Medicare Coverage Significantly Expanded for the Eversense E3 CGM System
Ascensia Diabetes Care and Senseonics Holdings, Inc. announce Medicare expansion for Eversense E3 CGM System, providing access to all people with diabetes using insulin and non-insulin users with hypoglycemia history. The Eversense E3 offers unique features like up to 6-month sensor wear duration, high accuracy, removable transmitter, and predictive alerts.
The expansion of Medicare coverage to include the Eversense E3 CGM System represents a significant shift in healthcare policy that could have far-reaching implications for both the diabetes care market and the broader healthcare industry. By extending coverage to all insulin-using individuals with diabetes and those with a history of problematic hypoglycemia, the Centers for Medicare & Medicaid Services (CMS) are acknowledging the clinical value of implantable CGM systems. This decision could lead to increased adoption rates, as the financial barrier for eligible Medicare beneficiaries is lowered.
From a policy perspective, the move aligns with broader efforts to improve chronic disease management and preventive care, potentially reducing long-term healthcare costs associated with diabetes-related complications. It also reflects an evolving understanding of the necessity for personalized healthcare solutions that cater to individual patient needs and preferences.
The market implications of Medicare's expanded coverage for the Eversense E3 CGM System are substantial. Ascensia Diabetes Care and Senseonics Holdings stand to benefit from a larger addressable market, as the policy change effectively enlarges the potential customer base. This could translate into increased sales volume and market share for the Eversense E3, particularly as it differentiates itself with features such as a 6-month sensor wear duration and a removable transmitter.
Furthermore, the competitive landscape of the CGM market may experience shifts as other players in the space may need to innovate or adjust pricing strategies in response to the Eversense E3's enhanced market presence. The long-term impact could include accelerated research and development within the industry, as companies strive to meet the new standards of care established by such policy changes.
The clinical implications of the expanded Medicare coverage for the Eversense E3 CGM System are quite positive. The system's unique features, such as the up to 6-month sensor wear duration and predictive on-body alerts, offer substantial benefits for diabetes management. For patients, particularly those who are elderly or have manual dexterity issues, the reduced need for frequent sensor insertions can improve quality of life and adherence to continuous glucose monitoring.
However, it is also important to consider the training and support required for patients transitioning to this technology. Healthcare providers will need to ensure that patients are adequately educated on the use and maintenance of the implantable CGM system to fully realize its benefits and minimize potential complications.
02/12/2024 - 07:00 AM
The decision is further recognition of Eversense as an important option for people with diabetes
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).
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). 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.
“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. 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.”
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:
The longest lasting CGM available, with up to 6-month sensor wear duration and two sensor insertion and removal procedures per year
Exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5% * demonstrated in the PROMISE Study1 for the duration of sensor wear
The only CGM with a removable transmitter which can be taken on and off without wasting a sensor or adding a warm up period†
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
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/ . Alternatively, contact 1-844-SENSE4U (1-844-736-7348) to learn more about the first and only long-term implantable CGM system.
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.
About Ascensia Diabetes Care
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. 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. 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
About PHC Holdings Corporation
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. 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. www.phchd.com
About 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. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.
About 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. 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/ .
Forward-Looking Statements
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. 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. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
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* MARD of 9.1% was observed in primary sensor in the PROMISE Study
† There is no glucose data generated when the transmitter is removed
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20240212855948/en/
For more media enquiries, please contact:
ADC Communications Contact
lorraine.chandler@ascensia.com
Senseonics Investor Contact
Investors@senseonics.com
Source: Senseonics Holdings, Inc.
What is the significance of the Medicare expansion announced for the Eversense E3 CGM System by Ascensia Diabetes Care and Senseonics Holdings, Inc.?
The Medicare expansion provides access to all people with diabetes using insulin and non-insulin users with hypoglycemia history for the Eversense E3 CGM System.
What are some unique features of the Eversense E3 CGM System?
The Eversense E3 CGM System offers up to 6-month sensor wear duration, high accuracy, a removable transmitter, and predictive alerts.
Who are the first three Medicare Administrative Contractors (MACs) to publish final local coverage determinations (LCD) for the Eversense E3 CGM System?
Noridian, Palmetto, and National Government Services (NGS) are the first three MACs to finalize their expansion for the Eversense E3 CGM System.
Where can potential Eversense E3 users find more information about the CGM system?
Potential Eversense E3 users can visit www.ascensiadiabetes.com/eversense to learn more about the CGM system.
