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Health talks for single drug-resistant, antitumor drug
 
Author:中国铭铉 企划部  Release Time:2017-4-18 10:57:08  Number Browse:682
 
Medical network - April 18th April 14, the general office of human resources and social security ministry about 2017 national basic medical insurance, inductrial injury insurance and maternity insurance drug catalogue negotiations range of circular released, which means that access to health care medicine negotiation mechanism has been basically established. 
 
For new drug clinical required, thanks to the new mechanism, medicare drug drug pricing negotiations, can be directly hung net purchase, into the provinces into medical insurance directory will be no need to wait for more than 4 years of time. The author thinks drugs range analysis of this round of talks, good single drug-resistant, antitumor medicine and traditional Chinese medicine composition single medicine these three kinds of drugs. 
 
But, the risk and good coexistence. Degree of eventually positive question: one is to see negotiation price reduction, such as the first batch of less than 50% of the decline? Look into the provinces after hanging net, medicare pay what price? 
 
Health-care negotiation mechanism is difficult to establish 
 
Who planning commission to determine the first batch of drugs 
 
The establishment of the health care medicine negotiation mechanism lasted for more than two years. 
 
In February 2015 on the perfect public hospital drug centralized procurement guidelines "(countries do hair [2015] no. 7) for the first time put forward to some patent drugs, exclusive production of drugs, to establish open and transparent, participating mechanism of drug price negotiations. In October 2015, 16 ministries and commissions such as health development planning commission (bureau) organization has launched the first pilot work national drug price negotiations. According to China's major public health and disease prevention and control of medical needs, organize experts after sufficient demonstration, who planning commission selected price is high, the heavy burden of disease, patients benefit significantly in the treatment of hepatitis b, lung cancer and multiple myeloma pilot drug patent medicine as a negotiation. In the same year in late November, officially launched the national drug price negotiations. 
 
Rumors into development planning commission negotiation directory of drugs with five, but on May 20, 2016, the national health and family planning commission general office to release the results of our national drug price talks about notice only announced three drugs, respectively is glaxosmithkline (China) fumarate tenofovir two pyrazole cefuroxime ester, beida pharmaceutical ek hydrochloride for the treatment, astrazeneca. Fumaric acid tenofovir two pyrazole cefuroxime ester is the latest guidelines recommending a gleam of oral drugs for the treatment of chronic hepatitis b. The treatment for ek, is used for tumor is sensitive to the epidermal growth factor receptor (EGFR) mutations in patients with non-small cell lung cancer molecular targeted drugs. 
 
Perform trouble around 
 
According to a notice health development planning commission, the three drugs in 2016, the completion of negotiations by the end of June and drug concentration netting and purchase cycle in 2016 ~ 2017, no longer separately organized bargaining negotiations. In the same year on July 22, who planning commission issued "the talks will be held across drugs into the progress of all kinds of the compliance costs of medical insurance", there are 14 provinces will negotiate drug into all kinds of the compliance costs of medical insurance. It 14 provinces into health care, however, is not entirely town worker is basic medical treatment insurance and basic medical insurance for urban residents, more is a new type of rural cooperative medical care or a serious illness insurance, in addition, only a few provinces recognized individual products are included in the compliance costs of medical insurance. Who planning commission to promote in trouble. 
 
People club department relay "name" 
 
Until February 21, 2017, the human resources and social security ministry about issued by the national basic medical insurance, inductrial injury insurance and maternity insurance drug catalogue (2017 edition) notice to all three products into the medical insurance directory b, is the three drugs. In general, health b than hundred payment proportion of reimbursement, which means that the three drug prices more than 50% can only gain access to health insurance directory, medicare actually paid more discount. Fujian province in 2017 released by the health insurance payment standard sent the payment standard of the three drugs was 50%. In addition, the notice said, will explore establishing access to health care medicine negotiation mechanism. People club department determined via expert evaluation of negotiations negotiations drugs according to the rules, eligible drug into the medical insurance to pay limits, the list shall be issued separately. 
 
On February 23, 2017 people club department news center "people club department issued by the 2017 version of the catalogue of drugs mentioned in after from all provinces (autonomous regions and municipalities) of nearly 4000 clinical doctors, pharmacists, and healthcare management experts, preliminarily determines the 45 to negotiate drug, are of higher clinical value but relatively expensive, exclusive patent drugs. People club department after confirm whether enterprises have negotiations intention, publish to the society plans to negotiate drug list and group negotiation according to related procedure. On April 14, the published directory has 44, means one drug to determine not involved in the negotiations. 
 
44 negotiations drug positive analysis 
 
Good homebred class 1 chemical drugs 
 
44 negotiations in pharmaceutical chemical medicine or as the main categories, a total of 22. Import chemical medicine 15, domestic chemical medicine seven. In addition to the injection of paclitaxel liposome, the rest of the domestic chemical medicine is approved after 2010 class 1 new drug. Going into the directory of chemical medicine is given priority to with antitumor medicine. 
 
Biological products is given priority to with single resistance 
 
Biological products have 14 going into the directory, with imports accounted for nine, domestic five. In domestic biological products belong to the approved after 2010 has two, respectively is injection with urokinase of restructuring the original and compaq heap eye ophthalmic injection. Going into the directory of biological products is given priority to with single resistance. 
 
8 the commonness and analysis of Chinese traditional medicine 
 
Drug of the communist party of China has eight Chinese medicine 44 negotiations, six of them are traditional Chinese medicine injections, two is for oral administration. 8 2010 years in traditional Chinese medicine (TCM) is approved for lactones ginkgo biloba injection and ginkgo diterpene lactone meglumine injection, the rest from the fixed number of year of the approved in terms of how the "new" are out of the question. Just eight drugs in common, is the author thinks that the main effective component is relatively single. Indications, main is to improve the cancer patient's immune function and cardiovascular medicines. 
 
Most of TCM injections in 2017 version of health care use is limited, I wonder if after six TCM injections for negotiation price indications will be restricted or limited use hospital level. In addition, the traditional Chinese medicine injection current is also focused on the health insurance payment standard, fujian only willing to pay to enter the national essential drugs in traditional Chinese medicine injections, which means that the release of six TCM injections will not get reimbursement in fujian. 
 
Table 1 2017 national basic medical insurance, inductrial injury insurance and maternity insurance drug catalogue negotiations 
序号
药品名称
药品类型
适应症
生产厂家
1
银杏内酯注射液
中药
脑梗死,主要治疗脑血管病。
成都百裕制药股份有限公司
2
心脉隆注射液
中药
益气活血,通阳利水。为慢性心衰的辅助用药。
云南腾药制药股份有限公司
3
参一胶囊
中药
培元固本,补益气血。与化疗配合用药,有助于提高原发性肺癌、肝癌的疗效,改善肿瘤患者气虚症状,提高免疫功能
吉林亚泰制药股份有限公司
4
注射用黄芪多糖
中药
益气补虚。白细胞减少、生活质量降低、免疫功能低下的肿瘤患者。
天津赛诺制药有限公司
5
血必净注射液
中药
化瘀解毒。用于温热类疾病,瘀毒互结证;因感染诱发的全身炎症反应综合征;也可配合治疗多器官功能失常综合征的脏器功能受损期。
天津红日药业股份有限公司
6
复方黄黛片
中药
清热解毒,益气生血。主要用于急性早幼粒细胞白血病,或伍用化疗药物治疗及其他的白血病及真性红细胞增多症。
天长亿帆制药有限公司
7
注射用益气复脉(冻干)
中药
益气复脉,养阴生津。用于冠心病劳累型心绞痛气阴两虚证;冠心病所致慢性左心功能不全Ⅱ、Ⅲ级气阴两虚证。
天津天士力之骄药业有限公司
8
银杏二萜内酯葡胺注射液
中药
活血通络。用于中风病中经络(轻中度脑梗死)恢复期痰瘀阻络证。
江苏康缘药业股份有限公司
9
阿利沙坦酯片
化学药
降血压药
深圳信立泰药业股份有限公司
10
西达本胺片
化学药
国际首个亚型选择性组蛋白去乙酰化酶(HDAC)口服抑制剂,表观遗传调控剂类抗肿瘤药,用于治疗复发及难治性外周T细胞淋巴瘤。
深圳微芯生物科技有限责任公司
11
吗啉硝唑氯化钠注射液
化学药
治疗盆腔炎性疾病
江苏豪森药业集团有限公司
12
康柏西普眼用注射液
生物制品
治疗湿性年龄相关性黄斑变性
成都康弘生物科技有限公司
13
重组人血管内皮抑制素注射液
生物制品
联合NP化疗方案用于治疗初治或复治的Ⅲ/Ⅳ期非小细胞肺癌
山东先声麦得津生物制药有限公司
14
甲磺酸阿帕替尼片
化学药
二线化疗失败的晚期胃癌治疗
江苏恒瑞医药股份有限公司
15
注射用紫杉醇脂质体
化学药
抗肿瘤药,用于卵巢癌的一线化疗及以后卵巢转移性癌的治疗、作为一线化疗,可与顺铂联合应用。也可用于曾用过含阿霉素标准化疗的乳腺癌患者的后续治疗或复发患者的治疗。还可与顺铂联合用于不能手术或放疗的非小细胞肺癌患者的一线化疗。
南京绿叶思科药业有限公司
16
注射用重组人尿激酶原
生物制品
急性ST段抬高性心肌梗死的溶栓治疗。本药应在症状发生后时间窗内尽可能早期使用。
上海天士力药业有限公司
17
注射用尤瑞克林
化学药
轻-中度急性血栓性脑梗死。
广东天普生化医药股份有限公司
18
注射用重组人脑利钠肽
生物制品
患有休息或轻微活动时呼吸困难的急性失代偿心力衰竭患者的静脉治疗。
成都诺迪康生物制药有限公司
19
氟维司群注射液
化学药
新型雌激素受体拮抗剂,用于在抗雌激素辅助治疗后或治疗过程中复发的,或是在抗雌激素治疗中进展的绝经后雌激素受体阳性的局部晚期或转移性乳腺癌。
Vetter Pharma-Fertigung GmbH & Co. KG
20
喹硫平缓释片
化学药
治疗精神分裂症。
AstraZeneca Pharmaceuticals LP
21
替格瑞洛片
化学药
用于急性冠脉综合征
AstraZeneca AB
22
波生坦片
化学药
用于治疗WHO Ⅲ期和Ⅳ期原发性肺高压病人的肺动脉高压,或者硬皮病引起的肺高压。
Patheon Inc.
23
尼妥珠单抗注射液
生物制品
与放疗联合治疗表皮生长因子受体(EGFR)表达阳性的Ⅲ/Ⅳ期鼻咽癌。
百泰生物药业有限公司
24
甲苯磺酸索拉非尼片
化学药
治疗不能手术的晚期肾细胞癌,以及无法手术或远处转移的肝细胞癌。
Bayer Pharma AG
25
注射用重组人干扰素β-1b
生物制品
1.治疗某些病毒性疾病,如急慢性病毒性肝炎、带状疱疹、尖锐湿疣。2.治疗某些肿瘤,如毛细胞性白血病、慢性髓细胞性白血病、多发性骨髓瘤、非何杰金氏淋巴瘤、恶性黑色素瘤、肾细胞癌、喉乳头状瘤、卡波氏肉瘤、卵巢癌、基底细胞癌、表面膀胱癌等。
Boehringer Ingelheim Pharma GmbH and Co.KG
26
甲苯磺酸拉帕替尼片
化学药
适用于HER2过表达且既往接受过包括蒽环类、紫杉类和曲妥珠单抗治疗晚期或转移性乳腺癌患者的治疗。
Glaxo Operations UK Limited, (trading as Glaxo Wellcome Operations)
27
盐酸帕罗西汀肠溶缓释剂片
化学药
治疗各种类型的抑郁症。包括伴有焦虑的抑郁症及反应性抑郁症。
GLAXOSMITHKLINE INC.
28
碳酸司维拉姆片
化学药
治疗行血液透析的晚期肾病患者的高血磷症。
Genzyme Ireland Limited
29
贝伐珠单抗注射液
生物制品
1.转移性结直肠癌贝伐珠单抗联合以5-氟尿嘧啶为基础的化疗适用于转移性结直肠癌患者的治疗。2.晚期、转移性或复发性非小细胞肺癌贝伐珠单抗联合卡铂与紫杉醇用于不可切除的晚期、转移性或复发性非鳞状细胞非小细胞肺癌患者的一线治疗。
Roche Diagnostics GmbH
30
盐酸厄洛替尼片
化学药
用于局部晚期或转移性非小细胞肺癌。
Roche S.p.A.
31
利妥昔单抗注射液
生物制品
复发或耐药的滤泡性中央型淋巴瘤 (国际工作分类B、C和D亚型的B细胞非霍奇金淋巴瘤) 的治疗。
Roche Diagnostics GmbH
32
注射用曲妥珠单抗
生物制品
治疗HER2过度表达的转移性乳腺癌
Genentech Inc.
33
西妥昔单抗注射液
生物制品
单用或与伊立替康联用于表皮生长因子 (EGF) 受体过度表达的,对以伊立替康为基础的化疗方案耐药的转移性直肠癌的治疗。
Merck KGaA
34
利拉鲁肽注射液
生物制品
用于成人2型糖尿病:适用于单用二甲双胍或磺脲类药物最大可耐受剂量治疗后血糖仍控制不佳的患者,与二甲双胍或磺脲类药物联合应用。
Novo Nordisk A/S
35
注射用重组人凝血因子Ⅶa
生物制品
用于下列患者群体的出血发作及预防在外科手术过程中或有创操作中的出血。1.凝血因子Ⅷ或Ⅸ的抑制物]5BU的先天性血友病患者;2.预计对注射凝血因子Ⅷ或凝血因子Ⅸ,具有高记忆应答的先天性血友病患者;3.获得性血友病患者;4.先天性FⅦ缺乏症患者;5.具有GPⅡb-Ⅲa和/或HLA抗体和既往或现在对血小板输注无效或不佳的血小板无力症患者。
Novo Nordisk A/S
36
雷珠单抗注射液
生物制品
适应症为用于治疗湿性(新生血管性)年龄相关性黄斑变性(AMD)
Novartis Pharma Stein AG
37
依维莫司片
化学药
1、舒尼替尼或索拉非尼治疗失败的晚期肾细胞癌。
2、需治疗但无法根治性手术切除的伴结节性硬化的室管膜下巨细胞星形细胞瘤(SEGA)。治疗SEGA的疗效是根据SEGA的体积改变来确定的。尚未证明飞尼妥1可使SEGA患者临床获益?例如改善肿瘤相关症状、延长总生存时间。
Novartis Pharma Stein AG
38
碳酸镧咀嚼片
化学药
用于慢性肾衰患者高磷血症的治疗。
Hamol Limited
39
来那度胺胶囊
化学药
1.多发性骨髓瘤:合用地塞米松治疗已经接受过至少一种疗法的多发性骨髓瘤患者。2.骨髓异常综合症:用于具有5q缺失细胞遗传学异常的骨髓增生异常综合征所致的输血依赖性再生障碍性贫血患者的治疗。
Celgene International Sarl
40
醋酸阿比特龙片
化学药
用于治疗转移性去势抵抗性前列腺癌。
Patheon Inc.
41
注射用硼替佐米
化学药
用于多发性骨髓瘤患者的治疗。
BSP Pharmaceuticals S.r.l.
42
注射用英夫利西单抗(限克罗恩病)
生物制品
适应症为类风湿关节炎本品是疾病控制性抗风湿药物。
Cilag AG
43
托伐普坦片
化学药
用于治疗高容或等容性低钠血症伴心力衰竭、肝硬化、抗利尿激素分泌异常综合征。
浙江大冢制药有限公司
44
泊沙康唑口服混悬液
化学药
用于两性霉素B或伊曲康唑难治的侵袭性曲霉病患者或不能耐受这些药物治疗的患者。
Patheon Inc.,Whitby Operations
(source: salty data V3.2, indications from literature or network, for reference only) 
 
Summary > > > 
 
From 44 to negotiate drug, good sheet resistance, antitumor medicine and traditional Chinese medicine composition single medicine, also illustrates the above category drugs is the national support object. From the point of enterprise, the negotiations drugs there are quite a few from the domestic listed companies, this aspect about the potential new drugs mainly lies in the hands of domestic listed companies, on the other hand shows the stronger government affairs ability of listed companies in China. 
 
According to the provisions of article 7, health care drugs identified the national price negotiations, the net purchase directly, the next step is expected to come to negotiate the price of this kind of drugs and medical insurance payment standard. 
 
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