Issue 133
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.
Going to skip the bullets today to dig right into this eyebrow-raising Aetna policy document. Also: Curious to hear your reactions to it, Should payers continue to evaluate prescription digital therapeutics as a group? Did a friend forward this to you? You, too, can win friends and influence people via newsletter forwards by clicking right here. Become the newsletter-forwarder we both know you were meant to be. Act fast! This offer won’t last forever (I am not immortal).
Aetna: These 13 Rx-only digital therapeutics have insufficient evidence and we won’t pay for them.
If you remember just four short months ago (Fridays Issue 119), E&O had a scoop about pacific northwest health insurance company Premera Blue Cross posting a new policy document that explained why they would not pay for prescription digital therapeutics. Well, a week ago a bigger (and nationwide) payer, Aetna, published its own clinical policy focused on prescription digital therapeutics. Aetna reached the same conclusion as Premera:
“Aetna 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:
- [Welldoc’s] BlueStar Rx
- [Cognoa’s] Canvas Dx
- [Hygieia’s] d-Nav
- [Akili’s] Endeavor Rx
- Freespira
- [LIVMOR’s] Halo AF Detection System
- [Voluntis/Aptar’s] Insulia
- [Renovia’s] leva Pelvic Health System
- [Theranica’s] Nerivio
- NightWare
- [Pear Therapeutics’] reSET
- [Pear Therapeutics’] reSET-O
- [Pear Therapeutics’] Somryst.”
Aetna’s policy document appears to be based on research the insurer conducted in October and November 2021. Like Premera, Aetna went through and summarized the results published in the medical literature for each of the PDTs it named in its list above, but it seemed like Aetna’s review was a bit less pointed than Premera’s. Some of Aetna’s blurbs about the evidence didn’t make clear why the payer wasn’t convinced by the results.
It still strikes me as odd that both Premera and Aetna have created medical policies for a category of therapeutics that spans so many different therapeutic areas. Does it really make sense for payers to evaluate prescription digital therapeutics as a category? Aetna referred to them as “a novel therapeutic class.” As one reader told me: This review is more of a “modality” review than a more traditional therapeutic class review. It’s weird and might be unprecedented? Back to Aetna’s policy doc.
Here’s a quick rundown of an important line or two from each product’s evidence review:
Here’s Aetna on Welldoc’s BlueStar Rx:
“The results did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG-WLC] -0.42, 95% Confidence Interval [CI] -1.05 to 0.21; p=0.19). Additionally, no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and healthcare utilization behaviors were observed. Significant variation in app usage by site was noted such that participants from one site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124), whereas participants at another site showed a notable decrease in app usage (median 9; IQR 6-51). The investigators concluded that there was no difference between intervention and control arms for the primary outcome of glycemic control measured by HbA1c levels and the low usage of the app among participants warrants further study of patient and site-specific factors that increase app usage.”
Here’s Aetna on Cognoa’s Canvas Dx:
“While significant accuracy improvement compared to standard screening tools in measurements of AUC, sensitivity, and specificity was demonstrated, the authors discuss a myriad of confounding factors in the clinical analysis and also note the results are statistically limited. Additional clinical studies are warranted to firmly support the findings of this study that a mobile, machine learning process can be a reliable method for detection of autism outside of clinical settings.”
Aetna’s summary criticism of Hygieia’s d-Nav:
“The investigators concluded that automated insulin titration guidance in combination with healthcare provider support provides superior glycemic control compared with stand-alone healthcare provider support. However, there is additional need to perform an evaluation across large healthcare systems to validate these findings.”
Aetna’s summary of the results from Akili’s Endeavor Rx studies:
“The investigators concluded based on the evidence, AKL-T01 might be used to improve objectively measured inattention in pediatric patients with ADHD with minimal adverse events.”
Aetna’s summary of the Freespira study was one of a few where the payer didn’t explicitly call out how the study’s results fell short of its standard:
“This study served as a benchmarking analysis against a prior published controlled trial and confirmed prior clinical results and further supported the viability of CGRI in the treatment of PD.”
LIVMOR’s case was cut and dry:
“Currently, there is a lack of published peer-reviewed evidence available.”
Aetna’s summary of the evidence for Voluntis/Aptar’s Insulia subtly noted that the PDT showed similar results to another group in the study that was cared for by a team using phone call-based check-ins:
“The absence of severe hypoglycemia was noted in the telemonitoring groups. Mild hypoglycemia frequency was similar in all groups. The investigators concluded both telemonitoring systems improved glycemic control to a similar extent without an increase in hypoglycemic episodes.”
For Renovia’s study Aetna pointed out:
“Notably, this study was prematurely stopped due to device technical considerations.”
Aetna pointed out that in one of Theranica’s studies “a device-related adverse event was observed,” but it didn’t spell out anything else about the two small studies it highlighted from the company.
NightWare got the same review LIVMOR did: “Currently, there is a lack of published peer-reviewed evidence available.”
For Pear’s reSET, Aetna included this summary line:
“The investigators noted that additional investigation is needed to assess effectiveness in non-specialty clinical settings and to distinguish the effects of the community reinforcement approach and contingency management facets of TES.”
For Pear’s reSET-O, Aetna’s summary only includes positive conclusions:
“The investigators concluded that TAU plus a digital therapeutic improves clinically significant patient outcomes including abstinence from illicit opioids and retention in treatment compared with TAU.”
Similarly, Aetna’s review of Pear’s Somryst data didn’t include any explicitly negative conclusions. At worst, they were wishy-washy:
“The investigators concluded that internet-delivered CBT-I may have a pivotal role in the communication of effective behavioral treatments.”
Clinical trial updates from Akili, Woebot, Apple, Pear, and Adhera
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.
Akili posts details of STARS Adults study for ADHD
Akili actually started this study at the end of November 2021, but just posted details on CT [dot] gov recently. The new study is similar to a few of Akili’s other recent ones but this study focuses on adults instead of children or teenagers:
“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.”
Yale-Mayo study of Pear’s insomnia PDT Somryst begins recruiting
Small update on this Somryst study E&O has tracked since last May: It’s now recruiting. As a reminder, this one pairs Somryst (PEAR-003) with a Fitbit device through a platform named Hugo:
“This will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia using a novel patient-centered data-sharing platform with linkage to Fitbit for 61 weeks.”
Adhera Health’s study of its VR therapeutic for perioperative care
New details on a new study of a SaMD. Here’s the background on Adhera Health’s CARINAE:
“Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure. Provision of education and information about the surgery can be a crucial component of the preoperative experience and is inversely related to levels of preoperative anxiety. However, resource constraints make face-to-face education sessions untenable, given cost considerations and time investment by trained health personnel… According to this, the Software as a Medical Device (SaMD) CARINAE, aims to support patients and caregivers during the whole perioperative process. SaMD CARINAE consists of an mHealth mobile application for patients and caregivers, a Virtual Reality headset for patients, and a web application for healthcare professionals.”
Apple and Anthem push back their asthma SaMD study’s end date to December 2023
Small update: Apple and Anthem changed their planned primary completion and final completion dates for their study of an asthma SaMD to December 2022 and December 2023 from March 2022 and March 2023, respectively. Notably, the companies ticked the box that this will be an FDA-regulated device.
Woebot’s study of its DTx for teenagers, W-GenZD, is complete
No results yet but Woebot noted that its study of a DTx for depression in adolescents recently finished up:
“The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.”
More on the DTx:
“W-GenZD is powered by natural language processing and machine learning techniques, the brief, self-guided intervention draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT-A) and some elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile medical application is designed to be targeted, relevant, tailored, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.”
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