An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *

Medicare Coverage Significantly Expanded for the Eversense E3 CGM System

On February 12, Ascensia Diabetes Care, announced that Medicare has significantly expanded access to the Eversense E3 CGM System with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs).

Ascensia Diabetes Care is a global diabetes care company, and Senseonics Holdings, Inc., a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes.

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 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 six-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 Study[1] 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†; and
• 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.

* 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

*Inclusion in Pharma Fridays does not suggest an endorsement by Endocrine News or the Endocrine Society.