Implantable CGM company Senseonics has received approval from the FDA for the non-adjunctive indication for its Eversense device.

Senseonics is only the third company to secure this indication, which allows a CGM to be used for insulin dosing in lieu of a fingerstick glucometer, though patients will still need to use fingersticks twice a day for calibration.

The company plans to go live with the new product in Q4 2019, along with a new app patients will need to download in order to make use of the new indication.

“Receiving the non-adjunctive indication from the FDA marks a major milestone for Senseonics,” Tim Goodnow, president and CEO at Senseonics, said in a statement. “The Eversense CGM will soon be used as a replacement to fingersticks to make treatment decisions. We expect this will allow our users to more conveniently and confidently live their lives with fewer interruptions.”

WHY IT MATTERS

As well as being a competitive differentiator, the nonadjunctive claim has repercussions for reimbursement as well, as the labeling required for Medicare coverage.

“This approval is another step toward providing access to Eversense CGM for people 65 and older, as non-adjunctive labeling is the first requirement for Medicare coverage,” Goodnow said. “We look forward to working with the Centers for Medicare & Medicaid Services leadership team to explore opportunities for Senseonics to provide Eversense and its benefits to the Medicare population.”

According to the Kaiser Family Foundation, in 2016 one third of Medicare Beneficiaries had diabetes, so the group is a large and desirable market for a CGM company.

Finally, this clearance brings Senseonics into what is currently a very exclusive club — with only Dexcom and Abbott currently approved for nonadjunctive claims.

WHAT’S THE TREND

Dexcom has the distinction of being the first company to secure the nonadjunctive labeling in December 2016 for the Dexcom G5. The Dexcom G6, its successor, also launched with the labeling. It took the better part of a year for Abbott to catch up, getting the labeling for the Freestyle Libre in Septemeber 2017, but with a compelling difference: Abbott is the first and only device to eschew fingersticks even for calibration.

Senseonics, meanwhile, only received FDA clearance of any kind a year ago in June 2018, focusing before that exclusively in international markets, mostly in Europe. In March, the company announced a program to make the CGM available for just $99 for patients whose insurance won’t cover it.

ON THE RECORD

“This FDA dosing indication helps reduce the burden that patients face when managing their diabetes,” Dr. Francine R. Kaufman, an endocrinologist and chief medical officer at Senseonics, said in a statement. “Patients have expressed that many of the unique features of Eversense — its long-term use, removable transmitter and predictive, on-body vibe alerts — allow them to be more discreet as they manage their diabetes. In a recent analysis, we have seen that early Eversense users in the US have experienced 62% time in the target range for sensor glucose values of 70-180 mg/dL during their first sensor wear. This non-adjunctive dosing claim is yet another benefit for those patients who want to manage their diabetes with greater ease and freedom.”