Ustekinumab

12月20日，北京市医保局发布了第一批CHS-DRG付费新药新技术除外支付名单，18个药品、4个耗材、2个诊疗项目被先行纳入。 按照国家医保局的计划，距离实现DRG全覆盖还剩一年，但实际运行中，DRG对新技术的冲击已经开始显现，很多医生抱怨，设定支付天花板后，医生不敢贸然使用效果更好但更昂贵的药品、耗材、器械。 北京早在2022年7月就着手启动“除外支付”，只要是有创新性、临床获益的产品，如果对DRG支付标准有较大影响，可申报除外支付资格，相关费用不纳入病组点数计算，让医生再贵也敢用。 时隔近两年半，这份名单终于和大家见面。 健识局发现，此次发布的18个药品中有15款已通过国谈纳入医保目录，14款是抗肿瘤药大品种，包括5款PD(L)-1抑制剂、2款BTK抑制剂、2款PARP抑制剂等。其余涉及罕见病、自免用药。 值得一提的是，这份名单中外资品种占了绝大部分，比如PD(L)-1抑制剂，除了恒瑞的卡瑞利珠单抗外，全都是阿斯利康、罗氏等外资企业的品种，因此业内有评价称，在当前背景下这实际为进口药留了一条活路。 目前发布的只是“第一批”名单，北京已经开通第二批的申报。北京某三甲医院的院长告诉健识局：“北京市的办法比较完备，既为新技术开了道口子，使医生不被DRG缚住手脚，但同时又限制了使用条件，不至于使这道口子成为决堤之口。” 鼓励创新药使用 控费是DRG支付改革的基本目标。在DRG的紧箍咒下，一个患者的医疗费低于标准额，医院就有收入；超出费用，医院就亏损。为了至少不超支，医院必然会管控成本，控制支出。 但在临床实践中，医生们很快发现了问题：DRG支付标准是按照历史医疗收费数据测算出来的，没有将新技术考虑在内。 如今创新药物、创新器械层出不穷，如果用上这些贵的产品，总费用就很难控制在标准线内。 这在肿瘤患者身上体现得尤为明显。2022年4月发表于《卫生经济研究》的一份研究报告显示：药品费用是恶性肿瘤患者住院费用最主要的部分，占比远远高于位列第二的诊断费用。为了控制成本，很多医院不敢用、或者不敢多用创新药。 从目前北京市除外支付的办法和药品名单来看，这一趋势很可能会得到控制。 北京市纳入“除外支付”的大多是三年内新获批的药品，或是增加功能、适应症的药品，以及新纳入医保目录的药品，大部分是公认有突出疗效的肿瘤药，比如PARP抑制剂奥拉帕利、尼拉帕利，BTK抑制剂伊布替尼、泽布替尼，第三代EGFR-TKI奥希替尼、ALK二代靶向药阿来替尼等。 北京甚至考虑到了医保外药品的使用需求。18个品种中包含了I药度伐利尤单抗、O药、K药这3种。 而且，北京的管理办法覆盖到了仿制药和生物类似药，这给国产替代开了绿灯，奥拉帕利、奥希替尼、艾曲泊帕乙醇胺片、伊布替尼、乌司奴单抗5个品种的仿制药也能豁免DRG。 仍有条件限制 相比药品，北京对创新器械、耗材的审查明显更为严苛，第一批仅入选了经导管主动脉瓣膜系统-经导管主动脉瓣膜、经导管二尖瓣夹及可操控导引导管-二尖瓣夹导管输送系统等4个创新耗材。 有业内人士告诉健识局：有两款耗材属于同一套手术系统，临床上主要用于治疗二尖瓣狭窄等心脏疾病，“过去二尖瓣狭窄要开胸，做完手术患者要在ICU住近一礼拜，用这种新技术做完手术第二天患者就能回家”。 业内人士介绍，这套耗材价格不菲，要近20万元。目前北京能开展这类手术的医院，主要就是安贞和阜外两家。 除了药品和医疗器械外，北京的除外名单还把机器人手术辅助操作和经宫腔镜子宫异常组织机械旋切术加入了进来。 总体来看，第一批除外支付项目的选择标准比较高，口子开得不算大。而且名单上的项目也要符合一定的条件才能除外，计算方式比较严格。 前述三甲医院院长告诉健识局：放太开的话，大家可能会乱来，设定好范围，能够让这个口子不至于成为决堤之口。 不过，办法中有两点可以让业内庆幸： 一是，尽管设置了三年的支付有效期，但办法规定，期满后，依据使用数据情况这些创新药械可能被纳入DRG病组中支付。这意味着，除外支付政策让新产品有展示自己新形成规律的可能性，让市场充分地去验证它、接纳它、磨合它。 二是，北京打算将这一机制常态化运行下去。通知表示，市医保局将常态化开展CHS-DRG付费新药新技术除外支付申报工作，并提醒各有关企业及定点医疗机构认真对待申报工作。 撰稿丨李傲 编辑丨江芸 贾亭 运营｜山谷 插图｜视觉中国 声明：健识局原创内容，未经许可请勿转载 当严肃医疗围墙被打破后，如何用好内容触达大众心智 新规 | 审计署：这些医药相关学协会，整改！ 国内首个iPSC来源细胞治疗帕金森病新药获批临床

GUANGZHOU, China, Dec. 24, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has partnered with Tabuk Pharmaceutical Manufacturing Company (a fully-owned subsidiary of Astra Industrial Group), a leading pharmaceutical company in the Middle East and North Africa (MENA) region, for BAT2206, its ustekinumab biosimilar, under which Tabuk will have exclusive rights to manufacture, distribute and market the drug in Saudi Arabia. Continue Reading Bio-Thera Solutions Partners with Tabuk Pharmaceuticals to Commercialize BAT2206, a Stelara® (Ustekinumab) Biosimilar in Saudi Arabia BAT2206 is a proposed biosimilar to Jansen's Stelara®. Bio-Thera has filed for regulatory approval of BAT2206 with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). This partnership will leverage Tabuk's strong local presence, sales and marketing capabilities in Saudi Arabia. Under this agreement Tabuk Pharmaceuticals will hold the marketing authorization and will be responsible to manufacture, register, import, and promote BAT2206 in Saudi Arabia. Bio-Thera will be responsible for full development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China. "Bio-Thera is pleased to establish a partnership with Tabuk to commercialize our ustekinumab biosimilar program in Saudi Arabia", said Dr. Shengfeng Li, CEO of Bio-Thera. "Tabuk is a leading pharmaceutical company in the MENA region and is a great partner to ensure patients in Saudi Arabia have the best access to BAT2206." Ismail Shehada, CEO of Tabuk Pharmaceuticals "We are excited to announce our partnership with Bio-Thera that will enable us to deliver unique and specialized health solutions aimed at enhancing the well-being of people in Saudi Arabia. We are confident that this partnership supports our efforts to manufacture and localize biosimilar products in the region and strengthen our market leading position in line with our strategy. This also stands as a commitment from our side to support the 2030 vision of Saudi Arabia through localizing biopharmaceutical products in the Kingdom." About BAT2206 (ustekinumab) BAT2206 is a proposed biosimilar to Jansen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. In the EU, Stelara® is currently approved for the treatment of 1) moderate to severe plaque psoriasis in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, 2) active psoriatic arthritis, alone or combined with methotrexate, in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs), 3) moderately to severely active Crohn's disease in adults whose condition has not improved enough with other treatments for Crohn's disease or who cannot receive such treatments, 4) moderately to severely active ulcerative colitis in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE/ BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). About Tabuk Pharmaceutical Manufacturing Company Tabuk Pharmaceutical Manufacturing Company is a leading Saudi pharmaceutical company with a regional presence in the Middle East and North Africa. Tabuk Pharmaceuticals develops, manufactures, markets and distributes various branded generics, in addition to manufacturing pharmaceutical products for renowned international partners at its manufacturing sites in Saudi Arabia, as part of its continuous efforts to cover the needs of patients by providing high quality medicines. Tabuk Pharmaceuticals is a major player in the pharmaceutical sector not only in the Kingdom of Saudi Arabia, but also in the Middle East and North Africa, thanks to its four state-of-the-art manufacturing sites located in Tabuk and Dammam in the Kingdom, as well as in Sudan and Algeria, and orchestrated by a team of more than 2,400 employees. Tabuk pharmaceuticals reaches patients in 18 countries in the Middle East and Africa, in addition to futuristic plans to expand its presence in the region. Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT2206, or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. Stelara® is a registered trademark of Johnson & Johnson Corporation 2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 3. TOFIDENCE™ is a trademark of Biogen 4. Avzivi® is a registered trademark of Sandoz AG 5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] Tabuk Pharmaceutical Manufacturing Company Wisam Al Khatib [email protected] SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED