Issue 180
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 a few recent happenings in FDA-regulated and pharma-focused digital health…
- No official announcement yet but the FDA granted a 510(k) clearance to an over-the-counter ECG app developed by wearable device company Garmin this past week. With the clearance, Garmin is the latest consumer device company to follow AliveCor, Fitbit, and Samsung down the path forged by Apple’s 2018 direct-to-consumer ECG app De Novos.
- Speaking of the FDA: The agency formally published a new class II medical device category in the Federal Register this week following its 2020 De Novo clearance of Mahana Therapeutics’ prescription digital therapeutic for irritable bowel syndrome (IBS). The new device category is: “We have named the generic type of device computerized behavioral therapy device for treating symptoms of gastrointestinal conditions, and it is identified as a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.” This is all a formality really as the device has been an available predicate for 510(k) applicants since it went through the De Novo process two years ago. Another reminder of how slowly the FDA’s official processes work currently.
- One more thing… HHS’s ambitious All of Us Research Program “is looking for a new partner to provide technology and research services to help develop the program’s future participant experience.” In case you’ve forgotten, the program aims to enroll 1 million people in the 10-year program “to help researchers understand more about why people get sick or stay healthy… People who join may share information about their health, habits, and what it’s like where they live. By looking for patterns in this information, researchers may learn more about what affects people’s health.” So, obviously, there are multiple digital health components here. The current partners include DC-area digital health company Vibrent Health and San Diego’s Scripps Research Translational Institute. “The selected awardee(s) will also be expected to transition the program’s current participant and study staff services.” The grant tops out at $37.5 million annually.
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).
Pear’s Florida Medicaid win is its best yet
Pear Therapeutics announced coverage for reSET and reSET-O by Florida Medicaid this week. The decision follows similar but different agreements with other state Medicaid programs. In Florida Pear seems to have found the type of coverage that the company has been seeking since it first started down the path of prescription digital therapeutics. And Florida seems to treat the company’s digital therapeutics more like drugs than Pear’s other Medicaid partners do.
Massachusetts
Pear’s first big Medicaid deal was in Massachusetts and it is similar to the one it announced with Florida this week. There’s a slight difference, however. While Massachusetts became the first state to cover two of the company’s PDTs for all Medicaid patients in the states, it added Pear’s products, reSET and reSET-O, to its “Non-Drug Product List” effective November 1, 2021. Meanwhile, Florida added the two PDTs to its “Florida Medicaid Preferred Drug List“. Interesting that Florida was comfortable adding the software to its drug formulary while Massachusetts used a non-drug list instead.
Oklahoma
At the start of 2022, Pear announced that Oklahoma’s Medicaid program would make Pear’s reSET and reSET-O available thanks to a recent amendment that allowed the state to “implement voluntary Medicaid value-based drug purchasing agreements.”
“Effective January 1, 2022, reSET and reSET-O will be made available to Oklahomans enrolled in Oklahoma Medicaid, commonly known as SoonerCare… Leveraging Oklahoma’s State Plan Amendment to implement voluntary Medicaid value-based drug purchasing agreements, the agreement between Pear and OHCA will use performance and outcomes-based benchmarks.”
While this arrangement has a unique value-based drug purchasing angle, Pear often refers to it as an “access agreement” instead of a coverage decision. As far as I can tell, Pear’s other Medicaid wins fall into this category. Pear’s access agreements with Medicaid programs are typically funded in non-traditional ways, like via State Opioid Response (SOR) grants.
Eight other states
Pear has told investors on past quarterly earnings calls that it has had ten states pay for its products as of the end of Q3 2022. Those include the states mentioned above along with Alabama, Indiana, Kentucky, Michigan, North Carolina, Ohio, South Carolina, and Wisconsin. I suspect most of these were limited access agreements that used SOR grants.
California
One other recent Medicaid-related win for Pear was its recently announced pilot with California’s Medicaid program, Medi-Cal. Like the SOR grant-funded programs mentioned above, this agreement was not a coverage decision by the state. It also isn’t making reSET or reSET-O fully available but rather positioning Pear as a manager for contingency management tracking and distribution:
“The pilot program will allow eligible Medi-Cal members, across 24 counties in California, to take part in a structured 24-week outpatient program that will be followed by at least six months of additional recovery support services. Pear Therapeutics will partner with DHCS to deliver, implement, and manage this program, specifically by managing the electronic tracking and distribution of incentives to Medi-Cal members who participate in this contingency management pilot.”
All of that makes clear why the Florida announcement is big news for Pear. It’s the first Medicaid deal since Massachusetts that is an actual coverage decision — and, what’s more, Florida included Pear’s PDTs on an actual drug formulary too.
Clinical trials: MedRhythms says it met primary in pivotal, Pear’s Somryst+Fitbit study, and more
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.
Met primary endpoint: MedRhythms’ PDT pivotal trial for chronic stroke
No details yet, but MedRhythms announced that its pivotal trial for its first digital therapeutic, which treats gait deficits in chronic stroke, met its primary endpoint. More once the study results make their way into a medical journal later this year. Here’s the relevant line from the announcement:
“MedRhythms announced today that the company’s pivotal trial for MR-001, a novel digital intervention in development to treat gait deficits in chronic stroke, was successfully completed and met its primary endpoint.”
Done recruiting: Pear’s Somryst+Fitbit study
Pear is done recruiting for this study on a version of Somryst code-named PEAR-003b that pairs it with a Fitbit device. The company managed to enroll its anticipated 100 participants:
“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.”
New: Siva Health AG is conducting an interventional study to validate its cough-counting wearable
Here’s a little more on the 50-participant trial:
“Participants will receive standard care and be asked to wear SIVA-MVP on their chest during the day and charge it on the bedside during sleep for 14 days. Every evening, they will be prompted by the SIVA-MVP smartphone application to indicate the timing of their main meals.”
New: Israel-based Hedonia is now recruiting for a study of its FTP-based digital therapeutic for depression at MGH
More on FTP in the study description below:
“The study is a randomized controlled treatment study comparing changes in depressive symptoms over 8 weeks between individuals with Major Depressive Disorder (MDD) who have access to an FTP-based mobile phone application and a control group not engaging with the app. FTP, the process of Facilitating Thought Progression, trains the brain’s cognitive thought process to expand, accelerate, and be more creative, to alleviate depressive symptoms.”
New: Japan’s Chugai Pharmaceutical is conducting a study to develop a novel objective digital biomarker for celiac disease
No details on the maker of the wearable but given the data it will track, it could be any number of consumer wearables or some lesser-known, research-only device. More on the study here:
“This is a decentralized study to primarily explore a novel objective digital biomarker (i.e., Gluten Dependency Index) for celiac disease-related responses triggered by gluten exposure using a wearable biosensor. This study also explores a novel objective blood biomarker specific to celiac disease activity and evaluates participant symptoms, lifestyle and an objective comprehensive measurement (e.g., activity, stress and sleep) in celiac disease participants.”
Done recruiting: Better Therapeutics and Catalyst Health Network study on a prescription digital therapeutic for Type 2 diabetes
While the company did not disclose whether it hit its goal of 250 participants or not, Better is done recruiting for its BT-100 study with Catalyst:
“BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) in patients with type 2 diabetes.”
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.
