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Eversense E3 CGM系统的医疗保险覆盖范围显著扩大

Medicare Coverage Significantly Expanded for the Eversense E3 CGM System

businesswire 等信源发布 2024-02-12 19:00

可切换为仅中文


PARSIPPANY, N.J.--(BUSINESS WIRE)--Ascensia Diabetes Care, a global diabetes care company, and Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced that Medicare has significantly expanded access to the Eversense E3 CGM System, the longest lasting CGM available, with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs)..

新泽西州帕西帕尼(商业新闻)——全球糖尿病护理公司Ascensia Diabetes Care和医疗技术公司Senseonics Holdings,Inc.(纽约证券交易所美国代码:SENS),专注于为糖尿病患者开发和制造长期植入式连续血糖监测(CGM)系统,今天宣布,前三家医疗保险管理承包商(MAC)通过实施本地覆盖率确定,为基础患者提供植入式CGM,医疗保险已大大扩大了对Eversense E3 CGM系统的访问,这是可用的持续时间最长的CGM。。

Medicare coverage has been expanded for implantable CGMs to include all people with diabetes using insulin, removing the previous requirement for multiple insulin administrations per day. The new policy has also been updated to cover non-insulin-users who have a history of problematic hypoglycemia. Noridian, Palmetto and National Government Services (NGS) are the first three MACs to publish final local coverage determinations (LCD).

植入式CGM的医疗保险覆盖范围已扩大,包括所有使用胰岛素的糖尿病患者,取消了之前每天多次服用胰岛素的要求。新政策也已更新,以涵盖有问题低血糖病史的非胰岛素使用者。Noridian、Palmetto和National Government Services(NGS)是首批发布最终地方覆盖率确定(LCD)的三家MAC。

The earliest MAC expansion becomes effective on February 25, 2024 and the companies expect the remaining MACs to finalize their expansion in the near future..

最早的MAC扩展将于2024年2月25日生效,公司预计剩余的MAC将在不久的将来完成扩展。。

“We welcome this policy change and look forward to bringing this differentiated CGM option to millions of more Americans through Medicare,” said Rudy Thoms, VP, CGM Commercial US of Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE: 6523). “Eversense E3 is a truly unique technology and optionality is key in diabetes care, where what works for one person does not always work for all.

“我们欢迎这一政策变化,并期待通过医疗保险将这种差异化的CGM选择带给数百万美国人,”PHC控股公司(TSE:6523)子公司Ascentia Diabetes Care的CGM Commercial US副总裁鲁迪·托马斯(Rudy Thoms)表示。“Eversense E3是一项真正独特的技术,可选性是糖尿病护理的关键,在糖尿病护理中,对一个人有效的并不总是对所有人有效。

In particular, our Medicare users love that this twice-yearly CGM offers them unparalleled reliability and flexibility, without the burden of regular self-insertions and the constant reordering of supplies. It is important that people with diabetes have the same access to the benefits of a fully implantable, long-term CGM, as they do to traditional CGMs [that have a much shorter lifespan], and so we are thrilled to see this expansion.”.

特别是,我们的医疗保险用户喜欢这种每年两次的CGM为他们提供无与伦比的可靠性和灵活性,而不需要定期自我插入和不断重新订购用品。重要的是,糖尿病患者可以像传统的CGM(寿命短得多)一样获得完全植入式长期CGM的益处,因此我们很高兴看到这种扩展。”。

Designed by Senseonics (NYSE American: SENS) and brought to people by Ascensia, the Eversense E3 CGM System offers people a fully implantable option that is highly-differentiated from traditional CGMs:

Eversense E3 CGM系统由Senseonics(纽约证券交易所美国证券交易所代码:SENS)设计,由Ascensia带给人们,它为人们提供了与传统CGM高度不同的完全植入式选项:

The longest lasting CGM available, with up to 6-month sensor wear duration and two sensor insertion and removal procedures per year

持续时间最长的CGM,传感器磨损持续时间长达6个月,每年有两次传感器插入和拆卸程序

Exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5%* demonstrated in the PROMISE Study1 for the duration of sensor wear

卓越的准确性,PROMISE研究1证明了传感器磨损持续时间的平均绝对相对差异(MARD)为8.5%*

The only CGM with a removable transmitter which can be taken on and off without wasting a sensor or adding a warm up period†

唯一配有可拆卸发射器的CGM,可以在不浪费传感器或增加预热时间的情况下打开和关闭†

The only CGM with predictive on-body alerts to never miss a critical event, especially at night while sleeping or when away from your phone

唯一一款具有预测性身体警示功能的CGM,可随时提醒您不要错过重大事件,尤其是在夜间睡觉或远离手机时

Potential Eversense E3 users can go to www.ascensiadiabetes.com/eversense to learn more about the program and find out if they are eligible. Physicians, nurse practitioners and physician assistants who are interested in offering the Eversense E3 CGM System can sign up at https://www.ascensiadiabetes.com/eversense/become-a-provider/.

潜在的Eversense E3用户可以访问www.ascinsiadiabetes.com/Eversense了解更多有关该计划的信息,并了解他们是否符合资格。有兴趣提供Eversense E3 CGM系统的医生、护士和医生助理可以在https://www.ascensiadiabetes.com/eversense/become-a-provider/.

Alternatively, contact 1-844-SENSE4U (1-844-736-7348) to learn more about the first and only long-term implantable CGM system..

或者,请联系1-844-SENSE4U(1-844-736-7348),以了解有关第一个也是唯一一个长期植入式CGM系统的更多信息。。

Ascensia Diabetes Care, the maker of the CONTOUR® Blood Glucose Monitoring (BGM) System portfolio and exclusive distributor of Eversense® Continuous Glucose Monitoring (CGM) Systems, is a PHC Holdings Corporation (TSE: 6523) company.

Ascentia Diabetes Care是CONTOUR®血糖监测(BGM)系统组合的制造商,也是Eversense®连续血糖监测(CGM)系统的独家经销商,是一家PHC控股公司(TSE:6523)。

About Ascensia Diabetes Care

关于Ascensia糖尿病护理

Ascensia Diabetes Care is a global company focused entirely on helping people with diabetes. Its mission is to empower those living with diabetes through innovative solutions that simplify and improve their lives. It is home to the world-renowned CONTOUR® portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® Continuous Glucose Monitoring Systems from Senseonics.

Ascentia Diabetes Care是一家全球性公司,专注于帮助糖尿病患者。它的使命是通过创新的解决方案来简化和改善糖尿病患者的生活。它拥有世界著名的CONTOUR®血糖监测系统组合,也是Senseonics Eversense®连续血糖监测系统的独家全球分销合作伙伴。

These products combine advanced technology with user-friendly functionality to help people with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, it collaborates closely with healthcare professionals and other partners to ensure its products meet the highest standards of accuracy, precision and reliability, and that it conducts its business compliantly and with integrity.

这些产品将先进的技术与用户友好的功能相结合,帮助糖尿病患者管理自己的病情,并对他们的生活产生积极影响。作为糖尿病界值得信赖的合作伙伴,它与医疗保健专业人员和其他合作伙伴密切合作,确保其产品达到准确性、精确度和可靠性的最高标准,并确保其业务合规、诚信。

Ascensia is a member of PHC Group and was established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation. Ascensia products are sold in more than 100 countries. Ascensia has over 1,300 employees and operations in 31 countries. For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com.

Ascensia是PHC集团的成员,于2016年通过PHC控股公司收购拜耳糖尿病护理公司成立。Ascensia产品销往100多个国家。Ascensia在31个国家拥有1300多名员工和业务。有关更多信息,请访问Ascentia糖尿病护理网站:http://www.ascensia.com.

About PHC Holdings Corporation

关于PHC控股公司

PHC Holdings Corporation (TSE: 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex.

PHC控股公司(TSE:6523)是一家全球医疗保健公司,其使命是通过具有积极影响并改善人们生活的医疗保健解决方案为社会健康做出贡献。其子公司(统称为PHC集团)包括PHC Corporation、Ascensia Diabetes Care Holdings AG、Epredia Holdings Ltd.、LSI Medience Corporation、Mediford Corporation和Wemex。

Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2022 were JPY 356.4 billion with global distribution of products and services in more than 125 countries.

这些公司共同开发、制造、销售和服务糖尿病管理、医疗保健解决方案、生命科学和诊断领域的解决方案。2022财年,PHC集团的综合净销售额为3564亿日元,产品和服务在全球125多个国家分布。

www.phchd.com.

www.phchd.com.

About Senseonics

关于Senseonics

Senseonics Holdings, Inc. (“Senseonics”) is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM system Eversense® E3 includes a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor.

Senseonics Holdings,Inc.(“Senseonics”)是一家医疗技术公司,专注于开发和制造血糖监测产品,旨在通过差异化的长期植入式血糖管理技术改变全球糖尿病社区的生活。Senseonics的CGM系统Eversense®E3包括一个完全插入皮肤下的小型传感器,该传感器与传感器上佩戴的智能变送器通信。

The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone..

葡萄糖数据每5分钟自动发送到用户智能手机上的移动应用程序。。

About Eversense

关于Eversense

The Eversense® E3 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 180 days in persons with diabetes age 18 and older. The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time a day after day 21, and when symptoms do not match CGM information or when taking medications of the tetracycline class.

Eversense®E3连续血糖监测(CGM)系统适用于连续测量18岁及以上糖尿病患者长达180天的血糖水平。该系统用于替代用于糖尿病治疗决策的手指血糖(BG)测量。在第21天之后,当症状与CGM信息不匹配或服用四环素类药物时,仍然需要手指棒BG测量来进行校准,主要是每天一次。

The sensor insertion and removal procedures are performed by a health care provider. The Eversense E3 CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://www.ascensiadiabetes.com/eversense/safety-info/..

传感器的插入和拆卸程序由医疗保健提供者执行。Eversense E3 CGM系统是一种处方设备;患者应该与他们的医疗保健提供者交谈以了解更多信息。有关重要的安全信息,请参阅https://www.ascensiadiabetes.com/eversense/safety-info/..

Forward-Looking Statements

前瞻性声明

Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements regarding expectation for the timing of other MAC expansions of coverage, statements regarding announced changes taking effect as planned, statements regarding growing the awareness, adoption, growth and potential of Eversense, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

本新闻稿中关于Senseonics未来预期、计划和前景的任何声明,包括关于其他MAC扩展覆盖时间的预期声明,关于宣布的变化按计划生效的声明,关于提高Eversense的知名度、采用率、增长率和潜力的声明,以及其他包含“相信”、“期望”、“打算”、“可能”、“项目”、“将”、“计划”和类似表述的声明,构成1995年《私人证券诉讼改革法》含义内的前瞻性声明。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the ongoing commercialization of the Eversense product, uncertainties inherent in PHC Group’s development of a dedicated CGM business, uncertainties inherent in Ascensia’s performance and other commercial initiatives, including the ability to hire, retain and effectively incentivize the dedicated CGM workforce, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2022, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof.

由于各种重要因素,实际结果可能与此类前瞻性声明所显示的结果存在重大差异,包括:保险公司、监管和行政流程和决策的不确定性、Eversense产品持续商业化的固有不确定性、PHC集团发展专门CGM业务的固有不确定性,Ascensia业绩和其他商业举措固有的不确定性,包括雇佣、保留和有效激励专门的CGM员工的能力,与当前经济环境相关的不确定性以及Senseonics截至2022年12月31日的年度报告10-K表中详述的风险因素中所述的其他因素,截至2023年9月30日的10-Q表季度报告以及Senseonics在“风险因素”标题下向SEC提交的其他文件。此外,本新闻稿中包含的前瞻性声明代表了Senseonics截至本文日期的观点。

Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update .

Senseonics预计随后的事件和发展将导致Senseonics的观点发生变化。然而,虽然Senseonics可能会选择更新。

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* MARD of 9.1% was observed in primary sensor in the PROMISE Study

*在PROMISE研究中,在主要传感器中观察到9.1%的MARD

† There is no glucose data generated when the transmitter is removed

†拆除变送器时不产生葡萄糖数据

1 Garg S. et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study. Diabetes Technology & Therapeutics 2021; 24(2): 1-9.DOI: 10.1089/dia.2021.0182

1 Garg S.等人。下一代长达180天的长期植入式Eversense连续血糖监测系统的准确性和安全性评估:PROMISE研究。糖尿病技术与治疗2021;24(2):1-9.DOI:10.1089/dia.2021.0182