臺灣藥品給付「其他協議」實施特性分析

Abstract

研究背景與目的：本研究欲由公開資料中，探討國內執行藥品給付「其他協議」(managed entry agreement, MEA)之特性及其與新藥健保收載之關係。 研究方法：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MEA 特性。並以食品藥物管理署公告之2016~2020年核發新藥許可證清單作為對照組，探討實施MEA對於新藥之健保收載比率與審查時間之影響。 研究結果：2018年10月至2021年10月底為止，共要求77件藥品給付MEA案例，其中12 件仍在協議中，已簽訂的協議中，3件於110年10月終止，2件重新再議。要求的協議中，以財務為基礎之MEAs有 63件 (82%)，以效果為基礎之MEAs有4件 (5%)，未說明MEAs類型者有10件 (13%)；以藥物治療分類系統分析，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%)。2016~2020年間年核准之新藥，簽訂MEA而收載入健保者，以癌症新藥居多。2018年以前尚未實施MEA制度時，約25~33% 癌症新藥未能納入健保給付；於實施MEA制度之後，終得因簽訂MEA而納入健保給付範圍：2016年核准之癌症新藥未實施MEA前之收載比率為41.7%(平均審查時間為466日)，自2018年9月MEA公告實施後，因簽訂MEA而收載者有33.3%，故總收載比率增為75.0%；2019年核准之癌症新藥收載比率為87.5%，其中因簽訂MEA而收載之比率為62.5%(平均審查時間為518日)，未簽訂MEA比率為25.0%(平均審查時間為366日)；2020年核准之癌症新藥收載率為38.5%，簽訂MEA比率為23.1%(平均審查時間為387日)，未簽訂MEA比率為15.4%(平均審查時間為281日)，因此長期趨勢有待觀察。 結論：國內簽訂之MEA特性與其他各國類似，多為以財務為主的協議，並且以抗腫瘤與免疫調節類藥物為主。原來未能納入健保給付的藥品，透過簽訂MEA而得以納入給付；簽訂MEA而收載入健保者以癌症新藥居多。

Objective: The study intends to investigate the characteristics of managed entry agreement (MEA) for drug reimbursement in Taiwan based on open data. Method: Based on the published data on the official website of National Health Insurance Administration (NHIA), the MEAs requested during Pharmaceutical Benefit and Reimbursement Scheme Joint committee (PBRS) meeting to be signed between NHIA and the industry are investigated. In addition, a list of new drug approved during 2016 ~2020 that was published by Taiwan Food and Drug Administration was taken as a control group to investigate the impacts of MEA implementation on the rate and duration for new drugs to be included in the NHI scope. Results: During the period between October 2018 and October 2021, there were 77 MEAs requested, 12 out of the 77 MEAs have not been concluded; for the signed MEAs, 3 MEAs have been agreed to terminate and 2 have been requested for re-discussion. Among the required agreements, there are 63 finance-based MEA (82%), 4 performance-based MEAs (5%), and 10 MEAs not specified (13%). Analyzing the therapeutic areas of the drugs listed with MEAs by Anatomical Therapeutic Chemical (ATC) Classification, most of them are antineoplastic and immunomodulating drugs (ATC-L, about 73%), followed by anti-infective drugs (ATC-J, about 12%). For new drugs approved during 2016~2020, more oncological new drugs were included in the NHI scope with MEAs. Before MEA regulation, around 25~33% oncological new drugs couldn’t be reimbursed by NHIA; after MEA regulation implemented, these drugs can finally be reimbursed by signing MEAs with NHIA: For oncological drugs approved in 2016, the NHI inclusion rate was 41.7% (review time: 466 days), after MEA implemented in Sept. 2018, additional 33.0% of oncological drugs approved in 2016 could be reimbursed with MEAs, which led to a total of NHI inclusion rate of 75%; for oncological drugs approved in 2019, the total NHI inclusion rate was 87.5%, among them, 62.5% were included with MEAs (review time: 518 days), and 25.0% without a MEA (review time: 366 days); for oncological drugs approved in 2020, the NHI inclusion rate was 38.5%, 23.1% were included with MEAs (review time: 387 days) and 15.4% without a MEA (review time: 281 days). Therefore, the trend in long term is to be observed. Conclusion: The characteristics of the MEAs are similar with other countries, most of them are financial-based agreements, and mainly focus on antineoplastic and immunomodulating drugs. The drugs that couldn’t be reimbursed by NHIA finally can be reimbursed by signing MEAs with NHIA; more oncological new drugs were included with MEAs.