Issue 136
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 digital health:
- Thanks for all the feedback on last week’s analysis of the Akili Interactive SPAC documents. One reader pointed out that the company actually did disclose the number of patients it has treated with EndeavorRx to date: 2,600. About 600 of those are from its clinical studies.
- AliveCor officially announced its new, credit card-sized ECG device: KardiaMobile Card. E&O readers had a heads-up on this one back in December soon after AliveCor secured a 510(k) for it. (Remember: This is the clearance that finally knocked Apple off its perch for having the quickest FDA clearance for a digital health device.)
- I guess you could say things are getting pretty serious: Biogen mentioned “digital therapeutics” in its annual report filing (10-K) with the SEC for the first time ever. This is the fourth sentence from the opening lines of the company’s overview of its business: “Lastly, we are focused on accelerating our efforts in digital health to support our commercial and pipeline programs while also creating opportunities for potential digital therapeutics.” A recent job post for a digital therapeutics lead at Biogen indicates the company wants to “lead and grow a digital therapeutics portfolio through external partnerships… with prescription and non-prescription digital therapeutic companies.”
- Two days after Christmas, Japanese pharma Shionogi, which is also a partner to Akili, inked a $40 million deal with SUSMED to commercialize a prescription digital therapeutic for insomnia. On a recent investor call, Shionogi said that based on the results of its Phase 3 trial, it plans to apply for a New Drug Application (NDA) for the PDT to secure market authorization in Japan. It plans to submit this month.
- Another Japanese pharmaco announced another deal with a similar dollar amount attached this week: Otsuka forged an exclusive agreement with Jolly Good. “This agreement, which establishes a partnership between advanced VR video technology maker Jolly Good and Otsuka Pharmaceutical, which has an extensive knowledge, experience base, and network in psychiatry, will facilitate the development of an SST that uses VR for a variety of mental disorders and the creation of new platforms going forward.”
- PDT company Blue Note Therapeutics also entered into a licensing agreement this week: Blue Note signed “an agreement with the University of Sydney for the exclusive licensing of ConquerFear, a metacognitive intervention to teach patients effective ways to cope with the fears associated with the potential for cancer recurrence.”
- The AMA’s CPT Editorial Panel is meeting right now to add and remove new CPT codes, including a handful of digital health-related ones. I wrote up a few of the meeting’s agenda items back in Issue 130. Those included Cat III codes for “remote autonomous AI-based insulin dose calculation and titration” as well as the removal of two Cat III related to Remote Therapeutic Monitoring Services that the AMA panel accepted in September. Going into the meeting this week, participants (called “interested parties” in AMA-speak) withdrew one focused on smoking cessation counseling but they didn’t make changes to the ones mentioned above. (We’ll see what shakes out in a few weeks.)
- One more thing… The FDA’s Bakul Patel, who has led the agency’s digital health policies for many years, has a new title: Chief Digital Health Officer of Global Strategy and Innovation. Patel was previously the Director of CDRH’s Digital Health Center of Excellence (DHCoE), which is now seeking a new director.
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OptumRx will deny all requests for authorization of “prescription digital applications”
This is the fourth in a series that unearths large health insurance companies’ policies related to coverage for prescription digital therapeutics. Previous ones include E&O’s analysis of this one from Anthem, this policy from Aetna, and a coverage policy from Premera.
This week I found a similar policy, which it calls a program, from the largest health insurance company, UnitedHealth Group. It took effect on July 1, 2021. (Read through until the end for a weird twist to this one related to Pear.)
Each of the companies has its own phrasing for prescription digital therapeutics. United refers to them as “prescription digital applications” usually but also “Computer Based Treatment for Cognitive Behavioral Therapy (CBTCBT)”.
“The program is for prescription digital applications, including but not limited to EndeavorRx, reSET, reSET-O and Somryst.”
Like the other three policies I’ve dissected so far, UHG considers prescription digital applications unproven and not medically necessary. UHG didn’t pick apart the individual studies for each prescription digital application it mentioned, however. It just dismissed them as a group:
“A review of the current literature does not support Computer Based Treatment for Cognitive Behavioral Therapy (CBTCBT) for the treatment of ADHD, as an outpatient therapy to treat alcohol, cocaine, marijuana, and/or stimulant substance use disorders, or for the treatment of chronic insomnia.”
“The studies available for review are limited due to the recent development of the technology. There is limited evidence showing CBTCBT effectiveness as an adjunct therapy when combined with clinical monitoring. Though short-term benefits have been seen, long-term efficacy of CBTCBT has not been determined. CBTCBT is considered unproven until additional studies are available and the devices are for sale in the United States.”
United concludes that:
“Computer Based Treatment for Cognitive Behavioral Therapy (CBTCBT) such as EndeavorRx*, reSET*, reSET-O* and Somyrst* are unproven and not medically necessary. All requests for authorization will be denied by OptumRx. All requests for therapy must be submitted through the appeals process to the UnitedHealthcare Pharmacy appeals team for consideration.”
UHG used the bolding on those three words — not me. The asterisks lead to a note at the bottom of the document that points out “*Digital Application devices are typically excluded from coverage.”
The final caveat that UHG added:
“Notwithstanding Coverage Criteria, UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD10) and/or claim logic. Use of automated approval and re-approval processes varies by program and/or therapeutic class.”
This has been sort of written about elsewhere, but never in relation to this policy document: It was just six weeks after the policy document above was first published that Pear Therapeutics announced in a press release that it was “pleased to team with OptumRx and their customers to provide patients with access to innovative, FDA-authorized PDTs.”
Wait a minute. While OptumRx clearly states in the document above that it will deny any request to pay for PDTs, Pear seemed to take this policy as an opportunity to capitalize on UHG acknowledging its existence. Inherent in the creation of a policy like this is the PBM’s willingness to list them on a custom formulary for employers willing to pay for the PDTs themselves.
Still: That press release was quite a move by Pear. At the time of Pear’s press release, a publication named Sleep Review asked OptumRx to confirm the news that it would include Pear’s insomnia prescription digital therapeutic, Somryst, in its formulary. Optum wrote back at the end of August 2021 by specifically referring to its “standard formulary”:
“Unfortunately the information in Pear Therapeutics press release, which has now been removed from their newsroom and is unavailable, was inaccurate and misleading. Somyrst is not on our standard formulary and we did not approve that press release nor any communications about us partnering together.”
Here’s a link to the UHG/OptumRx coverage policy for prescription digital applications.
Clinical trial updates from Akili, Calm, Boehringer Ingelheim, and Alivecor
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.
Boehringer Ingelheim and Yale complete study that tests out Noom, Conversa, Bodyport for CHF
This BI study just finished up in November with 182 participants. No results yet, but the study should be entirely over by April. Here’s the summary:
“This study is an unblinded, 4-arm, parallel group randomized controlled trial to measure the efficacy of four digital health technologies in improving the management of care and quality of life of patients with congestive heart failure (CHF). Patients actively managed by one of Yale New Haven Hospital’s heart failure-based clinics will be eligible for this study and approached for consent. Enrolled subjects will be randomized to one of four groups: a control (usual care) arm, or to one of three intervention arms, each of which assesses one of three digital health technologies. These technologies are:
- BodyPort: A data-driven smart scale that provides enhanced cardiac monitoring and risk assessment data.
- Noom: A live, data-driven coaching application providing personalized diet and weight management.
- Conversa: An automated conversational platform providing patient motivation and educational tools for CHF management.”
Clinical trial for the wearable, remote monitoring Opum Digital Knee orthotic
Opum, which secured FDA clearance for its sensor-equipped Digital Knee wearable back in 2020, just posted details of its clinical trial, which it hopes recruits about 60 participants:
“This study will investigate the effects of the ODK used in a medial off-loader brace with remote patient monitoring. This randomized control trial will have 2 groups: A control group receiving a medial unloader brace and a personalized home exercise program, and an intervention group which will receive an ODK in a medial off-loader brace, and a home exercise program with remote patient monitoring. These subjects will be followed for 12 weeks and assessed for changes in pain, function, and quality of life.”
Akili pushes out its Sickle Cell Disease EndeavorRx study one month
Small update: Akili has pushed back its Sickle Cell Disease (SCD) study by one month. It is now expected to finish up on December 31, 2022, not November 30. Here’s a brief snippet from the summary:
“This pilot study is examining the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a sample of 20 children with SCD ages 8-16 who are being treated with chronic blood transfusion therapy.”
Alivecor’s 12-lead Kardia device study won’t finish until June 2022
AliveCor originally intended to complete its study in full by the end of March, but it has pushed it back until June now. This is for the next big device launch from the company, which will offer a 12-lead device if all goes to plan:
“The purpose of this study is to collect clinical validation data to support an FDA submission for a 510(k) for the Kardia 12L hardware which enables the simultaneous diagnostic quality recording of all 6 limb leads and any chest lead. We will be recording both Leads V2 and V4 in a sequential fashion along with the Limb leads and a simultaneous 12-lead ECG to validate the hardware and a Deep Neural Network model which expands the 7 leads into a complete 12-lead ECG. The 12-lead ECG used for validation of the recordings and the 12-lead synthesis model is the GE Cardiosoft System which is FDA cleared.”
Calm’s RCT to see if anchoring plus rewards help people develop a meditation habit
In this new 555-participant randomized study, Calm wants to figure out if anchoring and in-kind rewards help new paying Calm users to develop a meditation habit at a higher rate. (I couldn’t figure out what the rewards were exactly, but the study does include $20 incentives for completing some of the baseline activities so it might be cash?) Jump to the second section below if you are more interested in the breakdown of the three arms, but here’s part of the objectives section from the clinical trial’s writeup:
“The purpose of this study is to evaluate the use of anchoring strategies in combination with pragmatic in-kind rewards to identify the most optimal strategy for establishing persistent meditation habits with a mobile app. The investigators aim to (1) assess the adherence persistence to a 10 minutes per day Calm prescription in new, paying self-initiated Calm subscribers; (2) investigate the mediating effect of anchoring plan adherence on adherence persistence to the Calm prescription; and (3) estimate the dynamic relationship between meditation adherence and stress. Investigators hypothesize that (1) participants using anchoring strategies in combination with pragmatic in-kind rewards will be more likely to adhere to the Calm prescription than the control condition (with greater adherence observed among those participating in the anchoring plus time-contingent reward intervention), (2) greater adherence to anchoring plans will lead to higher adherence persistence, and (3) greater reductions in stress will be associated with more persistent meditation adherence across study groups.” “Investigators aim to recruit N=555 new, paying self-initiated Calm subscribers. Participants will be randomized into one of three groups: (1) AC+ARwdC intervention (N=185; anchoring plus in-kind rewards conditional on anchoring plan adherence), (2) AC+RwdC intervention (N=185; anchoring plus in-kind rewards conditional on meditating at any time of day), and (3) usual Calm control condition (UC) (N=185; using Calm without in-kind rewards).”
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