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附錄
附錄一 HER2 陽性乳癌相關治療藥品之健保給付規定[12]
(一) Aromatase Inhibitors
1. Exemestane(如 Aromasin Sugar Coated Tablets):(88/11/1、90/10/1、99/6/1、
105/8/1)
(1) 限停經後或卵巢切除後,且女性荷爾蒙受體(estrogen receptor)陽性之 晚期乳癌病患,經使用 tamoxifen 無效後,方可使用。
(2) 具有雌激素受體陽性之停經婦女,使用 tamoxifen 至少兩年之高危險早期 侵犯性乳癌的輔助治療,且不得與 tamoxifen 或其他 aromatase inhibitor 併用。使用時需同時符合下列規定:(105/8/1)
A. 病歷上應詳細記載手術資料、病理報告(應包含 ER、PR 之檢測結果且 無復發現象)。
B. 本案藥品使用不得超過三年。
2. Anastrozole(如 Arimidex):(88/6/1、92/3/1、93/6/1)
(1) 停經後雌激素接受器為陽性或不清楚之局部晚期或轉移性乳癌第一線治 療。(92/3/1)
(2) 停經後婦女晚期乳癌,雌激素接受器為陰性,但曾對 tamoxifen 有陽性反 應者。(92/3/1)
(3) 停經後婦女罹患早期侵犯性乳癌,經外科手術切除後且雌激素接受器為 陽性,且有血栓栓塞症或子宮內膜異常增生的高危險群,而無法使用 tamoxifen 治療者。(93/6/1)
備註:療程期間以不超過五年為原則。血栓栓塞症或子宮內膜異常增生的高 危險群需符合下列情形之一:
A. 有腦血管梗塞病史者。
B. 有靜脈血栓栓塞症病史者。
C. 有子宮異常出血病史,且「經陰道超音波檢查」判定為子宮內膜異常增 生的高危險群。
3. Letrozole:(88/11/1、90/10/1、92/3/1、97/11/1、98/11/1、99/9/1、102/8/1)
(1) 接受抗動情激素治療失敗的自然或人工停經後之末期乳癌病人之治療、
停經後之局部晚期或轉移性乳癌婦女患者之第一線治療用藥。
(2) 停經後且荷爾蒙接受體呈陽性,有淋巴結轉移之乳癌病人,作為 tamoxifen
治療五年後的延伸治療,且不得與其他 aromatase inhibitor 併用。使用時 需同時符合下列規定:(97/11/1)
A. 手術後大於等於 11 年且無復發者不得使用。
B. 每日最大劑量 2.5mg,使用不得超過四年。
(3) 停經後且荷爾蒙接受體呈陽性之早期乳癌病人,經外科手術切除後之輔 助治療,且不得與 tamoxifen 或其他 aromatase inhibitor 併用。使用時需 同時符合下列規定:(98/11/1、99/9/1、102/8/1)
A. 每日最大劑量 2.5mg,使用不得超過五年;
B. 若由 tamoxifen 轉換使用本品,則使用期限合計不得超過 5 年。
(4) 病歷上應詳細記載手術資料、病理報告(應包含 ER、PR 之檢測結果且 無復發現象)及用藥紀錄(如 tamoxifen 使用五年證明)。
(二) Docetaxel:(用於乳癌部分)
1. 局部晚期或轉移性乳癌。
2. 與 anthracycline 合併使用於腋下淋巴結轉移之早期乳癌之術後輔助性化學治 療。(99/6/1)
3. 早期乳癌手術後,經診斷為三陰性反應且無淋巴轉移的病人,得作為與 cyclophosphamide 併用 doxorubicin 的化學輔助療法。(101/9/1)
(三) Gemcitabine(如 Gemzar):(用於乳癌部分)
限用與 paclitaxel 併用,可使用於曾經使用過 anthracycline 之局部復發且無法 手術切除或轉移性之乳癌病患。(94/10/1)
(四) Paclitaxel 成分注射劑:(用於乳癌部分)
限用於:
1. 已使用合併療法(除非有禁忌症、至少應包括使用 anthracycline)失敗的轉 移性乳癌患者。(91/4/1、94/1/1)
2. 腋下淋巴轉移之乳癌且動情素受體為陰性之患者,paclitaxel 可作為接續含 doxorubicin 在內之輔助化學治療。(91/4/1、94/1/1、98/8/1)
(五) Toremifenetab(如 Fareston):(88/6/1)
限用於停經後,且女性荷爾蒙接受體(estrogen receptor)為陽性之轉移性乳癌 病患。
(六) Vinorelbine:(用於乳癌部分)
1. 限用於轉移性乳癌病患。
2. 本成分之口服劑型與注射劑型不得併用。
(七) Uracil-Tegafur(如 Ufur):(用於乳癌部分)
限轉移性乳癌之病患使用。
(八) Doxorubicin hydrochloride liposome injection(如 Lipo-Dox、Caelyx):(用 於乳癌部分)
限用於用於單一治療有心臟疾病風險考量之轉移性乳癌患者。(93/11/1)
(九) Capecitabine(如 Xeloda):(用於乳癌部分)
1. Capecitabine 與 docetaxel 併用於治療對 anthracycline 化學治療無效之局部晚
1. Capecitabine 與 docetaxel 併用於治療對 anthracycline 化學治療無效之局部晚