President and CEO Kevin Sayer said the company will file for Medicare coverage of the G6, while it continues to work out an issue that prevents beneficiaries from using a feature that lets data be displayed or shared on cell phones.
Dexcom’s new G6 continuous glucose monitoring (CGM) system, approved last month by FDA, represents a leap forward for people with diabetes on intensive insulin therapy—it’s smaller, easier to use, and factory calibration means no finger sticks are required. A new sensor is approved for a 10-day life, compared with 7 days for the Dexcom G5.
The system offers better technology that will make it easier integrate CGM with automated insulin delivery systems and other diabetes management solutions, increasing options for those with either type 1 (T1D) and type 2 diabetes (T2D).
Early feedback has been overwhelmingly positive, said Kevin Sayer, president and CEO of Dexcom, in an interview with The American Journal of Manage Care® (AJMC®). “The interest is extremely high,” he said, both from patients hoping to try the system, and from doctors who had patients enrolled in studies. “They’re ready to move their patients over immediately when we launch the new system,” Sayer said.
Dexcom will launch the G6 within the second quarter of 2018. “This is going to be a real game changer for us,” Sayer said.
Until Abbott gained approval for its flash CGM last year, FDA had been reluctant to allow factory calibration, which frees patients from having to use finger sticks to confirm accurate blood glucose readings. Notably, Dexcom created a system that still allows users to calibrate the system with finger stick tests if they choose, an option that Sayer said may appeal to parents of children with T1D. So far, the Abbott Freestyle Libre and the Dexcom G6 are the only CGM systems that do not require finger sticks.
A trade-off with the Dexcom G6: Because there are no more finger sticks, FDA has required that the sensor shut off after 10 days, so that patients change sensors to ensure accuracy. Already, discussions about “work arounds” have cropped up online, as many have come to rely on using the sensors for up to 14 days to save money. Over the years, patients have told AJMC® of battles with both commercial payers and Medicare suppliers, who sometimes skimp on diabetes supplies despite clear FDA paramaters for use.
Sayer said these stories frustrate him. “We know how much good the system does to help you take care of yourself,” he said.
Conversations with payers. Sayer said that Dexcom is in conversations across the payer community, and will do a new filing with Medicare for the G6. Dexcom broke ground when its G5 system became available to Medicare beneficiaries in 2017; the company first convinced FDA to update its approval to allow patients to make dosing decision based on CGM data, then CMS updated its reimbursement policies on durable medical equipment (DME), the Medicare category that covers Dexcom’s G5.
However, CMS has not made it easy: it still refuses to pay for the Dexcom G5 if the beneficiary uses the app that allows blood glucose data to be viewed on a cell phone or shared with a caregiver.
Sayer said Dexcom continues to work with CMS on this issue, but acknowledged it’s frustrating. “This is not just a hindrance, it’s a tough thing for us as well,” he said. Dexcom must run data checks on Medicare beneficiaries, and if it catches people using the phone app, it calls those users and asks them to stop, because Medicare won’t pay.
Last summer, a Government Accountability Office report faulted CMS for its outdated technology policies, which it said limit innovation. But for now, Sayer said the DME standards remain unchanged, and because the Dexcom receiver is the only part of the system that lasts 3 years, CMS requires its to be used exclusively.
New groups of users? The G6 is smaller, about the thickness of a Ritz cracker. It’s one-handed insertion device conceals the needle used to change the sensor, and is less painful than earlier versions. “Young users will really like this,” Sawyer said (the G6 is approved for those age 2 and older).
Long term, Sayer believes the coming wave of users will be those with T2D. Dexcom has results in hand that show that the use of CGM results in lower A1C in patients with T2D using multiple daily injections of insulin, not just those using an insulin pump—and those results were based on older CGM models that required patients to calibrate the device twice a day.
T2D users may be a small share of the earliest G6 users, Sayer said, but their numbers will grow. Medicare’s approval of the G5 for T2D patients on intensive insulin therapy opens the door for those conversations. “We will see that occurring,” he said.