランダ国立保健医療研究所 (ZIN) は,医薬品に関する以前のスコーピングおよび共同臨床評価報告書に焦点を当てて,そのHTAプロセスを調整しました.
科学分野:
- 健康政策
- 規制科学
- 薬剤評価
背景:
- 欧州保健技術評価 (HTA) 規制 (HTAR) は2025年1月に開始され,EU加盟国による共同臨床評価 (JCA) 報告書の検討を義務付けている.
- そのため,既存のHTAの枠組みとプロセスを国内で調整する必要がある.
研究 の 目的:
- 新しいHTARの下でのオランダのHTAプロセスの予想される変更について説明します.
- HTARのためのオランダ国立保健機関 (Zorginstituut Nederland, ZIN) の準備と実施戦略の概要を述べる.
- EU HTARの将来の拡大に係る経験を共有する.
主な方法:
- プロジェクト・ガバナンス・構造とZINの現在の医薬品の評価・評価プロセスの継続的なギャップ分析
- 特定されたギャップと課題に基づく具体的な行動計画の策定
- ZINのHTAプロセスへの影響の分析,以前のスコーピングとJCAレポートの利用を含む.
主要な成果:
- ZINのHTAプロセスの2つの主要な影響:早期のスコーピングフェーズと,国家評価の出発点として機能するJCAレポート.
- 情報/知識,IT/テンプレート,コミュニケーション/利害関係者への関与,能力/リソース,および財政的な側面に関するカテゴリー別でのギャップ,課題および問題
- ZINは徹底した実施計画を策定し,HTARの準備を進めている.
結論:
- ZINは,HTARを国内HTAプロセスに実装する準備ができています.
- ZINは2025年から医薬品のJCA (共同評価者) の役割を担う準備ができています.
- ZINの実施経験の共有は,他の加盟国やEU HTARの将来の発展に役立つ.
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