Issue 100
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. And, wow, I can’t believe it: Today’s issue marks the 100th edition of this weekly! Time flies when you’re digging into the Clinical Trials [dot] gov database.
E&O Fridays.
OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- The German government added three new digital health apps to its country-wide list of reimbursed and prescribable digital therapeutics. GAIA’s alcohol use disorder DTx vorvida, CANKADO’s PRO app for breast cancer, and Mindable’s DTx for panic disorder and agoraphobia all made the cut. Each is priced at around 500 Euros for 90 days of use. See the full list and exact pricing in the E&O DiGA tracker here.
- Publicly-listed (France) digital health company Voluntis provided investors an update this week. Voluntis has six active agreements with pharmacos: Abbvie, Biocon, Bristol Myers Squibb, Eisai, Novartis and Sanofi. Only one of its 11 digital offerings is commercialized so far, with the expectation that most of the rest will be by 2024. Voluntis is shooting for between $10 million and $15 million in “commercial invoicing” for 2021.
- Germany-based, rare disease-focused pharma company Vicore has inked a deal with Alex Therapeutics to develop a CBT-based DTx for people with idiopathic pulmonary fibrosis (IPF). Vicore also hired the Digital Therapeutic Alliance’s European lead Jessica Shull as its new head of digital therapeutics.
- CNS and critical care-focused pharmaco Ethypharm has created a new business unit called Digital Therapy SAS. It tapped Hélène Moore to lead it as EVP. The company recently partnered with GAIA and has said its first DTx will focus on depression.
- One more thing… Remember that student-led project that used a rolled-up piece of paper attached to a smartphone’s microphone to diagnose kid’s earaches? It used to be called Edus Health, but it’s back as Wavely Diagnostics. In mid-2020 Arna Ionescu Stoll, who you may remember from IDEO and Proteus Digital Health, joined as the company’s CEO. Its device is not yet FDA-cleared.
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Puzzling: More digital therapeutic-related CPT codes floated at the AMA’s Editorial Meeting
The American Medical Association’s CPT Editorial Meeting going on right now. It’s a hush-hush, everyone-signs-an-NDA type of meeting, so it’s difficult for an outsider to get a clear sense of what’s going on there.
The big hint, as always, is the meeting’s public agenda, which shows a couple of candidate CPT codes are up for discussion at this week’s meeting. (Remember, this is close to the earliest stage of billing code creation, so these may end up getting withdrawn, combined, etc.)
What’s odd, however, is they appear to overlap with the five Remote Therapeutic Monitoring codes E&O first reported on back in January.
Here’s an excerpt from Issue 085 (click the link for the full background here):
Like the existing RPM codes, the new RTM CPT codes correspond to three kinds of services. Here are the notes related to the new codes from the October AMA meeting:
“Accepted addition of five new codes 989X1, 989X2, 989X3, 989X4, 989X5 to report remote therapeutic monitoring initial set-up patient education, device supply and treatment management services.”
The May AMA CPT Editorial Meeting’s agenda includes three proposed CPT code changes or additions that caught my eye:
- Cat III – Validated Digital Behavioral Therapy for Substance Use
- Cat III – Remote Cognitive Behavioral Therapy Services
- Cat III – Remote Amblyopia Treatment
The first two bullet points are for proposals that would seem to overlap with the already accepted five codes from October’s meeting, right? Isn’t remote therapeutic monitoring inclusive of digital behavioral therapy for substance use as well as remote CBT services? And what’s the difference between “validated” digital behavioral therapy and remote CBT?
The seeming duplication of efforts is all the more puzzling if those RTM codes from October end up securing some kind of actual reimbursement from CMS while these Category III codes remain on the books to simply track utilization for some far-off, hoped-for CMS reimbursement.
In the near term, would that lead to a carve-out where digital therapeutics for substance use and those that use CBT don’t get reimbursed but others do? (That sounds absurd, but remember, we’re talking about the US healthcare system here.)
I’m curious what ends up happening with the RTM codes later this year. Maybe once the official descriptions of those codes are public, this mystery of nuance will reveal itself. (But, hey, if you know what’s going on here and are able to explain this to me, hit reply.)
The third proposed CPT code from my list above is for remote amblyopia treatment, which sounds tailor-made for the digital therapeutic from Amblyotech. (Yes, that’s the company that Novartis acquired last year.) The CPT request reads:
“Establish codes 0X57T, 0X58T, 0X59T to report treatment of amblyopia with continuous eye-tracking technology, remote patient-initiated treatment and transmission to a remote surveillance center.”
New SPAC: Decentralized trials startup Science 37 posted $24M in 2020 revenue up from $14M in 2019
Decentralized clinical trials company Science 37 has agreed to go public via a SPAC merger with LifeSci Acquisition II Corp that values Science 37 at slightly more than $1 billion.
“Science 37 believes that the success and future of clinical research demand the ability to activate and provide any patient, regardless of premises; a network of traditional providers, telemedicine providers, mobile nurses, and remote coordinators; and a flexible operating system to navigate between on-site and off-site research and care.”
Science 37 brought in $23.7 million in 2020 revenue, up from the $14.1 million it posted for 2019. The company expects to hit $52 million in revenue this year and is forecasting revenues just north of $100 million for 2022.
Science 37 added 27 new customers during the past five quarters — Q1 2020 to Q1 2021.
One of the more interesting slides in its investor presentation, which you can read in-full here, provided some details — including contract value — on 12 recent deals:
Clinical trial updates: AstraZeneca Amaze, UHG diabetes reversal, Kaia COPD, Noom NASH
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 had mentioned in previous issues.
In early April, AstraZeneca announced that it was collaborating with Mass General Hospital on two studies to pilot its new Amaze chronic condition management program, which is built on BrightInsight’s platform. New details are out this week on one of the studies. This 50-person asthma-focused trial aims to evaluate the implementation of Amaze within clinical practice and the results will help AstraZeneca make modifications to the platform or its implementation process.
“Each participant will be asked to complete the symptoms log daily for up to 6 months. Additional surveys will be completed throughout the study by participants and MGH clinical staff. The disease management platform includes a patient mobile application where patients can enter daily symptoms, communicate with their healthcare providers, and access educational materials. Additionally, the healthcare providers will have access to a dashboard that is integrated with the EMR and patient app.”
UnitedHealth Group is kicking off its diabetes reversal clinical study this month, which is likely using its Level2 program but doesn’t mention it by name in its study posting:
“The study team will study the efficacy of a high intensity medical weight loss intervention paired with a digital platform to create weight loss and induce remission of type 2 diabetes mellitus (T2DM) compared to a diabetes self-management education intervention. The digital platform provides the capability to tailor the treatment plan, provide automated support, and alert providers when a participant may need more support from the clinical team.”
UHG is using Abbott Freestyle Libre CGMs to collect blood glucose readings from the 30 anticipated participants. The study is largely focused on a diet-based intervention.
Kaia Health — which raised $75 million last week and I somehow failed to include it in my Monday edition this week — expects to complete its long-running COPD clinical trial in June.
“Increasing Physical activity (PA) is considered to be an important factor in efficient management of chronic obstructive pulmonary disease (COPD). The successful methods required to achieve improvements in PA following Pulmonary Rehabilitation (PR), however are sparsely reported. Therefore, the investigators conduct this trial to evaluate the effectiveness of using a COPD management program delivered to the patient through a mobile medical application Kaia COPD-App, after the completion of a PR.”
Noom is conducting a 16-week, 40-participant proof-of-concept study to evaluate “weight loss efficacy of Noom Healthy Weight (HW), a mHealth lifestyle intervention, in patients with [nonalcoholic steatohepatitis (NASH)].” Noom expects to kick it off in June.
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