バイオシミラーインスリンをヨーロッパで採用する障壁:混合方法の研究
Elif Car1, Garm Habets1, Arnold G Vulto1,2
1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Diabetes, obesity & metabolism
|September 1, 2025
まとめ
製品特性と医師の習慣などの要因により,ヨーロッパではバイオシミラーインスリンの使用が制限されています. これらの障壁を克服することは 患者のアクセスと手頃な価格の改善の鍵です
科学分野:
- 薬学経済と健康政策
- 内分泌学
- 薬物開発
背景:
- バイオシミラー・インスリンは,患者さんの手頃な価格とアクセス性を高めることを目的としています.
- 導入されているにもかかわらず,ヨーロッパではバイオシミラーインスリンの使用率は依然として不十分です.
- バイオシミラー・インスリン治療の潜在的利点を阻害する.
研究 の 目的:
- 欧州医薬品庁 (EMA) が承認したインスリン製品とその払い戻し状況の最新の概要を提供すること.
- バイオシミラーとオリジナルのインスリンを処方する医師の決定に影響を与える重要な要因を探る.
- バイオシミラーインスリンを欧州市場で利用するための障壁と促進要因を特定する.
主な方法:
- 定量分析と質分析を組み合わせた混合手法である.
- EMAが承認したインスリン製品の定量分析と,欧州9カ国の払い戻しのデータ
- 定性的な段階では20人の医師と 半構造面接を行い 処方効果を理解しました
主要な成果:
- EMAが承認したインスリン剤は43種類 (1996年−2022年),そのうち6種類 (14. 0%) はバイオシミラーである.
- EMAが承認したインスリンに対する平均補償額は56. 3%で,国によって異なる.
- 医師の処方決定は,製品に関連する要因 (例えば,第2世代のアナログ,デバイスの互換性),業界要因 (例えば,会社の評判,マーケティング),および医師の習慣によって影響を受けた.
結論:
- バイオシミラー・インスリンがヨーロッパで採用されることが限られているのは,相互に関連した複数の要因が原因です.
- 製品の特性,製薬業界の影響,医師に関連する要因は重要な障壁です.
- これらの障壁を克服し,バイオシミラーインスリンの使用を促進するために,標的を絞った政策介入が必要である.
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