Issue 142

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:

• Typo correction: Last week (Issue 141) I had a typo in my write-up of Woebot’s recent funding: “Leaps by Bayer, the impact investment arm of Bayer AG, made a $9.5 million investment in Woebot Health. The company just raised a $90 billion Series B last year and now has a total of $123.5 million in funding.” Yes, that should have been “million”. As always I regret the error (and much else).
• For the first time, Germany has removed a prescription digital therapeutic from its DiGA formulary. Today the government removed Mika, a digital health program for people with cancer developed by German company Fosanis. The app joined the DiGA formulary almost exactly one year ago on a temporary basis, which suggests it was not able to prove its efficacy during its one-year probation period. Other DiGA apps have extended their provisional period by a number of months or as much as one year to buy more time to prove their worth. Mika cost €499 ($548) for 90 days of use.
• Pear Therapeutics announced a deal with SoftBank that may one day bring a version of Somryst to the Japanese market. “Pear will develop digital therapeutic applications for the treatment of sleep/wake disorders for the Japanese market and SoftBank will investigate the Japanese market potential for those applications, and SoftBank has an option to negotiate an exclusive license for Pear’s digital therapeutics for sleep/wake disorders in Japan.” Pear also announced that it is now in EHR giant Epic’s AppStore (App Orchard).
• AppliedVR has renamed its prescription digital therapeutic EaseVRx, which treats chronic lower back pain, to RelieVRx. The PDT secured a De Novo clearance last year. RelieVRx is set for limited commercial rollouts this year before a full commercial launch in 2023.
• Speaking of commercial launches: This week metaMe revealed how it plans to bring its FDA-cleared IBS PDT Regulora to market. “Through a multi-year partnership, Indegene will work with metaMe Health to use its flexible and capital-efficient commercial model to educate healthcare providers, patients, and payers about the benefits of this innovative treatment. To help metaMe Health launch Regulora, Indegene brings deep healthcare expertise and advanced omnichannel capabilities powered by artificial intelligence and machine learning. Indegene’s unique Co-Commercialization model ensures that Regulora reaches the right patients while allowing metaMe to focus on its mission of developing innovative Prescription Digital Therapeutics.”
• The Digital Therapeutics Alliance as well as individual companies like Limbix have asked the FDA to consider extending its proposed 180-day post-PHE period to give companies that launched psychiatric-related digital health devices during the pandemic under the enforcement policy (in other words — without FDA market authorization) more time to secure clearance. The DTA writes: “The pandemic has created barriers and delays in executing clinical trials, such as significantly longer institutional review board (IRB) times and difficulties conducting remote recruitment and enrollment. These factors may make the current Phase 2 timeline more challenging for our member companies to meet, potentially putting patient access to needed care at risk. In addition, given the potential unexpected volume of incoming submissions and product reviews the FDA will be responsible for conducting – particularly since the Agency does not know how many products came on the market under these policies – we want to ensure that the Agency has sufficient resources and time to execute the steps laid out in the Guidance within 180 days of the implementation date.”
• One more thing… It’s a few weeks old now, but I found this Health Affairs piece by CVS Health and Big Health executives a worthwhile read on what digital therapeutics companies need to do to produce “gold-standard evidence.”

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RIP: AstraZeneca’s AMAZE remote patient monitoring platform heads to Huma

After reading through the coverage of this week’s news that AstraZeneca had sold its AMAZE platform to its clinical trials partner Huma… I’m confused. Despite all the congratulatory tweets and Linkedin posts, this transaction is an admission that AstraZeneca’s original ambitions for AMAZE never came to pass, right? Remember AstraZeneca’s three stages for digital in R&D? They included these two:

AMAZE clearly positioned AstraZeneca to fulfill the “stage two” goals. It also would have set it up for the more ambitious goal in “stage three” to potentially become “a healthcare provider beyond medicines for certain medicines.” Shedding the AMAZE asset appears to be a setback. Isn’t this yet another example of a pharma-led innovation project that was sunsetted by changing strategic priorities and budgets? What’s your read on this transaction?

(P.S. I’m also not clear on the terms of this transaction. It seems like AstraZeneca may have traded its AMAZE assets for equity in Huma. This brief notice from one of Huma’s M&A advisors reads that way. CNBC reported the transaction value was around $33 million but couldn’t figure out if actual money changed hands.)

New CPT codes requested to tweak Remote Therapeutic Monitoring and track utilization of various VR therapies and AI tools

Given how many digital health-related codes I found in the May 2022 AMA CPT Editorial Panel Meeting agenda, I’ll skip a clinical trial round-up this week. Expect a mega round-up of trials in next Friday’s issue.

(CPT Explainer: If you’re not familiar with the CPT system, the AMA owns a copyright on CPT codes. It also convenes various medical specialty societies to come together throughout the year to decide which new codes are needed, which codes need to be updated, and which should be removed. This explainer on CPT codes is a good resource to understand their importance, the different types of classes of codes, and more.)

Here’s what’s on the agenda for the next meeting of the AMA’s CPT Editorial Panel. These are the digital health-related codes that the industry has requested the panel consider. Oftentimes, these proposed codes are withdrawn prior to the meeting or combined with each other to cover broader categories. Still, it is interesting to gauge which areas of digital health are seeking codes this spring.

The most relevant news: First up, an interesting set of proposed tweaks to the Remote Therapeutic Monitoring Services suite of 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 only AI-related CPT application that did not request Cat III was this one:

• AI Generated Oncologic Therapies — Establish code 9X021 to report the use of an analytic tool to assist in determining the appropriate treatment pathway for oncology patients

Most of the digital health-related code applicants asked for Cat III codes. Interestingly, these were typically VR-related or AI-related. One of the proposed Cat III codes was focused on opioid medication adherence, but that one has already been withdrawn. Here are the rest:

• Cat III – AI Analysis for Cardiac Function Services — Establish codes X044T, X045T, X046T, X047T to report artificial intelligence (AI) to ECG data for possible detection and autonomous generation
• Cat III – Virtual Reality-Mediated Therapy — Establish code X050T to report virtual reality-mediated therapy
• Cat III –Virtual Reality (VR) Procedural Dissociation Services — Establish codes X051T, X052T, X053T, X054T to report Virtual Reality (VR) Procedural Dissociation services
• Cat III – AI Assisted Epidural Placement — Establish codes X048T, X049T to report epidural spinal needle placement using a software system that integrates Artificial Intelligence
• Cat III – Computer-based Musculoskeletal Assessment — Establish code X055T to report augmentative computer-based analysis of motion, posture, gait, and muscle function utilizing surface mechanomyography (sMMG)
• Cat III – Non-invasive GI Myoelectrical Measurement — Establish code X069T for reporting gastrointestinal myoelectrical activity
• Cat III – Intracardiac Mapping — Establish code X042T to report non-invasive electrocardiographic 3-dimensional cardiac mapping
• Cat III – AI Assisted Developmental Behavioral Assessment — Establish codes X056T, X057T, X058T, X059Tto report multi-modular neurodevelopmental and behavior assessment system with augmentative algorithmic analysis

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