中国肿瘤药领域面面观

中国肿瘤药领域面面观,Professor Dr. Zhao Ping Cancer Hospital CAMS P.R. China 2013 11 16 广州,Former President of Cancer Institute & Hospital CAMSSecretary-in-Chief of Cancer Foundation of ChinaDirector of National Cancer Prevention and Control OfficeFormer Director of National Cancer Registration CenterDirectorial Committee Member of China Cancer Hospital Association General secretary of Asian National Cancer Center AllianceFormer Chief Editor of Chinese Journal of OncologyChief Editor of China Tumor Clinical Year BookRepresentative of Beijing Municipal Peoples CongressRepresentative of CPPCC,Present Post,近40年中国恶性肿瘤发病率态势,数据来源：(中国2012年肿瘤登记年报),中国癌症的发病率与死亡率,China is the largest market forthe drugs for tumors in the world,1.3 billion population3 million new patients with cancer/year25 billion yuan/year for drugs for tumors in China,数据来源：(中国2012年肿瘤登记年报),中国常见恶性肿瘤发病率与死亡率,Cancer therapies,SurgicaltherapyMedical therapy Radiotherapy,Others,Traditional medicaltherapyImmune therapyGene therapy,紫杉醇(Paclitaxel) - 1999年上市,Indication 一线化疗失败或多次化疗失败的转移性卵巢癌(ovary cancer)和乳 腺癌(breast cancer)及非小细胞肺癌的一线和二线治疗 对于头颈癌、食管癌、精原细胞瘤、复发非霍奇金氏淋巴瘤有一定疗效 Effect非小细胞肺癌：紫杉醇联合顺铂治疗晚期非小细 胞肺癌缓解率为21%-27% 1年生存率31%-38.9% 中位生存期 7.8-9.9个月 Price 进口 泰素 30mg/支 1334.00元/支 国产 协和紫素 30mg/支 371.45元/支,Chemical therapy,托瑞米芬（Toremifen)- 2002年上市,Indication 绝经后雌激素受体阳性或不详的转移 性乳腺癌Effect 一线治疗绝经后晚期乳腺癌总有效率 （45%-54%)临床获益率74%-92%price 法乐通 60mg/片 30片/盒 377.00元/盒,Endo-Hormone Equilbrium Modultors Tormfen Formestane Letrozole Anastozole Exemestane Goserlin,吉非替尼Gefitinib 2007年我国上市,Indication 非小细胞肺癌Effect EGFR阳性者有效率 71.2% 阴性者1.1% Price 易瑞沙 0.25g/片 10片/盒 4695.00元/盒,Target TherapyGefitinib Cetuximab Erlotinib Beacizumab Sorafenib Ritixizumab Sunitinib Gemtuzumab Imatinib Trastuzumab,Drugs for Tumor in directory,Drugs for Tumor in directory,Drugs for Tumor in directory,Drugs for Tumor in directory,Drugs for Tumor in directory,Decision making,New drug use approval to enter the hospital after the clinical trial(phase III) and approved by CFDANew drug used in the clinic decided by the hospital pharmacy committeeClinical use of drugs for tumor according to the patient condition（Individual therapy）,Chinas drug policy,Drug tariffs（ 15%）to raise the medical medicine Drug price forming mechanismThe National Development and Reform price department or local price department accounting produces the highest retail price （ceiling price）United centralized bid evaluation experts provinces have priced in 各省统一集中招标 专家评定产生（purchase price中标价） The hospital drugs bonus policy （hospital retail price 零售价）,Cost-effect-Pay,Too expensive comparing with the incomeWorld average month salary 9327yuanChina average month salary 4134 yuan易瑞莎 0.25g/片 10片/盒 4695元/盒 法乐通 60mg/片 30片/盒 377元/盒,International experiences,Germany：Patients get medicine pharmacy paid by medical insuranceFrance：Full reimbursement drugs government pricing medicineJapan：15 thousand drugs government pricing medicineUSA：According to the market independent pricing government rarely intervention medicineCanada：Drugs prices government controlUK：Drugs price standard system control capital return rateIndia：74 basic drugs government pricing medicine,Chinas Medical Health System reform,Target Everyone have the right to basic health care 1.3 billion people have health insurance and new rural cooperative medical(low level and unversal coverage) Challenge Medical price vs medical technology progress Who pay for the patients How much they can pay up,The reform of the system of drugs,Cancel the affordance of drugsBisic drugs in the directory (371) full reimbursementDrugs in the directory of the medical insurance 90% reimbursement for the urban residentsDrugs in the directory of new rural cooperation medical system 80% reimbursement for the peasantsDrugs w. patent（Target drugs ）no reimbursemen,索坦项目,临床试验捐赠,患者关怀,药品捐赠,回顾性研究,中国药品捐赠项目,索坦捐赠发药情况,备注：2008年数据时间段2008.7.1-2008.12.31 2012年时间段为2012.1.1-2012.4.10,1. 药品发放特征 自08年开始，患者领药数量逐年激增 仅2011年一年发药量就占总发药量的47% 预计2012年全年发药量将达到5.4万瓶,折合人民币7亿多,每年发药情况（瓶）,2008,2009,2010,2011,1477,9980,21280,35660,2012,赫赛汀援助项目,赫赛汀援助项目,中国药品收入占比,中国医院药品收入,2002 03 04 05 06 07 08 09 10 11年-药品 1616万元 1733 2045 2383 2599 3127 3924 4846 5825 6817 2011年 全国综合医院平均收入与支出 药品销售收入 6817万元 支出 6384万元 利润 433万元 医疗服务收入 8519万元 支出9290万元 亏损 771万元,治理医药领域商业贿赂,刑法163条 公司 企业 非国家工作人员医疗机构中国家工作人员 在药品 医疗器械 医用卫生材料等医药产品采购活动中个利用职务便利 索取销售方财务 或者非法收受销售方财务 为销售方财谋取