Issue 143
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.
Here’s what’s going on in FDA-regulated and pharma-focused digital health:
- Last week’s write-up of AstraZeneca’s divestment of its AMAZE platform brought in a lot of reader responses (I’m still working through responding to them all.) So far everyone who wrote in agreed with my general conclusion.
- Back in Issue 140, I wrote about a new bill recently introduced to Congress: the Access to Prescription Digital Therapeutics Act, which would establish a Medicare benefit category for prescription digital therapeutics. Here’s what I wrote: “The Biden administration is set to release its budget in a few weeks’ time. If there is a mention of this in there, that’s one good signal. President Biden also spent a good amount of time discussing access to mental health during his State of the Union address, and I hear this bill aligns with the administration’s objectives there. (If a big bill focused on access to mental health services starts making the rounds on the Hill soon, then I’ll be sure to check whether language from APDTA is included.) Finally, APDTA needs more co-sponsors (and maybe more people from the industry) to help push it through. So, I’m curious to see which other Congress members and industry groups back it.” Well, the president’s budget doesn’t specifically reference any of the language in APDTA, but it did call for increased access to evidence-based treatments for OUD. (Pear took that as a positive sign.) Maybe more interestingly, the Senate finance committee published a report on mental health that makes the case for federal action (read a big legislative package). I could see APDTA getting tucked into legislation like that.
- A couple of readers also emailed about the removal of cancer-focused digital health program, Mika, from Germany’s prescription digital health formulary, DiGA. Since I wrote about it, Fosanis, the developer of Mika, announced (German) that it plans to resubmit Mika to the program (some time around August) once it has results from a clinical trial that it expects will prove Mika’s efficacy.
- One more German DiGA update: Another reader let me know that Vivira, a digital therapeutic for treating MSK pain is now permanently listed in the DiGA formulary after its trial period. However, the German government required Vivira to whittle down its original set of claims because its single-arm study only proved “improvement in health” but not “improvement in quality of life” or “reduction in the duration of the disease.” Vivira also now only claims to treat back pain and cannot make claims about treating knee or hip pain based on its current evidence base.
- Back in August 2020 when I published The Evidation Health Report, the company had publicly disclosed that it had nearly 4 million participants in its Achievement platform, which it uses to recruit participants for clinical studies. One of the ways it keeps participants engaged in the Achievement program, which is now just named Evidation too, is via monetary rewards (Paypal, gift cards, etc.) in exchange for sharing data (If you need a refresher or want specifics, re-read the report linked above.) Anyway, up until recently, Evidation hasn’t updated its publicly disclosed figure for how much money it had awarded participants via Achievement. For years the company just said “more than $500,000” had been paid out. Recently, Evidation updated the figure so it now reveals that the company has paid out more than $7 million over the years.
- The news you know: You likely already read that Google has submitted data from the Fitbit Heart Study to the FDA as part of a 510(k) to add a passive AFib monitoring algorithm to the company’s Fitbit devices. (Apple already offers this functionality.) “In 2020, the team launched the Fitbit Heart Study, with nearly half a million people who use Fitbit. The goal was to test our PPG (Photoplethysmography) AFib algorithm, which passively looks at heart rate data, to alert people to signs of an irregular heart rhythm. We presented the study results at the most recent American Heart Association meeting, showing that the algorithm accurately identified undiagnosed AFib 98% of the time. We’ve submitted our algorithm to the FDA for review. This is one of many ways we’re continuing to make health even more accessible.”
- The FDA granted Biobeat another 510(k) for its remote patient monitoring patch: The device now can monitor respiratory rate and body temperature in addition to previously IFUs secured for monitoring blood pressure, blood oxygen saturation, and pulse rate. The company is probably best known for its “cuffless” blood pressure monitoring feature.
- One more thing… A quartet of FDA officials penned a piece in Nature’s open access Digital Medicine journal to help spread the word that the agency has officially adopted a definition for the term “digital biomarker.” Read the commentary here to get the full definition.
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Pear tells investors: Think enterprise software sales not pharma-like doc detailing
Following its SPAC onto the public markets last year, Pear hosted its first real investor call and Q&A with Wall Street this week. There were no real surprises in Pear’s 10-K, which showed the company hit the 2021 $4 million revenue goal it told investors to expect when it revealed its SPAC plans last summer. So, instead of digging into the financials, I stuck to the color the company provided to analysts at the end of the presentation. A few parts of the Q&A portion of the call stood out for me:
- Pear’s employer strategy: Develop relationships with large employers to get them to put pressure on their PBMs to get Pear’s PDTs onto their formularies.
“…making sure we are valued by the customers of these PBMs. That is where we have taken an employer strategy. You heard in the call today: We have adoption by a top ten employer in the US. These are some of the largest customers of the PBMs and they have a position of prominence in the PBM industry… Thus far PBM positioning has not been an impediment to our revenue generation.”
- Pear’s provider strategy is more like an enterprise software sale than pharma-like physician detailing.
“At a very high level, our strategy resembles much more that of an enterprise software provider within healthcare than it does a traditional pharmaceutical company. And what I mean by that is: As opposed to detailing doc-by-doc, what we tend to do is detail either center-by-center or organization-by-organization. What that creates is a topdown mandate that then allows us to embed — and when I say embed, I mean physically embed via things like EMR integration and things like our Pear [dot] MD dashboard. And via that top-level embedding, we are able to target clinicians en masse… What I would be thinking in 2022 is not scripts-per-clinician ratios but I would be looking at [is] what are our conversion of larger clinics and health systems are moving forward.”
- Pear’s government reimbursement strategy is something E&O has tracked closely. Pear’s CEO Corey McCann connected a few of the dots there during the Q&A too:
McCann clarified for the analysts that the company’s work convincing state Medicaid to add reimbursement for PDTs has been largely for the benefit of reSET and reSET-O since the target patient populations for those PDTs are largely on Medicaid. On the other hand, Somryst’s potential patient population is largely Medicare and commercial, McCann said.
“We are engineering coverage via fee-for-service state Medicaid that ultimately compels Managed Care organizations who are run by large commercial payers to provide coverage for reSET and reSET-O. That’s a fantastic entree into coverage for Somryst. In addition, we have mentioned the Access to Digital Therapeutics Act. That is an act that would create coverage across fee-for-service Medicare as well as some other channels. We believe that is an act that if it comes to fruition would have a large impact on Somryst, again, because many of these patients are Medicare patients.”
McCann reviewed the already announced news that Massachusetts and Oklahoma’s Medicaid plans have agreed to reimburse for Pear’s PDTs, while Michigan has set up a grant to explore reimbursement. McCann also said that Pear has been making inroads in Indiana, Ohio, and Kentucky.
Clinical trial updates: Apple-Janssen, Better, Azumio, Pear, Wise, Lumosity, Calm and more
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.
Apple and Janssen scale down enrollment expectations for the Heartline study
Originally, Apple and Janssen expected 150,000 participants in their Heartline study, but this week the company changed it to 28,000.
“The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.”
The companies also tweaked the wording of their various primary and secondary outcomes measures, but none of those appeared to be a significant change.
Better Therapeutics and MGH test diabetes PDT vs a sham
One of Better’s newest clinical trials aims to enroll 500 participants with Type II diabetes to test BT-001 vs a sham app. More on the intervention:
“Identifying maladaptive thoughts based on misinformed core beliefs that lead to disease-promoting behaviors; replacing maladaptive core beliefs with adaptive ways of thinking; and providing collaborative construction of behavioral exercises to test core beliefs. Each week, BT-001 asks participants to complete a new lesson, along with one skill exercise. The lessons are expected to take between 10-20 minutes to complete. In addition to completing a lesson and skill, participants will be directed to report plant-based meals consumed and minutes of exercise completed and to measure their blood sugar daily.”
Azumio and UCSF work to validate a camera-phone powered diabetes screener
Long-time mobile health app developer Azumio, which is best known for its Instant Heart Rate app, has moved into deeper, more regulated territory. This new study with UCSF indicates the company hopes to bring a novel diabetes screener to market:
“The Validation of the Diabetes Deep Neural Network Score (DNN score) for Screening for Type 2 Diabetes Mellitus (diabetes) is a single center, unblinded, observational study to clinically validating a previously developed remote digital biomarker, identified as the DNN score, to screen for diabetes. The previously developed DNN score provides a promising avenue to detect diabetes in these high-risk communities by leveraging photoplethysmography (PPG) technology on the commercial smartphone camera that is highly accessible.”
Lowered enrollment expectations: Wise Therapeutics dials back its enrollment goal from 500 to 150 for its study on its GAD/SAD DTx ABM-01.
Johns Hopkins now recruiting for Pear’s reSET-O study in acute care settings
Johns Hopkins is sponsoring this pilot study of Pear’s prescription digital therapeutic for opioid use disorder, reSET-O. While details first posted a year ago, the study is now recruiting:
“This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit.”
Lumosity to take on Akili with video game-based treatment for ADHD study
Lumos Labs, the company that created the popular cognitive game site Lumosity, just posted details on a study for a video game-based treatment for ADHD. Details are thin on the hoped-for 472-participant study. The initial study will focus on both safety and effectiveness.
“Guided ADHD Therapy for Managing the Extent and Severity of Symptoms – A Randomized, Controlled, Parallel-group, Intervention Study to Assess an At-home, Game-based Digital Therapy for Treating Adult Patients With Attention-Deficit/Hyperactivity Disorder”
Ad Scientiam is attempting to create a new depression scale called REDRESS
The company is now recruiting for a study called “Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale (REDRESS).” More:
“REDRESS was inspired by several standard depression scales used and recommended by the French Health Authority, augmented with digital active and passive activity monitoring, speech analysis and emotional processing assessment.”
Calm tests whether its program can reduce stress and improve sleep during pregnancy
“Purpose: Test the effects of using Calm for its impact on stress, anxiety, and sleep in pregnant women using the following aims:”
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