Is Dexcom on Its Way to No More Fingersticks?

Dexcom has long envisioned a future where patients with diabetes don't need confirmatory fingersticks to make decisions about their treatment. 

Now, that future may be one step closer than before. 

The company, a major maker of continuous glucose monitors (CGMs), has announced that an FDA advisory panel will consider the issue of non-adjunctive labeling at a meeting on July 21.

Right now, Dexcom's CGM products have adjunctive labeling, meaning they are meant to be used alongside other standard glucose monitoring methods, like fingersticks. Getting non-adjunctive labeling would enable patients to skip confirmatory fingersticks before making decisions on insulin doses. Patients would still need to calibrate their CGM using fingersticks.

Getting non-adjunctive labeling is also a key step toward securing Medicare reimbursement coverage for CGMs.

Dexcom filed a PMA supplement with FDA last fall for non-adjunctive labeling--also called a dosing claim--on its approved G5 CGM system. The device already has CE Mark for this labeling.

Dexcom president and CEO Kevin Sayer told analysts on this week's first quarter earnings call that the company has been discussing the issue with FDA for almost a year and a half. "We have always believed that the information provided by CGM provides much better information for making an insulin dosing decision at a single finger stick, particularly when we look at the accuracy and performance of our system with our Software 505 algorithm," Sayer said, according to a Seeking Alpha transcript of the call. 

The European launch of Dexcom's G5 Mobile allowed patients in Europe to skip confirmatory finger sticks, though at least two daily fingersticks are still needed to calibrate the device. Discussing that launch on the company's third quarter earnings call in November 2015, according to a Seeking Alpha transcript, Sayer said, "We have always said that CGM will ultimately be the standard of care in diabetes management, and we see a clear path to the day when the only reason to take a finger stick will be to calibrate your sensor . . . or for a safety check to ensure proper sensor performance."

Sayer explained on the call that the company has been working closely with FDA to provide any extra data. The supplement filing included clinical data gathered using the company's Software 505 algorithm, thousands of treatment scenario simulations, and several human factor studies, he said. He added that FDA will be considering the technology's accuracy, the software's capabilities, and ability to ensure patient safety.

If the advisory panel offers a positive recommendation and FDA grants approval of a non-adjunctive label, Sayer said he expects a "very significant post-market study" would be required. Other CGM makers will likely be paying close attention, too. "The panel meeting could very well set the tone for all future CGM products," he said.

Gaining a non-adjunctive label is important for Dexcom's bid to get Medicare coverage for CGMs. CMS does not allow coverage for the technology as long as it is "adjunctive," and Medicare reimbursement is important to prescribers and users. Sayer noted, "As I've gone out in the field and met with physicians, question number one every time I walk in an office is 'When are you going to get Medicare?' So, we need this labeling." The company has not yet determined its CMS plan of attack if FDA approval is secured, but Steve Pacelli, executive vice president of strategy and corporate development, said on the call that Dexcom may approach individual, regional Medicare Administrative Contractors first before seeking a national coverage determination.

Non-adjunctive labeling may also help boost CGM adoption. Sayer said that there are some physicians who don't prescribe CGMs to patients because they note fingersticks are still required. "With this claim, we will be able to go to that group and say, 'Look, recommend this for your patients, they don't have to take finger sticks before they make the treatment decision.' This will be a very, very good outcome for us and we'll be able to get deeper and into more physicians," Sayer said, according to the call transcript.

It's too early to say what will happen at the July 21 panel meeting or what FDA will ultimately decide. For now, Dexcom is busy preparing. "We look forward to the opportunity and will take what comes, but we will be ready, rest assured. We will not lack for preparation here," Sayer said.

[Image courtesy of PAT138241/FREEDIGITALPHOTOS.NET]