In a conference call the morning after a landmark vote, Dexcom's president and CEO said the company will not wait for final FDA approval to start talks with CMS.
Dexcom will begin meeting with CMS about bringing its continuous glucose monitoring (CGM) technology to the Medicare population, now that an FDA panel has endorsed using its G5 mobile system to replace finger sticks for dosing insulin.
“We remain committed to expanding CGM access to the Medicare population,” Dexcom President and CEO Kevin Sayer said Friday morning during an investor’s call, which followed Thursday’s vote to recommend the Dexcom G5 receive a “nonadjunctive” indication.
Panel members voted 8-2 that Dexcom’s G5 system was safe and that benefits of the new label outweighed the risks; they also voted 9-1 that the new use of CGM would be effective. (For coverage of Thursday’s hearing, click here.)
If the full FDA accepts the recommendations, this would mean patients and clinicians could get formal instruction on how to dose off CGM and when it is appropriate. Right now, the FDA requires a self-management blood glucose test for all treatment decisions. Patients told the panel that CGM dosing is both common and highly effective, and Dexcom studies show the number of daily finger sticks declines with regular CGM use, while patients’ clinical indicators improve.
Even while it works with FDA to develop requirements for post-marketing studies and the precise language that would go with the new indication, Dexcom officials said they would begin talks with CMS about expanding coverage under its provisions for durable medical equipment. Medicare coverage would be unlikely before 2018, Sayer said.
While Medicare coverage was not the focus of Thursday’s meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel, the impact of the recommendation was not lost on anyone. Both doctors and patients who spoke at a packed public hearing discussed the effect that the vote might have on Medicare coverage. The patient representative on the panel, Anna McCollister-Slipp, even said it was a chief reason for meeting, only to be warned that FDA cannot consider cost in decisions.
Right now, CGM’s status as an “adjunctive” technology has prevented Medicare approval, because CMS wil not pay for “precautionary” or unnecessary technology. This means patients with type 1 diabetes (T1D) who gain glycemic control with CGM lose coverage once they turn 65. Those who can’t afford CGM lose access at an age when glycemic control becomes more difficult. Often, patients who have lived diabetes for decades no longer feel symptoms of hypo- or hyperglycemia.
“This population has a very high risk of hypoglycemia,” Sayer said. CGM is not only invaluable to the Medicare population, but he sees it as “mandatory.”
A few Medicare Advantage plans permit CGM coverage, and there have been a handful of multi-step appeals, most notably by patient Jill Whitcomb, who won a decision that allowed other patients to gain coverage based on her case. But only those patients willing to go through lengthy appeals have Medicare coverage. (For a first-person account of a Medicare CGM appeal, click here.)
Dexcom doesn’t know precisely how many patients have lost access to CGM because of Medicare’s policy, but they know there is a group waiting for the policy change. Sayer said the “bigger question” involves patients with advanced type 2 diabetes (T2D), “who have never had access to CGM.” He said the numbers who lose access each year might not be large enough to affect earnings, but, “they are significant enough to make us feel badly. The emails are not fun.”
It’s not clear yet whether Dexcom will seek a national approval from the outset or get a regional approval through a Medicare Administrative Contractor that could be expanded. What’s clear, Sayer said, is that the company isn’t going to wait for the full FDA to act on Thursday’s recommendations.
“We are not going to passively sit back and wait,” Sayer said.
He praised the many doctors, scientists, and especially patients and parents who traveled to the hearing in Gaithersburg, Maryland, to tell the panel how CGM has changed their lives; some said CGM had saved them from being “dead in bed.”
Among them was Lynn Wickwire, a patient advocate at Joslin Diabetes Center, who has lived with T1D for 71 years and has been hypo-unaware for many years. “My wife has not given me glucagon for severe hypoglycemia once since I started on CGM,” he said. “Before then, it was every few months.”
Referencing Medicare’s current policy, Wickwire said, “I urge the committee to be cognizant of the bigger picture.”
“We have said for many years that we aim to replace finger sticks, and this is a very big step,” Sayer said Friday. “We thank our patients for their overwhelming support,” he said.