Issue 101
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.
OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- The Digital Therapeutics Alliance is looking for a CEO “to lead the organization to its next phase of growth.” Megan Coder, the organization’s executive chairman, tells me she plans to stick with the organization for the long term.
- According to an article in STAT, Pear Therapeutics has ambitions to build a platform that would help other digital therapeutics companies get to market. Pear is starting to think beyond its own products and “teasing the idea that it might one day provide the tech scaffolding on which a broad market of digital health tools could be built.”
- FDA cleared Bigfoot Biomedical’s Unity Diabetes Management System, which includes “connected smart pen caps that recommend insulin doses for people using multiple daily injection (MDI) therapy.”
- One Drop received a CE Mark for its Blood Glucose Prediction Analysis Engine, which forecasts “glucose levels up to eight hours in advance for people living with prediabetes, type 2 diabetes, and gestational diabetes.”
- Voluntis also secured a CE Mark for a new version of Oleena that helps people with cancer self-manage an increased number of symptoms. “This new CE-marked version of Oleena, a Class IIa medical device in Europe, is also authorized for marketing in the United States.”
- One more thing… Biofourmis has poached Amazon’s Dr. Maulik Majmudar as its new CMO. Majmudar was the company’s medical director and helped lead the Amazon team that developed its wearable device, Halo.
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Average price of a Rx digital therapeutic: $635
One of the reasons E&O tracks the German government’s relatively new reimbursement program for prescription digital therapeutics is to get a sense of the pricing for these interventions. While the pricing in Germany appears to be lower compared to the disclosed pricing of prescription digital therapeutics in the US, the data set is probably too small to make any helpful conclusions based on that.
Still, since we now have pricing for 20 prescription-only digital therapeutics, I figured it was a good week to take a look at the watermark. Based on the 20 price points listed below, the average price of a prescription digital therapeutic today is $630 per treatment, which is generally three months in duration.
Pear Therapeutics’ PDT for opioid use disorder is one of the outliers with a pricetag of about $1,600, but — as has been pointed out to me before — that includes $500 in incentives that could go back to the patient. And reducing reSET-O down to a $1,100 price brings the average down to about $610 per treatment for the group.
Here are the prices E&O has been tracking both in the German database (converted to $USD) as well as for US-based prescription digital therapeutics companies:
- Pear Therapeutics – reSET-O (opioid use disorder) – $1600.00
- Pear Therapeutics – reSET (alcohol use disorder) $1000.00
- Freespira – Freespira (panic attacks/PTSD) – $925.00
- GAIA – elevida (MS) – $903.14
- Pear Therapeutics – Somryst (insomnia) – $899.00
- Mindable Health – Mindable (agoraphobia) – $699.44
- Selfappy – Selfappy – $655.72
- zanadio – aidhere (obesity) – $606.91
- CANKADO – PRO-React Onco (breast cancer) – $606.91
- GAIA – velibra (agoraphobia) – $578.01
- GAIA – vorvida (alcohol use disorder) – $578.01
- mementor – somnio (insomnia) – $563.44
- Rehappy – Rehappy (stroke rehab) – $545.22
- Invirto – Sympatient (agoraphobia) – $520.21
- Fosanis – Mika (cancer) – $508.79
- Akili Interactive Lab – EndeavorRx (ADHD) – $450.00
- GAIA – deprexis (depression) – $361.25
- vivira – vivira (MSK) – $291.40
- Newsenselab – M-sense Migraine – $267.13
- mynoise – Kalmeda (tinnitus) $142.04
Which prescription digital therapeutics’ price points am I missing? Hit reply if you know any additional pricing info and I’ll add it to the list…
Clinical trial updates: Winterlight, Woebot, Sonde, ResApp, Blue Note, Chorus, Better, NightWare
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 had mentioned in previous issues.
Winterlight Labs is now recruiting for its study on a speech-based digital biomarker for psychiatric disease. If you recall, Winterlight has licensed its tech to Pear Therapeutics for a variety of indications, including Alzheimer’s, depression, insomnia, schizophrenia, opioid use disorder, and substance use disorder.
“The purpose of this study is to gather longitudinal data to examine how speech features and symptoms change over different intervals of time and the reliability of repeated, high-frequency test administration. Participants will complete a variety of speech and language tasks using the Winterlight Assessment (iOS app) every day for 30 days. The following is the list of assessments that participants will complete; 1) Daily assessment of mood, 2) Winterlight assessment which contains a series of verbal response tasks where participants are recorded through a tablet app, and 3) Clinical assessments.”
Woebot Health published results from a study that included 36,070 users. It examined whether “Woebot, the company’s proprietary relational agent, establishes a therapeutic bond with users — a construct long thought to be the unique domain of human-to-human interactions.”
“The bond that Woebot formed with users appeared to be non-inferior to the bond created between human therapists and patients. Participants’ bond with Woebot was also established in just 3-5 days—far faster than the bond scores in the comparison studies that were all measured between 2 and 6 weeks.”
ResApp‘s pilot study to collect individual sound recordings to screen for COVID–19 is also now recruiting.
Meanwhile, Sonde Health just completed a similar study:
“This is a confirmatory study that seeks to examine whether respiratory-responsive vocal biomarkers have potential to respond to COVID-19 infection status and respiratory symptom severity. Patients with suspected COVID-19 and healthy controls will submit daily voice samples and symptom inventories on their personal smartphone devices for 14 days.”
Blue Note Therapeutics made a number of tweaks to its clinical trial for AttuneRx, its prescription digital therapeutic for cancer patients that it quietly launched thanks to the FDA’s waiver for psychiatric devices during the pandemic. For one, Blue Note removed all references to the DTx’s brand, AttuneRx, and changed those to “BNT001”. The company also pushed out its estimated completion date from January to December 2022. Finally, the company changed the study’s primary objective to “develop and refine procedures for eligibility screening, suicide risk assessment, and delivery of the app as an aid prior to the launch of a phase III randomized trial.”
“This phase II trial studies the effect of a digital application (app), BNT001, on cognitive-behavioral stress management in patients with stage I-III breast or lung cancer. The app is designed for cancer patients to treat anxiety and depressive symptoms related to their cancer diagnosis. The purpose of this study is to develop and refine procedures for eligibility screening, suicide risk assessment, and delivery of the app as an aid prior to the launch of a phase III randomized trial. The impact of the app in managing stress and improving quality of life and mood is a secondary aim.”
Chorus Health has set up a clinical trial for its digital therapeutic for menopause, Caria. The company does not expect this to be an FDA-cleared intervention, according to the clinical trial filing.
“The Caria app is publicly available on the Apple app store. It is an interactive native app that provides education on menopause as well as symptom tracking/feedback features, social support as well as cognitive-behavioral and relaxation techniques. Participants will be given an ‘unlocked’ version with all content available at no charge. The app sends out occasional automated emails to users to remind [them] of [the] features of the app and to encourage them to return to the app. Users can opt-out of reminder features.”
Better Therapeutics, which recently announced plans to go public via a SPAC merger, posted the details of its clinical trial for its first digital therapeutic, which is focused on diabetes management:
“The study will utilize an open-label, randomized, parallel-group design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) when compared to SOC alone in patients with type 2 diabetes. The screening period will consist of a 30-day run-in during which time HbA1c will be assessed twice for confirmation of eligibility.”
NightWare pushed its study out another year and doesn’t expect to complete it until August 2023 now:
“The NightWare application uses physiological markers obtained via the smartwatch to determine by proprietary algorithm whether a participant is in the early stages of a nightmare, but has not yet awoken in distress. As directed by the algorithm, the smartwatch then applies varying degrees of vibratory stimulation to the wrist over variable lengths of time with the intention of arousing the participant from sleep without eliciting an awakening.”
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