Issue 141
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 (Issue 140) I included a teaser about a new pharma licensing deal of a prescription digital therapeutic. Well, on Monday Happify announced that Zuellig Pharma has licensed its Ensemble prescription digital therapeutic to distribute it in 13 countries in Asia. The deal also includes a similar license for an as-yet-unnamed Happify PDT that treats chronic insomnia: “A prescription digital therapeutic used to treat chronic insomnia based on the principles of Cognitive Behavioral Therapy (CBT) that includes interventions, patient education and skill-building that leverages text messaging, videos, quizzes and Happify Health’s conversational artificial intelligence (Al) chatbot, Anna.”
- Meanwhile, it looks like Pear Therapeutics’ lobbyists have been busy in Delaware and Minnesota. The Delaware state senate passed a bill that cites moves by Medicaid in Massachusetts and Oklahoma to pay for PDTs focused on substance use disorders as a precedent for doing the same in Delaware’s Medicaid program. Also this week: State legislators in Minnesota are discussing a bill that will study and pilot PDTs for SUD with an eye on future Medicaid reimbursement.
- Roche Diagnostics is working with Lark Health to co-develop a digital health program for preventing and managing atherosclerotic cardiovascular disease (ASCVD) and coronary artery disease (CAD). Lark Heart Health program aims to launch later in 2022.
- Leaps by Bayer, the impact investment arm of Bayer AG, made a $9.5 million investment in Woebot Health. The company just raised a $90 billion Series B last year and now has a total of $123.5 million in funding.
- Sober Grid, a social media community for people in recovery, inked a deal with Walgreens that adds it to the retail pharmacy chain’s Find Care digital health platform. Sober Grid’s addition also mean Orexo’s digital therapeutics vorvida and deprexis are now available through Walgreens via Sober Grid. (Considering those DTx were developed by GAIA and licensed to Orexo — it’s becoming quite a long line of middlemen to get to the patient.) Walgreen’s Find Care is a bit different from the CVS Point Solutions Manager program or Evernorth’s Digital Health Formulary. Find Care is a consumer-facing portal. It’s more like a “digital front door” to virtual care than a formulary or menu of PBM, pre-negotiated employer-facing programs. More here.
- One more thing… I missed this one last month somehow: The FDA granted DynamiCare Health “Breakthrough Device Designation for DCH-001, a prescription-only digital therapeutic intended to treat tobacco use disorder complicating pregnancy and childbirth.”
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German government shares results from the first year of its reimbursed prescription DTx program
By now many of you are likely aware that the German government issued a report chockful of findings and data from the first year of its pioneering reimbursed, prescription digital therapeutics program, DiGA. However, the published report is in German so I figured (now that it’s a bit of a slow news week) it might be worthwhile to write up some of its findings here in English too. Here are 10 findings from the German government’s DiGA report, which analyzed the program’s first year (September 2020 through September 2021):
- At the end of the one-year period, exactly 50,112 DiGA had been prescribed or approved. Almost 80 percent (39,300) of them had been activated by redeeming the respective activation code that came with the prescription.
- As a result, the German government paid €12.8 million ($14.2 million) to reimburse for these prescriptions. Of this, around €5 million was spent on reimbursing for DiGA focused on behavioral health conditions.
- Notably, only 5 of the 20 DiGA were permanently included in the government’s formulary — meaning they had proved efficacy already. The other 15 had not proved their efficacy and were included on a temporary basis to give them a year or two to gather data.
- Of the more than 50,000 DiGA prescribed during the first year, 90 percent were prescribed by doctors or psychotherapists, while 10 percent were used after the approval of the health insurance company. (Those are the two ways patients can get access to these reimbursed digital health programs. Direct requests for access made by the patient to the insurance company are clearly the less common route.) Of the doctor-prescribed DiGA, about one-third were prescribed by general practitioners. ENT specialists prescribed about 20 percent and orthopedists prescribed another 17 percent.
- Women made up a majority of the patients who actually activated a prescription for a DiGA. Some 70 percent of the redeemed prescriptions for DiGA were activated by women.
- The average age of patients redeeming their DiGA prescriptions was 46.
- Six of the temporarily admitted DiGA managed to extend their trial period from one-year to two while they try to gather more evidence of their DiGA’s benefits: Kalmeda, Vivira, zanadio, Invirto, M-sense, and Selfapy — Depression.
- The report noted that the overall number of redeemed DiGA prescriptions continued to increase during the first year. The average monthly number of redeemed DiGA ended up at around 4,300.
- Kalmeda, a DiGA for tinnitus, had about 8,600 activations, while Vivira had about 8,000 and zanadio had around 6,100.
- The DiGA with the most follow-up prescriptions (for the same patient) were M-sense, zanadio, and Rehappy.
Clinical trial updates: Mayo Clinic, Pear Therapeutics, diaMentis, and Alevio
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. Just three studies this time around. (As I said above, it’s a slow news week…)
diaMentis is testing a diagnostic SaMD test for schizophrenia and bipolar disorder type 1
This 300-person observational study aims to help diaMentis refine a software-based diagnostic test that aims to differentiate schizophrenia from bipolar disorder type 1:
“This study will further assess ERG components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test (classified as a Software as Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I.”
Alevio and UPenn researchers developing an autism spectrum disorder mobile health emotion regulation app
This study aims to develop and test a digital health program for school teachers who have students with autism:
“School-based behavioral approaches to managing challenging behaviors in children with ASD are limited by three key factors: 1) children with ASD often have difficulties communicating their emotions; 2) it is challenging to implement evidence-based, personalized strategies for individual children, and; 3) it is difficult for teachers to track which strategies are successful for individual children. The investigators’ personalized mobile-health emotion regulation application (m-health app) will pair heart rate tracking with digital tools to help reduce challenging behavior by supporting stress detection, reminding teachers of specific behavioral strategies and helping teachers to track progress.”
Pear Therapeutics presented interim data from Somryst study
At a sleep medicine industry conference, Pear Therapeutics presented interim data from its DREAM study, which is evaluating Somryst, its PDT for chronic insomnia. Here’s how Pear described the findings in a recent press release:
“Interim data from the DREAM study (NCT04325464), a remote, virtual, open-label, decentralized clinical trial evaluating Somryst, analyzed in mid-Q1 2022, had 991 patients enrolled to date. In 779 patients who completed end-of-treatment (EOT), the population achieved statistically significant and clinically meaningful reductions in insomnia severity (ISI), sleep onset latency (SOL), and wake-after-sleep onset (WASO) from baseline to post-treatment at nine weeks, and in the 193 patients who completed the 6 months follow-up, significant improvements in ISI, SOL, and WASO, were all maintained through six months. As part of its PearCreate platform, Pear has developed its own decentralized and fully virtual clinical trial infrastructure for participant recruitment, screening, consent, enrollment, follow-up, and progress tracking, which was used for the DREAM study.”
Mayo Clinic has finished recruiting for its smartphone-based fetal heart rate monitoring device
Mayo Clinic has recruited 52 out of a hoped-for 50 participants for its smartphone-based fetal heart rate monitor study:
“Researchers are assessing the ease of use and accuracy of the HeraBEAT device, a new device used with a smartphone to monitor fetal heart rate during pregnancy.”
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