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Back衛福部研議開放原廠藥自付差額,增加民眾用藥選擇
衛福部研議開放原廠藥自付差額,增加民眾用藥選擇
Health
自由时报1 hour agoHealth3 min readChina

衛福部研議開放原廠藥自付差額,增加民眾用藥選擇

石崇良部長表示將研議建立差額負擔制度,以兼顧學名藥政策與民眾用藥需求

Quick Look

衛福部長石崇良於9月1日表示,衛福部將研議開放原廠藥「自付差額」制度。此舉旨在兼顧推廣學名藥政策與民眾用藥選擇權,讓民眾在原廠藥與學名藥之間有更多彈性,目前相關機制尚在研議階段。

AI-generated summary

Why It Matters

目前健保藥品給付依規範辦理,無差額負擔機制。學名藥與原廠藥具相同主成分、劑量及劑型,並需通過生體相等性試驗。

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衛福部長石崇良今(1日)表示,目前健保藥品並沒有「差額負擔」制度,但為兼顧推動學名藥、生物相似性藥品政策,以及民眾用藥選擇,衛福部將研議開放原廠藥「自付差額」,讓有需求的民眾自行選擇。這項研議促使民眾想進一步了解原廠藥、學名藥差異。

石崇良說明,目前健保藥品給付均依健保規範辦理,並沒有讓民眾選擇「自付差額」的機制,原則上是納入健保給付或不給付;納入健保後,民眾則依現行規定負擔部分負擔。

不過,部分原廠藥專利期屆滿後,已有學名藥上市,目前原廠藥與學名藥在健保制度下並沒有讓病人透過補差額指定原廠藥的機制。石崇良表示,未來將研議是否建立差額負擔制度,讓民眾在原廠藥與學名藥之間有更多選擇。

原廠藥、學名藥差在哪?主成分與療效都相同

根據衛福部食藥署衛教資料表示,民眾至醫療機構就醫或到藥局領藥時,可能會遇到醫師開立學名藥,或者藥師詢問是否可以學名藥替代,讓不少民眾感到疑惑。到底什麼是學名藥、學名藥的優勢在哪裡?

食藥署說明,原廠藥是藥廠經過長期研發與實驗、取得專利的新藥;學名藥則是於新藥專利期過後,證明品質、安全與療效與原廠藥相當的藥品。因此,學名藥與原廠藥具有相同主成分、劑量及劑型,且須透過藥品生體相等性(BE)試驗來證明具有相同療效。

衛教資料提及,針對學名藥品質,於我國上市前採用與原廠藥相同之審查標準,且其製造廠亦需符合國際醫藥品稽查協約組織之藥品優良製造規範(PIC/S GMP)。

讓醫療資源運用更有效

食藥署表示,學名藥因為無需重複執行藥理與毒性試驗、臨床試驗等,而大幅降低生產成本,因此藥品價格降低,可以有效減少醫療支出,使醫療資源有效運用,所以許多國家皆積極推廣使用學名藥,例如美國、日本學名藥涵蓋率皆達70-90%以上。

食藥署還提到,近年受國際疫情、戰爭等因素影響,導致國際藥品供應不穩定,發展學名藥可強化藥品供應的韌性,尤其國產學名藥,生產供應的穩定性較高,較容易協助調整產線,並配合加班生產,使藥品供應不間斷,以保障民眾用藥權益。

What to Watch

AI outlook — possibilities, not facts

  • 衛福部將針對原廠藥自付差額制度進行研議。

    Very likely · Within months

Open Questions

  • 差額負擔的具體實施細則為何?
  • 哪些藥品將納入自付差額範圍?

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This article was originally published by 自由时报.

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