台灣藥品給付協議實施特性分析

Characteristics of the implementation of managed entry agreements for drug reimbursement in Taiwan

目標：本研究欲由公開資料中，探討國內執行藥品給付「其他協議」政策之現況。方法：由中央健康保險署官網之公開資料，分析健保署與廠商簽訂之藥品給付其他協議特性。結果：2018年10月至2021年10月底為止，共要求77件藥品給付協議案例，其中12件仍在協議中，已簽訂的協議中，3件於2021年10月終止，2件重新再議。要求的協議中，以財務結果為基礎之協議有63件（82%），以療效結果為基礎之協議有4件（5%），未說明其他協議類型者有10件（13%）；以藥物治療（Anatomical Therapeutic Chemical, ATC）分類系統分析，案例中多數為抗腫瘤與免疫調節類藥物（ATC-L，約73%），其次為抗感染藥（ATC-J，約12%）。結論：各國支付者對於藥品給付關注的焦點議題各不相同，國內共擬會議中討論的焦點，多半是關注於藥品預算衝擊的問題。實施MEA之後，健保署得以再透過多元的協議內容，與廠商協議機密性價格折扣或療程費用上限等等方式，以多種工具使新藥使用能與國際同步，不但促進病人對於新藥之可近性，同時也管控健保的財務支出。

Objectives: The study investigated the characteristics of managed entry agreements (MEAs) in Taiwan by using open data. Methods: Data were derived from the official website of the National Health Insurance Administration (NHIA). The MEAs requested during the Pharmaceutical Benefit and Reimbursement Scheme Joint committee (PBRS) meeting to be signed between NHIA and the industry were investigated. Results: Between October 2018 and October 2021, 77 MEAs were requested, 12 of which have not been concluded. Among the signed MEAs, three were agreed to be terminated, and re-discussion was requested for two. Among the required agreements, 63 (82%) were finance-based MEAs, 4 (5%) were performance-based MEAs, and 10 (13%) were unspecified. An analysis of the therapeutic areas of the drugs listed in the MEAs by using the Anatomical Therapeutic Chemical (ATC) classification system revealed that most drugs were antineoplastic and immunomodulating drugs (ATC-L, approximately 73%), followed by anti-infectives for systemic use (ATC-J, approximately 12%). Conclusions: The focus of payers on drug reimbursement varies from country to country; in the local PBRS meeting, focus was identified as the main issue relating to drug budget impact. MEAs allow the NHIA to discuss with the pharmaceutical companies regarding a confidential discount or payment cap of a treatment course to facilitate patient access to new drugs while managing the healthcare expenditure.