February 03, 2022

Diabetes Devices - Early Feedback on Insulet's Omnipod 5 Approval

By Beth Gilbert
U.S. endocrinology practitioners are enthusiastic about the recent FDA approval of Insulet’s Omnipod 5, though they believe the device’s initial limited market release may allow Tandem to maintain momentum ahead of the full launch.

U.S. endocrinology practitioners are optimistic about Insulet Corp.’s long-awaited Omnipod 5, which received Food and Drug Administration (FDA) approval on Jan. 28, after multiple pandemic-related delays. “We have been long awaiting approval of the Omnipod 5, so it is great to see it get approved,” an endocrinologist said. Another said, “I am very excited about this device. Omnipod 5 was heavily anticipated.”

Omnipod 5 is the first tubeless automated insulin delivery (AID) system with compatible smartphone control (currently Android only) and integration with DexCom Inc.’s G6 continuous glucose monitor (CGM) system. The upgraded AID technology comes with all the advances of the previous-generation Omnipod (which has been attracting a younger generation of patients looking for a more discreet pump), including the incorporation of Omnipod DASH system, waterproof tubeless pod, three days (72 hours) of continuous insulin and accessibility through the pharmacy channel. Similar to OTR Global’s December findings, two sources reported pent-up demand for the Omnipod 5. “It is really great the Omnipod 5 finally got the approval. We had some patients waiting for it and we already had some patients calling us about it, so I expect that it will gain traction once it is available,” an endocrinologist said. An RN/CDE said, “Patients that are looking for a tubeless option now have so much more with this device

Insulet noted that the Omnipod 5 will initially be available in a limited market release, without specifying details on the timing of the full launch. “The launch is going to be limited at first, so it may take time for it to get to all patients,” an endocrinologist said. In the interim, all five sources expect market share momentum to continue for Tandem Diabetes Care Inc.’s Control-IQ, as long as the Omnipod 5 rollout remains limited. “The longer it takes for Omnipod 5 to ramp up, the more business Tandem can grow,” an endocrinologist said. OTR Global’s December and September reports found the delay in FDA approval of Omnipod 5 allowed Tandem to gain share from Insulet. “I have been waiting for the Omnipod 5 for three years. Three years ago, I was telling patients it was only going to be another year, and then the pandemic hit. So, I had a number of patients just going to Tandem instead. Now, at least, it finally got approved, and we are starting to see the light at the end of the tunnel, but I believe until the Omnipod 5 gets launched, Tandem’s Control-IQ will continue to make headway,” an endocrinologist said.

So far, none of the five sources has received specific details about the Omnipod 5 launch timing or undergone any training on the new device. “I reached out to our sales representative right away when I heard the approval come off the presses. Our representative said that they are undergoing and getting updates on training. The representative will come and talk to us in the next few weeks,” an endocrinologist said.

In line with OTR Global’s previous findings, all five sources believe the Omnipod 5 will have a moderate negative effect on Tandem once the device is fully launched and available to patients. “In the longer term, I think it will take some new pump user business away from Tandem,” an endocrinologist said.

Additional Quotes
“A few patients on Omnipod requested renewals knowing the device will shortly be approved for use with Dexcom’s G6."

“If a patient wants a pump right away, they should go with Tandem. Unfortunately, that gives the patient a four-year commitment before they can switch pump companies. It’s an individual decision”

“Until Insulet gets Omnipod 5 fully launched, Tandem’s Control-IQ will still gain traction. We do have some patients waiting for Omnipod 5, but others have moved toward Tandem’s Control IQ.”

“There will always be room in the diabetes market for the big three — Tandem, Medtronic [PLC] and Insulet.”