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薬剤保険の決定に有効性と費用対効果を活用する:イギリス,オーストラリア,カナダの比較
Fiona M Clement1, Anthony Harris, Jing Jing Li
1Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
JAMA
|October 8, 2009
まとめ
オーストラリア,カナダ,イギリスにおける国家薬物保険の決定は,比較効果と費用対効果の証拠に基づいています. これらの要因が勧告を導く一方で,代理店のプロセスやその他の考慮事項により,変動があります.
科学分野:
- 健康経済学とは
- 保健政策 保健政策
- 医薬品政策について
背景:
- 国家公的保険プログラムは,薬物保険の決定を,比較効果と費用対効果の証拠に基づいて行うことが多い.
- オーストラリア,カナダ,イギリスという3つの主要な国際法域は,このような証拠の利用をカバー決定に先駆けてきました.
研究 の 目的:
- 臨床的および費用対効果の証拠が,オーストラリア,カナダ,および英国の国内および全域での薬物保険の決定にどのように影響するかを描写する.
- 証拠に基づいた薬物カバープロセスで直面する一般的な課題を特定する.
主な方法:
- 遡及データに関する記述的分析が行われました.
- データ源は,カナダのコモン・ドラッグ・レビュー (CDR),英国の国立健康・臨床卓越研究所 (NICE),オーストラリアの製薬利益諮問委員会 (PBAC) でした.
- 2008年12月31日までの公開されている情報を収集しました.
主要な成果:
- 国立衛生と臨床卓越研究所 (NICE) は,提出件数の87.4%を推奨し,共通医薬品レビュー (CDR) の49.6%と,医薬品利益諮問委員会 (PBAC) の54.3%と比較した.
- 主な課題は,臨床効果の不確実性であり,しばしば不適切な試験設計,不適切な比較器,または検証されていない代理エンドポイントから生じる.
- 各国の推薦の差異が認められたのは,検討された薬剤,代理店のプロセス (価格交渉を含む),および類似薬 ("me too"薬) に対するアプローチの違いによる可能性がある.
結論:
- 国立衛生と臨床卓越研究所 (NICE),医薬品利益諮問委員会 (PBAC),共同医薬品レビュー (CDR) は,臨床的に有意義な効果に関する証拠の質と強さに関する共通の課題を共有しています.
- 比較的な効果と費用対効果は,他の関連する要因とともに,国家機関によって薬物保険の決定を支援するために利用されます.
- これらの評価プロセスの成果は,文脈的要因,代理人の手続き,交渉能力,そして潜在的に異なる社会的価値によって形作られています.
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