Issue 147
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 month I wrote about a whole slew of new digital health-related CPT codes that the AMA was set to debate in May. As that meeting draws closer, participants have tweaked the agenda and withdrawn some of the hoped-for codes. One of the withdrawn codes sought to change the language in the Cat II Remote Therapeutic Monitoring Services codes. As I wrote back in Issue 142 this was the change the applicant wanted to make to the RTM codes: “Therapeutic Monitoring Services — Establish code 9X023 to the Remote Therapeutic Monitoring Services family to report device supply and recordings to monitor chronic conditions; and revise 98975, 98976, 98977, 989X6 by adding nervous system status.” The other applicant code that I mentioned in March that has since been withdrawn focused on three-dimensional cardiac mapping, but the other ones I wrote up in Issue 142 are all still on the docket.
- Akili posted some new numbers for numbers of prescriptions written for EndeavorRx, which the company stresses is still in its “pre-launch” phase. During Q1 2022, prescribers wrote 668 total prescriptions for EndeavorRx. 503 were new scripts, while 165 were refills. Compare that to all of FY2021: 1,713 total scripts and 1,422 were new while 291 were refills. FY2021 also had a total of 877 prescribers vs 437 prescribers in Q1 2022. And 239 of them were new prescribers. Finally, 89 percent of total Rx were self-paid in Q1 2022, while 86 percent were self-paid for all of FY 2021. 10 percent of the scripts were reimbursed in FY 2021, while only 4.3 percent were in Q1 2022. Read more in this recent Akili presentation.
- The news you probably know: Noom is laying off about 25 percent of its coaches (495 people), Insider reported yesterday. The company is pivoting from text-based coaching to including video-based sessions too. Noom’s over-reliance on scripts for coaches made them seem like bots spitting out canned responses to some Noom users, so that shift makes sense. You would think they would need more coaches to handle the less scalable pivot to video-based, one-on-one coaching though, right? Unless it won’t be one-on-one?
- One more thing… Biofourmis raised a $300 million Series D led by equity firm General Atlantic along with some help from existing backers like CVS. The company also added former Medtronic CEO and chairman at Intel Dr. Omar Ishrak as its new chairman of the board.
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CVS makes it easier for Big Health to market Sleepio and Daylight to its customers when they pick up their mental health meds
Thanks in no small part to its longtime partner CVS Caremark, Big Health continues to make strides with its (non-prescription, non-FDA-cleared) digital therapeutics: Sleepio and Daylight. This week Axios reported that Big Health now has the ability to market its two digital therapeutics to CVS Caremark customers soon after they pick up their mental health medication. (To be clear, this isn’t for anyone picking up medications at a CVS. It’s just for Big Health’s employer and health plan clients who have contracts with Big via their PBM CVS Caremark.)
This is really an announcement about marketing.
Big Health was one of the first companies that CVS picked for pharmaceutical benefit reimbursement via its Point Solutions Management offering to employers and health plans. That relationship started back in 2019. So, for the past few years, Big Health has worked with CVS Caremark customers (who added Big Health to their contract with CVS Caremark) to market Daylight and Sleepio to their employee populations or health plan members. Like most digital health employee benefits, Big Health may have emailed them about the availability of Daylight and Sleepio or sent them a flyer in the mail. In all likelihood, everyone in that population received those marketing materials too.
This new announcement with CVS Caremark adds a new marketing tactic for Big Health. While it doesn’t expand the covered lives that Big Health can market to, the company will now coordinate with CVS Caremark to target their marketing materials so that they are triggered when someone fills or refills a prescription for a mental health condition.
I asked Big Health if the targeted marketing will take a different form vs the way the company has reached out to CVS Caremark covered lives in the past, but Big Health said that won’t change. It might be an email, a mailer, or maybe a text message in some cases. The key here is the medication refill or pick up is the triggering event.
Clinical trial updates from Pear, LifeScan, Limbix, Apple, Swing, GSK, Blue Note
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.
Now recruiting: Pear Therapeutics’ Spanish language Somryst study with Columbia University
I first reported on this study back in June 2021 (Issue 104), but it only just appeared in the clinical trials database this week. It features a culturally-adapted version of Pear’s prescription digital therapeutic Somryst:
“The primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (CBT-I) compared to minimally enhanced usual care (mEUC) on primary outcomes: reduction in insomnia symptoms at 9 weeks and 6 months post-intervention, using a standard scale among Spanish-Speaking Latina/o adults with chronic insomnia.”
LifeScan and Evidation to test four of LifeScan’s digital partners on economic and clinical value
Here’s an interesting study that pits Cecelia Health, Welldoc, Fitbit and Noom up against each:
“ECLIPSE will evaluate the clinical and economic value of OneTouch Solutions in a real world study design. OneTouch Solutions describes a selection of devices and health and wellness solutions that people with diabetes (PWDs) can access online via OneTouch Solutions (Cecelia Health, Fitbit, Noom or Welldoc, each in combination with OneTouch Verio Reflect blood glucose meter and the OneTouch Reveal mobile app (or Welldoc app for the Welldoc arm)). ECLIPSE is a large parallel arm digital health study combining advanced blood glucose monitoring solutions with a choice of four different health and wellness applications or services. There are four unique study arms that will run in parallel over one year. The primary (A1c) endpoint for each study arm will be after 6 months and subjects will continue to use the interventions for a full year to generate data on sustained engagement with these products and services, and to collect healthcare utilization and health insurance claims information.”
Limbix studies SparkRx in specialty care settings
This new study from Limbix follows on two now completed studies focused on the company’s flagship prescription digital therapeutic, SparkRx, which treats adolescent depression:
“The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children’s Health System of Texas (CHST).”
Pack Health, Daiichi Sankyo, and GSK study health coaching for people who have completed primary therapy for cancer
“This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 500 individuals with diverse cancer diagnoses will be enrolled across up to 5 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.”
Now recruiting: Pack Health and Sanofi are also now recruiting for a descriptive study focused on the experience of digital health coaching for adults with relapsed or refractory multiple myeloma.
Now recruiting: Swing Therapeutics’ study of a prescription digital therapeutic for fibromyalgia is now recruiting up to 300 participants.
Apple, Johns Hopkins, and the AHA changed primary outcomes measures for their cardiac rehab study
This is the study Apple is collaborating on for a cardiac rehab platform called Corrie Health:
“In this randomized clinical trial, the researchers are investigating whether a multi-component virtual cardiac rehabilitation program in addition to usual care will improve cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with atherosclerotic cardiovascular disease compared to usual care.”
The researchers changed their primary outcomes measures from measuring the change in LDL levels to improvement measured in a six-minute walk test. More here
No longer recruiting: Meanwhile, Blue Note Therapeutics is no longer recruiting for one of its clinical trials, which included two of its cancer-focused digital therapeutics: attune and cerena. The company ended recruitment for the study with 30 patients enrolled — much lower than the 553 participants it had originally anticipated.
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