Issue 169
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 this week in FDA-regulated and pharma-focused digital health…
- Request for requests: I received some great emails in response to this on Wednesday, but here’s another mention for the Friday readers: I’m working on a deep dive into “diabetes reversal” company Virta Health. Are there any angles you’d like me to dig into? Tips? Early pitch decks? Just hit reply to this newsletter.
- Di-Get Outta Here: For the fourth time, the German government removed a prescription digital therapeutic from its national formulary for reimbursed, prescription digital health programs. This time it was Esysta, Emperra’s diabetes management app for people who are on insulin. The app apparently did not show enough clinical benefit during its one-year provisional listing period to remain in the country’s digital health formulary. Here’s more on the set-up of the clinical trial (no specific results posted): “During the trial period, a randomized, controlled, prospective study with 166 test persons is to be carried out in order to show the effectiveness of ESYSTA for reducing the HbA1c value in a clientele of patients with diabetes mellitus. The study will be conducted prospectively over 6 months (intervention period) and 3 visits will be conducted (baseline, 3 months, 6 months) during which clinical endpoints will be monitored. The positive health care effect of improving the state of health by lowering the HbA1c value should be substantiated by secondary endpoints (responder analysis HbA1c, recording the incidence of hypo- and hyperglycaemic events, quality-of-life assessment).” Remember: Last week E&O reported that a stroke recovery app named ReHappy was kicked out.
- E&O has learned that at least one new digital health program is headed for a provisional listing next week: Germany-based Perfood’s low-glycemic diet program for the prevention of migraines. More on the company’s clinical study here.
- News you know: The FDA updated its list of cleared artificial intelligence and machine learning-enabled medical devices this week by adding 178 new devices. The agency also made it easier to download the entire table: Read through them all here.
- Sweden-based pharmaceutical company Vicore announced results from a pilot study of its first digital therapeutic, Almee, which treats anxiety in people with pulmonary fibrosis. (It co-developed the digital therapeutic with Alex Therapeutics.) The company’s topline finding from the study was that it was “safe, functional, user-friendly and reduced anxiety symptoms by 49% in patients with idiopathic pulmonary fibrosis (IPF).” Almee’s pivotal study should start before the end of the year. More.
- Last week I reported on a document that a group of prescription digital therapeutics companies have shared with members of Congress as part of its lobbying efforts to convince Congress to create a new Medicare benefit category for PDTs. Two readers asked me for the names of the companies that have PDTs on the market or pre-approval. Here’s the list along with the number of PDTs the document indicates the company has on the market or in its pipeline: Akili (2), AppliedVR (1), Behavr (1), Better Therapeutics (1), Blue Note Therapeutics (1), Click Therapeutics/Otsuka (1), Cognoa (2), Freespira (2), Happify/Twill (2), Luminopia (1), Mahana Therapeutics (1), MedRhythms (3), metaMe Health (3), NightWare (1), Pear (6), Renalis (1), Renovia (1), Welldoc (1), Woebot (4).
- One more thing… Speaking of that group’s recent trip to Capitol Hill, the bill they were lobbying for just racked up four more co-sponsors in the House. It now has 23 co-sponsors. The newest four are Rep. John Katko (R-NY), Rep. Stephen Lynch (D-MA), Rep. Daniel Kildee (D-MI), and Rep. Tom Emmer (R-MN).
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UnitedHealth’s Medicaid-Medicare plan for dual eligibles in Massachusetts adds coverage for Pear’s reSET-O and reSET
UnitedHealthcare Connected for One Care (Medicare-Medicaid Plan) is a health plan available to residents in Massachusetts that contracts with both Medicare and MassHealth Medicaid to provide benefits of both programs to enrollees (dual eligibles). UHG created this plan recently — in November 2021.
Here’s a little scoop: Starting in 2023, the plan will cover Pear Therapeutics’ prescription digital therapeutic for opioid use disorder, reSET-O, and its substance use disorder PDT reSET:
“You pay a $0 copay for the following prescription digital therapy: The plan covers reSET and reSET-O, a 12-week, on-demand cognitive behavioral therapy application downloadable to a smartphone. This therapy is indicated for adults being treated in an outpatient treatment program for substance use disorder and opioid use disorder. Treatment with reSET-O should be combined with therapy including transmucosal buprenorphine. Please work with your Provider and One Care Plan to determine if this will work for you. Call the Member Engagement Center for more information.”
The plan’s documents make clear that this is new for 2023 and that prescription digital therapeutics were not covered in 2022. The new coverage almost certainly comes from Pear’s value-based care agreement with MassHealth (Massachusetts Medicaid), which the company announced almost exactly one year ago.
Clinical trial updates: Noom, Eko, SilverCloud
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. Surprisingly few studies this week…
No results yet: Noom completed its study that compares Noom with coaches to Noom with no coaches
Noom managed to recruit 246 (out of the anticipated 250) participants for its coach vs. no coach weight loss study. The study is now complete but no results yet. The study was a randomized, parallel trial that included overweight men and women, but details are otherwise scarce:
“To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.”
Eko Devices pushes comparative trial out another year for AI-assisted stethoscope diagnosis for acute respiratory failure
Eko originally aimed to finish up its study this past summer, but it has now pushed out the study another year. The researchers tweaked the outcomes measures in the study from one-year to two-year periods. The study is still recruiting for its (anticipated) 100 participants:
“Once identified and consented, the subject will undergo both POCUS and AI-assisted lung auscultation using an Eko CORE stethoscope. The POCUS protocol described here is the standard of care for patients who present in acute respiratory failure to the Emergency Room and both groups will receive this standardized care during the study. Upon hospital discharge, the final discharge diagnosis will be used as the ground truth for assessing the accuracy of the POCUS protocol. The POCUS exam and the EkoAI exam may be performed wherever the subject is located in the hospital when first enrolled in the study. If possible, both exams should be performed immediately, in either order. They will be performed by the same examiner.”
SilverCloud and Kaiser Permanente to study three of SC’s digital mental health programs in new RCT
This (anticipated) 1,800-participant randomized control trial will compare three programs that SilverCloud offers to Kaiser Permanente members: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders, Space from Depression, and Space for Resilience. More:
“A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from [SilverCloud]’s existing library of programs) in a sample recruited from [Kaiser Permanente] primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate ‘holdout’ dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.”
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