Issue 144
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.
Surprisingly, slow week. Here’s what’s going on in FDA-regulated and pharma-focused digital health:
- CVS quietly made a rare addition to its Point Solutions Management program (similar to Evernorth’s Digital Health Formulary). CVS added Carrum Health. The PBM’s pitch for Carrum: “A value-based Center of Excellence platform that helps reduce plan sponsors’ surgical spend by over 45 percent through delivering quality care at upfront bundled prices.”
- The recently introduced “Access to Prescription Digital Therapeutics Act”, which would establish a Medicare benefit category for prescription digital therapeutics, gained new backers this week as Aimed Alliance organized dozens of patient advocacy groups and other non-profits to voice their support in a joint letter to the bill’s co-sponsors. Meanwhile, the Academy of Managed Care Pharmacy (AMCP) has set up a portal to make it easy for its members to send form letters to their representatives to urge them to co-sponsor the legislation.
- A few weeks back I reported on the first DiGA de-listing in Germany. Now another prescription digital therapeutic has been removed from the country’s formulary: M-Sense’s migraine-focused digital therapeutic. The DiGA was previously listed at €219.98.
- Germany’s DiGA formulary isn’t shrinking quite yet, however, as the it added a new program from HelloBetter, which now has five listed. “HelloBetter Panic is an interactive psychological therapy program to treat and reduce the severity of symptoms of panic disorder and agoraphobia with panic disorder. A randomized controlled study was able to prove a positive healthcare effect for patients with prior psychotherapeutic experience. The 12-week online course provides well-founded psychoeducation in texts, videos and audio as well as effective strategies from cognitive-behavioral therapy (CBT).” The 12-week program costs €599.
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).
Clinical trial updates: Pear, Blue Note, Talkspace, and UCSF
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.
Pear Therapeutics tweaks expected completion date, participant number and outcomes measures for its Somryst study
Pear Therapeutics is enrolling participants by invitation into a real world evidence trial for a version of its chronic insomnia digital therapeutic, Somryst. Recent changes to the trial include upping the expected participant number from 1,000 to 1,500 and adding new time points for outcome measures beyond the original 15 months and up to 24 months. Pear also pushed out the study’s expected end date by about 18 months.
Blue Note Therapeutics now recruiting for its PDT vs PDT trial for people with cancer
Curebase is helping Blue Note run the trial, which compares two of Blue Note’s PDTs:
“This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site.”
“The digital software devices, called attune and cerena, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.”
UCSF’s bit AFib study will use both Alivecor and Vivalnk devices
This massive 3,000 participant study aims to increase understanding of atrial fibrillation. Previously the study only mentioned using Alivecor devices but now UCSF said it would also use Vivalnk wearable devices and similar ones:
“Atrial fibrillation (also known as AFib or AF) is the most common abnormal heart rhythm and results in an irregular beating of the heart. Currently, there is no way of identifying patients at most risk for the development or progression of AFib or those that will best respond to treatment. The purpose of this study is to improve our understanding of AFib and to find new ways of identifying those patients most at risk for developing AFib, have progressive AFib or be less responsive to treatment. For this reason, the investigators are studying imaging, blood, and digital markers that may contribute to AFib.”
“Subjects will receive mobile devices (such as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for remote electrocardiographic (ECG) monitoring. Additionally, subjects will use features using a smartphone research app (on the Eureka Research Platform) to monitor other important things such as activity, sleep, heart rate and others as they are developed. All subjects will receive serial blood draws and saliva sample collections once a year. Subjects will also undergo annual imaging in the form of an echocardiogram (Echo). Evaluations will be taken at baseline and once a year for three years from the baseline visit. Additionally, electronic surveys will be administered periodically (eVisits occurring every 3-6 months) using the mobile app.”
Talkspace study compares text-based therapy to once-a-week video-chat psychotherapy for depression
This study aims to have 10 arms and as many as 1,000 participants:
“This partnership between Talkspace and the UW ALACRITY Center will determine how effective unlimited text-based psychotherapy for depression is when compared to once-a-week psychotherapy. This study will also determine what the best treatment options are for people who are not responding well to either unlimited texting or weekly psychotherapy. The results of this study will be a new product version of message-based care that can tailor psychotherapy intensity based on the needs of future consumers with depression.”
Links to E&O’s reports, databases, newsletters
The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 200 past issues of E&O newsletters here.
