Dexcom learned a valuable lesson in 2021, CEO Kevin Sayer told the JP Morgan Health Care Conference this week.
That lesson is that expansion and access go hand in hand.
In an interview with MD+DI on Wednesday, Sayer delved into that lesson, as well as other key issues related to the company’s 2022 prospects.
“Often, especially internationally, continuous glucose monitoring is thrown in a few buckets. One bucket is a fingerstick replacement and available to everyone, and another bucket is for people who really want to manage their diabetes well and are at very high risk,” Sayer said. “That high-risk category is a product with a lot of higher price. Our product was very lumped together in this higher end category in many of the regions.”
He explained that in healthcare, when there is an expensive product, the payers will often put a huge administrative burden around it that healthcare providers and/or patients have to go through to get the product. The idea behind this is that if the healthcare system is going to spend a lot of money, they want to make sure that the user is willing to jump through the hoops to gain access. That’s where Dexcom found itself last year, particularly in Germany, a market where the company has grown successfully, but still hasn’t gained access to most of the patients who would benefit from the company’s continuous glucose monitoring (CGM) system.
“So we went to the reimbursement community and said, ‘Look, we don’t need this high price, we’re happy to lower our prices and create a different yield per year per patient model if you put us on an equal footing with others in terms of the administrative burden,” says Sayer. “And by lowering that pricing, you increase access to the product, then it’s much, much easier to expand.”
One of the reasons that strategy makes it easier to expand, he said, is because the people who pay for the product no longer create barriers. Not only that, but it can help ease the documentation burden that healthcare professionals have to go through to provide the device, such as running a trial period.
Dexcom has taken a really active approach to address these barriers in international markets, especially in regions where the company has a direct presence such as Canada, UK, Germany, and now Dexcom has acquired its distributor in Australia and New Zealand , the company plans to go after those markets in a similar fashion.
Sayer referred to a study conducted by researchers in Belgium published and presented last year that compared Dexcom’s system to a competing CGM system.
“They took patients on their product, put them on ours, and showed how much healthier these patients were on our product than the competitor’s,” Sayer said. “Lower A1Cs, more time in range, everything was great. And at the end of this presentation someone said, ‘Does that mean you’re going to move all your patients to Dexcom?’ And the person speaking said, ‘I can’t because the government doesn’t want to fund it.’ When you hear something like that, you say, ‘Hold on, we need to fix this.'”
Newly released Dexcom G7 data is ‘incredibly impressive’
In a Q&A following Sayer’s presentation at the JP Morgan Health Care Conference, Robbie Marcus, a senior analyst at JP Morgan, noted that the Dexcom G7 data is “incredibly impressive.”
“Accurate between pediatrics and adults, and that’s very hard to do across all days, across all stats,” Marcus said.
The data, first presented to the public at the virtual conference, is the same data Dexcom has submitted to the FDA in support of the device’s approval.
In the trial, G7 outperformed regulatory interoperable continuous glucose management (iCGM) standards with better time-in-range performance of 93.3% compared to the FDA’s standard of 87%. The way the accuracy of CGM technology is measured is by a standard known as Mean Absolute Relative Difference (MARD), and the G7 recorded a MARD of 8.1% in children and 8.2% in adults.
“This is a real-time, factory-calibrated iCGM that is going to set a new standard in the industry,” Sayer said during his presentation at the JP Morgan Health Care Conference. “As I’ve said many times, whatever you love about G6, G7 will do better.”
One of the reasons patients are so eager to get their hands on the new G7 sensor is that it’s 60% smaller than the G6. There’s also a smaller, easier-to-use receiver for those patients who choose that platform, and there’s more information in one place, Sayer said. Dexcom has also moved key insights currently found in the company’s Clarity system directly to the G7 app.
“The performance of this product is something I really never thought I’d see in nearly 30 years in this industry,” Sayer said. “And notice the number of patients in this study in the matched pairs… this data set is three times larger than our G6 data set and much larger than any data set anyone else in the industry has ever produced. With a sample size of this size , there is absolutely no doubt about how this system will perform.”
Sayer said the company filed an application with the FDA for approval of G7 in the fourth quarter of last year. Regarding the CE marking for G7, Sayer said the company had expected it to happen in the quarter as well, but the new medical device regulation process in Europe has taken longer than expected.
“We’ve just had a lot of interaction with our regulatory authorities there. We hope we get to the end of it and wind down. We don’t see any showstoppers as far as we get approval, we just don’t I don’t have it,” said Sayer. learned a valuable lesson for myself, the sense of urgency of the approvers probably doesn’t match mine…but we’ve had some good cooperative interactive discussions here and hope we can get through it soon.”
Conducting a clinical trial with such a large sample size, no less during a pandemic, brought with it its own set of lessons learned.
“First of all, we learned about the ability of the sites we used to actually house us,” Sayer said. “…So if one place had COVID issues, another place could double their patient upload, and vice versa. Everyone was in this together.”
He said the company has also learned the other thing that we’ve learned how to be more efficient with the mechanisms at play during a clinical trial.
“…We’ve learned how to do things much better than we’ve done in clinical trials before, and we’ll be able to apply that in the future.”
Is Dexcom concerned about the supply chain?
“Yeah, we were very concerned about that…for us the biggest impact, frankly, was the shipping,” Sayer said. “It took us a long time to get really good at making our G6 product. It’s taken us three years, and we’re finally really good at it, and we have some inventory on hand, so G6 is real not much affected by supply chain [challenges].”
But with a major product launch on the way, the supply chain could become a bigger concern.
“The biggest concern with G7, as you might guess, is there is a disposable transmitter, the sensor and the transmitter. … So we have to have a chip for each of them. We have worked very hard to make sure that [we’ll have] the chips we need for 2022 for 2023.”
In addition to securing commitments for those critical components, Sayer cited alternate product development plans in case it needed to turn around.
“We try to mitigate in every way possible.”