Issue 199
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 are a few quick happenings in FDA-regulated and pharma-focused digital health…
- Two weeks ago I revamped the E&O prescription digital therapeutic pipeline tracker, which is an attempt to track every PDT that is either currently under development or already commercially available in the US market. Thanks to one sharp-eyed reader, I’ve since added a few more prescription digital therapeutic candidates to the pipeline tracker. By my count, there are now 128 PDTs in pipelines. Which other ones am I missing?
- Efforts to provide a quicker reimbursement pathway for medical devices with FDA Breakthrough Designation took another step forward in recent weeks as CMS published “information to the public on the process we will use to provide transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process under the Social Security Act (the Act).” (TCET is the new MCIT, which stood for “Medicare Coverage of Innovative Technologies.” CMS repealed the MCIT rule in November 2021.) The problem for most Software as a Medical Device companies that have secured Breakthrough Device Designations is that they likely don’t fall into a Medicare benefit category, and having a benefit category is a requirement under CMS’ newly proposed TCET pathway. (It’s also the issue that the Digital Therapeutics Alliance is lobbying Congress to fix via its bill to create a new Medicare benefit category for prescription digital therapeutics.) Most digital health companies that commented on MCIT a few years back focused on this benefit category issue. I suspect many of the comments on TCET from digital health companies will also highlight this. The comment period is open until August 28, 2023.
- Following my panel at the Digital Therapeutics Alliance Summit earlier this month, the reporters over at Informa’s Medtech Insight asked one of my panelists, Oklahoma Medicaid’s senior pharmacy director Terry Cothran about the state’s agreement with Pear Therapeutics. Cothran told them via email that once the state analyzes the data from its reSET-O value-based agreement, it will try to collect money from Pear if it owes them based on the outcomes. (So, I guess Germany’s DiGA digital therapeutics companies aren’t the only ones facing potential clawbacks from payers?) Read the full article here, which includes a worthwhile recap of my panel (without mentioning the moderator, of course) and artfully crops me out of a photo of the panel on-stage.
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New Database: 150+ clinical trials from prescription digital therapeutic companies
After updating the Exits & Outcomes PDT Pipeline of Pipelines tracker earlier this month, I figured it was time to publish a related tracker that E&O readers have requested for some time.
Here’s my attempt at tracking all of the clinical trials that companies building prescription digital therapeutics are undertaking right now along with those studies that these companies have previously completed, terminated, or paused. This tracker builds on the pipeline tracker above, so it includes the same set of companies. And, yes, I do have plans to build more of these for companies outside of the niche prescription digital therapeutic go-to-market. Stay tuned for more on that soon.
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Trial updates: Akili beyond ADHD, Lumos Labs, BMS, DynamiCare, Johns Hopkins-Apple
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
Now recruiting: Two Akili clinical trials focused on EndeavorRx beyond ADHD
Surprised to see some progress on two clinical trials focused on Akili’s EndeavorRx.
The first is sponsored by Children’s National Research Institute and is studying EndeavorRx’s ability to improve cognitive functioning in children with sickle cell anemia. More:
“Children with sickle cell disease (SCD) exhibit significantly reduced cognitive functioning (often difficulties with attention) compared to peers and siblings without SCD. EndeavorRx (Akili Interactive Labs: Boston, MA) is an FDA-approved home-based, electronic attentional-control training program designed to treat attention problems in youth. Users access EndeavorRx on a tablet device for 25-30 minutes each day, 5 days per week, for 4 weeks. The program involves training in a game-like environment that repeatedly challenges attentional-control abilities and adapts to user performance, becoming more difficult over time as performance improves. This pilot study is examining the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a sample of 20 children with SCD ages 8-16 who are being treated with chronic blood transfusion therapy.”
The second Akili study that is now recruiting is also sponsored by Children’s National Research Institute. It is focused on EndeavorRx’s ability to improve attention deficiencies in children aged 8 to 16 who are survivors of acute lymphoblastic leukemia or brain tumor. More:
“EndeavorRx, an FDA-approved electronic attentional-control training program, may be one intervention to help remediate executive functioning difficulties experienced by survivors. Although the program has been efficacious for youth with Attention-Deficit/Hyperactivity Disorder (ADHD), it has not yet been tested among survivors of childhood ALL or brain tumor. We propose to assess the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a pilot randomized, controlled trial. Survivors of ALL or brain tumor who are between the ages of 8 and 16 and have been off-therapy for at least one year will be included. The goal is to enroll and screen approximately 50 survivors across three pediatric oncology centers, in order to identify 40 participants with attention difficulties who will be randomized to one of two treatment arms.”
New: Lumos Labs’ new RCT on digital programs to improve cognition
As I’ve noted in recent newsletters, Lumos Labs, the makers of brain game Lumosity have been steadily building up a number of clinical studies that mark the company’s foray into digital medicine. It continues to position itself as a challenger to Akili. Its latest is an RCT that it expects will enroll 834 participants. More:
“The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.”
No longer Medicaid-focused? DynamiCare tweaked the population demo for its tech-enabled treatment for alcohol use disorder RCT
DynamiCare Health finished up recruiting for its contingency management in AUD study. It ended up recruiting 236 participants — just shy of the 300 it originally anticipated. The more curious change, however, was the removal of most of the mentions to Medicaid in the study’s descriptions. For example, the study’s official title used to end with “at scale in a Medicaid population” but it now simply ends “at scale.” Similarly, being a Medicaid patient is no longer listed as an inclusion criteria for participants. More:
“This … project is a clinical effectiveness and cost-effectiveness random controlled trial (RCT) of DynamiCare Health’s innovative smartphone/smart debit card remote digital coaching program, which integrates Contingency Management, Recovery Coaching, and cognitive behavioral therapy (CBT), to address alcohol use disorder (AUD) in 300 adults.”
Bristol Myers Squibb joins Azumio study to validate a digital biomarker for screening diabetes
I first wrote about this study back in early 2022, but the news this week is that BMS has joined the study as a collaborator. The study is not yet recruiting, but the researchers expect an FDA-regulated device to emerge from their efforts. Here’s how I framed it last time: 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 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.”
Now recruiting: Johns Hopkins University study on Corrie platform (co-developed with Apple) for AFib management
This is the latest RCT focused on the Corrie platform, which Apple co-developed with Johns Hopkins researchers. Corrie appears to be an attempt to build a tech-enabled services business on top of the Apple Watch’s ECG screening capability. This study is now recruiting:
“The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.”
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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