Orexo prices DTx at $600 to $1,000. Pear: $1,000 to $1,600.

Issue 045.

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Digital health research from Brian Dolan. 9680e452-e6b2-4094-9dd7-2c2081fa1deb.png

Welcome to E&O.

Last week’s newsletter had a 54 percent open rate. Here’s what’s happening this week:

We are coming to the end of week two in self-isolation up here in the Greater Boston Area. Here’s hoping all of you are staying safe and feeling healthy. Onward.
If you have plans to launch a digital health product in France, the Dutch government commissioned an in-depth analysis of all things “e-health” in that country. Perhaps coincidentally, Health Advances has a (shorter but still in-depth) look at digital health in France this month, too — read it here.
Last week I mentioned the FDA’s move to allow medical device makers to tweak their clearances for remote monitoring devices in order to use them in the fight against COVID–19. Alivecor was among the digital health companies that answered that call: Alivecor’s six-lead ECG device can now be used to measure a patient’s QTc and detection of potentially dangerous QT prolongation: “A prolonged QTc can lead to a potentially fatal side effect, called drug-induced sudden cardiac death (DI-SCD), associated with the use of several medicines now being used in the treatment of COVID-19.”
Google may have been a bit overzealous policing its Android App store for app makers that tried to capitalize on the COVID–19 pandemic: Sanvello Health (formerly called Pacifica), which offers an app to help with anxiety, depression, and stress, announced its app would be free to use because of the outbreak. After a surge in downloads, Google removed the app from the store temporarily and warned the company against taking advantage of the coronavirus crisis. After a day of looking more closely at it, Google reversed the decision and reinstated the app. No good deed… as they say.
Cognoa, which is developing digital therapeutics focused on autism spectrum disorder and ADHD, announced that CEO Brent Vaughn was stepping down. Former Chrono Therapeutics CEO David Happel is taking the helm at Cognoa. Cognoa expects to get its first FDA clearance in 2021. (Looks like Chrono Therapeutics, which Happel led for the past two years is out of business: Website and social media accounts are all deleted and most of the employees have new gigs based on LinkedIn.)
Livongo shared some (very) limited data on its coaching capacity along with which types of members are most likely to ask a coach for help. The partially unlabeled chart in the blog post indicates that the number of diabetes response alerts (triggered by members’ numbers being out of range, for example) has doubled in the past year.
Finally, AstraZeneca announced this week that it has tapped BrightInsight to power its digital health platform. The biopharma will initially leverage BrightInsight to collect real-world evidence data related to chronic care. AstraZeneca has longterm plans to add digital therapeutic products to the platform, too.

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Orexo reveals pricing for alcohol and opioid use disorder DTx: $600 to $1,000 per treatment

At its investor summit this month, Swedish biopharma Orexo shared new details on launch plans for the alcohol (vorvida) and opioid use disorder (OXD01) digital therapeutics it has licensed from GAIA. Orexo plans to price the two digital therapeutics between $600 and $1,000 per treatment, which Orexo says positions its products below list prices for Pear Therapeutics’ two competitive DTx offerings: reSET ($1,000) and reSET-O ($1,600), which are also for alcohol and opioid use disorder, respectively.

Orexo expects to generate between $120 million and $200 million in net sales for vorvida — five years post-launch — using the lower $600 pricepoint and targeting the market share figures outlined in the image above. Vorvida is not yet cleared by the FDA, but Orexo expects clearance sometime in Q2, followed by a swift commercial launch in Q3 of this year.

Expectations for its opioid use disorder DTx (codenamed OXD01, for now) are similar, but this product isn’t expected to launch for a few more years. Orexo aims to submit OXD01 to the FDA sometime in 2022, after completing clinical trials in 2021.

Watch the DTx portion of Orexo’s investor summit presentation by clicking here.

FDA clears Pear Therapeutics’ insomnia DTx, Somryst — its third market authorization

You’ve likely already read that the FDA has cleared Pear Therapeutics’ insomnia digital therapeutic, Somryst via the 510(k) process. Somryst also went through the FDA’s Pre-Cert evaluation process, but that was really just a practice run for the agency as it continues to figure out how Pre-Cert should work.

(On that note, this write-up over at MedTechDive has a status update on Pre-Cert, which includes Bakul Patel admitting, “I don’t think we are out of the woods… we are continuing to understand the feasibility of this program.” Implying the future launch of Pre-Cert is in doubt? As I wrote a few weeks back, the FDA seemingly asked Congress to authorize Pre-Cert when it made its case to the appropriations committee for its annual budget.)

Back to Somryst.

Like Pear’s other digital therapeutics, Somryst is based on a digital intervention that Pear licensed. In this case, the licensed intervention wasn’t an academic pursuit but a direct-to-consumer offering, called SHUTi (pronounced “shut eye” but also an amazing acronym: “Sleep Health Using The internet”). Pear’s FDA clearance announcement cites two peer-reviewed studies, and both of those were actually studies of the original SHUTi program. They include this 303-person RCT published in JAMA and this larger RCT published in Lancet Psychiatry.

Up until October 2018, anyone could go to the SHUTi website and buy access to SHUTi, which was created by a small firm named BeHealth. Most of BeHealth’s team has since joined Pear and is helping to bring Somryst to market.

SHUTi came in two flavors: SHUTi, which ran a one-time fee of $135 for 16 weeks of the program, or SHUTi Professional, which was priced at $156 for 20 weeks of access but required users to have a “clinical access coupon” from their doctor.

SHUTi offered:

Six interactive classes, which took 45-60 minutes to complete each, and were offered over a six-week period
The initial six weeks were followed by 10 or 14 additional weeks of access — based on the program selected.
Online daily sleep diaries
Personalized sleep window recommendations each week
Interactive features (similar to quizzes)
Sleep improvement progress reports
Option to integrate with Fitbit devices
And printable reference materials to share with friends and family.

Somryst, by contrast, is a nine-week program that will be available via prescription-only to adults 22-years-old and older. More on the specifics of the program here. As mentioned in the article above, Pear has priced its other two digital therapeutics at $1,000 and $1,600 each. I’m curious to see how Somryst is priced now that it is FDA-cleared and available via prescription only.

I assume this is coronavirus-related, but the FDA hasn’t updated its 510(k) database online in six days, which is why Somryst’s 510(k) filing record isn’t online yet.

Quick links to E&O research reports

The links below aim to make it easier for paying subscribers to find the long-form research reports on the E&O site:

The Digital Health Enrollment Report (Subscribers-only Link)
The Omada Health Report (Subscribers-only Link)
The Google Health Report (Subscribers-only Link)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)

That’s a wrap on Issue 045. Flatten the curve.