Issue 070
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Digital health research from Brian Dolan.
Welcome to E&O.
Last week I wrote about Click’s maybe, someday $500M deal with Boehringer Ingelheim, Pear’s full patent holdings, and more.
Here’s what’s happening this week:
- Thanks to everyone who sent ideas, tips, and intros for the upcoming Virgin Pulse report I’m working on… keep them coming…
- Amwell raised a bit more than it expected in its IPO Thursday: $742 million. Not sure this has been reported anywhere else yet: On its way out to the public markets, Amwell received one last attempted kick in the breech from Teladongo. Teladongo lobbed a patent infringement allegation that could impact 5 percent of Amwell’s revenues: “On September 14, 2020, we received a letter from Teladoc Health, Inc. alleging that certain of our cart products and associated peripherals infringe upon their patents. While we can provide no guarantees about the outcome of any potential dispute, we believe that these claims lack merit and, if Teladoc attempts to bring these claims to court, we intend to defend against them vigorously. Moreover, even if we were found to infringe upon any valid claim of these patents, our revenues from the Carepoints products approximated 5 percent of our revenues in 2019.”
- More on this in the Apple story below but… Fitbit secured 510(k) clearance for its Fitbit ECG App for over-the-counter use — joining the ranks of Alivecor, Apple, and Samsung as companies with clearances for software under the QDA product code (“Electrocardiograph Software For Over-The-Counter Use”). Reminder: Google is in the process of running through a gauntlet of regulatory hurdles to complete its acquisition of Fitbit.
- The Digital Medicine Society had a big launch this week with what looks to be a great resource on digital clinical measures. The Playbook is a free guide to “developing and deploying digital clinical measures across clinical research, clinical care, and public health.” There’s also a companion Master Class.
- On that note — this publication caught my eye — it uses a novel digital measure based on hand movement. Here’s the study’s conclusion: “Our findings support the use of wrist-worn devices to derive activity and gesture-based digital outcome measures for patients with schizophrenia with negative symptoms in a clinical trial setting.”
- One more thing… The FDA’s Digital Health policy group published an update on its progress with the Pre-Cert Program as well as a new FAQ. The update is probably more notable for what’s not in it: No sense of when the program could move out of pilot stage and into an actual, new regulatory pathway. No indications that additional companies have been added to the program. The FAQ stresses that no products have been cleared thanks to this pilot Pre-Cert program.
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After Apple Watch 6 launch, is Apple headed to the FDA for asthma and sleep apnea detection SaMDs?
Apple introduced its latest Watch this week during a virtual event. I’m sure you heard the big news was that the Watch will now offer a pulse oximetry feature that Apple is calling simply Blood Oxygen.
Prediction: This is the first move toward a regulated sleep apnea detection app.
“With Apple Watch Series 6 you can measure your blood oxygen right from your wrist… The new Blood Oxygen app lets you take a measurement in just 15 seconds. And Series 6 also captures periodic background readings and stores them in your health app. So, if you wear your Apple Watch to bed, it can record background measurements while you sleep,” Apple’s COO Jeff Williams said during the virtual event.
How Apple spins up SaMDs… Wellness app with no claims –> ResearchKit studies –> Regulated SaMD with light claims
Apple launched the original Watch with heart rate tracking. It then took the time to study how that same sensor could be used more like an ECG in ResearchKit-powered studies. Then it announced FDA market authorizations for its ECG offering. I think of this week’s Blood Oxygen app as the wellness predicate it will use to build a sleep apnea detection app — just like Apple progressed from wellness-related heart tracking to ECG. And, as in AFib, they’ll stick to sleep apnea detection, while being careful not to move into diagnosis or treatment.
Remember: Withings has already said its ScanWatch will offer sleep apnea detection in some markets, as I noted in Issue 064.
No new FDA clearance: As you might expect, I spent most of the virtual event listening while refreshing the FDA’s 510(k) database, just in case the agency had timed yet another SaMD clearance for Apple with the company’s big September launch event. But no such luck. This Blood Oxygen feature is not FDA-regulated SaMD. At least not yet.
Fitbit’s funny timing: Surprisingly, the agency did seem to time its SaMD clearance for Fitbit’s new ECG app with Apple’s event. Remember: When Apple announced its two De Novos in September 2018, regulatory experts were left scratching their heads as to how Apple got the agency to time the clearance with its conference. It sure seems like Fitbit did the exact same thing and asked the FDA to hold their clearance until the day of Apple’s event to act as something of a counterpunch to Apple’s assured news cycle dominance that day. I noticed that the FDA didn’t update its 510(k) database for a few days, and at some point last night it posted Fitbit’s clearance with a clearance date of September 11th. That’s four days before Apple’s event. Fitbit announced the clearance on September 15th, which is the same day Apple held its event.
What about asthma? If you recall E&O’s long-form report on Apple’s healthcare hiring last year, one of the digital health entrepreneurs that had joined Apple’s ranks was Bronwyn Harris, the CEO and Founder of asthma-focused startup, Tueo Health. About a week after E&O’s report went out, CNBC reported (https://www.cnbc.com/2019/05/24/apple-acquires-asthma-detection-start-up-tueo-health.html) that Harris had joined Apple after it acquired Tueo.
Think of the children: Tueo was focused on helping parents monitor their child’s asthma symptoms while they were asleep. This sure seems relevant to a periodic, background blood oxygen sensing app that, as Williams noted above, will take readings while the wearer sleeps. This will be trickier for Apple to offer up as a regulated app like its ECG offerings. The FDA authorized those for Apple Watch wearers who are 22 or older. Creating a regulated detection app for children would be a heavier lift.
Apple announced that it was working with Anthem on a study related to asthma that would make use of the Blood Oxygen app and also provide participants with a sleep sensing mat from Beddit, which Apple acquired in 2017. The details released so far do not indicate the study is focused on a pediatric population.
Heart failure and COVID–19 studies too: The other two studies Apple announced would use the new Blood Oxygen app to study heart failure and COVID–19.
Apple is so good at toeing the regulatory line on marketing claims: Apple obviously has a ton of lawyers and knows what it is doing when it comes to making statements about its unregulated health offerings. Still, you have to marvel at the way the company brings up medical applications in roundabout ways in between listing off the actual features of the new Watch:
“Blood oxygen saturation, also known as SpO2, is like a vital sign. It is a key measurement that contains critical information about your breathing and your circulation… Blood oxygen and pulse oximetry are terms that we’ve heard a lot about during the COVID pandemic. As you breathe, your heart and lungs work together to deliver oxygen throughout your body. Blood oxygen saturation is an indication of how well this system is functioning and of your overall respiratory and cardiac health. And pulse oximetry is how you measure it. Now, the Blood Oxygen app on Series 6 lets you measure your blood oxygen for fitness and wellness purposes from your wrist, anywhere, and at any time. This is a great new tool for your overall well-being,” Sumbul Ahmad Desai M.D., Apple’s VP of Health, said at the event.
Desai starts by talking generally about blood oxygen while rooting it in the medical world. “Vital sign”… “Critical” … “COVID pandemic” … “Respiratory and cardiac health.” She then transitions to the Watch itself and steers clear of medical claims. “Fitness and wellness purposes” … “Tool” … “Overall well-being.”
ICER draft report questions Pear’s reSET-O cost-effectiveness and clinical efficacy
The 116-page draft report from ICER on digital therapeutics for opioid use disorder dropped this week. I first mentioned this effort in Issue 059 back in July.
The results are underwhelming.
The analysis focused on three different offerings: Pear Therapeutics’ reSET-O, The Connections app, and The DynamiCare app. Here are some highlights from the results, which seemed to be written with a shrug:
“The evidence rating is the same for all three apps: comparable or incremental. There is no direct, peer-reviewed evidence on the efficacy of any of the apps in the population of interest. All three apps are based on implementing behavioral interventions with some randomized trial evidence supporting their efficacy, although the impact of these interventions is modest at best and remains controversial. The use of the apps is unlikely to be harmful to patients. Thus, there is moderate certainty that the digital apps are comparable to MAT alone (due to no identified harms) and there may be incremental benefits.”
At current pricing, Pear’s reSET-O is probably not cost-effective, according to ICER:
“Our base case results suggest that the use of reSET-O in addition to outpatient MAT may provide clinical benefit in terms of increased [medication assisted therapy] MAT retention, which may have implications for cost offsets and clinical gains compared to outpatient MAT alone for adults with OUD. At current WAC pricing, and given available evidence, these potential cost offset and clinical gains were not enough to generate incremental cost-effectiveness estimates beneath commonly cited cost-effectiveness thresholds. The results were sensitive to many parameters, especially the effect of the digital therapeutic on retention and abstinence days. However, even given parameter uncertainty, the probability of a cost-effective findings at current pricing was extremely rare.”
ICER also argued that its model was generous to Pear:
“Our model extrapolated potential benefits from increased retention associated with reSET-O over a five-year time horizon, despite no evidence available after time on digital therapeutic. This is a strong model assumption that benefits the digital therapeutic and is an important area for clinical evidence generation.”
ICER said its study was limited by the companies’ lack of peer-reviewed evidence:
“This study is primarily limited by the evidence gaps, resulting from a dearth of peer-reviewed evidence and limited applicability of peer-reviewed evidence to the real-world setting. Only one digital therapeutic (reSET-O) had sufficient peer-reviewed evidence to support inclusion in a cost-effectiveness model. However, the applicability of the published evidence for reSET-O is questioned as it used a different delivery setting (internet-delivered at a clinic versus app-delivered at home) and different incentive structure and amount. Further, no evidence from after the completion of the digital therapeutic is available, despite publications of this evidence dating back to 2014. Also, the comparator arm in the pivotal trial for reSET-O was not reflective of standard of care; therefore, we made adjustments to the contingency management comparator to compare reSET-O to standard of care.”
As noted above, these are draft results. ICER is opening up the document to additional public comments for the next few weeks. The organization has not weighed in on many other digital health categories, but it did analyze Diabetes Prevention Programs a few years ago.
In its final report back in 2016, ICER concluded that for digital DPP:
“We also judge the evidence for the CDC-recognized intensive lifestyle programs using a digital with human coach design to provide an incremental or better (B+) net health benefit when compared to usual care for patients with prediabetes.”
That is one step above the grade it gave the three apps for opioid use disorder: C+, which means comparable or incremental net health benefit when compared to usual care.
Quick links: E&O research reports and databases
The links below aim to make it easier for paying subscribers to find the long-form research reports and databases on the E&O site:
The Evidation Health Report (Subscribers-only Link)
Database: Rx-only Digital Therapeutics Pipeline of Pipelines (Subscribers-only Link)
Database: Online Diabetes Prevention Program Companies (Subscribers-only Link)
Database: Digital Health PPP Loans (Open Access)
The Proteus Digital Health Report (Subscribers-only Link)
The Hinge Health Report (Subscribers-only Link)
The Digital Health Enrollment Report (Subscribers-only Link)
The Omada Health Report (Subscribers-only Link)
The Google Health Report (Subscribers-only Link)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)
That’s a wrap on Issue 070 of E&O.
