Issue 156
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:
- The news cycle appears to be slowing down a bit as we head into the Fourth of July holiday weekend here in the States, so just four things in the round-up today before moving on to a longer piece on a new payer policy and a substantial review of recent clinical trial updates…
- AliveCor announced this week that the judge in its International Trade Commission (ITC) case against Apple has made an initial determination that Apple did infringe on some of AliveCor’s patents related to electrocardiogram (ECG) tech. The final decision will be made by a larger panel of ITC judges no later than October 26, 2022. The ITC has the power to ban the imports of Apple Watches with the infringing technology if the initial determination holds, but before it comes to that, it is much more likely that Apple will pay AliveCor to license its IP — just like it did AliveCor’s longtime investor, Qualcomm back in 2019. That one ended in a multi-billion dollar deal.
- The Digital Therapeutics Alliance sent a letter to the sponsors and co-sponsors of the Access to Prescription Digital Therapeutics Act of 2022 to thank them. I wonder if this thank you note is intended to be a nudge since the bill hasn’t moved much since it was introduced a few months back. Also: The letter of support lists big medical device lobby group AdvaMed as one of its signatories, which I believe is the first time it has come out publicly in support of the bill. (Re-read Issue 140 of this newsletter for more on what this bill specifically includes and what its backers hope to achieve through it.)
- Cognito Therapeutics raised $50 million led by FoundersX in Silicon Valley. An SEC filing shows the company sold more than $53.3 million in equity (out of a hoped-for $126.2 million total offering amount). Some of that $53.3 million also included convertible debt that was converted into equity. STAT has more on the raise here (subscription required).
- On a recent episode of Eugene Borukhovich’s DTx Podcast, he managed to get NightWare CEO and co-founder Grady Hannah to share that NightWare had been prescribed 200 times to active military servicemembers. That’s up from the 100 prescriptions E&O reported back in February (Issue 138). So, they’re averaging 25 prescriptions a month right now. NightWare uses the Apple Watch’s sensors and the company’s own app to detect when a person with PTSD is having a nightmare, then “the system rapidly delivers short vibrations to interrupt nightmares without waking the patient.”
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Déjà vu all over again: Paramount, a small insurer in Ohio and Michigan makes the case against prescription digital therapeutics
Paramount Healthcare, a small health insurance company in Ohio and Michigan with about 75,000 covered lives that’s owned by not-for-profit ProMedica, published a new coverage policy at the beginning of June focused on prescription digital therapeutics. It bears a strong resemblance to past coverage policies but also includes a few unique flourishes, so I figured I’d write this one up. (For example, the document specifically states that just because there is a HCPCS or CPT code for something, that doesn’t mean it’s covered.)
Here are some excerpts, starting with the criteria that Paramount used to determine that no prescription digital therapeutics are worthy of coverage yet:
“The following general Criteria are applied to digital health products, including digital therapeutic products, not already addressed in any other Medical Policy. The use of a digital health product in the treatment or prevention of any health condition may be considered medically necessary when all of the following criteria are met:
- The digital health product has been prescribed by a healthcare practitioner providing medical oversight; and
- The digital health product has been Food and Drug Administration (FDA) approved for the requested indication; and
- High-quality evidence demonstrates the digital health product improves clinically meaningful net health outcomes as much or more than an established alternative; and
- The improved net health outcome provided by the digital health product is attainable outside of experimental/investigational settings.
The use of a digital health product in the treatment or prevention of any health condition is considered experimental/investigational/unproven when the above criteria is not met; including but not limited to general wellness and fitness application, which are not considered therapeutic in nature.”
In its summary of evidence section, Paramount points to either not enough evidence or no net health outcomes improvement for each of the digital therapeutic categories it researched. And here is the list of prescription digital therapeutics that Paramount provided as a reference, which includes a few odds and ends like “digital infrared thermal imaging” (huh?):
“Paramount considers the following prescription digital therapeutics (PDTs) experimental and investigational because there is insufficient evidence in the published peer-reviewed literature to support their effectiveness; not an all-inclusive listing: BlueStar Rx, Canvas Dx, d-Nav, Endeavor Rx, Freespira, Halo AF Detection System, Insulia, leva Pelvic Health System, Nerivio, NightWare, reSET, reSET-O, Somryst, Glooko Mobile Insulin Dosing System, Go Dose System, My Dose Coach, Mahana IBS (formerly Parallel or Regul8), Digital infrared thermal imaging”
As I mentioned above, the kicker is this line about billing codes. Just speculating, but I bet the advent of CPT codes and the HCPCS code that Pear successfully secured from CMS are likely what led to Paramount’s team creating this policy document in the first place:
“Note, the fact a new service or procedure has been issued a CPT/HCPCS code or is FDA approved for a specific indication does not make the procedure medically reasonable and necessary.”
Clinical trial updates from Boehringer Ingelheim, Click Therapeutics, Koa Health, Akili, and Moderna
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.
Boehringer Ingelheim and Click Therapeutics post details about their study on a novel prescription digital therapeutic for schizophrenia
This one has been in the works for years, but I believe it is the first time the companies have posted details about their clinical study in the government’s database. The single-arm, seven-week feasibility and acceptability trial will focus on both the treatment and education components of Click’s digital intervention candidate. The study kicked off at the end of March and includes 48 participants. Here’s a bit more on the CT-155 study:
“CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia. During a PDT development lifecycle, iterations of the PDT may be scientifically evaluated in a user population that is clinically representative of the intended patient population. Data generated via this evaluation can be used to drive the modification and optimization of specific therapeutic components contained within a given PDT.”
Another new one: Click Therapeutics “basket study” on its platform’s ability to improve mood symptoms and cognition across a variety of conditions
Here’s a new one from Click. “Basket study” is a new term for me:
“CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a multimodal treatment in future prescription or non-prescription software-based digital therapeutics (PDT/DTx). CT-100 contains a class of Digital Neuro-activation and Modulation (DiNaMo) components. DiNaMo components target key neural systems (including, but not limited to, systems related to cognitive control, sensory-, perceptual-, affective-, pain-, attention-, social-, and self-processing) to optimally improve patients’ cognitive and mental health. The CT-100-001 DiNaMo is designed to improve cognitive impairments and mood challenges.”
“The purpose of the proposed basket study is to evaluate initial effects of the CT-100-001 DiNaMo (the Study App) on cognitive functioning and related outcomes compared to Care-As-Usual across several non-DSM-5 indications with known high prevalence of cognitive impairments due to the illness and/or treatments: Multiple Sclerosis, Mild Cognitive Impairment, and Cancer.”
Moderna is outfitting study participants with wearables to track reactions to mRNA vaccines to maybe find a digital biomarker
Here’s an interesting one from ModernaTx:
“The purpose of this study is to explore the physiological and behavioral impact of the immune response to vaccines after receipt of investigational or approved messenger ribonucleic acid (mRNA) vaccines using wearable medical sensors, with the potential of establishing a digital biomarker of vaccine response due to stimulation of the immune system.”
“Wireless wearable digital devices (including a small patch, modified watch, and datahub smartphone with electronic Patient Reported Outcomes [ePRO] capability) will be provided to each participant enrolled in the study.”
Akili pushes back its COVID brain fog study’s estimated completion date and tweaks inclusion criteria
Akili updated its COVID-related brain fog study by pushing out its anticipated completion date to January 2023. The company previously hoped to be done this month. One hint as to why: Akili also made it a little easier to participate in the study. The company added a line to its inclusion criteria so that more people who previously had COVID could participate. Originally, the study required participants to have been diagnosed via a PCR test, but now the inclusion criteria reads:
“… (or reported experience of COVID-19 symptoms with a documented positive antibody test or clinical diagnosis based on symptoms and accompanying physician’s note) …”
Meanwhile, Koa Health tightened up its exclusion criteria by barring participants who had previously used a CBT-based (cognitive behavioral therapy) app for obsessive-compulsive disorder (OCD) from participating in its feasibility, acceptability, and efficacy study for two digital health interventions at MGH.
“The primary aims of this study are to test the feasibility, acceptability, and efficacy of two digital health interventions for adults with OCD recruited nationally. Eligible subjects (N=120) will be randomly assigned (50/50 chance) to 12 weeks of app-based CBT on their personal Smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home. All participants will have access to a coach to help guide them through their assigned program. Total participation time for the study is approximately 6 months, and all study appointments (5 total) occur over secure phone or video conference call.”
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