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Tuesday, July 28, 2015

FDA近期查廠: 常熟神隆 (血癌藥API) + 中國賽進Sagent (針劑充填凍乾) !!

神隆常熟廠 最快年底投產 2015-07-27 00:37:18 經濟日報 記者黃文奇/台北報導台灣神隆總經理陳勇發表示,公司旗下的常熟廠歷經多年努力,近期美國食品藥物管理局(FDA)可望前往查廠,最快今年底、明年初將正式投產。業界指出,這比公司預定的2016年查廠提前一年,進度超前。陳勇發說,公司客戶有多個美國新藥產品進入三期臨床,其中兩個產品市場規模較大,包括抗感染與帕金森氏症領域,未來陸續上市後可望彌補近兩年產能減損。神隆近年經歷大宗產品,如減肥藥Qsymia因銷售不佳,客戶拉貨速度減緩,加上紫杉醇原料短缺等,造成公司從20122013年營運陸續下滑,如今都已經陸續獲得緩解。陳勇發說,神隆已經從谷底翻轉、進入穩定期,市占率回到過去水準。常熟廠方面,未來將面向歐美市場,預期第4季前會收到通知,最快年底前將來查廠,查畢若無缺失則兩個月內美國FDA就會有正式函文,常熟也能夠開始加入生產行列,貢獻營運。陳勇發說,過去台南南科廠給美國FDA查畢後,以零缺失通過,由於已經有南科廠的經驗在前,對於常熟廠的查廠也會很有信心。據悉,常熟廠對於美國FDA的查廠,早就準備好了。神隆表示,為了促使FDA提前查廠,神隆與客戶Sagent將原本在南科生產的原料藥DMF轉移到常熟,並由Sagent生產一批註冊批針劑,讓FDA能加速查廠進度。近期,FDA已經完成Sagent的查廠,並且詢問神隆常熟廠的地址,一般預期,這表示FDA很快就是通知神隆,要前往查驗常熟廠。此外,常熟的原料藥代工與新藥原料藥生產也同步進行中。代工產品有三項正在洽談,臨床用藥則有九個。三個代工均屬於生產量能較大的產品,預估將可帶來一定的營運貢獻。陳勇發說,現在談的三個代工產品,分屬三家不同的歐美公司,最快明年出貨美國,由於常熟廠過去都是虧錢的角色,預期明年可讓現金流能夠開始貢獻,將彌補一大塊財務黑洞,對公司營運有大助益。另外,協助客戶開發的即將上市產品的原料藥中,有兩個產品市場較大,包括抗感染與帕金森氏症,而抗感染產品又分兩個適應症,其中,醫院感染管控領域的適應症,已經獲美國FDA核准,下一個適應症也已經準備送件中,最快明年上市。陳總苦拚實幹 帶企業轉型台灣神隆總經理陳勇發來自台南佳里小鎮,17年前毅然跳出舒適圈,進入神隆從基層員工一路做到總座,如今雖然領導一個全球大型原料藥廠,言談中仍保有一絲來自土地的純樸之情。陳勇發從大學到博士都是念化學,1991年取得美國韋恩州立大學化學博士學位,博士研究的領域是藥物,當年回國後卻進入中油的嘉義溶劑廠(煉貯研究所)擔任研究員,待了七年,1998年也就是神隆成立的隔年,便辭去中油工作轉戰原料藥。陳勇發坦言,煉油已經無可突破,待在那裡也只能做些「小事」,因為有志難伸、毅然決定出走。當時陳勇發要走,被同事笑說,「有沒有搞錯,一般人要進這個單位,不得其門,你竟然要跳出去,」因為以前那個單位,過的像是公務員中的退休生活,可謂錢多、事少、離家近,但陳勇發想發揮的是製藥的專才。現在的陳勇發,接下神隆創辦人馬海怡的棒子,雖然遇到國內生技產業困頓的時刻,他表示,現在雖是青黃不接的時候,但神隆也很快就會轉型,脫胎換骨。

台灣神隆與美國針劑藥廠賽進(SAGENT Pharmaceuticals)共同研製抗癌製劑 國內原料藥廠台灣神隆(股票代號:1789) 與美國針劑藥廠賽進 (Sagent, 股票代號SGNT.US)今日宣布簽署合作協議,雙方共同研製用於治療血癌的抗癌針劑,今年六月已送交美國食品藥品管理局(FDA)上市申請,最快於2016年年底核准後隨即在美上市。本合作不僅是神隆跨足製劑領域、實現原料藥結合製劑(API+ANDA)「雙A策略」下第一項進攻美國市場的產品,亦可啟動美國FDA至神隆位在江蘇常熟的神隆醫藥公司查廠認證,開啟該廠進入國際規範市場大門,爭取高端原料藥的廣泛商機。台灣神隆總經理陳勇發博士表示:「神隆很榮幸能與長期合作夥伴美國賽進製藥進一步結盟,積極耕耘抗癌針劑的市場。美國賽進是國際間特殊針劑用藥領域的翹楚,在抗癌針劑類別擁有寬廣的產品線,並於全美各地醫療機構鋪建綿密的行銷通路,業務實力堅強;而台灣神隆已成功開發高技術門檻的冷凍乾燥針劑的技術,加上在原料藥產品長期累積的研發製程能力,雙方將結合彼此的優勢和專長,進一步提高該產品的競爭力,搶攻全球市占率,首戰是美國市場。」據估計,該項用於治療血癌的藥物於美國2013年的市值高達2.5億美元。根據協議,神隆台灣廠負責該藥物原料藥及針劑開發的工作,常熟廠則負責原料藥的生產,再運交位於成都的賽進中國製藥(Sagent China)代工凍乾針劑,之後由美國賽進向美國FDA送交學名藥上市的申請及後續的市場行銷。本次合作結合了雙方關鍵的競爭優勢,運用神隆在高活性抗癌原料藥及針劑的研製實力,而賽進中國是極少數中國境內通過美國FDA查廠的針劑廠,全廠採用封閉隔離技術。中國首批獲准直接銷往美國的癌症針劑産品即由該公司生產。台灣神隆正積極實踐在中國發展的階段性及多元化的目標。在歐美大藥廠需要於中國境內符合國際GMP及工安環保水準的代工夥伴情況下,神隆常熟廠除了可就近提供國際新藥公司所需的專業配套的外包服務及技術支援外,本合作案將提供原料藥加製劑的垂直整合服務模式,與下游廠商合作完成歐美藥品查驗登記,外銷終端產品以搶攻全球市場。公司計劃進一步將常熟廠的原料藥與中國高端藥廠共同開發製劑,申請中國藥證註冊,以回應大陸市場對高品質藥物的強勁需要。隨著當地經濟發展及醫改政策的推動,市場持續快速成長,神隆將持續結合台南總廠與常熟廠的資源,拓展國際市場版圖,提昇全球競爭力。

減重應用: 糖尿病長效注射GLP-1藥物(Exenatide (Byetta, Bydureon/ microsphere) and liraglutide (Victoza))

Byetta, Victoza and Bydureon for diabetes lose weight  M. Regina Castro, M.D.

Exenatide (Byetta, Bydureon) and liraglutide (Victoza) are taken by injection, similar to insulin, but they're not insulin. These medications are in a class of drugs called incretin mimetics, which improve blood sugar control by mimicking the action of a hormone called glucagon-like peptide 1 (GLP-1). Among other things, these drugs stimulate insulin secretion in response to rising blood sugar levels after a meal, which results in lowering of the blood sugar. Byetta, Bydureon and Victoza not only improve blood sugar control, but may also lead to weigacause weight loss. They appear to help suppress appetite. But the most prominent effect of these drugs is that they delay the movement of food from the stomach into the small intestine. As a result, you may feel "full" faster and longer, so you eat less. Byetta is injected twice daily, and Victoza is injected once a day. Bydureon, a newer formulation, is injected once a week. These drugs do have different effects and side effects to consider. Exenatide (Byetta, Bydureon). The most common side effect of exenatide is mild to moderate nausea, which improves with time in most people. Several cases of kidney problems, including kidney failure, have been reported in people who have taken exenatide. Rarely, exenatide may cause harmful inflammation of the pancreas (pancreatitis).

Liraglutide (Victoza). Some studies have found that liraglutide reduces systolic blood pressure and triglycerides, in addition to improving blood sugar control. The most common side effects are headache, nausea and diarrhea. Clinical studies have also shown that liraglutide may cause pancreatitis.

BYDUREON (exenatide extended-release for injectable suspension) is supplied as a sterile powder to be suspended in diluent and administered by subcutaneous injection. Exenatide is a 39-amino acid synthetic peptide amide with an empirical formula of C 184H282N50O60S and a molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val­Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 BYDUREON is a white to off-white powder that is available in a dosage strength of 2 mg exenatide per vial or per pen. Exenatide is incorporated in an extended-release microsphere formulation containing the 50:50 poly(D,L-lactide-co-glycolide) polymer (37.2 mg per dose) along with sucrose (0.8 mg per dose). The powder must be suspended in the diluent prior to injection. The diluent for the BYDUREON vial is supplied in a prefilled syringe within each single -dose tray. The diluent for the BYDUREON Pen is contained within each single -dose pen. Each configuration contains sufficient diluent to deliver 0.65 mL. The diluent is a clear, colorless to pale-yellow solution composed of carboxymethylcellulose sodium (19 mg), polysorbate 20 (0.63 mg), sodium phosphate monobasic monohydrate (0.61 mg), sodium phosphate dibasic heptahydrate (0.51 mg), sodium chloride (4.1 mg), and water for injection. Sodium hydroxide may be added during manufacture of BYDUREON Pen for pH adjustment.

 

逸達 (Foresee ) 生攜手神隆(ScinoPharm) 開發 緩釋leuprolide injectable

台北生技獎 創新能量露鋒芒 20150727 04:10 黃台中 協助生技產業快速發展,台北市政府主辦的2015台北生技獎24日舉行頒獎典禮,副市長周麗芳揭曉各獎項得主,讚許獲獎單位的創新技術內容,展現台灣生技產業豐沛優越的創新能量外,多項技術更應用在生活與醫療,實現守護民眾的用心。因應生技產業發展逐步成熟,研發成果漸顯露光芒,2015台北生技獎以「新創技術」、「國際躍進」、「技轉合作」3大獎項,呈現在生技「國際化」、「創新價值」及「技術承接」的研發成就,73件參賽標的在技術、財務、智財等面向之水準均相當優異,在激烈的競爭評比後,出線的13件獲獎標的成為生技產業界「創新價值」、「國際布局」、「產學銜接」絕佳典範。新創技術獎金獎:台灣浩鼎生技公司,銀獎台灣生醫材料公司,銅獎台睿生物科公司,國際躍進獎金獎:雃博公司,銀獎台耀化學公司,技轉合作獎金獎:財團法人國家衛生研究院,銀獎清華大學,銅獎成大醫學院生化暨分生所。精專生醫公司、安盛生科公司、逸達生物科技公司、陽明大學、台北醫學大學分獲新創技術與技轉合作類優等獎。

 2015臺北生技獎得獎名單  2015-07-24 16:40:25 經濟日報 曹松清  「新創技術獎」:金獎是台灣浩鼎生技公司,標的名稱是「癌症免疫療法-OBI-822 抗癌疫苗新藥」;銀獎是台灣生醫材料公司,標的名稱是「創新泡沫式人工腦膜」;銅獎是台睿生物科技公司,標的名稱是「口服抗癌新成分新藥 TRX-818 暨多重標靶作用與獨特抑癌細胞類管道形成之開發計畫」。優等獎有精專生醫公司的「自動化線性排列式膜管核酸(DNARNA)純化系統」、安盛生科公司的「結合智慧型手機之創新血糖量測系統」、逸達生物科技公司的「新型緩釋藥物輸送平臺技術及其快速產品商業化的應用」。「國際躍進獎」金獎是雃博公司的「智慧型減壓氣墊床組系列」;銀獎是台耀化學公司的「膽固醇暨磷酸鹽結合劑原料藥之銷售」。「技轉合作獎」金獎是財團法人國家衛生研究院的「新穎抗糖尿病DPP4抑制劑DBPR108-從新藥探索到產業發展的歷程」、銀獎是國立清華大學的「球面型人工視網膜晶片系統」、銅獎是成大醫學院生化暨分生所的「專一性拮抗組合蛋白之新穎蛋白質藥物及其醫藥用途」。優等獎有:國立陽明大學的「低氧間葉幹細胞的臨床應用:異體移植及其衍生物效用」、臺北醫學大學生醫器材研發暨產品試製中心的「3D列印技術」。

逸達 / Foresee is capitalizing on the wealth of opportunities afforded by its proprietary platform technologies and new chemical entities (NCEs). FP is developing promising products based on its technologies internally and partner some of its product opportunities with development and/or commercialization companies at appropriate stages along the development process.

FP-001:Prostate Cancer  Prostate cancer is the most common non-skin cancer and the second leading cause of cancer death among men in the United States. According to National Cancer Institute, about 240,890 new cases of prostate cancer will be diagnosed and about 33,720 men will die of prostate cancer in 2011. About 1 man in 6 will be diagnosed with prostate cancer during his lifetime. Hormonal therapy is the standard palliative treatment in men with advanced prostate cancer. Long-acting gonadotropin releasing hormone (GnRH) agonists have greatly contributed to physician use of and patient compliance with this therapy. However, the current commercially available depot products must be supplied in complicated dosage forms, i.e., microparticles and double syringe packages separating active ingredient from carriers. Reconsititution or mixing immediately prior to administration is required, which is not user friendly and may result in inaccurate doses. Needle clogging has been frequently encountered in some cases with microparticles. FP-001 is designed to overcome the drawbacks of the commercial depot products containing GnRH agonists. By using a proprietary delivery system, the stability of the depot formulation is significantly improved, resulting in a much longer shelf-life. Therefore, the final drug product can be manufactured and supplied in a ready-to-use syringe. This product is less expensive to manufacture and is user friendly, which leads to better patient compliance and treatment outcome. It has been shown that FP-001 depot can deliver GnRH agonist and suppress testosterone below castrate levels for at least 6 months in rats. FP has initiated a Phase 3 clinical study of FP-001 for the treatment of advanced prostate carcinoma. For more information, please visit the study detail page at http://clinicaltrials.gov/ct2/show/NCT02234115?term=foreseeacer&rank=1.

FP-025: Asthma and COPD  COPD is the fourth leading cause of death in America, claiming the lives of 120,000 Americans in 2002. An estimated 10.7 million U.S. adults have COPD, but there may be many more undiagnosed cases. The costs associated with COPD are staggering, with in excess of $30 billion spent annually. The average Medicare expenses for patients with the disease are 2.5 times greater than for those without the disease. COPD is currently the Fourth leading cause of death in the United States and is expected to move to the number-three position by the year 2020. Smoking is the primary risk factor for COPD-approximately 80 to 90% of COPD deaths are caused by smoking. In spite of declining tobacco use in the United States, prevalence of COPD is expected to increase because of the lag time between tobacco exposure and disease development. Over the next 20 years, medical costs related to COPD will total approximately $832.9 billion in the United States, according to a study that presented at the American Thoracic Society International Conference on May 2006. FP-025 is a novel oral, highly potent and selective non-hydroxamate, matrix metalloproteinase-12 (MMP-12) inhibitor for the treatment of asthma and COPD. In preclinical studies, FP-025 has demonstrated a profile that suggests the potential for oral dosing and a unique pharmacological and favorable toxicological profile. The favorable characteristics of FP-025 is likely due to its direct action via inhibition of MMP-12 enzyme with much greater selectivity over other MMP's. FP has initiated a "Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers". For more information, please visit the study detail page at http://www.clinicaltrials.gov/ct2/show/NCT02238834?term=Foresee+pharmaceutical&rank=1.

FP-002: Acromegaly and Carcinoid Tumors  Acromegaly is a disabling and rare hormonal disorder that is associated with a reduction in life expectancy if left untreated. Carcinoid tumor is a rare and slow-growing form of cancer that may develop anywhere in the body where neuroendocrine cells exist, but primarily in the gastrointestinal tract and lungs (~99%). The standard treatments for both acromegaly and carcinoid syndromes are using somatostatin peptide analogues, including octreotide and lanreotide, to inhibit the production of growth hormones. The long-acting depots, Sandostatin LAR and Somatuline Autogel (monthly injection), are preferred for better patient compliance. The combined world market was approaching $1.5 billion in 2009. The chronic, life-long treatment with the current leading treatment, Sandostatin LAR, which consists of intramuscular injections every 4 weeks, is costly. Difficult reconstitution prior to and needle clogging during injection is also an issue. Less frequent and more convenient administration will be highly desirable. FP-002 is designed to overcome the drawbacks of the commercial depot products. Needle clogging is eliminated by formulating somatostatin analog as a liquid. Stabilized somatostatin analog formulation is obtained by preventing interaction between the analog and polymer using a novel proprietary delivery system. The final drug product can be manufactured at a lower cost and supplied in a ready-to-use syringe. It can be administered subcutaneously instead of intramuscularly and is more user-friendly, which leads to better patient compliance and treatment outcome. The stability of the fill-finished product has been shown to be stable for at least two years under controlled storage conditions. FP-002 has also been shown to deliver and maintain therapeutic levels of somatostatin analog for at least 3 months in rats and rabbits.

FP-004: Substance Abuse and Pain Relief  Drug abuse and addiction is a growing worldwide problem, including addiction to heroin and opiate analgesics. According to the National Institute of Health, about 8.3% percent of Americans aged 12 or older were current illicit Opiate users in 2006. Statistics show that Opiate abuse and Opiate addiction cost Americans over $484 billion annually. This figure includes healthcare costs (and abuses of that system), lost job wages, traffic accidents, crime and the associated criminal justice system costs. It has clearly been demonstrated that drug addiction treatments result in reductions in drug use and crime, and improvements in health and social functioning. FP-004 is a novel, subcutaneously injectable formulation of an opioid receptor agonist designed to deliver one to three months of medication following a single treatment. It is expected to provide more consistent therapeutic levels of the opioid receptor agonist with less variability between administrations and over time. This long acting formulation will improve patient compliance and prevent from misuse. This product is in discovery development stage for opioids detoxification. It will also be indicated for chronic pain conditions such as low back, osteoarthritis, and neuropathic pain.

FP-005: Type 2 Diabetes  Diabetes affects an estimated 23.6 million people in the US (90 percent to 95 percent have type 2 diabetes) according to the American Diabetes Association. Statistics showed diabetes was the fifth leading cause of death from diseases in 2007. Diabetes costs $116 billion annually in direct medical costs and costs $58 billion annually in indirect costs (loss of work, disability, loss of life)1 . Despite the introduction of new medications over the last decade, many diabetic patients are unable to control their blood sugar.2 Exenatide is the first in a new segment of anti-diabetic agents called incretin mimetics and is dosed subcutaneously twice daily. An extended-release formulation of exenatide, BYDUREON, has been shown to be administered once weekly and demonstrated superior blood sugar control compared to common diabetes medications such as sitagliptin, pioglitazone and insulin glargine. FP-005 is a novel, subcutaneously injectable formulation of GLP-1 analog designed to deliver one to three months of medication following a single treatment. It is expected to provide more consistent therapeutic levels of the GLP-1 analog to better control blood sugar levels over time. This long acting formulation will improve patient compliance and may slow the disease progression. It will provide a substantial advantage over BYDUREON and other injectable GLP-1 analogs currently in development.

FP-008: Diabetic Retinopathy  FP-008 has been demonstrated to be a promising candidate for the treatment of diabetic retinopathy (DR) which affects more than 4 million US adults 40 years and older. Presently, there is no FDA approved drug for the treatment of DR despite a large market opportunity. To date, only laser treatment to the retina is approved. The off-label use of intravitreal injections of Avastin or Lucentis or steroids are the only acceptable alternative to the laser treatment. This is indeed an unmet medical need. FP-008 has been shown to inhibit the IGF-1 signal transduction pathway in RPE cells, resulting in decreased VEGF production in conditions such as DR. In the past, the problem lied in the difficulties in delivering a high enough effective dose of medications to the retina by systemic administration and in formulating a stable intravitreal injection of FP-008. Foresee believes FP-008 will provide a new, safe and effective option for the treatment of DR with bioavailability for at least six months to one year.

Other Research Projects  FP is also conducting studies to evaluate the feasibility of applying SIF to several other compounds. Use of SIF platform for these compounds is expected to improve their delivery profiles and to achieve better efficacy. Once preclinical proof-of-concept is demonstrated, the compound will be selected to enter development phase.

ScinoPharm & Foresee  30th, 2013 - Foresee Pharmaceuticals, Inc. entered into joint venture agreement with ScinoPharm Taiwan, Ltd., a public traded Taiwan based leading process R&D and API manufacturing service provider to the global pharmaceutical industry. To maximize the potential for our products to make a difference in patients' lives, Foresee has entered into joint venture agreements with ScinoPharm Taiwan, Ltd., a leading process R&D and API manufacturing service provider based in Taiwan. The strategic partnership between Foresee and ScinoPharm will enable Foresee to expedite the development of sustained release drug products to benefit patients. ScinoPharm's expertise and leadership in active pharmaceutical ingredient manufacturing and drug product development will play a critical role for the Joint Venture to successfully develop the leuprolide injectable drug products.• The joint venture will focus on the development of leuprolide injectable drug products for the treatment of advanced stage prostate Cancer. This long-acting release formulation has the potential to provide important therapeutic benefits.• ScinoPharm will be the exclusive provider of the leuprolide active pharmaceutical ingredient ("API") for the joint venture.

國際醫療 醫美人才 供過於求

國際醫療 台灣發展牛步 2015-07-27 03:52:12 聯合報 記者余佳穎/台北報導台灣人口高齡化速度驚人,醫事人員需求殷切,不過醫美為首的「國際醫療產業」項目,近年人才需求卻出現減緩現象,國發會日前發布人才需求供需統計顯示,台灣醫療機構「國際醫療」新增人才需求僅193人。衛福部官員表示,國際醫療包含重症住院、外國人門診等項目,本次調查又以美容醫學(醫美),健康檢查產業(健檢)為主要項目。根據主計總處日前公布資料,台灣去年底執業醫事人員數為27.2萬人,比十年前增加7.9萬人,其中護理人員14.3萬人,人數較93年底增40.6%,醫師則由93年底4.8萬人增至103年底6.2萬人,加計其他醫事人員,每萬人口執業醫事人員數115.9人。醫療院所病床數計161,491床,較93年底增加18,148床或12.7%,以人口數換算,每萬人口病床數68.9床,較93年底增加5.7床。不過,根據國家發展委員會日前發布「重點產業人才供需調查及推估」資料,今年度整體來看,醫美榮登「供過於求」第2,新增供給有3843人,但新增需求僅有193人,求供比僅有0.05。官員表示,目前全台有國際醫療認證會員醫院機構僅有63家,由於可提供國際醫療的醫院不多,需求自然低。官員認為,台灣國際醫療具「便宜又大碗」優勢,醫療技術發達又收費低廉,同樣的項目收費便宜,僅有歐美國家35折;此外,台灣醫療服務主打「溫馨」,醫護人員友善,比起歐美「某種程度冷冰冰」,算是台灣的優勢。「不是全世界都聽過台灣,能見度還要突破。」官員坦言,台灣市場能見度仍然不夠,是現階段發展國際醫療的困境。因此近期包含輔導醫療機構取得國際醫療證照、品牌建構等計畫,希望帶動更多醫療院所加入,提升整體競爭力。

國務院 定調 "大病保險"趨勢 商業保險將介入避免"供給制造需求"

大病保險,給公眾"穩穩的幸福" 中央政府門戶網站 www.gov.cn 2015-07-27 07:18 來源: 人民日報 同時發揮政府和市場的作用,才能更好地提高大病保險的保障質量,守住社會公平底線 "救護車一響,一頭豬白養",這句流傳多年的民間諺語,也許很快就要成為歷史。近日召開的國務院常務會議決定,2015年底前使大病保險覆蓋所有城鄉居民基本醫保參保人,支付比例達到50%以上,今後還要逐步提高。到2017年,要建立比較完善的大病保險制度。國務院的決定,針對的正是百姓的"痛點"。看病,尤其是看大病,治療費用高昂,可説是一種災難性支出,很多家庭難以承受,因病致貧、返貧的現象時有發生。在基本醫保基礎上再次報銷的大病保險,像一個"穩定器",給大病患者家庭結結實實地兜了底。筆者曾在青海採訪過一戶人家,4口人中只有女兒每月有相對穩定的1000多元打工收入,婆婆常年患骨關節病和肺部疾病,當次14457.78元醫藥費,新農合結算9011.10元,大病報銷4156.34元,自付僅1000多元。大病保險政策在當地落地運行半年多,就使一萬多個家庭避免了因病致貧。然而,從各地試點情況來看,雖然大病保險實施後,實際報銷比例提高了12個百分點左右,但仍存在籌資不穩定、償付壓力大等問題。從大病保險的制度流程看,籌錢、管錢、花錢,是相互聯係的三個階段,前兩個階段的制度完善,同樣重要而艱巨。只有創新性地融合社會保障和商業保險,同時發揮政府和市場的作用,才能更好地提高保障質量,守住社會公平底線。大病保險的背後,有一套籌資機制支撐。按照測算,人均籌資達到39元,才能避免家庭發生災難性支出。然而現實中,很多地區只是將新農合、城鎮居民醫保籌資總額的5%劃為大病保險資金,人均籌資水平達不到測算的標準,支付比例難以逐步提高。這就需要政府主導,不斷完善籌資機制,提高保障水平。 同時,各地對于大病保險合理保障范圍執行的力度也不一樣,存在標準不一的問題。比如,大病的范圍,以病種劃分還是以實際發生的醫療費用劃分?基本醫療標準不明,哪些藥品、項目屬于基本醫療范疇?什麼樣的人群被認定為"沒有支付能力",需要在大病保險報銷的基礎上進行醫療救助?看起來是技術問題,但在醫療保險這個"精細活"裏,處理好這樣的技術問題,才能防止內部分配中"劫貧濟富"現象的發生。 而在資金管理上,則需要更多依靠市場機制。醫療領域被視為準"公共綠地",使用者對于醫療資源,也有著很強的"排他佔有性"。在"供給制造需求"理論下,容易産生過度醫療。去醫院看病,大小檢查做個遍,藥品開了一大堆,是常有的事;患者因為有醫保,也不怕這樣的過度服務。醫患"合謀",導致醫療費用居高不下,造成保險資金使用面臨支付難題。在這樣的情況下,讓商業保險公司經辦大病保險,可以發揮其專業的精細管理、風險管控的優勢,嚴密堵住漏洞,控制費用增長,遏制過度醫療,提高資金使用效率。這正是市場手段的效率所在。當然,由于商保公司具有趨利性,需要對其實行更嚴格的監管,避免其"逆向選擇",或發生"搭車賣保險"等不合規行為。 大病保險讓百姓收獲了安定感,是一件大善事。讓大病保險的制度更合理、更完善,才能讓這一善舉釋放持久的紅利,讓人民群眾有"穩穩的幸福"。(李紅梅)