Issue 198

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…

• I mentioned the new ISO definition of digital therapeutic in last week’s newsletter. Since then, I’ve talked to a few readers about it. One sticky wicket that came up in a few of those calls (and an email) was the word “alleviate”. The new definition includes software that “treats” or “alleviates” vs the old definition that included “treats, prevents, or manages.” Is “alleviate” too broad?
• Correction: Speaking of last week’s newsletter, I mixed up who worked with the DTA on a couple of recent projects. The Digital Therapeutics Alliance worked with both Health Advances and Healthware Group on the various reports and toolkits it launched last week. The DTA partnered with Healthware Group to create a series of DTx Policy Reports — the first one analyzes the various and evolving policy frameworks for digital therapeutics in Europe. Health Advances teamed up with the DTA to create a new guidance document that outlines a new classification of digital health technologies. You can read that here. As always, I regret the error (and much else).
• And speaking of the Digital Therapeutics Alliance: At the DTA’s Summit in Washington D.C. last week, Dr. Steve Pearson, the president of ICER (The Institute for Clinical and Economic Review) stood up at the end of the last full day of programming and said that ICER has recognized that it may have a role to play as a health tech assessment organization in the digital space. Part of that might be redesigning ICER’s approach to evaluating digital health technologies, he said. Part of that might be helping payers get “on track”. Pearson said his group had just finished a systematic interview of 18 major payers in the country. ICER’s first question to this group was “With whom should we speak about how you assess digital health technologies?” Not a single payer had an easy answer to that question, Pearson said. Pearson closed his comments by noting that ICER currently has five job openings for positions that will help the org better assess digital health moving forward. The job ads explain ICER’s intent: “ICER is expanding its reach by broadening our Health Technology Assessment (HTA) activities to evaluate Digital Health Technologies (DHTs). This is a broad and rapidly innovating class of health technology with distinctive pathways for development, regulatory approval, uptake, and reimbursement.” (If you aren’t familiar with ICER’s relevance to digital therapeutics, go back in time to 2020 and read E&O Issue 077 “ICER Rips Pear” from the archives.)
• Then read on for some highlights from changes I made to E&O’s Pipeline of Pipelines database, which attempts to give a snapshot of the various prescription digital therapeutics that are currently in the pipelines of various companies. Which ones did I miss? Hit reply to this newsletter to let me know.

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Analysis: 125 prescription digital therapeutics in the pipeline as of 2023

It’s been a while since I’ve updated Exits & Outcomes PDT Pipeline of Pipelines tracker, which is an attempt to provide you with a snapshot of the prescription digital therapeutics that are currently in development or commercially launched in the United States. So, this week I dug in and revamped it. (Paying subscribers to E&O can search and scan the mini-database over at the Exits & Outcomes site right here.) Here are a few notes on the changes and a few things I found interesting:

Total number of PDTs in the tracker is now 125 vs 100 previously: While the total number tracked in here has grown, I also left a number of digital therapeutics in here that have been “paused” by companies. In some cases the companies have made clear they don’t intend to pause development forever, but I’m sure this is the end of the road for some of these candidates. Akili and Woebot are two examples of companies that have announced pauses.

Boost from new pipelines of Arcade Therapeutics and Lumos Labs: Both Arcade Therapeutics (formerly known as Wise Therapeutics) and DTC Lumosity brain game developer Lumos Labs have posted ambitious pipelines since my last update. So, I’ve included them both in the tracker for the first time. As I’ve noted before in past newsletters’ clinical trial round-ups, Lumos looks to be following in Akili’s footsteps: An adult ADHD digital therapeutic is its pipeline’s first candidate.

Pear asset tracking: Following the bankruptcy asset sale, I noted where each of Pear Therapeutics’ candidate digital therapeutics is headed, and I assume many of those assets are heading to the new entity set up by former Pear executives, Harvest Bio. Harvest seemed to end up with most of the candidates with just a few exceptions. I’ll update the tracker again when it becomes clear what the new owners do with each of their purchases.

Future product reveals from metaMe Health and MedRhythms: One of the reasons I started tracking companies’ pipelines in the first place was to figure out how their future plans shift over time. Two new candidate digital therapeutics that I hadn’t noticed before came from metaMe and MedRhythms. MetaMe is working on a pediatric version of its FDA-cleared Regulora PDT for IBS pain. Meanwhile, MedRhythms no longer mentions its Alzheimer’s digital therapeutic but it added candidates for post-acute stroke, functional neurological disorder, and cognition. Very possible the companies have revealed these plans elsewhere, but those were all new to me.

Check out the tracker for other changes and let me know what you find interesting. If I’m missing anything — let me know that too — just hit reply to this newsletter.

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

The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:

• Read through the long-form E&O research reports here.
• Search and sort the E&O databases here.
• Skim more than 200 past issues of E&O newsletters here.