Issue 182
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 are two recent happenings in FDA-regulated and pharma-focused digital health…
- Question for readers: It’s come up in a number of calls over the past few months (maybe even the past year at this point), but I haven’t heard any great solutions to this challenge. While trying to raise new capital, health startups with a prescription digital therapeutics go-to-market understandably don’t want to use Pear Therapeutics or Akili as comparables for valuations. Is there any way around that though?
- Another DiGA discount: Germany’s prescription digital therapeutics formulary reduced the price of another DiGA this week: HelloBetter’s Vaginismus Plus. The digital health program was previously listed at a flat fee of €599 and is now €235.
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Hawaii, Maryland, and Arizona state lawmakers consider bills that would unlock Medicaid reimbursement for prescription digital therapeutics
Two weeks back I mentioned that the state legislature of Minnesota was considering a bill that would add prescription digital therapeutics to the list of covered services in its Medicaid program. This week three more states are fielding similar bills:
Hawaii
Hawaii’s state legislature is considering a bill that would instruct the states department of health to:
“conduct a study to determine the feasibility of implementing a pilot program to integrate prescription digital therapeutic products approved by the federal Food and Drug Administration in outpatient treatment programs for persons with substance use disorder and persons with opioid use disorder in the State.”
Obviously, Pear’s lobbyist efforts are behind this one. Interestingly, Jill Puckett, a lobbyist at Otsuka America wrote the state lawmakers in response to the Hawaiian bill:
“Because opioid use disorder and substance use disorders often overlay underlying mental health conditions we encourage this study to also include digital therapeutics for mental health treatment. In that we are asking that you please consider behavioral health as a whole in this bill.”
Maryland
Maryland’s lawmakers are considering a bill with language that is much broader than the ones typically driven by Pear’s lobbyists. This one looks to mirror the effort at the national level to convince state Medicaid directors to cover PDTs. Here’s the bill’s text:
“Requiring the Maryland Medical Assistance Program to provide coverage for prescription digital therapeutics for Program recipients; and defining ‘prescription digital therapeutic’ as a product, a device, an Internet application, or any other technology approved by the federal Food and Drug Administration that has an approved indication for the prevention, management, or treatment of certain medical conditions, primarily uses software to achieve results, and requires a prescription.”
Arizona
Finally, a bill before the Arizona legislature would create a $10 million pilot program to test out Pear’s reSET-O:
“The pilot program shall begin not later than October 1, 2023 and shall be operated until October 1, 2025 or until the monies appropriated for the program are spent, whichever occurs first. Within six months after the termination of the pilot program, the department of health services shall prepare a report, using data supplied by the contracted vendor of the FDA-authorized prescription digital therapeutics and aggregated claims data, describing the department’s findings regarding the impact of the pilot program.”
Clinical trials: NightWare, Twill, Big Health, and Revibe
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
Done recruiting: Twill (FKA Happify) enrolled 367 in its Ensemble study for major depressive disorder and generalized anxiety disorder
I mentioned a few weeks back that Twill had stopped recruiting for its Ensemble study, but this week I noticed the company revealed just how many participants it managed to enroll in the study. They managed 367 out of an originally anticipated 750. Here’s more on Ensemble, code-named HPDT-DA-013, and the study:
“This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.”
Delayed: NightWare pushes its study completion date back to August 2024 and adds new collaborators
NightWare, which offers an FDA-cleared prescription digital therapeutic for treating nightmares associated with PTSD, pushed back its To Arouse Not Waken study by a year. The company also added three new VA medical centers as collaborators: Louis Stokes VA Medical Center, Walter Reed, and Fort Belvoir Community Hospital. It also dropped James A. Haley VA Hospital as a partner on the study. More:
“This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.”
New: Revibe Technologies’ study on wearable therapeutics for kids with ADHD
Here’s a new one:
“The purpose of this study is to evaluate and compare three different investigational wearable digital interventions to determine if they are helpful for improving symptoms and functioning in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). The study is a randomized controlled trial of three investigational wearable digital therapies. An online screening questionnaire will evaluate eligibility for the study. Parents and teachers will complete baseline measures, after which the child will wear the assigned device to school Monday-Friday for a four-week period. Parents and teachers will complete the measures again at the end of the four-week intervention period. Compliance with wearing the device will be monitored remotely.”
Big Health study on Sleepio for preventing MDD recruited 1,237 participants
Big Health managed to recruit more than the anticipated 1,000 participants it expected for its study on using Sleepio as part of a care model to prevent major depressive disorder. It recruited 1,237 participants total. More:
“This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.”
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