医学--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 CAMS Secretary-in-Chief of Cancer Foundation of China Director of National Cancer Prevention and Control Office Former Director of National Cancer Registration Center Directorial Committee Member of China Cancer Hospital Association General secretary of Asian National Cancer Center Alliance Former Chief Editor of Chinese Journal of Oncology Chief Editor of China Tumor Clinical Year Book Representative of Beijing Municipal Peoples Congress Representative of CPPCC Present Post /10 万 人 口 发病率 年 中国癌症发病率在今后30年还将继续上升 人口老龄化是首要的因素 生活方式 的作用日显突出 全球癌症发病率最高的国家是丹麦589/10万 亚洲最高的国家 是日本483/10万 中国癌症发病率控制在400/10万 是奋斗的目标 也是可能实 现的 近40年中国恶性肿瘤发病率态势 地 区 性别 发病率 (1/105) 中标率 (1/105) 世标率 (1/105) 累积率 0-74% 全 国 合 计 男女 合计285.91 146.87 191.72 22.08 男性 317.97 165.92 220.33 25.68 女性 253.09 129.49 166.04 18.64 城 市 男女 合计303.39 150.31 195.74 22.23 男性 330.19 165.50 219.84 25.25 女性 276.15 137.09 175.03 19.44 农 村 男女 合计249.98 139.68 182.88 21.76 男性 293.10 166.94 220.94 26.65 女性 205.25 113.07 146.24 16.83 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 死亡率 (1/105) 构成比 (%) 中标率 (1/105) 世标率 (1/105) 累积率 0-74% 184.67 84.36 114.32 12.89 184.67 228.14 109.78 149.91 16.88 228.14 140.48 60.67 81.92 9.08 140.48 181.54 79.21 107.76 11.92 181.54 222.53 102.17 140.13 15.47 222.53 139.97 57.92 78.50 8.56 139.97 196.34 106.05 141.69 16.98 196.34 248.94 141.40 190.00 22.74 248.94 142.36 72.50 96.58 11.35 142.36 China is the largest market for the drugs for tumors in the world 1.3 billion population 3 million new patients with cancer/year 25 billion yuan/year for drugs for tumors in China 城城 市市农农 村村 肿瘤名 称 死亡率 肿瘤名 称 死亡率 肺癌48.76 胃癌 41.29 肝癌 23.81 食管癌 37.60 胃癌 22.64 肺癌 36.03 结直肠癌 16.44 肝癌 33.38 食管癌 10.51 结直肠癌 8.76 胰腺癌 8.09 胰腺癌 5.59 乳腺癌 5.77 脑脑瘤 4.31 淋巴瘤 4.24 白血病 3.46 胆囊癌 4.23 乳腺癌 3.23 白血病 4.14 淋巴瘤 2.89 肿肿瘤合瘤合 计计 181.54 肿肿瘤合瘤合 计计 196.34 城城 市市农农 村村 发病率1/105 发病率 1/105 1 肺癌58.81 胃癌 48.57 2结直肠癌 35.78 肺癌 42.80 3胃癌 30.20 食管癌 38.44 4肝癌 26.63 肝癌 32.98 5 乳腺癌 25.94 结直肠癌 16.40 6食管癌 14.21 乳腺癌 11.51 7甲状腺癌 8.25 子宫颈 癌 5.96 8 淋巴瘤 8.21 脑瘤 5.49 9 胰腺癌 8.19 胰腺癌 5.41 10 膀胱癌 8.11 白血病 4.25 肿肿瘤合瘤合计计 303.39303.39肿肿瘤合瘤合计计 294.98294.98 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 CancerCancer therapiestherapies SurgicaltherapySurgicaltherapy Medical therapyMedical therapy RadiotherapyRadiotherapy n n OthersOthers Traditional Traditional medicaltherapymedicaltherapy Immune therapy Gene therapy 紫杉醇紫杉醇(Paclitaxel)(Paclitaxel) - - 1999 1999年上市年上市 IndicationIndication 一线化疗失败或多次化疗失败的转移性卵巢癌一线化疗失败或多次化疗失败的转移性卵巢癌( (ovary cancer)ovary cancer)和和乳乳 腺癌腺癌 (breast cancer)(breast cancer)及非小细胞肺癌的一线和及非小细胞肺癌的一线和二二线线治疗治疗 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 EffectEffect 非小细胞肺癌：非小细胞肺癌：紫杉醇联合顺铂治疗晚期非小细紫杉醇联合顺铂治疗晚期非小细 胞肺癌缓解率为胞肺癌缓解率为21%-21%- 27% 127% 1年生存率年生存率31%-38.9%31%-38.9% 中位生存期中位生存期 7.8-9.97.8-9.9个月个月 PricePrice 进口进口 泰素泰素 30mg/30mg/支支 1334.001334.00元元/ /支支 国产国产 协和紫素协和紫素 30mg/30mg/支支 371.45371.45元元/ /支支 Chemical therapyChemical therapy 托瑞米芬（托瑞米芬（T Toremifenoremifen) )- 2002- 2002年上市年上市 IndicationIndication 绝经后雌激素受体阳性或不详的转移绝经后雌激素受体阳性或不详的转移 性乳腺癌性乳腺癌 EffectEffect 一线治疗绝经后晚期乳腺癌总有效率一线治疗绝经后晚期乳腺癌总有效率 （45%-54%45%-54%) )临床获益率临床获益率74%-92%74%-92% priceprice 法乐通法乐通 60mg/60mg/片片 3030片片/ /盒盒 377.00 377.00元元/ /盒盒 Endo-Hormone Endo-Hormone EquilbriumEquilbrium ModultorsModultors T Tormfenormfen FormestaneFormestane LetrozoleLetrozole AnastozoleAnastozole ExemestaneExemestane GoserlinGoserlin 吉非替尼吉非替尼GefitinibGefitinib 2007 2007年我国上市年我国上市 IndicationIndication 非小细胞肺癌非小细胞肺癌 EffectEffect EGFREGFR阳性者有效率阳性者有效率 71.2% 71.2% 阴性者阴性者1.1%1.1% PricePrice 易易瑞沙瑞沙 0.25g/ 0.25g/片片 1010片片/ /盒盒 4695.004695.00元元/ /盒盒 Target Target TherapyTherapy GefitinibGefitinib CetuximabCetuximab ErlotinibErlotinib BeacizumabBeacizumab SorafenibSorafenib RitixizumabRitixizumab SunitinibSunitinib GemtuzumabGemtuzumab ImatinibImatinib TrastuzumabTrastuzumab Drugs for Tumor in directory 名称调价单位调前售价调后售价 抑那通粉针(注射用醋酸亮丙瑞林微球)3.75MG支20871992.2 达菲林粉针(注射用曲普瑞林)3.75MG支1890.21772.45 法禄达(醋酸甲羟孕酮片)500MG*30片盒(30片)848847.98 法禄达(醋酸甲羟孕酮片)500MG*30片盒(30片)847.98720 科赛斯粉针(注射用醋酸卡泊芬净)50MG瓶19971792.42 科赛斯粉针(注射用醋酸卡泊芬净)50MG瓶1792.421975.03 科赛斯粉针(注射用醋酸卡泊芬净)70MG瓶25782292.08 科赛斯粉针(注射用醋酸卡泊芬净)70MG瓶2292.082549.64 威凡片(伏立康唑片)200MG*10片盒(10片)4659.993942.8 威凡片(伏立康唑片)200MG*10片盒(10片)3942.84447.97 斯皮仁诺注射液(伊曲康唑注射液)250MG/25ML支1096.991028.9 斯皮仁诺注射液(伊曲康唑注射液)250MG/25ML支1028.9987 威凡粉针(注射用伏立康唑)临时200MG支14501278.5 威凡粉针(注射用伏立康唑)临时200MG支1278.51384.02 诺雷德缓释植入剂(醋酸戈舍瑞林缓释植入剂)3.6MG支20951989.03 注射用磷酸氟达拉滨浙江海正50MG瓶18401322.98 泽菲粉针(注射用盐酸吉西他滨)1GM瓶12421033 艾力粉针(注射用盐酸伊立替康)100MG瓶1646.91225 艾力粉针(注射用盐酸伊立替康)100MG瓶12251322.5 Drugs for Tumor in directory 赛珍R粉针(注射用培美曲塞二钠)200MG支26801994 赛珍R粉针(注射用培美曲塞二钠)200MG支19942206.85 万珂粉针(注射用硼替佐米)3.5MG支1363512730 万珂粉针(注射用硼替佐米)3.5MG支1273013635 力比泰粉针(注射用培美曲塞二钠)100MG瓶3473.263394.44 力比泰粉针(注射用培美曲塞二钠)100MG瓶3394.443817.35 爱立汀粉针(注射用培美曲塞二钠)500MG瓶6750.044573 爱立汀粉针(注射用培美曲塞二钠)500MG瓶45735172.7 奥诺先粉针(注射用右丙亚胺)250mg支518.65529.23 茵福粉针(注射用因卡膦酸二钠)10mg支2912.952310 茵福粉针(注射用因卡膦酸二钠)10mg支23102570.25 普来乐粉针(注射用培美曲塞二钠)200mg支3567.32003 普来乐粉针(注射用培美曲塞二钠)200mg支20032217.2 拉司太特软胶囊(依托泊苷软胶囊)25MG*40粒盒(40粒)943934 格列卫胶囊(甲磺酸伊马替尼胶囊)100MG*120粒盒(120粒)2550023575 格列卫胶囊(甲磺酸伊马替尼胶囊)100MG*120粒盒(120粒)2357525500 艾去适胶囊(磷酸雌莫司汀胶囊)140MG*40粒盒(40粒)1152.661077.3 艾去适胶囊(磷酸雌莫司汀胶囊)140MG*40粒盒(40粒)1077.31152.64 蒂清胶囊(替莫唑胺胶囊)50MG*7粒盒(7粒)2565.632305.99 蒂清胶囊(替莫唑胺胶囊)50MG*7粒盒(7粒)2305.992565.63 Drugs for Tumor in directory 维维康达胶囊(替吉奥胶囊)20MG*42粒盒(42粒)2132.922045 维维康达胶囊(替吉奥胶囊)20MG*42粒盒(42粒)20452265.5 索坦胶囊(苹果酸舒尼替尼胶囊)12.5MG*28粒盒(28粒)1310011734 索坦胶囊(苹果酸舒尼替尼胶囊)12.5MG*28粒盒(28粒)1173413100 泰道胶囊(替莫唑唑胺胶囊)20MG*5粒瓶(5粒)12801175.8 泰道胶囊(替莫唑唑胺胶囊)20MG*5粒瓶(5粒)1175.81265.92 泰道胶囊(替莫唑唑胺胶囊)100MG*5粒瓶(5粒)53004633 泰道胶囊(替莫唑唑胺胶囊)100MG*5粒瓶(5粒)46335241.7 爱爱斯万胶囊(替吉奥胶囊)20MG*140粒盒(140粒)9950.00018333.5 爱爱斯万胶囊(替吉奥胶囊)20MG*140粒盒(140粒)8333.59497.27 易瑞沙R片(吉非替尼片)250MG*10片盒(10片)55004695 瑞宁得片(阿那曲唑唑片)1MG*14片盒(14片)673633.59 康士得片(比卡鲁鲁胺片)50MG*28片盒(28片)14051357.4 弗隆片(来曲唑唑片)2.5MG*30片盒(30片)15061393.56 阿诺诺新片(依西美坦片)25MG*30片盒(30片)16511616.7 福至尔片(氟他胺片)250MG*100片瓶(100片)14691367.72 多吉美R片(甲苯磺酸索拉非尼片)0.2GM*60片盒(60片)2519224267 特罗凯罗凯R片(盐盐酸厄洛替尼片)150mg*7片盒(7片)42154600 艾朗粉针针(注射用唑唑来膦膦酸)4MG瓶16041067.2 择择泰粉针针(注射用唑唑来膦膦酸)4MG支29442539 Drugs for Tumor in directory 天晴依泰注射液(唑唑来磷酸注射液)4MG/5ML支17941181.05 楷莱脂质质体注射液(盐盐酸多柔比星脂质质体注射液)10ML:20MG 支8823.957528.4 楷莱脂质质体注射液(盐盐酸多柔比星脂质质体注射液)10ML:20MG 支7528.48571.41 乐乐沙定粉针针(注射用奥沙利铂铂)50MG支26932635 中人氟安(植入用缓释缓释氟尿嘧啶嘧啶)100MG瓶761.95675.5 福达华华粉针针(注射用磷酸氟达拉滨滨)50MG支2438.62356.14 健择择粉针针(注射用盐盐酸吉西他滨滨)1.0GM支20651982.48 健择择粉针针(注射用盐盐酸吉西他滨滨)200MG支506500.94 泰素注射液(紫杉醇注射液)30MG/5ML支13161334 安素泰注射液(紫杉醇注射液)30MG/5ML支1294.81292.88 泰索帝注射液(多西他赛赛注射液)20MG/0.5ML支19801919.75 力比泰粉针针(注射用培美曲塞二钠钠)500MG瓶1339712011 力比泰粉针针(注射用培美曲塞二钠钠)500MG瓶1201113397 业业立宁粉针针(注射用盐盐酸博安霉素)10MG支943822.08 业业立宁粉针针(注射用盐盐酸博安霉素)10MG支822.08859.14 业业立宁粉针针(注射用盐盐酸博安霉素)10MG支859.14822.08 美罗华罗华注射液(利妥昔单单抗注射液)50ml:500mg支1995017486 美罗华罗华注射液(利妥昔单单抗注射液)50ml:500mg支1748619950 美罗华罗华注射液(利妥昔单单抗注射液)10ml:100mg支4312.53712 美罗华罗华注射液(利妥昔单单抗注射液)10ml:100mg支37124182.55 Drugs for Tumor in directory 美罗华罗华注射液(利妥昔单单抗注射液)10ml:100mg支37124182.55 赫赛赛汀粉针针(注射用曲妥珠单单抗)440MG支2562421688 赫赛赛汀粉针针(注射用曲妥珠单单抗)440MG支2168824854.95 赫赛赛汀粉针针(注射用曲妥珠单单抗)440MG支24854.9524500 开普拓注射液(盐盐酸伊立替康注射液)40MG/2ML支1646.521465.58 开普拓注射液(盐盐酸伊立替康注射液)40MG/2ML支1465.581599.16 艾力粉针针(注射用盐盐酸伊立替康)40MG支860.89770.25 艾力粉针针(注射用盐盐酸伊立替康)40MG支770.25799.53 恩度注射液(重组组人血管内皮抑制素注射液)15MG/3ML支1125.85992 恩度注射液(重组组人血管内皮抑制素注射液)15MG/3ML支9921054.55 开普拓注射液(盐盐酸伊立替康注射液)5ML:0.1GM支27372440.64 开普拓注射液(盐盐酸伊立替康注射液)5ML:0.1GM支2440.642720.48 震达粉针针(注射用唑唑来膦膦酸)4MG支1610747.6 震达粉针针(注射用唑唑来膦膦酸)4MG支747.6773.49 尼妥珠单单抗注射液(泰欣生)临时临时10ML:50MG支36803419 尼妥珠单单抗注射液(泰欣生)临时临时10ML:50MG支34193680 爱爱必妥注射液(西妥昔单单抗注射液)20ml:100mg支46984303 爱爱必妥注射液(西妥昔单单抗注射液)20ml:100mg支43034698 亿迈亿迈林注射液(盐盐酸伊立替康注射液)2ml:40mg支750776.25 艾思美(异氟烷烷)100ML瓶(100ML)653.88629.32 活宁液体(异氟烷烷)100ML瓶(100ML)667.03645 Decision making New drug use approval to enter the hospital after the clinical trial(phase III) and approved by CFDA New drug used in the clinic decided by the hospital pharmacy committee Clinical 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 mechanism The 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 income World average month salary 9327yuan China average month salary 4134 yuan 易瑞莎易瑞莎 0.25g0.25g/ /片片 1010片片/ /盒盒 46954695元元/ /盒盒 法法乐通乐通 60mg/60mg/片片 3030片片/ /盒盒 377 377元元/ /盒盒 International experiences Germany：Patients get medicine pharmacy paid by medical insurance France：Full reimbursement drugs government pricing medicine Japan：15 thousand drugs government pricing medicine USA：According to the market independent pricing government rarely intervention medicine Canada：Drugs prices government control UK：Drugs price standard system control capital return rate India：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 drugs Bisic drugs in the directory (371) full reimbursement Drugs in the directory of the medical insurance 90% reimbursement for the urban residents Drugs in the directory of new rural cooperation medical system 80% reimbursemen