Issue 134

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:

• Many of you forwarded last week’s newsletter on Aetna’s prescription digital therapeutics policy. So, I figured I’d follow it up with another one. This one is older (not brand new like Aetna’s was) but it’s still relevant because it is currently in effect. Scroll down for details on how Anthem, the largest of the Blues, values “Mobile Device-Based Health Management Applications,” which — once you read Anthem’s definition — you’ll see they are the same thing as prescription digital therapeutics (PDTs).
• But first: Another DiGA price change. I’m surprised the German government has tweaked the prices on so few of the prescription digital therapeutics in its federal formulary. They are supposed to renegotiate after year one and many are well past that mark. Well, this week one company’s PDT got a raise: Sympatient’s VR-based CBT treatment for anxiety, named Invirto, is now priced at €620 ($703) up from €428.40 ($486) in its first year. (The prices include the cost of the VR device for this one too.) More in E&O’s DiGA tracker here.
• Sanofi announced that it had tapped BrightInsight to power one of its digital health offerings. The announcement did not let slip which complex chronic conditions the SaMD will focus on: “Leveraging the BrightInsight Platform, Sanofi’s digital companion application will provide easy access to patient services and support patients from therapy onboarding to chronic disease management with the aim to enhance patients’ healthcare experiences and outcomes. The solution is comprised of a patient mobile app, which integrates with third-party systems for the creation of a connected ecosystem, and will enable users to manage their complex conditions with custom profile and content, and step-by-step therapy administration guidance. The app will be available first in the US and then launch across international markets.”
• Evidation also announced that Sanofi was re-upping its partnership with the real world data company after nearly a decade of working together.
• Since securing its FDA De Novo back in June 2021, Cognoa’s autism spectrum disorder diagnosis aid, CanvasDx is now available via prescription. Instead of setting up a telemedicine portal to prescribe CanvasDx to patients, Cognoa tapped specialty pharmacy Orsini Specialty Pharmacy. Despite being a digital therapeutics and diagnostics company, Cognoa is asking prescribers to print out an Rx form and fax it to Orsini.
• NightWare, which secured a De Novo for its PDT (reduces sleep disturbance from nightmares) in November 2020, has said previously that it aimed to have commercial coverage by 2022. It currently has coverage from TriCare for active-duty military personnel. This document from the company explains how prescribers should write prescriptions to ensure TriCare accepts them. I thought this “special note” was particularly interesting: “This device is medically necessary. NightWare is a Class II medical device that delivers the NightWare therapy through a dedicated closed system specially provisioned smart watch and phone. The phone and watch have no capability aside from running NightWare and the ability to call 911 in an emergency. It cannot make calls; it cannot run other applications. This is a single purpose device. Therefore, the requested device does meet TRICARE DME requirements.”
• New 510(k): FDA recently cleared G-Tech Medical’s “EKG for the Gut.” While the company updated its site to note the FDA clearance it also said the device is not yet for sale. The company’s device aims to help monitor gastrointestinal motility conditions, and it is “a wireless, wearable patch-based system that reads electrical signals from the digestive tract.”
• I gave IBS prescription digital therapeutic company Mahana Therapeutics a hard time about its virtual clinic’s name (GutDocNow) last month. Since then the company tweaked the branding. It is now simply calling it the Digital IBS Clinic. As I wrote back then, Mahana tapped GenieMD to provide the white-labeled telemedicine channel.
• Surprised to see that EndeavorRx-maker Akili Interactive Lab is hiring a National Account Director for Employer Groups given its flagship product is a prescription digital therapeutic. The job description, however, explains one of the responsibilities is to “garner support from Employers such that they request their PBM or health plan carrier to provide access to Akili Interactive’s products.”
• The news you know: Even though it broke a few hours ago, you likely heard that PE firm Francisco Partners has agreed to purchase the Watson Health assets from IBM.
• One more thing… While you need to sign up and create an account for access, HumanFirst has added a new free-tier to its Atlas of more than 1,200 wearables, sensors, and software-based tools that can be used in clinical trials.

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Anthem: These 9 Rx-only digital therapeutics have insufficient evidence and we won’t pay for them.

Last week I wrote up Aetna’s reasons for not covering 13 prescription digital therapeutics. And four short months ago (Fridays Issue 119), E&O had a scoop about pacific northwest health insurance company Premera similar policy document on PDTs lacking evidence. This week I’ll dig into one from Anthem, a massive health insurance company with 45 million covered lives.

Despite being a Blue licensee like Premera, Anthem’s policy document includes its own criteria and arguments. Like Premera and Aetna, however, Anthem reaches the same conclusion on prescription digital therapeutics: They’re not medically necessary. At least not yet.

Here’s how Anthem thinks about PDTs as of April 2021:

Anthem reviews nine prescription digital therapeutics and also acknowledges that its list is not exhaustive:

• Welldoc‘s BlueStar Rx — “Evidence of BlueStar’s clinical efficacy remains to be established in addition to defining factors that may affect individual and site-specific variations that impact the application’s usage as recommended.”
• Hygieia‘s d-Nav Insulin Guidance System — “Longer-term data on net health outcomes is currently lacking. Current data is limited to a single study of small sample size.”
• Resonea‘s Drowzle — (This was a new one for me.) “Studies evaluating real-world application are lacking, as is data describing how screening results impact diagnosis and management of [obstructive sleep apnea] as compared to generally accepted standards of medical practice.”
• Akili‘s EndeavorRx — “Study limitations include enrollment of only children with an objective baseline deficit in attentional function and those not currently receiving medical treatment for ADHD, thus representing a small subset of the ADHD population. In addition the study-period was limited to just 28 days of follow-up. Finally, it is uncertain whether the treatment results in clinically significant outcome or benefits commensurate to generally accepted standards of medical practice.”
• Freespira — “Currently available evidence evaluation of Freespira lacks comparison to generally accepted standards of medical practice and is limited by small sample sizes despite the prevalence of panic disorder in the general population, and bias resulting from loss to follow-up.”
• LIVMOR‘s Halo AF Detection System — “No published peer-reviewed evidence.”
• Voluntis‘ Insulia (really it’s Aptar now, right?) — “Current data is limited to a short period of evaluation and the comparison arms sample sizes were small.”
• NightWare — “No published peer-reviewed evidence.”
• Pear‘s reSET-O — “Current data is limited to short-term follow-up, and impact on net health outcomes has not been demonstrated. Few of the published studies assess the use of the reSET-O when used outside of a clinic (for example, when downloaded directly to a personal device such as a mobile phone or tablet).”

These policies have their subtleties but they’re also repetitive. Here’s a link to the Anthem policy. And (since so many of you asked) here’s the link to Aetna’s policy that I wrote up last week. (While I prefer you just forward this newsletter to colleagues… if you feel the need to post about this on social media, I’d appreciate it if you mention E&O as your source. Thanks!)

Clinical trial updates from Novartis, Roche, Biogen, Vertex, Pear

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. Novartis, Roche kicking off its Multiple Sclerosis digital biomarker validation study this month Here’s an interesting one that aims to start up this month:

Meanwhile, Biogen is kicking off an MS biomarker study of its own:

This wearable-powered study just started recruiting even though it doesn’t have too many details up yet. The title gets you the gist:

Vertex Pharmaceuticals just finished up a study that used wearable to track coughing in cystic fibrosis patients

The study enrolled 51 participants and included a wearable as well as a cough monitoring system:

Quest Diagnostics acquired Pack Health, which works with a number of pharma companies to add digital health coaching to their clinical trials

You likely saw the news that Quest acquired Pack Health. This week Novartis posted details on a QoL clinical trial that is pretty typical of the trials Pack Health partners with pharma companies on. The brief description is below but click here for the full posting. (Pack previously worked with Sanofi and BMS too.)

Pear tweaked its inclusion criteria and anticipated end date for its gamified reSET-O study

Pear originally hoped to finish up its patient engagement study for PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder. The new PDT is a different version of Pear’s flagship reSET-O. The study was supposed to finish up in December 2021 but Pear pushed the end date back to August 2022. The company also tweaked its inclusion criteria so people who people within their first 120 days of starting buprenorphine treatment could participate. Before it was 60 days. More:

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