Issue 103
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.
OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- AliveCor filed its third lawsuit against Apple this week. This one is an antitrust suit (clearly taking a cue from Epic Games). AliveCor alleges that Apple made a series of anticompetitive moves to cripple its SmartRhythm app for the Apple Watch so that it would not compete with Apple’s FDA-cleared ECG app. (E&O was the first to report that AliveCor shut down SmartRhythm back in 2019.)
- Doximity just filed for an IPO. Its S-1 shows it posted $206.9 million in revenue for the twelve months leading up to March 31, 2021. Almost twice what it brought in the year prior. Doximity describes itself as the “leading digital platform for US medical professionals, as measured by the number of US physician members, with over 1.8 million medical professional members… [or] more than 80% of physicians across all 50 states and every medical specialty.” Most of its revenue comes from pharma companies, but it also offers remote care tools to its physicians. 300,000 unique providers used Doximity’s telehealth tools in Q1.
- Belgium, which put together a somewhat similar digital health program to Germany’s DiGA, still hasn’t given any digital health interventions its Level Three designation, which would unlock reimbursement from the government. The 31 apps in the Belgian government’s database all have CE Marks (Level One) and some have demonstrated interoperability with the country’s eHealth platform (Level Two).
- The FDA granted Breakthrough Device Designation to Woebot’s digital therapeutic for the treatment of postpartum depression (PPD), which is codenamed WB001.
- Two weeks ago I mentioned that One Drop has secured a CE Mark for its blood glucose prediction analysis engine. This week One Drop announced a CE Mark for a similar trend analysis engine, but this one is for people with high blood pressure.
- One more thing… AppliedVR just received a $5 million growth capital term loan from Silicon Valley Bank as its continues to develop EaseVRx, a virtual reality-based digital therapeutic that treats conditions related to chronic pain. (EaseVRx is another DTx with Breakthrough status from the FDA.)
Whoa, whoa… Hey there, stranger. Was this paying subscribers-only newsletter forwarded to you? Follow me over to E&O HQ for a minute.
Four formularies that list Akili’s EndeavorRx
The news you know: Akili Interactive Labs just raised a big Series D: $110 million plus another $50 million in debt financing. Neuberger Berman Funds led the round.
The funding will help accelerate the launch of its first commercialized product, EndeavorRx. It’s already available and prescribable today, but so far Akili has been executing a slow roll-out strategy.
As Akili CEO Eddie Martucci said in a recent podcast interview:
“We actually swung nearly 180 degrees in the other direction from a kind of big bang pharma launch, and have instead been pursuing these smaller, more targeted tests, where we’re seeing live patients come through live prescriptions come through full payment cycle, full use cycle, and we’re adapting and iterating because we’ve decided we want to model and so for us, that meant start in a lean way and grow over time.”
E&O reported a few weeks ago that Akili just began marketing EndeavorRx directly to caregivers via targeted Facebook and Instagram ads. Those started in mid-May.
Despite the decidedly slow rollout, Martucci told the Boston Business Journal that a handful of formularies had already added EndeavorRx — even though Akili hadn’t approached them to do so yet. He didn’t share any names, however.
That got me thinking and I dug around to see if I could find any evidence of which formularies added EndeavorRx in recent months. Here are a few examples:
OptumRx’s formulary for state employees in Alaska
OptumRx, the PBM owned by UnitedHealth Group, included EndeavorRx in its 2021 formulary for state employees in Alaska. EndeavorRx is listed as a Tier 4 drug, which in this formulary means it is the “highest-cost” and “non-preferred”.
“Many Tier 4 drugs have lower-cost options in Tier 1, 2 or 3. Ask your doctor if they could work for you.”
California’s Medicaid formulary facilitated by Anthem Blue Cross
Anthem’s formulary for California Medicaid beneficiaries lists EndeavorRx in its Medicaid-approved Drug List formulary for 2021. EndeavorRx’s listing in this formulary really shows that PBMs don’t know where to put digital therapies. EndeavorRx is featured under the confusing header: “DIGITAL THERAPY – VITAMINS AND MINERALS.” In this case, the formulary uses a two-tier system and EndeavorRx is labeled as a Tier 2 drug. Anthem explains:
“Tier 2 drugs are the drugs not preferred by your health plan. They may be generic or brand drugs, based on how well they work and their cost compared to other drugs used for the same type of treatment. Some are generic drugs that may cost more because they’re newer to the market. Tier 2 drugs may require your doctor to ask us to review the coverage. This process is called preapproval or prior authorization.”
MedImpact’s formulary for Louisiana State University
LSU’s new PBM partner for 2021, MedImpact, also included EndeavorRx in its formulary for 2021. Two things are interesting about this listing.
First, MedImpact positioned EndeavorRx in a category called “Digital Therapy” under a macro-category called “Miscellaneous Therapeutic Classes.” The “Digital Therapy” subcategory is sandwiched between chelating agents and homeopathic products.
Second, EndeavorRx is listed alongside Pear Therapeutics’ DTx: reSET, reSET-O, and Somryst. Interestingly, all four of these digital therapeutics seem to be listed in this formulary thanks to a partnership with SilverCloud, which seems to help onboard people.
Each of the digital therapy products are noted as Tier 3, which is the highest tier for this formulary.
CVS Caremark’s flexible formulary for New York state employees
EndeavorRx is also listed in a formulary that CVS Caremark put together for New York State employees. EndeavorRx is grouped together with the three commercialized Pear Therapeutics DTx in this one just like in MedImpact’s (noted above). The digital therapeutics in this formulary are also designated as Tier 3.
Clinical trial updates: Pear Therapeutics, GAIA, Limbix, BehaVR, Akili Interactive Labs
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 had mentioned in previous issues.
Kaiser Permanente pilots Pear’s reSET and reSET-O in primary care clinic
Kaiser Permanente’s non-randomized pilot study of Pear Therapeutics’ reSET and reSET-O prescription digital therapeutics kicked off this month. The group expects 700 participants:
“Non-randomized parallel groups pilot study to evaluate intervention delivery, data collection, and analysis procedures. Two primary care clinics will implement the reSET and reSET-O digital therapeutics for substance use disorders. There will be one clinic per arm in this pilot study. Implementation strategies will be varied across arms.”
GAIA’s ceprica for both tension headache and migraine
This RCT is expected to include 520 participants in Germany:
“This trial was designed to evaluate the effectiveness of a dialogue-based online intervention (ceprica) that provides information regarding cognitive behavioral therapy (CBT) in patients with A) tension-type headache and B) migraine.”
“The study aims to test the hypothesis that ceprica has a greater positive impact on psychometric parameters than the active control. The effect of ceprica will be examined in two sub-trials (A, B) each compared to a control group with access to evidence-based online information. The intervention groups will have access to the online program for a period of three months in addition to routine treatment. The primary endpoints are self-reported days with headache and self-reported mean pain intensity.”
Limbix Health’s VR exposure therapy for social phobia
This 44-person, randomized trial kicked off at the end of 2018 but Limbix expects it to finish up by the end of 2021:
“The purpose of this study is to test the efficacy virtual reality videos to facilitate exposure therapy in social anxiety disorder (SAD). The exposure therapy videos are the focus of this experiment. … Individuals who experience a difficult time building social relationships, accomplishing everyday tasks, or pursuing job interviews can practice those same behaviors in a controlled environment.”
“Specifically, we aim to test the following hypotheses: (1) Virtual reality exposure therapy intervention (vs. waitlist control condition) is effective for treating SAD symptoms. (2) Participants who received the VRET will experience maintenance of treatment gains following 3-month and 6-month post-termination of treatment. (3) Users of the virtual reality exposure therapy will demonstrate high amounts of acceptability of the treatment.”
Limbix and BehaVR team up for VR for chronic pain study
This 36-person study started up in March. It looks to be zeroing in on whether audio delivery is enough or if VR shows a greater effect:
“To assess treatment with an at-home Virtual Reality Guided Imagery (VR-GI) intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview.”
Akili’s study on cancer-related cognitive impairment
This study from Akili showed up in the database earlier this month, and it is a good example of how Akili sees its cognition-focused therapeutic expanding into many more therapeutic areas. This particular study, however, doesn’t seem to include Akili’s FDA-regulated software:
“This clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors. Cancer-related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors. CRCI includes perceived or objective problems with memory, executive function, and attention/concentration. CRCI has a negative impact on survivors’ ability to work, carry out routine activities, and engage in social and family relationships. CRCI may result in significant distress and reduced quality of life. Certain electronic games may help improve attention and memory function in cancer survivors and reduce symptoms of CRCI.”
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