Issue 123
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:
- Pear Therapeutics announced that Massachusetts’ Medicaid program, MassHealth, has decided to cover Pear’s substance use disorder prescription digital therapeutics reSET and reSET-O. On Twitter, Andrey Ostrovsky, MD, FAAP, the former Chief Medical Officer of Medicaid, observed that MassHealth (probably) made its deal with Pear a value-based contract because Pear didn’t have Medicaid beneficiaries in its research studies.
- Withings announced that the FDA had cleared its wearable, ScanWatch, which can “monitor heart rate, atrial fibrillation through ECG, breathing disturbances, blood oxygen levels through SpO2, sleep, and physical activity.” The company plans to launch it in the US next month. It’s already available in Europe and Australia.
- One more thing… Cala Health quietly secured a new FDA clearance this month for its wearable Trio. The company already had an FDA clearance for the device and it snagged Breakthrough Designation days after it submitted this second FDA 510(k). Here’s what Cala wrote during its Breakthrough designation announcement a year ago: “Cala Trio is currently FDA-cleared to relieve hand tremors from essential tremor (ET). The Company expects to initiate the next clinical trials evaluating the therapy in the treatment of action hand tremors in patients with Parkinson’s disease by the end of 2020.” In all likelihood, the new clearance is for treatment of action hand tremors in patients with PD.
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Germany’s first prescription digital therapeutic price renegotiation
Germany’s DiGA program has come and gone and the very first digital therapeutic that made it into the program has renegotiated its price upward. Germany-based mynoise has convinced the German government’s national health insurance fund (GKV) to increase the price of its tinnitus digital therapeutic, named Kalmeda. It went from €116.97 — its price during the first year in the DiGA program — to €203.97 today as it begins its second year in the government’s formulary. As far as I can tell, no other digital therapeutics in DiGA have renegotiated a price change for year two yet. Germany did add three more digital therapeutics to the DiGA program in recent weeks:
- Oviva Direct for Obesity
- Companion Patella powered by Medi (MSK app)
- Novego: coping with depression
More details on these three, including their initial pricing, right over here in the E&O DiGA tracker.
Trial updates: Apple-Biogen, Blue Note, Woebot, and Curio
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.
Apple and Biogen are now recruiting for their cognitive decline study
Here’s a curious coincidence: That WSJ piece from last month about Apple working to add cognitive decline features to its products, published less than 24 hours after Apple and Biogen began to officially recruit participants for its study.
Remember: The study is ambitious as it hopes to enroll 23,000 people. I wonder if the WSJ coverage helped to get the word out? Here’s the study’s brief description:
“The primary objectives are to develop and validate a classifier using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage to distinguish individuals with normal cognition from those with mild cognitive impairment (MCI) and to develop and validate a cognitive wellness score that tracks fluctuations in cognitive performance over time using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage.”
Blue Note Therapeutics also now recruiting
Small update: Blue Note is now recruiting for its study of BNT001, a prescription digital therapeutic for stress management in adult cancer patients:
“This single arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application. BNT001 delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.”
Woebot’s Gen Z depression and anxiety study is done recruiting
Woebot recruited 246 participants for its study on a digital therapeutic for mild-moderate depression and anxiety in adolescents. It had hoped to recruit 184 participants originally. More on the intervention:
“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.”
Curio Digital Therapeutics to study usability of its Stella DTx for postpartum depression
Here’s a new one: Curio Digital Therapeutics just posted details on its forthcoming single-arm, usability study for its cognitive behavioral therapy-based postpartum depression digital therapeutic, Stella.
“Women between 18 and 50 years of age who have had a live birth within 4 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 65 women residing in the state of New York, New Jersey and Connecticut will be recruited to participate in the study. Patient reported outcomes of mild to moderate depression (using EPDS) will be verified by a behavioral health therapist using the Hamilton Depression Rating Scale (HAM-D).”
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