Issue 175
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 this week in FDA-regulated and pharma-focused digital health…
- A few new twists and turns in the AliveCor-Apple patent lawsuits and potential import ban. (Even some just now breaking news… read this blurb until the end for that.) First, the news you likely know: Apple successfully convinced a panel of judges at the USPTO’s Patent Trial and Appeal Board (PTAB) that the three AliveCor patents in dispute were ruled unpatentable. A judge at the International Trade Commission, which is set to decide whether or not to ban the import of Apple Watches by this coming Monday, had previously ruled that Apple had infringed on two of AliveCor’s patents. After the PTAB ruling earlier this week, Apple immediately filed the PTAB decision with the ITC and asked for an emergency stay in the case. AliveCor responded by noting to the ITC that Apple has asked been asking the ITC to wait for a decision from PTAB from the very beginning and the ITC has always turned Apple down. AliveCor basically wants the ITC to ignore the PTAB ruling since the ITC already ruled on the patent infringement and, AliveCor argues, it is only supposed to make its final decision about an import ban on Apple Watches based on public benefit grounds. Certainly curious timing from PTAB — handing down its decision just days before the ITC’s December 12 deadline. Breaking: The ITC just decided to delay their deadline from December 12 to December 20 in light of the PTAB decision and Apple’s request.
- The Access to Prescription Digital Therapeutics bill, which would create a Medicare benefit category for prescription digital therapeutics were it to become a law, just secured another high-profile senator as a co-sponsor: Senator Cory Booker (D-NJ).
- Di-nied: Germany’s national, reimbursed prescription digital therapeutics program, DiGA, just removed another digital health program for failing to prove its effectiveness during its provisional listing. (This is the fifth to be removed. 33 out of 38 are currently available either on a provisional or permanent basis.) Selfapy’s Online Course for Panic Disorder was removed in mid-November after “no positive supply effect could be demonstrated for the DiGA.”
- Back in the States the FDA posted a new mini-database of all the virtual reality and augmented reality-enabled medical devices that it has cleared over the years. I asked an FDA spokesperson about the timing of this new resource focused on AR/VR. Why now? “There were a few reasons – we recognize that this is an area of growing interest and we wanted to publish it as a resource to the public about these devices and the FDA’s work in this area. I would note that the publication is also timely after hosting the July PEAC meeting regarding Augmented Reality (AR) and Virtual Reality (VR) Medical Devices.”
- One more thing… The Digital Therapeutic Alliance put out a worthwhile whitepaper focused on how digital therapeutics companies should think about evidence generation and trial design. Read it here.
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AMA to (once again) consider CPT billing codes for remote uroflowmetry, text-based telemedicine, and psychedelic drug monitoring
What’s old is new again: The initial agenda is out for the American Medical Association’s CPT Editorial Panel’s February 2023 meeting, and it includes three groups of codes for digital health-related services that had previously attempted to make their bid in front of the panel but ultimately withdrew their submissions or — in one case — were postponed. Significantly fewer digital health-relevant CPT code submissions for this next meeting, and as noted above the relevant ones are all ones E&O has reported on in the past.
First up the Cat II codes:
“Remote Patient Multi-day Comprehensive Uroflowmetry – Establish two codes 9X073, 9X074 to report remote patient multi-day comprehensive uroflowmetry” (a very similar submission was made for the September 2022 meeting but was ultimately withdrawn) See E&O Fridays Issue 166.
“Telemedicine Modifier: Establish a new modifier X0 to report synchronous (live), text-based telemedicine service” (a similar but less concisely worded version of this one was submitted and withdrawn at the September 2022 meeting too.)
Finally, a similar submission for Cat III codes that were submitted and then withdrawn just before the September 2022 meeting:
“Cat III – Psychedelic Drug Monitoring Services – Establish three Category III codes X088T, X089T, X090T and Category III guidelines to report Psychedelic Drug Monitoring Services”. Key difference this time around is that the submitter is only asking for three codes instead of four. It’s unclear what the four codes corresponded to last time, but in that prior submission, the applicant explained they were “for reporting psychedelic drug monitoring services; and create a new subheading ‘Continuous Therapeutic Monitoring, Assessment and Intervention for Psychedelic Medication’ with guidelines.”
Clinical trial updates: Akili, Dreem, Novo-Ksana, Storyful, Silvercloud, Woebot, and Swing 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 that E&O mentioned in previous issues.
Completed: Akili’s study on EndeavorRx for adolescents with ADHD
This study finished up in September but the company just updated the study’s page in the government database this past week. Remember: EndeavorRx is currently only available for kids aged 8-12, so this study is to support the company’s submission for a new FDA clearance for EndeavorRx that would expand its label to include adolescents aged 13 to 17. More:
“This study is a multi-center, unblinded/non-controlled study to evaluate objective attention functioning and ADHD symptoms and impairments in adolescents aged 13 to 17 years old, with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 4-weeks of AKL-T01 treatment.”
Finished recruiting: Akili’s study on EndeavorRx for adults with ADHD
So, the adult submission to the FDA is likely to follow the adolescent one mentioned above. More:
“This study is a multi-center, unblinded/non-controlled adaptive design study to evaluate objective attention functioning and ADHD symptoms and impairments in adults with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 6 weeks of AKL-T01 treatment.”
New: Dreem’s CBT for insomnia program and device studied to determine its effect on dementia risk (and Alzheimer’s) over time
Dreem, a direct-to-consumer sleep tracking device company that has pivoted in B2B now too, is developing an FDA-cleared device that includes a CBT for insomnia program. This study is focused on that program paired with an exercise program to see its affect on dementia risk. The study’s title specifically mentions “Alzheimer’s” so it may be even more tightly focused. More:
“Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy – Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).”
New: Novo Nordisk taps Ksana for teen mental health and obesity prevention app
This pilot study started up in early November and should finish in March. More:
“The primary aim of this project is to examine the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in a 2 x 2 (gender x condition) designed pilot study in a sample of 100 youth (18-25 years old) with (1) elevated depressive symptoms (PHQ-8 score ≥10) and (2) overweight/obesity (BMI ≥ 25 and/or reporting a parental history of overweight/obesity). The study will examine the feasibility and utilization of the mobile app intervention with coaching compared to that of the mobile app intervention without coaching.”
New: San Diego VA, NIDA and VRx Medical test feasibility of AR-based digital therapeutic for arthritis
This 36-person study is on the Nottingham Arthritis App for Arthritis Pain. More:
“The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with chronic hand joint pain due to arthritis.”
Now recruiting: Storyful Health and Duke’s heart failure study
E&O has reported on this study in prior issues. Storyful is led by a former Verily exec. More:
“The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction.”
Now recruiting: Washington University School of Medicine’s Silvercloud (now a part of Amwell) study on a digital program for anorexia nervosa
Remember: Silvercloud is now a part of American Well (aka Amwell). More on this study:
“The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period.”
Terminated: Woebot’s RCT for a head-to-head digital therapeutic for depression vs educational app
Woebot terminated this study “due to difficulty enrolling patients in the proposed time frame.” More:
“The primary aim of this study is to investigate the difference in depression symptoms at 4-weeks across two types of programs for addressing depressive symptoms, including Woebot (WB002) and Digital Education (ED002). The secondary aim of this study is to investigate the difference in anxiety symptoms at 4-weeks across the two programs. The tertiary aim of this study is to evaluate the feasibility, acceptability, and satisfaction of each program.”
Tweaks to Swing Therapeutics’ study on a digital therapeutic for fibromyalgia
Swing noted that this was a Phase 3 study after previously claiming that the label wasn’t applicable to this study. Also: it changed its primary outcome measures. The company deleted its first outcome measure: Mean change from baseline (CFB) in the FIQ-R total score at 12 weeks. FIQ-R is the revised Fibromyalgia Impact Questionnaire, which is one of the common outcome measures for studies about the medical condition. More on the 300-participant study:
“PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive assigned therapy for 12 weeks.”
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