Issue 155
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:
- Let’s start with this Journal of Medical Internet Research study that everyone is talking about from Johns Hopkins and Rock Health. Real head-scratcher. I want to like it. The team assessed 224 digital health startups that have raised at least $2 million in venture capital, are based in the US, and have made claims related to treating, preventing, or diagnosing a medical condition. The researchers then awarded them points for every clinical trial they have listed in the government’s clinical trials database as well as every FDA market authorization they have secured. As you might expect, the study concludes that few digital health companies have demonstrated “clinical robustness”. (C’mon: At most, this study is awarding points for attempts at clinical robustness or showing an interest in maybe working toward clinical robustness.) Should a clinical trial that shows an intervention had no effect be awarded the same number of points as one that showed positive outcomes? And for those companies that seek an a-OK from the agency: Isn’t the FDA just reviewing data from these same clinical trials? Don’t get me wrong: This study is starting the right conversations, but it doesn’t actually assess clinical robustness in digital health.
- Another point for Qardio: The FDA granted Qardio a new FDA clearance for the second version of its QardioArm device, which is the company’s “wireless smart blood pressure device”. The agency hasn’t posted the summary document yet, and the company has yet to announce it — so no word on what makes the second iteration of the device different from the first.
- Three steps forward… Pear Therapeutics’ September 2021 value-based agreement with pharmaceutical benefits manager Prime Therapeutics is starting to bear fruit. Two of Pear’s prescription digital therapeutics have made their way onto some of the formularies that Prime manages for its customers — Blues plans. For example, as of July 1, 2022, Pear’s reSET and reSET-O are both listed as new additions to Blue Cross Blue Shield of Nebraska’s prescription drug list. Similarly, BCBS of Texas, which also contracts with Prime as a PBM, added reSET and reSET-O with once per 365 days dispensing limits starting in April. Finally, Florida Blue, as of April 2022, lists reSET and reSET-O as Tier 3 on its HMO formulary. For that one Tier 3 means “Preferred Brand Name Prescription Medications.”
- One step back… CVS Caremark’s Chief Innovation Officer Dr. Daniel Knecht wrote a piece in FierceHealthcare that argued the industry needs a solid definition of the term “digital therapeutic”. I sent Knecht a message to ask if this was a rebuke of the years-long effort from the Digital Therapeutics Alliance to do just that (I’ll report back if he responds). CVS is notably not a member of the DTA, but Big Health, one of its longtime digital therapeutics partners has been since its early days.
- This week’s big digital-pharma partnership: Biogen has tapped Happify Health for digital tools for people with Multiple Sclerosis. “The Happify Health solution, which brings together a digital tool configured for MS and a care community (Kopa), offers holistic health and wellness support, with access to neurology providers (doctors, nurse practitioners, physicians assistants and nurses) as well as mental health specialists, dietitians, and rehabilitation professionals. The online community that recently launched provides a place for those living with MS to ask experts questions and discuss the physical and mental challenges they are facing with patients in similar stages. Happify Health uses its proprietary AI technology to personalize content to patients’ life stages, symptoms and interests.”
- One more thing… Politico has a worthwhile piece on the critical role that telehealth will likely play in the years ahead following the Supreme Court’s decision this morning to overturn Roe v Wade.
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Clinical trial updates from Finland, Sidekick, ResMed and Gatorade
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.
Finnish researchers test video game-based digital therapeutic for major depressive disorder in 800-person randomized trial
Here’s a big study that appears to be entirely run by academic researchers at Aalto University (despite the existence of at least a couple digital health companies that share the digital therapeutic’s name “Meliora”). More on the study here, but read on for a snippet from the study’s description:
“The study is a comparator-controlled, randomized, double-blinded intervention study aimed at assessing the effects of the investigational device MEL-T01, “Meliora”, on the symptoms of major depressive disorder (MDD). MEL-S01 acts as a comparator. MEL-T01 is a game-based digital-therapeutics (DTx) medical software device developed at Aalto University and is intended to be used as a treatment for MDD together with treatment-as-usual (TAU). MEL-T01 implements personalized cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects.”
mobile Health AG and palleos healthcare GmbH study app for breast cancer side effects in Germany
Another study out of Europe: These two companies are set to study this CE Marked app’s medical benefit for people who experience side effects from breast cancer therapy:
“The PRO2 study is being conducted by palleos healthcare GmbH, the sponsor of the study, with the participation of an expected 585 patients at 40 study sites in Germany and 10 study sites in the German-speaking part of Switzerland with the aim of investigating the medical benefit of the smartphone application consilium care (app) with regard to the occurrence of side effects in breast cancer therapy. Furthermore, the potential impact on the application of the chemotherapy, the number of unplanned doctor visits, as well as hospitalizations and how often the app is used will be investigated.”
Sidekick Health studying its digital offering for non-alcoholic fatty liver disease (NAFLD) patients
Sidekick seems to be in the news often in recent weeks. Here’s it’s a bit about its latest study:
“Sidekick Health has developed a digital behavioral change program (SK-241) specifically designed for people with metabolic derangements and non-alcoholic fatty liver disease (NAFLD). The SK-241 is delivered through a mobile application and aims at improving lifestyle and health outcomes by focusing on improving diet, increasing activity levels and reducing stress. In this study, the feasibility of the newly developed digital behavioral change program (SK-241) will be evaluated in a minimum of 30 individuals with a NAFLD diagnosis. The primary aim is to explore the acceptability of the SK-241 program by its users, in addition to exploring changes in clinical outcomes and medication adherence after a 12-week intervention with 6 months follow up.”
Now recruiting: University of Virginia’s study on digital tools for monitoring symptoms and adverse events for lung cancer patients
“In this study, patients who are taking oral tyrosine kinase inhibitor (TKI) therapy for lung cancer will be asked to participate in a remote monitoring system for up to 24 weeks. The system will include: a smartphone application (app) developed at the University of Virginia called Sensus. Sensus will be downloaded to the participant’s smartphone. The app will collect active data (such as through surveys) and passive data (such as accelerometer data). a fitness watch called a Fitbit will be given to the participant to be used during the study. The Fitbit will collect information such as steps and average heart rate. a smart pill cap called RX Cap will be given to the participant to be used during the study. The pill cap will collect information about how often a pill bottle is opened.”
ResMed and SleepScore Labs study app and advice engine’s ability to improve sleep
While this study originally appeared in January, a recent tweak added a waitlist mechanism as a control mechanism:
“The study is a single-blinded randomized waitlist controlled trial that aims to assess changes in objective and self-report sleep improvement through use of a dynamic and personalized sleep improvement smartphone app and advice engine in those with poor sleep (i.e., subclinical threshold insomnia) when compared to a waitlist control group after 6 weeks and 12 weeks.”
No results yet but Pepsi R&D completed its validation study of the Gatorade-branded, peel-and-stick sweat sensor that it started selling in 2021
Remember the Gatorade sweat sensor? (It basically tells you when it is time to drink more Gatorade after a workout.) Well, parent company PepsiCo completed its validation study of the patch with participation from the NBA’s G-League players. There’s no indication yet that the company is considering any kind of FDA marketing authorization yet. Results from the completed study are still forthcoming. Here’s the study‘s original aim:
“To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride concentration during moderate-high intensity practice against well-established reference methods in field conditions with basketball athletes”
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