Levothyroxine Sodium

点击上方的 行舟Drug ▲ 添加关注 国家集中采购药品与基本药物目录收录药品比较 来源 《医药导报》 2024年7月 第43卷第7期 作者 邓晓媚，张瑾，张哲弢，李会婷，柳晓，马旖旎，吴文信，史天陆 中国科学技术大学附属第一医院（安徽省立医院）药学部； 精准药物制剂与临床药学安徽省重点实验室 摘要 目的：比较第1~8批国家组织集中采购（集采）药品与2018年版国家基本药物（基药）目录的差异，分析药品品种差异的原因，为更新和完善我国基药目录以及国家集采药品政策提供参考。 方法：收集并整理集采药品目录与基药目录中药品类别、品种、规格、剂型等信息，通过归类比较找出其中差异，分析原因。 结果：39%集采药品为基药；按药理学分类，基药中有40种药品集采药品未涉及；抗凝血药及溶栓药类药品中，同时属于基药和集采的药品品种占比小于品规占比。 结论：集采药品与基药目录存在差异，具有一定的合理性，同时也存在待完善的问题。 关键词 国家药品集中采购；国家基本药物；比较 _ 正文 _ 国家基本药物（简称基药）是适应基本医疗卫生需求，保障供应，公众可公平获得的药品[1]，是临床用药的首选[2]。我国现行的2018年版《国家基本药物目录》优化了药品结构，可满足常见病、慢性病以及负担重、危害大疾病和公共卫生等方面的基本用药需求，并注重儿童等特殊人群用药[3]。 为深化医药卫生体制改革，完善药品价格形成机制，减轻患者药费负担，提高群众用药安全，2018—2023年，国家多部委多次通过国家药品集中采购（简称集采）相关方案[4⁃6]，且组织完成了集采工作8批。但与此同时，药品使用、种类范围、落实情况等方面问题依然存在[7]。集采药品目录和基药目录虽然制定背景不同，但都作为临床合理用药的重要参考，同时为医疗机构药品使用考核指标。两者在药品选择范围上的差异，可能导致医生临床决策时产生困惑，从而对医疗服务质量稳定性产生一定影响。因此，本研究通过比较上述两目录药品异同，分析差异原因，以期提高基药目录和集采目录在满足临床需求和不断完善方面的协调配合，同时减少临床医生用药选择困惑，提高药品使用合理性和医疗服务质量。 1 资料与方法 第1—8批集采目录参考上海阳光医药采购网[8]，基本药物见2018年版基药目录[3]。剂型或规格不同、主要化学成分或处方组成相同药品的列为同一品种；通用名、规格和剂型均相同的列为同一品规。 双人核对药品品种及品规。将集采药品分为2种情况：（1）双属性药品：药品同时被列入集采和基药目录；（2）非双属性药品：①名称不同，如集采目录中为厄贝沙坦片，基药目录中为缬沙坦片；②剂型不同，如集采目录中为甲钴胺片，基药目录中为甲钴胺胶囊；③规格不同，如集采目录中为达比加群酯胶囊75mg，基药目录中为达比加群酯胶囊110mg和150mg。 药理学分类参考药品采购使用管理分类代码与标识码（行业标准WS/T778⁃2021）中化学药品药理分类与代码及基本药物药理学分类，将基药目录和集采药品进行药理学分类汇总，描述药品分类并统计差异，统计双属性药品在基药目录中的品种占比和品规占比。具体方法举例：硝基咪唑类，基药品种为甲硝唑、替硝唑，集采品种为甲硝唑、替硝唑和奥硝唑，因此甲硝唑和替硝唑列为双属性药品，双属性药品在基药中的品种占比为100%；基药中甲硝唑品规为片剂0.2g、胶囊剂0.2g、甲硝唑氯化钠注射液100mL: 0.5g，替硝唑品规为片剂0.5g、胶囊剂0.5g。集采药品为甲硝唑片剂0.2g、氯化钠注射液100mL: 0.5g，替硝唑规格为片剂0.5g，奥硝唑规格为片剂0.25g和0.5g、注射液3mL: 0.5g和6mL: 1g。双属性药品品规为甲硝唑片剂0.2g、甲硝唑氯化钠注射液100mL: 0.5g、替硝唑片剂0.5g，双属性药品在基药中的品规占比为60%。 文章内容由凡默谷小编查阅文献选取，排版与编辑为原创。如转载，请尊重劳动成果，注明【来源：凡默谷公众号】。 2 结果 2.1 基药目录与集采药品目录基本统计描述 对基药目录进行品规拆分，对第1—8批集采目录进行品种合并，基药目录中基本药物化学药品和生物制品部分依据药理学分类，共涉及108个类别，共计417个品种，1126个品规。集采药品目录涉及72个类别，共计279个品种，443个品规，见图1。 2.2 基药与集采药品的药理学分类差异 参照基药目录，集采药品覆盖其68个药理学分类，占比63.0%，详见表1。 按照药理学分类，集采药品数量排名前10位的药理学类别分别是头孢菌素类，胰岛素及口服降糖药，抗高血压药，解热镇痛、抗炎、抗风湿药，抗精神病药，抗凝血药及溶栓药，抗病毒药，抗抑郁药，抗酸药及抗溃疡病药。大部分集采药品收录药品品种数少于基本药物，见图2。 头孢菌素类、其他抗菌药、硝基咪唑类、良性前列腺增生用药、抗肿瘤植物成分药、抗肿瘤激素类药、抗痴呆药和利胆药类，集采药品收录品种数高于或等于基本药物，见图3。 2.3 集采药品双属性药品的占比 集采药品目录中有171个（38.6%）为双属性药品；272个（61.4%）为非双属性药品，其中名称不符占64%，剂型不符占25%，规格不符占11%。 2.4 按药理学分类双属性药品占比 集采药品中良性前列腺增生用药、硝基咪唑类药物、抗甲状旁腺药物、局部麻醉药、头孢菌素类药物、喹诺酮类药物、利胆药的双属性药品品种占比达100%。抗凝血药及溶栓药，品种占比为29%，品规占比为38%，其他类别双属性药品品种占比均高于品规占比，见图4。 3 讨论 由国家卫生健康委员会联合国家中医药管理局发布的《国家基本药物目录》与国家组织药品集中采购和使用试点工作小组制定的药品集中带量采购目录，其目的均为规范医疗行为，促进合理用药。因此，两者纳入的药品存在共性，如集采药品数量排名前3的药理学类别为头孢菌素类、胰岛素及口服降血糖药和抗高血压药，这与基本药物目录高度重合，考虑感染、糖尿病、高血压作为常见病和慢性病的医疗费用较高以及患者疾病负担较重。但两者功能定位方面存在明显差异，基药是保证临床首选，防治必需，而集采政策旨在将基本医保药品目录内用量大、采购金额高的药品纳入采购范围，逐步覆盖国内上市的临床必需、质量可靠的各类药品，做到应采尽采。因此两目录内药品存在差异，并具有一定合理性，同时也存在待完善问题。 3.1 两者差异合理性 本研究发现，在同一药理学分类下，两者纳入药品品种存在差异，此种差异由两者的功能定位不同所致。以抗菌药物为例，集采目录纳入了更多的限制使用级及特殊使用级抗菌药物。考虑因基本药物核心理念为保障防治必需用药，结合抗菌药物的分级管理政策，并未过多纳入限制使用级及特殊使用级抗菌药物。集采药品政策要求结合医保药品目录，覆盖使用量大、采购金额高的药品，随着细菌耐药性的攀升和新型抗菌药物的研发，更多的抗菌药物被纳入到集采目录，其中就包括各种限制级和特殊使用级抗菌药物。 本研究显示，基本药物目录中尚有40种药理学分类药物未纳入集采，考虑部分药品使用具有局限性，受总体用量及金额所限，尚不适用于现阶段集采机制。如抗血吸虫病药物等抗寄生虫药，其疾病发病率存在地域性，该类药物属于药品实施分类采购的按照国家规定采购方式进行采购（如麻精药品、传染病和寄生虫病免费用药、部分疫苗、计划生育药品和中药饮片），为国家规定采购方式[9]；抗重症肌无力药如新斯的明和溴吡斯地明主要用于罕见病治疗[10]，解毒药所治疗的中毒疾病发生具有不确定性，需求量均较低，生产企业缺乏积极性[11]。 3.2 两者差异待完善性 双属性药品同时具备临床必需及价格优势，因此扩大双属性药品的范围有助于减轻群众用药负担，且有助于医疗机构完成基本药物和集采药品政策的双重考核。部分类别药品可以考虑纳入集采范畴，包括：①肠内营养药。营养不良作为全球性问题，各国指南均推荐对于存在营养风险和营养不良的患者进行营养治疗。尤其对于肿瘤患者、克罗恩病患者等炎症性肠病患者，营养支持是一种重要治疗手段[12⁃13]。对于存在或部分存在胃肠道消化吸收功能的患者，应优先考虑使用肠内营养治疗，而肠内营养制剂价格较高，限制了其临床使用，减少了患者获益。目前集采药品已部分覆盖肠外营养药，但未涉及肠内营养药物，该类药品可以考虑纳入集采范畴。②肝病辅助治疗药。感染性疾病、免疫功能异常、肿瘤、血液循环障碍等疾病均可能造成一定程度的肝脏损伤，同时抗肿瘤药、免疫抑制剂、抗结核药、部分中草药等药物也可能对患者的肝功能造成影响[14]。我国肝病辅助用药物处方量呈上升趋势[15]，医疗费用压力较大，该类药品纳入集采，可以发挥政策价格优势同时有助于规范药品合理使用。③甲状腺疾病药物。最新调查结果显示，我国老年人甲状腺疾病总体患病率50.96%[16]，甲状腺疾病的常用药物如左甲状腺素钠片、甲巯咪唑等临床使用量较高，单价适中，但考虑其总体销售金额较高，部分省份已将其纳入区域集采目录，建议纳入国家集采目录。④中成药。作为中华文化文明的瑰宝，中医中药在防治疾病方面发挥了其独特的优势，尤其在治疗新型冠状病毒感染中发挥了重要作用[17]。但中成药尚无一致性评价，需进一步探索符合中成药特点的集采方式。 另一方面，抗凝血药达比加群酯，基本药物目录纳入品规为110和150mg2种，集采目录在此基础上增加了75mg品规；临床实际治疗过程中，常用治疗方案为每日2次，每次110或150mg，而非75mg；从药物经济学角度看，中标的达比加群酯胶囊150mg规格单粒最低价格4.58元，75mg规格单粒价格为4.75元，可见，75mg规格并不具有更高的经济学优势，提示国家集采政策应结合药物经济学评价进一步优化准入细则。 综上所述，本研究以目录为抓手，分析集采药品与基药目录的异同。两者均重点关注常见病及慢性病等常用药物。集采药品药理学分类覆盖率有待进一步扩大，建议纳入肠内营养药、肝病辅助治疗药及甲状腺疾病药物等，适当提高双属性药品的占比可以更有效地实现合理用药安全性、有效性和经济性。同时集采政策应进一步关注临床用药合理性，建立相应调入和调出机制，并积极探索罕见病药、中成药适宜采购方式。 参考文献 详见《医药导报》 2024年7月 第43卷第7期 文章信息源于公众号凡默谷，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。 学如逆水行舟，不进则退； 心似平原走马，易放难收。 行舟Drug 每日更新 欢迎订阅+ 医药大数据|行业动态|政策解读

CHICAGO--( BUSINESS WIRE )--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the second quarter and six months ended June 30, 2024 and recent corporate events. “I am very pleased to report that we posted an outstanding quarter of $48 million in total revenue, which included record product revenue of over $46 million driven by strong demand for all three of our products. Our year-over-year product revenue growth of 26% represents the eleventh consecutive quarter of over 20% growth as our diverse product portfolio of Recorlev ® , Gvoke ® , and Keveyis ® all continue to meet important unmet needs for patients,” said John Shannon, CEO of Xeris Biopharma. “Our strong performance leads us to now envision full year results at the high end of our original range, and we’re tightening our guidance to $190-$200 million from the previous $175-$200 million. We also believe that this performance will enable us to perform at the higher end of our year-end cash range, so we’re tightening that guidance to $60-$75 million.” Mr. Shannon continued, “This is an exciting time for Xeris, and I’m thrilled to be leading as CEO for the next phase of our journey building upon the strong foundation we’ve created to drive our revenues and pipeline to new heights.” Second Quarter 2024 Highlights Three Months Ended June 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 20,046 $ 15,638 $ 4,408 28.2 Keveyis 13,128 14,088 (960 ) (6.8 ) Recorlev 13,338 7,167 6,171 86.1 Product revenue, net 46,512 36,893 9,619 26.1 Royalty, contract and other revenue 1,553 1,115 438 39.3 Total revenue $ 48,065 $ 38,008 $ 10,057 26.5 Commercial Products Gvoke ® : Second quarter net revenue was $20.0 million as compared to $15.6 million in the second quarter of 2023 – an increase of approximately 28%. Gvoke prescriptions topped 65,000 for the first time, growing 27% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 34% at the end of July. Keveyis ® : Second quarter net revenue was $13.1 million as compared to $14.1 million in the second quarter of 2023 - a decrease of approximately 7% due to generic competition. Net revenue was unchanged from the first quarter of 2024. Recorlev ® : Second quarter net revenue was $13.3 million – an increase of 86% compared to the second quarter of 2023. The average number of patients on Recorlev increased 124% from the same period in 2023 . Technologies Programs XeriSol™ levothyroxine (XP-8121) : In May, Xeris announced positive topline results from its Phase 2 multi-center, open label, study of XP-8121 for the treatment of adults with hypothyroidism. The Company anticipates an end-of-Phase 2 meeting with the FDA before year-end. XeriSol™ glucagon for pumps: In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics, Inc. for the development and commercialization of a unique glucagon product for use in Beta Bionics’ proprietary bi-hormonal pump and pump systems. Year-to-Date 2024 Financial Results Six Months Ended June 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 36,625 $ 30,671 $ 5,954 19.4 Keveyis 26,213 26,843 (630 ) (2.3 ) Recorlev 23,937 11,644 12,293 105.6 Product revenue, net 86,775 69,158 17,617 25.5 Royalty, contract and other revenue 1,928 2,046 (118 ) (5.8 ) Total revenue $ 88,703 $ 71,204 $ 17,499 24.6 Gvoke ® : Net revenue was $36.6 million for the six months ended June 30, 2024, a 19% increase compared to prior year. Gvoke prescriptions for the first half of 2024 were approximately 124,000 TRx’s, growing approximately 27% compared to the same period in 2023. Keveyis ® : Net revenue was $26.2 million for the six months ended June 30, 2024, a 2% decrease from last year due to generic competition. Recorlev ® : Net revenue was $24.0 million for the six months ended June 30,2024, a 106 % increase from last year, driven primarily by increases in the number of patients on therapy. Cost of goods sold remained relatively flat for the three months ended June 30, 2024 compared to the same period ended June 30, 2023. Cost of goods sold increased by $0.9 million for the six months ended June 30, 2024 compared to the same period ended June 30, 2023. The slight increase was attributable to higher product sales, partially offset by favorable product mix driven by higher sales of products with lower cost of goods sold. Research and development (R&D) expenses decreased slightly by $0.3 million for the three months ended June 30, 2024. For six months ended June 30, 2024, R&D increased by $2.7 million primarily due to higher spending for our pipeline and personnel related expenses. Selling, general and administrative (SG&A) expenses increased by $2.4 million and $7.1 million for the three and six months ended 2024, respectively, compared to the same periods ended June 30, 2023, due to higher personnel costs. Net Loss for the three months ended June 30, 2024, was $15.0 million, or $0.10 per share, and a net loss of $34.0 million, or $0.24 per share, for the six months ended June 30, 2024. Cash, cash equivalents, and short-term investments at June 30, 2024 was $77.6 million compared to $72.5 million at December 31, 2023. Total shares outstanding at July 31, 2024 was 148,998,825. Upcoming Investor Conferences Members of the senior management team will be participating in the following investor conferences: Wells Fargo Healthcare Conference, September 4-6, 2024 HC Wainwright Global Investor Conference, September 9-11, 2024 Cantor Global Healthcare Conference, September 17-19, 2024 Please check with each conference sponsor to arrange 1x1 meetings. Conference Call and Webcast Details Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results. To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=44e9222b&confId=68537 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Thursday, August 22, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 840547 To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/670337574 About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke ® , a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis ® , a proven therapy for primary periodic paralysis, and Recorlev ® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect ® , supporting long-term product development and commercial success. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com , or follow us on X , LinkedIn , or Instagram . Forward-Looking Statements Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, including projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the expected timing of an end-of-Phase 2 meeting with the FDA, its attendance at investor conferences, the composition of its executive team, and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Product revenue, net $ 46,512 $ 36,893 $ 86,775 $ 69,158 Royalty, contract and other revenue 1,553 1,115 1,928 2,046 Total revenue 48,065 38,008 88,703 71,204 Costs and expenses: Cost of goods sold 7,790 7,555 13,761 12,874 Research and development 5,759 6,087 13,580 10,925 Selling, general and administrative 39,993 37,635 78,373 71,240 Amortization of intangible assets 2,710 2,710 5,421 5,421 Total costs and expenses 56,252 53,987 111,135 100,460 Loss from operations (8,187 ) (15,979 ) (22,432 ) (29,256 ) Other expense (6,069 ) (4,538 ) (10,497 ) (8,095 ) Net loss before benefit from income taxes (14,256 ) (20,517 ) (32,929 ) (37,351 ) Income tax (expense) benefit (749 ) 675 (1,056 ) 675 Net loss $ (15,005 ) $ (19,842 ) $ (33,985 ) $ (36,676 ) Net loss per common share - basic and diluted $ (0.10 ) $ (0.14 ) $ (0.24 ) $ (0.27 ) Weighted average common shares outstanding - basic and diluted 148,345,549 137,338,071 144,372,512 137,250,465 XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 57,604 $ 67,449 Short-term investments 19,964 5,002 Trade accounts receivable, net 42,440 39,197 Inventory 42,977 38,838 Prepaid expenses and other current assets 7,355 5,778 Total current assets 170,340 156,264 Property and equipment, net 5,833 5,971 Intangible assets, net 104,343 109,764 Goodwill 22,859 22,859 Operating lease right-of-use assets 22,864 23,204 Other assets 5,494 4,540 Total assets $ 331,733 $ 322,602 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 5,798 $ 11,565 Current operating lease liabilities 5,307 3,495 Other accrued liabilities 23,494 23,510 Accrued trade discounts and rebates 23,275 22,149 Accrued returns reserve 16,197 14,198 Current portion of contingent value rights 420 19,109 Other current liabilities 997 1,167 Total current liabilities 75,488 95,193 Long-term debt, net of unamortized debt issuance costs 230,481 190,932 Non-current contingent value rights — 1,379 Non-current operating lease liabilities 34,016 34,764 Deferred tax liabilities 3,324 2,268 Other liabilities 7,710 4,848 Total liabilities 351,019 329,384 Total stockholders’ equity (deficit) (19,286 ) (6,782 ) Total liabilities and stockholders’ equity (deficit) $ 331,733 $ 322,602