Issue 210
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 are a few quick bullets on things happening in FDA-regulated and pharma-focused digital health:
- As Biogen deprioritizes digital health internally (more on that below), Pfizer lobbies CMS on prescription digital therapeutics. In a recent letter to CMS, Pfizer’s Senior Director, Head of Federal Policy US Policy and Government Relations Margaret Davis-Cerone wrote: “Revise Benefit Category Review in TCET process: Pfizer is particularly interested in ensuring the TCET pathway is crafted in a manner that is inclusive of PDTs. PDTs are patient-centered tools that can enhance health equity, facilitate personalized care, and prevent more invasive healthcare interventions. Understanding that many PDTs are new, innovative technologies and that current statute, regulation, and guidance do not offer clear instruction on which benefit category PDTs may fall under, Pfizer recommends that the TCET Benefit Category Review process as discussed on 88 Fed. Reg. at 41640 be revised to accept PDTs designated as Breakthrough Devices into the TCET pathway if such devices are ‘reasonably likely to fall within a Medicare benefit category, or are closely related to or supportive of a covered item or service.'”
- Missed this but last month Better Therapeutics disclosed that it had decided to price AspyreRx at $750 for a 90-day prescription. This is in line with what I wrote back in July (“between $500 and $800 net”) when the company announced FDA market authorization for the diabetes-focused digital therapeutic.
- My old colleague Jonah Comstock (we were both at MobiHealthNews during the early years of digital health) posted his notes from the DTx East event in Boston in the form of a live blog over at PharmaPhorum. I found these helpful to follow along from afar: Start here with his DTx East Day 1 notes.
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Biogen cuts digital health unit. Here are the 11 digital health programs it was running.
The news you know: Following some telling posts on LinkedIn, STAT broke the news this week that Biogen was shutting down its digital health business unit and laying off around 100 people focused on digital health. STAT also reported that its sources indicated Biogen will stop supporting a co-development deal with MedRhythms for MR-004, a Multiple Sclerosis-focused prescription digital therapeutic. Read STAT’s full write-up here.
Under its previous CEO, Biogen made digital health a core focus of the company. Biogen held a digital health-focused investor day in 2021, and in its 2022 annual report (10-K filing with the SEC) the company even added digital health and digital therapeutics to the first paragraph of its business description:
“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. We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities.”
Rather unprecedented for a big pharma. However, the section above was removed in the 2023 version of the annual report this past February. In fact, the report didn’t include a single mention of digital health. Back in 2022, Biogen pointed to four “value creation objectives” for its digital health programs:
- “Potentially improve efficiency of clinical development
- Evidence and companion technologies that may enhance risk/benefit profile of Biogen therapies
- Aim to expand market opportunities (screening, diagnosis, adherence, compliance)
- Potential adjacent source of revenue (prescription digital therapeutics, software as a service – imaging, digital biomarkers etc.)”
About a year ago, Biogen shared an overview of all of its digital health programs — 11 in total. They spanned Multiple Sclerosis, Alzheimer’s and other dementia, neuromuscular disorders, and more. Which of these are on the chopping block now isn’t entirely clear:
Biogen’s Multiple Sclerosis-related digital health programs: MR-004 — DTx — Development — MS Patients walking & independence —
“Biogen entered into a license agreement with MedRhythms to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis. The investigational prescription digital therapeutic uses a combination of sensors, software, and music based on Rhythmic Auditory Stimulation (RAS).”
Cleo/Aby — Digital Companion — In-Market — Patient Pathway Improvement —
“Cleo (Aby in North America) is a digital care companion app to help people live with Multiple Sclerosis. It provides information, tips, symptoms tracking, reminders, tailored programs for self-care such as nutrition, mindfulness, and a nurse chat.”
MS PATHS — Research Network — In-Market — Digital Biomarkers/Personalized Medicine —
“Uses advanced technologies to generate & collect standardized patient data during routine office visits potentially resulting in a large, high definition and diverse real-world MS cohort.”
CogEval — Cognitive Assessment — In-Market — Digital Biomarkers/Personalized Medicine —
“CogEval is an iPad-based assessment designed to evaluate cognitive function in-clinic for patients with multiple sclerosis.”
MS Performance Test — Digital Biomarkers — In-Market — Digital Biomarkers/Personalized Medicine —
“In-clinic assessment tool that aims to objectively quantify the major motor, visual, and cognitive systems, as well as quality of life and disease history for patients with MS. HCPs can access patient results at the point of care.”
Biogen’s Alzheimer’s and dementia-related digital health programs:
AI^2 ARIA Identification — Imaging AI — Development — Personalized Medicine —
“AI-squared may be integrated in radiologist workflow/PACS and aims to provide validated, automated MRI assessment report of quantification, severity status and location of ARIA-H and ARIA-E events.”
Intuition — Digital Biomarkers — Development — Digital Biomarkers —
“Virtual, observational study leveraging the Apple Watch, iPhone, and CANTAB battery to potentially discover digital biomarkers for MCI screening and potentially track cognitive changes in adults.”
Biogen’s neuromuscular-related digital health programs:
Physio [dot] me — Digital Companion — Development — Patient Pathway Improvement/Personalized Medicine —
“Digital physiotherapy companion that offers to perform at-home, tailored, secure exercise so NMD patients can potentially achieve their goals, measure progress and share progress with their care team.”
Capsule — VR solution — Development — Patient Pathway Improvement —
“Evidence-based medical device that combines immersion through virtual reality technology and medical hypnosis to potentially alleviate anxiety related to intrathecal injection procedures.”
Biogen’s other digital health programs (touch on most disease areas)
Konectom (Multiple Sclerosis, neuromuscular disorders, Parkinson’s) — Digital Biomarkers — Validation — Digital Biomarkers/Personalized Medicine —
“Smartphone-based digital measurement platform that aims to assess key neurological functions such as cognition, fine and gross motor control, walk, quality of life and mobility in clinical studies, in-clinic or remotely.”
Neurodiem — Digital Portal — In-Market — Patient Pathway Improvement —
“Independent information & education portal for HCPs specialized in the care of patients with neurological diseases. Allows HCPs to access scientifically-validated, independent content to help them remain at the forefront of their practice and deliver the best care to their patients.”
Trials: Biogen-Apple, Janssen, GAIA, and Arcade Therapeutics
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
Terminated: Biogen’s study with Apple on cognitive performance
As STAT and others have reported, Biogen terminated its study with Apple as part of its restructuring plans:
“Terminated (Study was terminated early as part of Biogen’s ongoing research and development portfolio management efforts.)”
Here’s a brief summary of the study, which managed to recruit an impressive 22,700 out of the 23,000 anticipated participants:
“The primary objectives are to develop and validate a classifier using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage to distinguish individuals with normal cognition from those with mild cognitive impairment (MCI) and to develop and validate a cognitive wellness score that tracks fluctuations in cognitive performance over time using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage.”
New: Janssen study on Care4Today for heart disease patients
Janssen posted a new three-month study of its Care4Today digital platform for heart patients:
“The purpose of this study is to assess the engagement and usefulness of Care4Today Connect CAD-PAD digital platform in participants with coronary artery disease or peripheral artery disease (CAD or PAD).”
Completed: GAIA’s study on its insonmia digital therapeutic, somnovia
Every week there’s a new update on a GAIA trial. This week it reported the completion of its 290-person trial for somnovia, its digital therapeutic for insomnia. More:
“The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.”
Delayed: Arcade Therapeutics study on ABM-01 digital therapeutic for anxiety
Arcade Therapeutics (formerly Wise Therapeutics) and its research collaborators Hunter College pushed back the primary completion date of this study by a year — June 2024. It’s now set to be entirely finished by August 2024. More:
“Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on SAD symptoms, and metrics of functional impairment during this time. After the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.”
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