Issue 128
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 happening in the world of FDA-regulated and pharma-focused digital health:
- The news you know: The FDA granted AppliedVR a de novo clearance for its prescription digital therapeutic, EaseRx with this IFU: “EaseVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.” The de novo established a new medical device product code, QRA, for “Virtual reality behavioral therapy device for pain relief.” The de novo process for AppliedVR officially took 7.5 months, which is almost eight times as long as the 28 days it took Apple to get its first de novo through.
- Meanwhile, Happify revealed results from a recent pilot study of 5,000 people with migraines who used a Happify digital therapeutic. The results have encouraged Happify to build a prescription digital therapeutic version of the software and set up an RCT.
- ResApp Health, which builds smartphone applications for the diagnosis and management of respiratory diseases, inked “a three year, non-exclusive licensing agreement” with Janssen “for the use of its ResAppDx technology in a respiratory syncytial virus (RSV) clinical trial.”
- Pear Therapeutics said some 900 health professionals in 35 states around the country had prescribed its prescription digital therapeutics 10,500 times by the end of Q3 2021. Total prescriptions for 2021 should hit 12,500. The company also added another $50 million as part of its forthcoming SPAC onto the public markets. Finally, Pear confirmed that it is still on track for $4 million in revenues this year.
- One more thing… Akili launched its first two Instagram influencer marketing campaigns this past week for its ADHD PDT EndeavorRx. The company tapped a 21-year-old Insta influencer who talks openly about his ADHD — Connor DeWolfe. Dewolfe counts more than 450,000 followers and his skit about EndeavorRx has racked up more than 41,000 likes and hundreds of comments so far. (Watch it here.) Akili’s other influencer ad spot was with a mom of a kid with ADHD via her family’s Instagram account, Global Munchkins. (Check it out.) According to that influencer’s media kit, she reaches mostly affluent women between the ages of 21-55.
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Cures 2.0 asks CMS to create plan for prescription digital therapeutic reimbursement and more
If you have followed the news this week around the recently introduced draft bill, Cures 2.0, then you probably heard about how it includes automatic reimbursement for breakthrough devices (so soon after CMS rescinded MCIT too) as well as language that directs the FDA to figure out how to incentivize wider adoption of decentralized clinical trials.
Another section worth highlighting focuses on payment for prescription digital therapeutics.
This piece was present in the discussion draft of the bill that floated around earlier in 2021, however, E&O first mentioned this back in May 2020 in Issue 050 when Cures 2.0 was a “concept paper.” Clearly, CMS coverage for PDTs has been a part of this bill from its earliest inception.
Assuming Cures 2.0 finds its way into law by piggybacking on something else in 2022, the timeline below suggests a report on PDT coverage could head to Congress sometime in mid to late 2023. S
o, any kind of broad coverage action on PDT reimbursement is still a couple of years out, right?
“Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, in collaboration with the Administrator of the Centers for Medicare & Medicaid Services, and following a request for information, shall submit to Congress a report containing a proposal that—
- (1) specifies, for purposes of payment and coverage under title XVIII of the Social Security Act, a definition for digital alternatives to treatment and therapies, including wearables and digital applications and platforms; (
- 2) establishes a standardized process for determining which technologies satisfy the definition pursuant to paragraph (1);
- (3) establishes a standardized process for determining coverage under such title of digital alternatives as defined pursuant to paragraph (1) that are prescribed by a physician; and
- (4) identifies an innovative system for payment under such title for such alternatives.”
Read the full text of the bill here.
Clinical trial updates from Beats Medical, Noom, and NanoVation
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.
Beats Medical posts its first clinical trial for Parkinson’s digital therapeutic
Beats just posted details on a 40-person interventional study “to evaluate the impact of a smartphone application that delivers at-home therapy exercises on patients’ self-management of gait, speech, and dexterity symptoms.”
The app intervention requires 30 minutes a day for four weeks. More on the intervention:
“The application delivers at-home, tailored allied health exercises (physiotherapy, speech and language therapy, and occupational therapy) for the gait, speech, and manual dexterity symptoms associated with Parkinson’s disease.”
Noom posted a number of minor updates to its various ongoing studies
Noom made a handful of small updates to its ongoing studies. Its study of its digital healthy habits program for people with breast cancer has completed recruitment with 30 participants enrolled. Noom’s 250-person study that “evaluated 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” did not finish up in August as originally planned — its final completion target is now March 2022. The same is true for another Noom study. This 370-person study is now set to finish up in full this coming March:
“The purpose of this study is to evaluate the effect of the Noom Healthy Weight Program, a digital behavior change weight loss intervention, on quality of life as measured both by self-report and objective measures, compared to a waitlist control condition.”
No results yet, but Noom’s 160-person study “to evaluate whether the Noom Healthy Weight Program, a digital behavior change weight loss intervention, creates a positive relationship with food, compared to a waitlist control group” did finish up in August.
NanoVation tests an investigational remote monitoring device for COPD
Israel-based NanoVation has developed “a wireless, wearable medical device, which includes nano-based sensors… [that] can seamlessly measure patient’s tidal breathing during daily activities. [SenseGuard] extracts series of critical respiratory parameters, including; Respiration Rate (RR), Inhalation and Exhalation duration and ratio (I/E), as well as novel biomarkers.”
More on the study:
“This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuard (SG) non-invasive wearable device, to detect, post-hoc, early respiratory changes due to exacerbation by daily monitoring of subjects with COPD, at home. Subjects with COPD, that were discharged following hospitalization due to AECOPD are most susceptible to experience another exacerbation during the first 6 months post admission. Hence, subjects that were discharged from the hospital due to AECOPD during the last 3 months are eligible to the study.”
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