健保多策略 因應台廠退出市場: 替代藥品 & 專案進口 ?!

17藥品健保停付 專家憂引藥廠退場 2015-08-24 〔記者林惠琴／台北報導〕健保署今年陸續接獲醫療院所反映部分藥品售價高於健保給付，不堪負荷，因此，九月一日起，擬針對十七種開價過高的處方藥停止健保給付；但其中有許多長命老藥，更有救命藥，台灣臨床藥學會理事長王春玉擔憂，若連台廠藥也用不起，只怕有一天要向落後國家買藥了！ 王春玉指出，停止給付藥品中，以緩解兒童腹瀉常用的生達高克痢懸乳液、急救常見的安星硫酸阿托品注射液等影響較大；除了是臨床常用藥物，也是不少醫院因應原先使用藥品退出，退而求其次的選擇。 王春玉以安星硫酸阿托品注射液為例說明，針劑產程嚴謹，調配多一分、少一毫都不行，健保原給付每毫升二．三七元已夠低，如今要求降價不成直接停付，業者不是退出市場，可能就是偷工減料，對民眾並非好事。醫勞盟理事長張志華說，雖有替代藥，醫護人員可能因不熟悉而造成調配困擾，且曾發生替代藥品更貴、藥效卻更差的情況。

健保署：給付依市調決定 健保署醫審及藥材組副組長程百君解釋，健保給付依市調而定，若業者售價高於給付並不合理，因此祭出十七項藥品調整方案，現已有四家藥廠提出改善計畫；除了降價，過去賣貴部分也願意以退款或折讓方式彌補醫療院所，包含永信無秘栓劑、參天製藥點眼液劑，以及中化製藥的強力施美藥膏與KERN PHARMA, S.L.的愛舒脈錠廿毫克，經審通過就不會停止給付。其餘部分藥品未通過「國際醫藥品稽查協約組織」（PIC/S）認證制度，且多數年用量占率低於十％，影響有限。若非用不可，自費不高，民眾應有能力負擔。在藥局藥品部分，也傳出浣腸劑、腦新、黃藥水等缺貨或停產。衛福部統計，自PIC/S認證制度上路，今年已有廿四家本土藥廠關門、十四家停產改善。食藥署藥品組簡任技正祁若鳳指出，相關藥品均有替代藥物，成份更新，因此確實價格可能會有所不同，會再了解。若藥品短缺，會以專案進口方式調藥。

彰基 郭守仁: 實戰八年 醫院併購成就 總資產198億!!!!

彰基打造未來醫院 隨身醫護不是夢 智慧醫療》攜手國內外醫材與資通訊大廠為了幫台灣最血汗、也最具國際競爭力的兩個產業找出路， 彰基總院院長郭守仁結合國內外大廠打造未來醫院，院內的每一套系統與設備，他都想好商業模式。 2015/08/24 出處：財訊雙週刊 第 483 期 作者：洪綾襄  和醫院資訊系統連動、動態顯示看診進度與停診狀況的電子看板；透過人流分析，預測該調派多少人力到現場的智能化櫃台；用物聯網與ＲＦＩＤ（無線射頻辨識系統）晶片管理昂貴的醫療器材，按一個鍵便能立刻追蹤顯示的智慧護理站……。這些醫院智慧化服務已經不是未來式，在規畫8年、耗資30億元打造的全新員林基督教醫院，都是現在進行式了。

異業結盟找出路 整合大小院所　規模緊追長庚 震撼業界的是，員基僅是彰化基督教醫院所屬的一間區域醫院，卻配置了全台最大的直升機停機坪，從停機坪直送開刀房的無菌動線設計，以及亞洲首座整合傳統開刀房與影像系統、備載多軸式機械臂、雙手術室滑軌ＣＴ（電腦斷層掃描儀）的複合式手術房（Hybrid OR）。一般病房也有大學問。每一張住院病床都配備一台病床服務平台（ＰＩＴ），雖然僅僅只是一塊觸控平板，卻能提供病患住院須知、餐點預定等各種資訊，刷一下健保卡，便能查詢手術計畫與所有檢查結果，想放鬆時可以上網、看電視、打網路電話；若有緊急狀況，點一下，就直通值班護士手機。看不到的地方更智慧。院內無數台來自全球各大品牌的高端醫療器材，搭載運作卻能無礙相連，病患使用ＣＴ後，ＣＴ便會主動發訊息到主治醫師手機報告結果，雲端病歷也會同步更新，相關訊息一併發送護理站。若醫師決定變更手術計畫，病患也能從病床服務平台查看，所有醫病交易都與醫院行政與財務系統相連，一出差錯都能調出歷史紀錄以釐清責任，也提升工作效率。若二林分院的儀器運作異常，系統會自動做緊急處置；網網相連，系統便有對話基礎，衍生出自己的智慧判斷。「這就是未來！」正要從彰化基督教醫院總院趕回員基現場，以確認新手術室的施工狀況的員基院長李國維，講到醫院的願景，也忍不住興奮起來。「我們真正要做的，是未來醫院。」這一年來他頻繁往返工地，車子早就蒙上一層厚厚的灰，卻也沒心思保養。彰基從一家百年教會醫院，在短短八年之間或併購、或合作，整合中部數10家大小醫療院所，下轄十個院區，資產總額來到198億元台幣，規模僅次於長庚，極具商業頭腦的彰基體系總院長郭守仁功不可沒。他也是力主醫院應主動與台灣資通訊廠商異業結盟，並將員林基督教醫院打造成未來醫院的關鍵人物。全球最大工業電腦廠研華，近年來早就脫胎轉型為物聯網公司，在巴西、中國等國陸續實現其各種智慧城市應用，難得在台灣能找到像彰基一樣的醫院願意投入智慧醫療。研華智能副總經理余金樹觀察，郭守仁近年常到中國大陸交流，發現大陸很有本錢蓋硬體、買設備，卻常不知道錢應該怎麼花，才能真正讓醫院變得智慧化，「郭總院長後來想想，講的沒有用，蓋一棟給你們看！」

TEVE口服 多發性硬化症 (Multiple Sclerosis) 新藥Nerventra (laquinimod),強化Copaxone戰線 力拼 Biogen (Tecfidera; natalizumab; interferon) & Novartis(fingolimod; interferon) 全面部署

Teva, Active Biotech complete enrollment in phase III CONCERTO trial of laquinimod in patients with RRMS Jerusalem, Israel ,Saturday, June 27, 2015, Teva Pharmaceutical Industries Ltd., the world's largest generic medicines producer, and Active Biotech, a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer, announced that the patient enrollment for the pivotal phase III CONCERTO trial of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) has been finalized, as well as a planned sample size re-assessment analysis of the study. CONCERTO is designed to evaluate the safety and efficacy of laquinimod (0.6mg or 1.2mg/day) with a primary endpoint of time to Confirmed Disability Progression (CDP), as measured by the Expanded Disability Status Scale (EDSS). The sample size reassessment was included as part of the protocol to confirm that the original assumptions are in line with the study and that the sample size is adequate. Based on recent agreement with FDA, under a Special Protocol Assessment (SPA) agreement, study completion will occur when either 260 events are reached or all patients complete 24 months of study treatment (whichever occurs first). CONCERTO study results are expected to be available toward mid-2017. Regulatory submission will follow study completion."We are committed to realising the full potential of laquinimod. The molecule has a unique mechanism for future treatment of MS and other neurodegenerative diseases by working directly in the central nervous system, showing promise to prevent brain atrophy and slow disability progression in these patients," said Michael Hayden, M.D., Ph.D., president of global R&D and chief scientific officer at Teva. Laquinimod is also being tested in phase II trials for the treatment of subjects with primary progressive MS and Huntington disease; two diseases for which no approved disease modifying therapies are available.  Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), progressive MS and Huntington's disease. The global, phase III, clinical development programme evaluating laquinimod in MS includes two completed pivotal studies, ALLEGRO and BRAVO (both 0.6mg/day). A third phase III trial, CONCERTO, is currently ongoing and evaluating two doses of laquinimod (0.6mg and 1.2mg/day) in 2,199 patients for up to 24 months. The primary outcome measure is time to three-month confirmed-disability progression as measured by the Expanded Disability Status Scale (EDSS). In the ALLEGRO and BRAVO trials, adverse reactions observed included headache, abdominal pain, back and neck pain, appendicitis, and mild, asymptomatic laboratory abnormalities, including liver enzyme elevations, haematological changes and elevation of CRP or fibrinogen levels.

Laquinimod (also known as Nerventra or ABR-215062) is a tablet being developed for relapsing remitting MS by Teva and Active Biotech. It is currently in phase 3 trials, but so far has been refused a license by the EMA.

The CONCERTO trial This phase 3 study began in 2013 and will evaluate two doses of laquinimod (0.6mg and 1.2mg) in approximately 1,800 people. The trial is expected to be completed in 2018. In February 2013, Teva filed for a patent in the USA for a mixed treatment of copaxone and laquinimod. This mix would be given as an injection and has been shown in laboratory models of MS to be more effective than the current treatment.

The ARPEGGIO trial This is a phase II multicentre study that began in January 2015. The study will investigate the effect of 48 weeks of treatment with laquinimod (at two different doses) or a placebo on brain volume changes in 375 people with primary progressive MS. The study will also record progression of disability, new lesions measured by MRI and cognition.

The BRAVO trial In 2014 the results of a two year phase 3 trial were published. This study included 1,331 people with relapsing remitting MS from all over the world, and compared the effects of 0.6mg of laquinimod with interferon beta-1a (Avonex), and a placebo drug. The study did not find a statistically significant reduction in relapse rates in participants taking laquinimod compared to the placebo group. However, laquinimod did have a significant effect on reducing rates of brain shrinkage and disability progression. The study has since been extended to further evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod (0.6 mg) in people with relapsing remitting multiple sclerosis.

The ALLEGRO trial  An earlier two year phase 3 trial in over 1100 people showed that a daily dose of 0.6mg of laquinimod reduced relapse rates by 23 per cent and disability progression by 36 per cent compared to a placebo.

展旺 抗生素Ertapenem (厄他培南) FDA P4 與Hospira拚速度

展旺培南產品具競爭利基；短期拐點賴美國市場 MoneyDJ新聞 2015-08-24 10:32:39 記者 蕭燕翔 報導 全球前三大培南類抗生素廠展旺(4167)，即將於下月8日轉上櫃。該公司雖現仍受高折舊拖累、尚處虧損；不過法人看好，該公司兩項既有培南類產品，最快第四季攻進美國市場後，將帶動全球市佔率明顯成長，也會是明年下半年力拼現金流轉正的關鍵，而長期獲利的跳升成長，則視針劑與P4類厄他培南在美國等已開發市場的市占增長而定。展旺成立於2004年，目前資本額18.6億元，因先前歷經幾度增資，現法人股東與一般自然人股東持股比例約近半。該公司是全球除義大利廠ACS、大陸海濱外，全球唯三家生產培南類抗生素對外銷售的原料藥廠，而過去該公司美洛培南、亞胺培南及針劑廠，雖都已取得台灣、美國、英國、日本認證，不過因先前合作製劑廠查廠未過等因素，至今尚未交貨美國等一線市場，現階段展旺在培南類抗生素原料藥市場，約佔有一成市佔率。事實上，培南類抗生素之所以全球競爭者有限，除製程難度高外，前期高投入的資本支出，也是一大關鍵，這亦為展旺這幾年都還受設備廠房折舊拖累虧損的主因。不過，展旺已提出三大重點改善計畫，並有部分收到成效，首要是美洛培南類原料藥產品，已與兩家銷美客戶達成協議，預計今年第四季開始交貨，且自有品牌或為他廠代工的針劑，力拼明年初至年中取得藥證。而根據推估，同樣一公克產品，美國美洛培南原料藥產品，售價約為現展旺銷售歐洲及全球市場同型產品的1.5倍。假設擴及針劑產品，售價則為全球及歐洲純原料藥的2倍；因此假設攻美進度如預期，將是展旺拉高新廠產能利用率及現金流的關鍵。法人的預期，隨美國市場營收挹注增溫，且年度資本支出高峰已於2013年見到，近兩年漸恢復正常，展旺最快明年下半年挑戰現金流轉正。不過，展旺抱持更大期待的明星商品，則在終端製劑還處專利保護的厄他培南類產品。根據估算，該類產品在美國市場潛值超過3.5億美元，現循P4挑戰原廠專利、且還在審件階段的廠商，僅有Hospira及展旺兩家，法人計算，假設有學名藥廠挑戰原廠專利成功，並取得三成市場，現有情況將有兩家均分，市場可期。展旺今年上半年在美洛培南新廠尚未的折舊拖累下，雖營收繳出21%成長，但每股淨損擴大至1.23元，法人預期，下半年營收將優於上半年，且虧損可望壓縮。明年在美國市場助攻下，營收年增率擴大，最快2017年挑戰年度損益兩平。

Ertapenem is a carbapenem antibiotic marketed by Merck as Invanz. It is structurally very similar to meropenem in that it possesses a 1-β-methyl group. Other members of the carbapenem group (imipenem, doripenem, and meropenem) are broadly active antibacterials that are used for infections caused by difficult to treat or multidrug-resistant bacteria (such as ESBL expressing Klebsiella pneumonia). They have very short serum half-lives and must be administered by intravenous infusion every 6 to 8 hours. Ertapenem differs from other carbapenems in having a somewhat less broad spectrum of activity (not against Pseudomonas aeruginosa ), and in that its extended serum half-life allows it to be administered once every 24 hours.

生達 糖尿病學名藥(Repaglinide )申請 FDA六年過關! 力抗美國群雄 (NOVO NORDISK/ LUPIN/ ACTAVIS TOTOWA / AUROBINDO / MYLAN / PADDOCK/ SANDOZ/ SUN PHARM)

生達四箭齊發 外銷要占50% 2015-08-24 04:53:05 經濟日報 記者黃文奇／台北報導生達製藥銷售四箭，美日台陸齊發。生達專攻美國的糖尿病用藥近期取得藥證，預計第4季在美上市，生達總經理范滋庭表示，未來會持續國際化並強化研發能量，加速推出新藥品項，聚焦中國、美國及日本三大市場，希望五年內達到外銷占比五成的目標。生達今年業績看好，范滋庭表示，下半年營運表現將優於上半年；而明年國內外市場發酵，獲利將齊揚。法人估，今年在新產品上市貢獻下，每股稅後純益（EPS）有機會挑戰2.5元，再創歷史新高。范滋庭表示，生達目前有挑戰第四類學名藥（Paragraph IV）的產品，包括抗多發性硬化症、降高血脂藥，也有機會在明年中以後上市，搶食近15億美元的市場大餅。中國市場方面，生達目前藥證申請也將加快腳步，其中，糖尿病藥可望在今年底、明年初取得，血栓也力拚明年上半年進入市場銷售。范滋庭表示，目前外銷營收占比約二成，以東南亞、中國為主，不過，受到健保藥價調降影響，生達上半年營收15.91億元，較去年同期小幅下滑，毛利率維持在四成以上，達46.48%，稅後純益約1.77億元，年減12.5%，每股稅後純益（EPS）為0.99元。不過，下半年在匯兌利益挹注與公司營運大翻轉下，生達營運可望繼續衝高。其中，范滋庭表示，美國首張藥證到手，打開生達銷美大門，意義重大。其中，美國市場已送審五項產品，降血糖的糖尿病用藥申請時間已六年，近期終於取得上市許可，而該產品又屬於基礎用藥，將透過美國經銷商銷售，將貢獻公司營運。中國市場方面，生達迄今已送件六項產品，今年在該國大力整頓藥品審查機制下，今年取證機會大增。另外，生達與日本DIA製藥合作設立的大陸泰州水性貼布工廠，目前主要生產代工及自創品牌的退熱貼為主，目前年產能2,000萬片，訂單超載，第4季有機會達單月損平，明年將會開始賺錢。台灣方面，代理日本大日本住友製藥在的精神科新藥LATUDA，美國銷售規模已經逾1億美元，近期已完成臨床，有機會在第4季取得藥證，明年上半年申請健保藥價。

Repaglinide is an antidiabetic drug in the class of medications known as meglitinides, and was invented in 1983. It is sold by Novo Nordisk under the name of Prandin in the U.S., GlucoNorm in Canada, Surepost in Japan, Repaglinide in Egypt by EIPICO, and NovoNorm elsewhere. In Japan it is produced by Dainippon Sumitomo Pharma.

A study funded by Novo Nordisk, the U.S. distributor for Repaglinide, compared their product with Nateglinide in "A randomized, parallel-group, open-label, multicenter 16-week clinical trial". They concluded that the two were similar, but "repaglinide monotherapy was significantly more effective than nateglinide monotherapy in reducing HbA1c and FPG values after 16 weeks of therapy." However, 7 percent of the Repaglinide patients "had minor hypoglycemic episodes (blood glucose <50 mg/dl) versus 0 patients for nateglinide"; this difference was not statistically significant. They also cited a 1-year study that concluded that "repaglinide had similar efficacy to glyburide."

Mechanism of Action Repaglinide lowers blood glucose by stimulating the release of insulin from the pancreas. It achieves this by closing ATP-dependent potassium channels in the membrane of the beta cells. This depolarizes the beta cells, opening the cells' calcium channels, and the resulting calcium influx induces insulin secretion.