Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

Oh man… last week I incorrectly described the deal between Almirall and Happify Health: They’re not building a new version of Happify’s Kopa platform, the companies are working on a different and new digital offering for people with psoriasis (click that link to read the release). Here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:

• The fourth-largest BCBS plan, Highmark, has expanded access to Freespira, an FDA-cleared digital therapeutic for panic attacks, panic disorder, and PTSD, to its members in Pennsylvania, Delaware, and West Virginia. The announcement follows Highmark’s original pilot of Freespira back in 2016.
• Elektra Labs is working to create “nutrition labels” for each of the more than 1,000 biosensors in its growing library. Each label will include at-a-glance information about the product’s data rights policy, security practices, clinical validation, and more.
• This one might make more sense in Wednesday’s employer-focused issue, but given his recent work in digital therapeutics, I included it here: Weight Watchers (they actually go by WW now, but c’mon) has appointed Adam Kaufman as its new General Manager of Diabetes. Kaufman spent many years building Canary Health. He was most recently the head of the digital therapeutics-focused joint venture, DTxL, which BCG set up with Abundant Venture Partners.
• DTC telemedicine company, Ro, which is rumored to be going public via a SPAC merger soon, quietly acquired all of the assets related to one of the products it sells, numbing wipes, which were formerly sold as a white-labeled product. Ro bought the product from its former partner, Veru, for $15 million in cash and two potential milestone-based payments of $2.5 million each.
• I missed this last month: Philips and Merck announced they were teaming up to “develop clinical-grade digital solutions for highly personalized fertility treatment” that will include digital health, advanced informatics, and AI-enabled ultrasound diagnostics.
• Apple posted a job ad that revealed it was working on “Apple-branded Health Hardware products,” which is a curious turn of phrase. (Turns out that phrase is no longer in the job ad, which you can read here.) An Apple weight scale seems like an obvious move. A blood pressure cuff is probable too — likely built by iHealth. My wildcard guess: Some kind of Apple-branded CGM made by someone else, like Dexcom.
• Science Translational Medicine published a paper by researchers that developed an Apple Watch-based “ambulatory monitoring system to track dyskinesia and resting tremor in patients with Parkinson’s disease.” Parkinson’s is not a new therapeutic area for the Apple Watch, however. It was a focus area for Apple’s health team years before the Apple Watch came out.
• The Google Health team had a big reveal this week: Shwetak Patel, Director of Health Technologies at Google Health announced an upcoming feature for the Google Fit app that uses the Android smartphone’s camera to detect pulse and respiratory rate. E&O readers saw this one coming — I went into this team’s projects in detail in The Google Health Report back in November 2019. (Philips has had similar technology for many years and has licensed it out to partners.)
• One more thing… This article was kind of funny. The analysis shows that the direct-to-consumer apps that have secured reimbursement from the German government’s DiGA program saw some increased downloads (based on AppStore analytics) since DiGA went into effect. But it’s just as likely (if not more so) that the higher number of downloads is not from doctors prescribing them but from people seeking these apps out on their own thanks to all the publicity surrounding the German government’s initiative. There’s no way to tell from this data source.

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Branson’s SPAC buys 23andMe as revenue dips

A SPAC led by Richard Branson’s Virgin Group acquired DTC genetics company 23andMe in a $3.5 billion deal. I was curious about 23andMe’s falling revenues, its expansion plans, and how Virgin will navigate this new acquisition given its loose ties to Virgin Pulse.

Revenue dropping about 30 percent year-over-year

23andMe had been open about its revenues falling in recent years. It even announced lay-offs. The drop in revenues is laid out in the investor presentation that accompanied the SPAC merger announcement, but the presentation also sets expectations that revenues won’t return to their 2019 levels until — maybe — 2025? The financial projections actually don’t go that far into the future.

23andMe brought in $441 million in revenues during 2019. That dropped to $305 million in 2020. The company expects 2021 to be even worse as it dips down to just $218 million before it hopes to start growing revenues again in 2022.

23andMe’s expansion plans: Genetics-based primary care

23andMe plans to continue selling its current kits while pursuing its therapeutics business with GSK, but the company is also moving into health services that it plans to recommend based on its customers’ genetic results. (This plan closely aligns with the HAAC SPAC-Color tie-up I predicted in E&O Mondays last week.)

23andMe plans to move in this direction with its subscription product, which it soft launched in October 2020. It currently has 75,000 subscribers. 23andMe’s surveys show that its customers have made behavior changes based on their genetic test results. While the details aren’t spelled out in the presentation, it seems like 23andMe will offer its users health services based on their results. Respiratory conditions, heart conditions, and diabetes are all referenced.

Virgin’s 23andMe vs. Virgin Pulse

I am curious how this deal might change Virgin Group’s relationship with Virgin Pulse — especially as 23andMe moves into digital health services. As I wrote in The Virgin Pulse Report, Branson’s group sold its stake in the company to private equity years ago. VP still licenses the Virgin brand, however, and Branson is required to do some promotion for it as a result.

Bills in Kentucky, New York urge Medicaid to pay for substance use disorder PDTs

This week, State Senator Dr. Ralph Alvarado introduced a bill in the Kentucky state legislature that calls for Medicaid reimbursement of digital therapeutics for substance use disorders:

Pear Therapeutics, which offers the prescription digital therapeutic reSET for substance use disorder, has a registered lobbyist working the Kentucky state legislature. Orexo US, which also offers a substance use disorder digital therapeutic, has three registered lobbyists in that state. Meanwhile, last month the New York state legislature sent a similar bill to committee, but this one more specifically focused on prescription digital therapeutics focused on opioid use disorder:

This bill is the third one in two years to circulate in Albany with similar language that’s tailor-made for Pear Therapeutics’ reSET-O.

Updates on clinical trials: Johns Hopkins-Apple, Centene-AmalgamRx, Pear reSET-O

Johns Hopkins and Apple reported results from their CareKit study of a program for heart attack patients. The group named their CareKit app, Corrie Health, and equipped the 200 participants with the app, Apple Watches, iPhones, iHealth blood pressure cuffs plus $10 for completing the surveys at the end. The researchers concluded that the offering results in more than $7,000 in savings over the standard of care and participants were satisfied with Corrie. (Here’s the full study protocol, if you want to dig into its design too.)

(What do you think? After reading this, I wonder if the recent speculation about Apple adding coaches and the job ad about Apple-branded Health Hardware above is all in preparation for a launch of something like this Corrie offering? Remember: Apple’s competitor AliveCor also started talking about cardiac coaches in January.)

The Cleveland Clinic terminated a clinical trial that aimed to use Withings devices to monitor blood pressure in patients diagnosed with type B aortic dissection or intramural hematoma who do not receive a surgical intervention during their hospitalization. The researchers said patient enrollment was too much of a challenge during the pandemic.

Pear Therapeutics is now recruiting for “a randomized, controlled, open-label, decentralized study to evaluate patient engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder.” Interestingly, a few years ago “PEAR-008” was Pear’s ADHD digital therapeutic, which it developed with SickKids, a children’s hospital in Toronto. (That DTx is no longer listed in its pipeline.)

Here’s how Pear describes PEAR-008 today:

“PEAR-008 is a new version of reSET-O, an FDA-authorized mobile application treatment (available by prescription only) for opioid use disorder. The study will examine if changing the application’s delivery format and enhancing clinical content affects how patients use and interact with the intervention. Prospective participants will complete a short screening assessment and if eligible complete informed consent procedures at the beginning of the Baseline visit. Qualifying participants will attend weekly virtual study visits during the 8-week treatment period.”

The 230 participants will be randomly assigned either the new reSET-O (PEAR-008) or reSET-O classic.

Amalgam Rx and Celgene are just beginning a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform. The pilot trial will study how having real-time data streaming to a healthcare provider’s portal changes the outcomes for patients using the platform. One cohort will have real-time data sharing, while the other will only share data (if they choose to) during visits with their provider. Researchers aim to collect engagement metrics and usability ratings. (Correction: I wrote Centene instead of Celgene in the original newsletter.)

Links to E&O’s reports, databases, newsletters

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• Read through the long-form E&O research reports here.
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