Senseonics’ 90-day Eversense CGM receives FDA approval for non-adjunctive insulin dosing claim – June 6, 2019

Launch anticipated “early” in 4Q19 with new app; critical step towards securing Medicare reimbursement; Twice daily calibration still required

Senseonics announced today that its 90-day Eversense CGM has just received FDA approval for a non-adjunctive insulin dosing claim. While Eversense still requires twice daily calibrations, Senseonics will no longer have to educate patients to take fingersticks before treatment decisions. A new app will launch with the indication “early” in 4Q19. This timing aligns with 1Q19 expectations, when management anticipated approval this summer and a launch “quickly thereafter.”

Importantly, this approval will allow Senseonics to apply for Medicare coverage, as the indication categorizes Eversense as a therapeutic CGM – following Dexcom’s G5 and G6 and FreeStyle Libre. Given that Eversense still requires calibration, Senseonics would presumably need a BGM partner like Ascensia for Dexcom’s G5. During the 1Q19 call, Dr. Goodnow expected Medicare reimbursement in “the 2020 time period.” Achieving Medicare reimbursement would be a major win for the company, and we’ll be interested to see how Eversense adoption looks in the older population – would it be more appealing?

As of 1Q19, Eversense was available to “over 66 million covered lives” in the US, and Senseonics is “well on the way” to reaching 100 million covered lives in 2019. We’re not sure if the Medicare population is included in Senseonics’ goal to secure an additional 150 million covered lives in 2020; however, if Senseonics is successful in gaining reimbursement, not only will Eversense be available to the 65+ population, but it could help with other private payers like UnitedHealthcare.

With the non-adjunctive indication checked off the list, next up on Senseonics’ pipeline roadmap is completing enrollment for its 180-day US clinical trial for Eversense XL in 3Q19. In a clever move, the first 90-days of the trial will go towards supporting an iCGM claim for the 90-day Eversense. Senseonics then plans to submit separately to FDA for Eversense XL with 180-day wear-time and reduced calibration.

  • At ADA, we’ll see results from Beta Bionics’ first in-human feasibility trial of the insulin-only iLet device with Senseonics’ 90-day Eversense CGM. Additionally, Senseonics will hold a product theater featuring newly appointed CMO Dr. Fran Kaufman in her first public appearance on behalf of the company. We also included Senseonics’ user acceptance study of Eversense in our list of most notable orals and Senseonics’ post market clinical follow-up registry demonstrating long-term safety of Eversense amongst our most notable posters.


--by Maeve Serino, Adam Brown, and Kelly Close