Enbrel/ Remicade / Humira / Stelara 用於乾癬 (Psoriasis) 健保付?!

乾癬惱人 新生物製劑見效 中時即時 葉書宏 2014年03月25日 18:34 52歲李姓女子罹患乾癬，20年來飽受折磨，乾癬脫落時整個頭皮紅通通相當不舒服，李女日前接受雙和醫院長效型生物製劑治療後已獲得改善。雙和醫院皮膚科主任李婉若表示，生物製劑可直接抑制發炎反應，不受病灶位置的影響。李女罹患乾癬20年，除了正統醫療之外，她也試過各種偏方，還曾經一早到淡水排隊登記，只為了拿到藥方，只是服完藥後，乾癬情況沒有獲得緩解，直到接受生物製劑治療，才讓她得以脫離乾癬的夢魘，目前李女仍持續接受照光治療，以維持成效。雙和醫院皮膚科主任李婉若表示，乾癬可以經由藥物和照光治療，但若病灶位於頭皮或指甲，藥物與照光治療都難以發揮療效，必須評估使用生物製劑，新一代的生物製劑因直接抑制發炎反應，不受病灶位置的影響。

Psoriasis Treatments: Now and in the Future Psoriasis Treatments: Injectable Biologics The last decade has seen some promising advances in the treatment of psoriasis. Systemic medications called biologics -- because they are made from living organisms -- may offer hope to people who haven't had success with other approaches or who are concerned about the toxicity of other medicines.

Biologic Treatments The shift in treatment has grown from a new understanding of the condition's basic cause. Many treatments for psoriasis -- such as topical creams and phototherapy -- treat the symptoms of the disease and reduce the effects of flare-ups. But biologic treatment targets the root cause. It either directly or indirectly blocks the effects of the T-cells, the immunological agents that cause the inflammation of psoriasis. Drugs like methotrexate and cyclosporine also affect the immune system, but they are far more likely to cause serious side effects. New biologic drugs are apparently more focused in their effects. Biologic therapy is a fairly new approach. So far, only these biologics drugs have been approved by the FDA for the treatment of psoriasis: Enbrel, Humira, Stelara, and Remicade. As with any drugs that suppress the immune system, biologic therapy could make your body more vulnerable to other infections and diseases. Some biologics may also cause some chronic diseases in remission -- such as tuberculosis -- to flare up. Biological medications may not be prescribed to a person who takes other medications that also suppress the immune system. One disadvantage to biologic medication is that it has to be given either by injection or by intravenous infusion. Infusion can take two hours per session. Still, many doctors say these new drugs can more effectively treat psoriasis with fewer side effects. Here's a rundown of the biologic medications used for moderate to severe psoriasis.

Enbrel was previously used as a treatment for psoriatic arthritis, but it is also approved for psoriasis.It is also approved for treating rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis (arthritis affecting the spine). Patients can inject Enbrel under their skin at home. You would use it twice weekly for three months. After that, you would inject it once a week. Side effects include skin irritation and rashes. It should not be used in people with multiple sclerosis and heart failure.

Remicade is approved for the treatment of severe plaque psoriasis. It is also approved for treating rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the spine), and Crohn's disease and ulcerative colitis (inflammatory bowel conditions). Patients receive Remicade as an infusion in a doctor's office. This treatment is given over a two- to three-hour period. Patients receive an additional infusion both two and six weeks after the first infusion and then every eight weeks. Tuberculosis, invasive fungal infections, and other serious infections have been reported in Remicade patients; some of the infections have been fatal. People taking Remicade should be monitored for signs of infection, and if a serious infection develops, the medication should be stopped.

Humira is also approved for the treatment of severe plaque psoriasis and rheumatoid arthritis. Patients can injection this medication under the skin every other week. People with heart failure or multiple sclerosis should not take this medication. Humira's side effects include serious and even fatal infections such as tuberculosis, an increased risk of certain types of cancer such as lymphoma, and an increased risk of autoimmune disorders such as a lupus-like syndrome.

Stelara is approved to treat moderate to severe psoriasis that involves large areas or many areas of the body. It improves plaque thickness, scaling, and redness. Stelara can increase your chances of serious infections, cancer, and a rare condition called reversible posterior leukoencephalopathy, which affects the brain and can cause death. Stelara is given by injection. After the first shot, patients get another shot four weeks later, and then a shot every 12 weeks.

Biologics are currently more expensive than conventional systemic treatments. However, the evidence suggests that they work well and pose fewer risks than other systemic therapies.

Source: 彰化基督教醫院/ 彰基藥訊 第二十一卷第四期

健檢MR-PET篩癌? ???

揪癌一機搞定！磁振正子掃描輻射低 【華人健康網 記者黃曼瑩／台北報導】 2014年3月11日 20:38 健檢揪出癌凶有新利器！國內領先全亞洲，引進磁振暨正子掃描儀MR-PET，即結合磁振掃描與正子造影於一機，不但準確率高達95%，而且幅射量較低，能精準檢測出腫瘤的代謝活性與組織大小定位，代表影像醫學邁進新的里程碑！磁振暨正子掃描儀MR-PET，結合磁振掃描與正子造影於一機。（攝影／黃曼瑩） 磁振暨正子掃描儀MR-PET，結合磁振掃描與正子造影於一機。（攝影／黃曼瑩） 大家熟知磁振造影掃描(MRI)與正子造影(PET)，過去，磁振掃描的磁場和正子造影的晶體，以往兩者會互相干擾，不可能共存於同一檢查室，但是，台大醫院影像醫學部施庭芳主任表示，現在已經突破技術，將MRI和PET整合於一機MR-PET，透過此磁振暨正子同步掃描，揪出癌蹤，能夠一次到位。此一突破性的進展，將引領未來5至10年的影像醫學創新與研發。

磁振暨正子掃描儀監測腫瘤活性與組織大小 MRI在臨床運用上是屬於高階影像檢查，可應用於全身各器官，優點是沒有輻射線，有利於診斷出早期的腫瘤。PET則是應用廣泛，包括癌症偵測及分期、腦部病變的評估。兩者合一的好處更在於能夠監測出腫瘤的代謝活性與組織大小，以及準確定位，可以早發現、早治療。

 

Joerg Reinhardt 回鍋 Novartis強化自主研發力

Novartis Chairman Stresses Need for R&D Investment March 22, 2014 3:46 a.m. ET 'We need to add value—life-prolonging or quality-of-life benefits,' says Novartis Chairman Joerg Reinhardt, pictured last month. European Pressphoto Agency BASEL, Switzerland— Novartis AG NOVN.VX +0.63%needs to continue investing in research to develop new drugs that national health-care systems are willing to pay for, a task that gets harder as generic versions of older medicines become available, the company's chairman said.Joerg Reinhardt, who assumed his role in August, says the benchmark for evaluating drugs is constantly rising as branded medicines lose patent protection, allowing for less-expensive copies to enter the market. Health-care systems will choose less-expensive generic drugs, which often work just as well as the original versions, to keep costs down, he said."We need to add value—life-prolonging or quality-of-life benefits—that are meaningful enough for payers around the world to say, 'Yes, I'm willing to pay a premium over generic opportunities,' " Mr. Reinhardt said in an interview. "With every new product coming off patent, the benchmark comes up."Mr. Reinhardt's comments come as pharmaceutical companies rethink their research-and-development efforts to channel resources to more-promising experimental drugs and avoid others that might be tempting but more difficult to deliver. Some companies, such as Merck & Co., MRK +0.45%are streamlining their operations, while leaning on outside labs for experimental drugs. Switzerland's Roche Holding AG ROG.VX +0.95% has reshuffled its R&D staff to revitalize its operations. Novartis raised its spending on in-house R&D by 5.6% last year to $9.85 billion, an amount Mr. Reinhardt said will remain stable. The budget was among the highest in the industry and bucked a broader trend. Spending on R&D across the sector dropped 2.2% to $135 billion last year from a high of $138 billion in 2011, according to PricewaterhouseCoopers. Novartis is consolidating its activities in Shanghai, Basel, Boston and La Jolla, Calif., a move intended to foster cooperation between researchers in different disciplines as teams of scientists bounce ideas off each other. The company also will be able to tap the academic communities of the four cities."A larger group of people benefiting from the infrastructure that's been created at a research place is a better approach than having small groups with limited infrastructure spread around the world," Mr. Reinhardt said.Born in Germany, Mr. Reinhardt earned a doctorate in pharmaceutical sciences and worked at Novartis and predecessor Sandoz for nearly 30 years. In 2010, he moved to Bayer AG BAYN.XE +2.15%to lead the health-care business after Joe Jimenez was chosen as Novartis's chief executive.Since returning, Mr. Reinhardt has demonstrated his commitment to R&D, spearheading the creation of a board subcommittee to oversee the company's research. The subcommittee, believed to be a first in the industry, is responsible for reviewing Novartis's R&D strategy and organization. It also will advise the board on scientific trends and activities that are critical to R&D.The purpose of the committee is to ensure that the board is closer to the decision-making process for one of the company's key investment areas, Mr. Reinhardt said.Because Novartis is facing challenges brought by the expiration of patents on blockbusters such as hypertension treatment Diovan and leukemia drug Gleevec, the company is smart to invest in research capabilities, said David Kagi, a health-care analyst with J. Safra Sarasin."They have a high need to invest in R&D, both to overcome their patent issues and because they are more exposed to price pressures," Mr. Kagi said. Part of the reason is that some of Novartis's drugs treat broad disease classes, such as diabetes or hypertension, which are treated by many drugs already on the market.Mr. Reinhardt said a year-old review of Novartis's portfolio was progressing and would be completed by year-end. Three of the company's smaller units—vaccines, over-the-counter treatments and animal health products—are under scrutiny for restructuring, joint ventures or sale.Novartis has had "conversations with different potential partners" about the units, Mr. Reinhardt said. He said acquisitions for as much as $5 billion were possible approaches to build the scale the smaller units need.The review also covers Novartis's one-third stake in Roche's voting stock, which Novartis started accumulating in 2001 with the idea of a possible merger. The deal didn't happen, though the companies operate in partnership on the sale of some drugs.Mr. Reinhardt said he didn't expect a bigger strategic interaction with Roche but said he had met with the company's new chairman, Christoph Franz.

Novartis chairman vows to preserve top R&D budget in retrenchment March 24, 2014 | By John Carroll At Novartis, only the top executives are allowed to discuss R&D strategy in any kind of a meaningful way. So when they talk, everyone--including the company's big research staff around the world--pays very, very close attention.So listen up: The new chairman at Novartis ($NVS), Joerg Reinhardt, sat down with The Wall Street Journal to review the company's careful restructuring--R&D is being concentrated in Basel, Shanghai, Boston and La Jolla, CA--and committed Novartis to maintain research spending at its current level near the $10 billion mark. That mark falls just behind Roche's research budget, the top R&D spender in the biopharma world with a 2013 budget of $10.23 billion. And it must be particularly welcome news in La Jolla.Reinhardt says R&D spending will remain level at a time many pharma rivals are cutting back. And everyone in the company should expect to see the work consolidated in key regions, something that is likely to reassure workers in designated areas while raising fears for everyone outside the protected zones.The Biotech Primer: An insider's guide to the science driving the biotech and pharma industriesThis 200-page book takes an in-depth look at the biotech industry and the science that drives it. Although the industry itself is constantly changing, these fundamental concepts upon which it is built will remain important for years to come - and decision-makers who understand these fundamentals will be better able to evaluate and predict new trends. Click here to buy today! Sign up for our FREE newsletter for more news like this sent to your inbox! "A larger group of people benefiting from the infrastructure that's been created at a research place is a better approach than having small groups with limited infrastructure spread around the world," Reinhardt told the Journal. And it gives the giant a chance to work more closely with the academics in those areas.The new strategy--overseen by a unique special committee--has already led to some significant alterations, especially with the closure of its research unit in Horsham, U.K., and some shifting of jobs and personnel in the U.S. The company has reportedly laid off thousands of staffers in recent months, including 500 at its home base in Basel.This strategy falls right in line with the brave new world of Big Pharma as defined by most of the top companies these days. That hub strategy inspired AstraZeneca to concentrate its forces in Cambridge, U.K., sacrificing Alderley. Sanofi ($SNY), largely foiled in an attempt to reorganize R&D in France, has been shifting into Boston. Pfizer ($PFE) and Roche ($RHHBY) have both eliminated big outlying research posts in major retrenching efforts.

 

 

秀傳醫總裁: 黃明和 101內建 健康會所

皇家御醫101彰化秀傳搶攻健檢大餅 華人健康網／記者張世傑／台北報導-2014年03月29日 下午18:15 愛家人，就先讓自己健康！國內健康管理機構如雨後春筍，不僅強調多元，更朝向「皇家御醫」個人化模式發展；彰化秀傳醫療體系，面對全球健康管理e化浪潮，緊密結合國內外臨床醫療資源，集資上億元經費，在台北地標101內設立「秀傳101皇家健康會所」，讓醫療產業服務創新加值，邁向國際化新領域。（影音／攝影記者張世傑）健康管理是毓防醫學重要一環，愛家人，就先讓自己健康。

找健康活得久首要幸福快樂 衛生福利部邱文達部長強調，國人平均壽命達79.51歲，男性76歲，女性83歲，預估台灣比歐美等世界先進國家，更快步入高齡社會，然而平均壽命的持續延長，並不等同於人人健康平安快樂。就如同機械一樣，平時就需要好好的照顧，定期的保養；在繁忙的生活中，若沒有適時的休閒，舒解壓力，健康很快就會出問題；呼籲國民平時在飲食上應「4少1多」，包括：少鹽、少油、少糖，少吃加工的食品，以及多攝取新鮮蔬菜水果，均衡飲食之外，還要有適當的運動，就能降低疾病致死的風險。

4PHealth健康管理金科玉律 秀傳醫療體系總裁黃明和醫師表示，隨著個體健康狀況的差異，如何在疾病預測（Prediction）、疾病預防（Prevention）、健康促進（Promotion）、自身參與（Participation）4個P的健康管理指標上（4P Health），達成對每個人有意義的疾病預防與健康提升，成為全球醫界共同關心的首要課題。

管理ｅ化5P服務健康新主流 黃明和總裁強調，在現代社會提倡預防醫學的趨勢下，醫界過去以「病人為中心的醫療照護」（Patient-Centered Care）的理念， 再擴大為照顧包括亞健康為對象的「以個人為中心的醫療照護」（Person-Centered Care）理念。因此在秀傳醫療體系除了落實外界4P Health的健康管理，必須再增加第五個P的健康管理指標：「個人化」（personalization），成為秀傳精緻的5P 健康管理（5P Health）指標。

皇家御醫健康經紀人護健康 黃明和總裁指出，健康管理ｅ化已是全球新趨勢，因為每個人的健康狀態不一，健康管理模式就有差異，醫護團隊需設計個人化的健康照護模式，才能確實改善與增進不同個體的健康，同時緊密結合國內外臨床醫療資源、遠距照護、養生保健，以及智慧健康雲等健康服務系統，才能開拓全新的醫療照護領域。「秀傳101皇家健康會所」的地點選在國際著名地標 - 台北101大樓，象徵秀傳101在醫療照護領域上的嶄新制高點。至於「皇家御醫」的概念，是由資深護理師擔任「健康經紀人」，並不僅專為高端人士服務，而是在台灣醫界樹立個人化的健康服務優良典範，為每一位需要照顧的人都須做到等同皇家級的超完美健康照護。

【健康自我管理4原則】：1.隨時掌握身體健康的狀態。2.由運動及日常生活習慣的改變以及調整飲食習慣做起。3.以適當的配套措施來調整人體的亞健康狀態。4.以儀器精確的追蹤達成健康檢查自我管理。

 

Gilead C肝藥太貴 需 說明定價原則

3月生技觀測指數陰天 中央社 (2014-03-26 08:06)（中央社記者許湘欣台北2014年3月26日電）德盛安聯3月生技觀測指數由過去連續兩個月代表晴天區的8分，跌落至陰天區6分。德盛全球生技大壩基金經理人傅子平指出，美國眾議院民主黨議員認為生技大廠吉列德（Gilead）新一代C型肝炎藥物療程定價過於昂貴，要求4月3日前說明定價原則，造成生技股回檔修正。不過，就算生技大廠有烏雲遮蔽，他預期，今、明兩年企業盈餘成長仍可達15%以上。傅子平認為，整體來看，生技業基本面仍佳，近期只是技術性修正，投資前景不變，但在NBI生技指數連漲5年後，建議以區間操作為主，特別是3月底到4月初的消息面淡季，市場獲利了結賣壓濃厚，對於負面消息市場反應較激烈，但未來只要銷售符合預期，且研討會釋出的相關數據只要良好，對指數應有激勵效果，特別是5月底將舉行腫瘤學會議，預期生技指數仍有表現機會。