Issue 119
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 going on this week in FDA-regulated and pharma-related digital health:
- The news you know: Two days ago CMS dealt a blow to those hoping to gain Medicare reimbursement via MCIT — a Trump administration-era payment pathway that would grant years-long reimbursement to (many) medical devices with Breakthrough designation from the FDA. This week CMS proposed to repeal the final rule. “We believe that the finalized MCIT/R&N rule is not in the best interest of Medicare beneficiaries because the rule may provide coverage without adequate evidence that the Breakthrough Device would be a reasonable and necessary treatment for the Medicare patients that have the particular disease or condition that the device is intended to treat or diagnose.”
- Interestingly, on that same day two days ago, the FTC published a policy statement on digital health not covered by HIPAA: “The Commission policy statement notes that apps and connected devices such as wearable fitness tracking devices that collect consumers’ health information are covered by the Health Breach Notification Rule if they can draw data from multiple sources, and are not covered by a similar rule issued by the Department of Health and Human Services. For example, a health app would be covered under the FTC’s rule if it collects health information from a consumer and has the technical capacity to draw information through an API that enables syncing with a consumer’s fitness tracker. Companies that fail to comply with the rule could be subject to monetary penalties of up to $43,792 per violation per day.”
- Luminopia, which has developed a TV-based digital therapeutic for the treatment of amblyopia, published positive results from its Phase III pivotal trial in the medical journal Ophthalmology.
- The German government added the 20th prescribable digital health offering to its DiGA program, which grants reimbursement (temporary in most cases) to digital health offerings that gain acceptance into the federal formulary. The latest addition is a knee pain-focused MSK program called Mawendo. More in the E&O DiGA tracker here.
- Renovia quietly secured its third FDA clearance for its leva pelvic health device and SaMD. The 510(k) took 31 days — just shy of Apple’s infamous 28-day De Novo!
- Otsuka envisions clinical social workers as key to its digital health ambitions with Abilify Mycite (and whatever else it does with its Proteus Digital Health assets moving forward). Based on comments it made to CMS this week about the proposed 2022 Physician Fee Schedule and the Remote Therapeutic Monitoring billing codes requirements: “CMS identifies physical therapists as one type of practitioner that would not be permitted to bill Medicare for the RTM services, as the codes are currently constructed. Clinical social workers are another type of practitioner that would face this problem. A clinical social worker must ‘(1) [p]ossess[] a master’s or doctor’s degree in social work; (2) [a]fter obtaining the degree, has performed at least 2 years of supervised clinical social work; and’ (3) meet certain state licensure requirements or [have] performed a certain number of hours of post master’s degree work in an appropriate setting. These practitioners play a critical role in mental health care and we anticipate that there will be forthcoming digital technologies in the mental health space that could be used by clinical social workers.”
- One more thing… Akili Interactive’s EndeavorRx, its “prescription video game treatment for kids 8-12 years old diagnosed with ADHD”, is no longer iOS-only — it’s now available to Android device users.
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Premera Blue Cross pokes holes in prescription digital therapeutics companies’ clinical results
Last month Premera Blue Cross published a coverage policy for prescription digital therapeutics that explains why it has decided not to pay for any of the prescription digital therapeutics on the market currently.
Premera describes itself as the largest health plan in the Pacific Northwest, serving more than 2 million people, in Washington state and Alaska.
Premera’s document takes a fairly inclusive stance for what constitutes a prescription digital therapeutic. While it notes in multiple places that this is not meant to be an exhaustive list, Premera specifically digs into seven PDTs from Pear Therapeutics (Somryst), Akili Interactive (EndeavorRx), Welldoc (BlueStar Rx), Cognoa (Canvas Dx), Freespira (Freespira), LIVMOR (Halo AF Detection System), and NightWare (NightWare). As of August 2021, Premera considers all seven of these “investigational”.
While there are a half dozen or so criteria listed, the one that seems most relevant is this one:
“There is credible scientific evidence* which permits reasonable conclusions regarding the impact of the prescription digital therapeutic on health outcomes… (*Credible scientific evidence means well-designed, well-conducted investigations published in peer-reviewed journals that demonstrate the technology can measure or alter physiological or psychological changes related to a disease, injury, illness or condition and that these changes positively affect health outcomes for an extended period of time.)”
The 22-page document (read it in full here) offers some insight into how commercial payers are pushing back against paying for PDTs. Here’s a rundown of the specific shortcomings that Premera seized on while reviewing the clinical studies of each of these already FDA-cleared SaMDs.
Cognoa‘s CanvasDx autism spectrum disorder (ASD) diagnostic aid:
“Limitations of this study are similar to the previous 2018 published study discussed above and include the following: the study was a retrospective analysis, the clinical validation was weighted towards an autism diagnosis since the participants were preselected as having a high risk of autism, the same n=162 validation sample cohort from the 2018 published study which was unblinded was added to a sample of N=213 that was blinded but now in this study a clinician questionnaire was added as well as the SRS-2 was added as a baseline screening tool and so this makes the clinical validation sample of the blinded study for all three modules still very small, the new clinician module was only tested at three academic tertiary care clinical centers so the ability to generalize its accuracy in a primary care setting cannot be made, and there is a potential for bias as the study authors were all affiliated with Cognoa. Prospective, well-designed, randomized studies are needed with larger sample sizes from the general population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.”
Akili‘s EndeavorRx for ADHD:
“The study reported that scores of validated attention measurement tools, (Test of Variables of Attention, Attention performance index [TOVA-API]) improved 47% vs 32% with the EndeavorRx than with the control inactive digital intervention. However, there were no between-group differences for secondary measures, which included the parent and clinician ratings of ADHD symptoms. The authors note that the trial is insufficient to suggest that AKL-T01 should be used as an alternative to established and recommended treatments for ADHD. Additional RCTs with more than one validated scale, and with longer-term follow-up are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.”
Pear Therapeutics‘ Somryst, a PDT that treats insomnia:
“Limitations of the reported trials: 2 of the studies had small sample sizes of < 100 participants, several of the studies had high attrition rates, and because all of the studies assessed the web-based SHUTi platform, it is unknown if there are differences in the patient experience using the Somryst app on a mobile device. RCTs that compare Somryst with in-person CBT-I and as an alternative or adjunct to sleep medication would be useful. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.”
Freespira for panic disorder or PTSD:
“Limitations of these studies include small sample size, lack of control groups, lack of randomization, and lack of blinding. Larger RCTs are needed with longer-term follow-up and with a comparator of other panic disorder treatments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.”
Welldoc‘s BlueStar Rx:
“Limitations include the following: Sample size was very small, lack of blinding could influence the results as the participants knew their actions and behaviors were being monitored as the intervention group received requests from the study interviewers to complete follow-up surveys, there were some reported technical difficulties where the Bluetooth adapter did not always transmit data and had to be manually entered into the phone as it was acknowledged that actually only 5 of 15 patients regularly used the Bluetooth mode of data entry…”
“Limitations of this study include the following: There was a high rate of drop-out, 34.5 percent (77/223). The authors note having the participants use a second smartphone rather than downloading the app to their cell phone may have posed a barrier to use and in this study the Diabetes Education Programs did not have communication with the primary health care providers which may have impacted support for use of the app. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.”
Premera only included one-liners for both LIVMOR and NightWare:
“There is no published peer-reviewed evidence for Halo AF Detection System.”
“There is no published peer-reviewed evidence for NightWare.”
Trial updates: Pfizer, AstraZeneca, AiCure, AppliedVR
Here’s E&O’s weekly roundup of changes and additions to clinical trials focused on FDA-regulated digital health devices and other pharma-related digital health.
Pfizer’s Crohn’s study with LyfeMD is now recruiting
Pfizer is working with academics in Canada to study a digital health program called LyfeMD that might be used together alongside the pharma company’s biologic Inflectra for Crohn’s disease. The study is now recruiting.
“…a digital health platform for patients living with both Crohn’s disease (CD) and Ulcerative colitis (UC). Dr. Raman and her team have developed an app called LyfeMD, by translating leading scientific research into a practical and engaging digital format. LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence-based lifestyle therapies. LyfeMD is one app with multiple features – ranging from a customized diet using anti-inflammatory principles identified from recent research led by Dr. Raman’s team, and exercise plans to mindfulness and stress reduction programs.”
AppliedVR’s sick cell disease trial to kick off next month
This AppliedVR study was set to start in July but is now looking to get started in October:
“This project will evaluate AppliedVR’s EaseVRx — a multi-modal, skills-based, 8-week, virtual reality, home intervention – in an exploratory randomized controlled trial for self-management of chronic pain among Black, young adults (ages 18-40) with sickle cell disease.”
AstraZeneca and Huma’s London-based pre-diabetes study now recruiting too
“Digital remote patient monitoring using blood pressure and blood sugar devices in combination with a smartphone application (‘the Huma app’). Participants are provided with home monitoring devices and download the Huma app. Participants are shown how to use the devices, how to input measurements into a smartphone and how to set personal goals. Data recorded via the Huma app is self-reported and includes activity data, diet information, blood glucose measurements, blood pressure measurements, weight, and the Diabetes Distress Scale (a self-reported questionnaire used to measure distress related to living with diabetes).”
AiCure and Merck Sharp & Dohme’s facial recognition DOT trial fizzles
This AiCure study (completed in early 2019) ended early after enrolling 11 participants instead of the hoped-for 75.
“Early termination due to discontinued funding led to small numbers of subjects analyzed, and study personnel were no longer available to work on this study.”
While the low numbers (for a three-arm study) probably made it insignificant, those randomized to the intervention seemed to take their medications less than the control group, but all were within the range of what was considered adherent. Here’s a description of the intervention:
“Automated [Directly Observed Therapy] (a-DOT), a smartphone app that uses facial recognition software and advanced features to detect non-ingestion, combines the accuracy of in-person DOT with the convenience of real-time centralized data collection and monitoring. Adding a daily side effect diary to a-DOT will further allow precise tracking of timing of both medication ingestion and side effects which may be compromising adherence.”
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