The company announced the coming U.S. launch for G7 in a Super Bowl Commercial with musician Nick Jonas last night. It’s slated to roll out on Friday, Feb. 17.
San Diego-based Dexcom met the category requirements for therapeutic continuous glucose monitor (CGM) systems set forth by CMS. This makes G7 accessible to all Medicare patients with diabetes who meet the eligibility criteria upon the Feb. 17 launch.
“When we set out to design G7, our goal was simple: to make the most accurate, easy-to-use CGM available for as many people with diabetes as possible,” said Kevin Sayer, chair, president and CEO of Dexcom. “The approval of Medicare coverage for G7 helps us deliver on that promise. Now Medicare patients with type 1 and type 2 diabetes will have access to the newest CGM technology that offers the most reliable, simple way to help people manage their diabetes more confidently.”
About the Dexcom G7
The Dexcom G7 received FDA clearance in December 2022. Sayer told Drug Delivery Business News that the company planned for an “aggressive” launch this year.
FDA’s indication for Dexcom G7 covers people with all types of diabetes aged 2 years and older. The device features a 60% size reduction from the previous generation, the G6. It includes a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past). It also features a 12-hour grace period to replace finished sensors for a more seamless transition.
In clinical trials, the system registered an 8.2% overall mean absolute relative difference (MARD), highlighting its accuracy.
G7 provides more information in one place with personalized insights, extended-wear design and more. It offers a simple wear experience, too. The user begins by unscrewing a cap, then putting the sensor on their body and pushing a button. The device is then turned on and can be paired with a smartphone.
The CGM also integrates with a redesigned and simplified mobile app. It features improved alert settings for enhanced discretion and an easier-to-read display. Users aged two and older can wear it on the back of the arm and those between two and 17 can wear it on the upper buttocks.
The new system also contains holdover features from the previous-generation G6. That includes no fingersticks, scanning or calibration and real-time glucose readings automatically sent every five minutes. It integrates with the CGM ecosystem, including Apple Watch, Garmin and other digital health apps. Remote monitoring with G7 allows for the sharing of glucose data with up to 10 followers.
More reimbursement wins to come?
In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.
Analysts suggested at the time that the decision marked a win for CGM makers, including Abbott and Dexcom.
“The comment period on the proposed LCD will run through November 19, after which a final determination will be made,” BTIG analyst Marie Thibault wrote. “We expect potential inclusion in the final determination will catalyze increased CGM adoption in this patient population, benefiting both [Abbott] and [Dexcom].”
Dexcom CTO Jake Leach told Drug Delivery Business News recently that Dexcom is “really excited” by the potential expanded coverage. He expects the decision to arrive in the second half of this year.
“We see that as just another validation of how CGM can really benefit people with diabetes,” Leach said. “This is a whole new group of folks that haven’t had access to it before. I think we’re going to really see some great outcomes as that population starts to use CGM more regularly. We’re really excited about G7 servicing that population when it becomes available.”
Sayer said on the company’s fourth-quarter earnings call that the population could nearly double Dexcom’s addressable reimbursement market in the U.S.
Last year, Thibault mentioned a 3 million-patient population, while Abbott CEO Robert Ford said the company estimates 4 million type 2 basal patients in the U.S., highlighting the reachable base.
