Issue 137
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’s going on in FDA-regulated digital health:
- A quick follow-up to the Optum/UnitedHealth policy I wrote up last week: While the insurance company lumped together Akili’s EndeavorRx with Pear’s reSET and reSET-O under the heading of computer-based CBT, Akili confirmed to me that EndeavorRx doesn’t use cognitive behavioral therapy. Are insurance companies not doing enough diligence on prescription digital therapeutics before typing these up? One insurer thinks the FDA can help (more on that below).
- Akili confirmed in an email to E&O that its Chief Marketing Officer and Head of Commercial Meghan Rivera is departing just as the company goes public via SPAC. “Meghan has done a great job as our chief marketing officer, building our core model and infrastructure, and a foundation to scale. She is leaving next month to continue her career in biopharma and, as we enter this next exciting phase at Akili and prepare to launch EndeavorRx, we’re actively recruiting for a chief commercial officer.”
- The FDA cleared Elastic Care’s LifePath Remote Patient Monitoring Platform via a 510(k). The summary document isn’t available just yet, but the company describes its wearable-plus-smartphone offering like so: “The LifePath-C system is intended for use by health care professionals for continuous monitoring of cardiac activity, respiration, temperature and activity/posture in adult patients within healthcare settings, both ambulatory and non-ambulatory, who require continuous monitoring of the above mentioned vital signs for up to seven days.”
- The news you know: I’m afraid to trip spam filters with this one so click through to better understand what this one is focused on, but Life [dot] io said this week that it has successfully gotten market authorization from the FDA via its Safer Technologies Program (STeP). As far as I can tell it’s the only SaMD to have done so?
- The German government added two new prescription digital health products to its DiGA formulary: HelloBetter’s Vaginismus Plus (€599) and Limedex’s Neolexon Aphasia (€487.90). More details in the E&O DiGA tracker here.
- The Digital Medicine Society (DiME) announced new collaborators for its Nocturnal Scratch initiative, which is developing a digital endpoint for atopic dermatitis. The new partners include Almirall, Lilly, Sanofi, and Leo Pharma. As I wrote back in Issue 126, while sponsors are collecting digital endpoints more and more, “the industry has yet to see a new medical product approved on the basis of a digital endpoint,” according to DiME. This collab hopes to change that.
- Last fall the state of Michigan’s budget passed with up to $1.2 million to fund a pilot program that would pay for Pear Therapeutics’ reSET and reSET-O for some Michiganders. Pear put out a release about that pilot program this week (but the first link includes many more details).
- One more thing… I’m tracking two bills in US statehouses that would open up more Medicaid reimbursement for prescription digital therapeutics. One is advancing in the Kentucky state legislature. The New York state legislature is kicking one around as well.
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Anthem asks FDA to help payers evaluate SaMD while PhRMA wants aligned guidance for software in NDAs and SaMD
There were a couple of interesting comments this week on the FDA’s draft guidance about documentation that medical device makers should include in premarket submissions for devices that include software functions (SiMD and SaMD).
FDA could do more to help payers make coverage decisions for SaMD
I was surprised to read that one health insurance company, Anthem, suggested that the FDA could do more to help payers make the decision to pay for SiMD/SaMD by requiring clinical utility and validity data in submissions. Here’s the relevant passage from Anthem’s comment to the FDA:
“FDA can use this update opportunity to bolster advancements in healthcare adoption of SiMD/SaMD by recommending sponsors include information on the clinical utility and validity of a device. While Anthem recognizes FDA’s role in drug and device safety and effectiveness, the current minimum approval package is not sufficient for aiding other essential healthcare stakeholders, such as healthcare payers and medical providers, in decision-making for adoption of devices. More robust data could enable medical societies to formulate recommendations about where devices fit into evidence-based care, better equip healthcare payers to consider devices for coverage determination and reimbursement, and bridge the existing time gaps for getting high-potential devices to the intended use population(s).”
The FDA needs to include CDER in this guidance or software-enabled combination products that go the NDA route will have a divergent pathway
Another suggestion from industry groups, including PhRMA, was that this draft guidance should include the Center for Drug Evaluation and Research (CDER) as well as CBER and CDRH, the two already mentioned, or risk creating different regulatory policies for combination products that go the New Drug Application (NDA) route. Here’s the relevant paragraph from the PhRMA comment:
“To ensure regulatory consistency across FDA Centers, PhRMA recommends FDA expand the scope of the draft guidance to include New Drug Applications (NDAs). PhRMA recognizes that the Center for Drug Evaluation and Research (CDER) is not a signatory to this draft guidance and that the types of premarket submissions that this guidance applies to do not currently include NDAs. The principles and recommendations set forth in this draft guidance, which would apply to biologic-led combination products, should apply to drug-led combination products as well. Failure to include NDAs (and have CDER as a signatory to the guidance) could lead to regulatory divergence across the Centers. Therefore, it is critical that CDRH, CBER, and CDER are all aligned regarding expectations reflected in this guidance. This will help to avoid duplication of efforts and promote regulatory clarity, consistency, and predictability for both sponsors and FDA reviewers. Moreover, the exclusion of NDAs appears to conflict with the draft guidance, Principles of Premarket Pathways for Combination Products, which suggests that review standards be consistently applied across all Centers.”
Clinical trial updates from Blue Note, Big Health, Cedars-Sinai
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.
Blue Note Therapeutics and Curebase compare anxiety PDTs attune and cerena
Yet another new clinical trial from Blue Note (this makes five). Here’s the summary:
“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.”
Boston University researchers test Big Health’s Daylight for GAD in people with chronic MSK pain
As is often the case, Big Health isn’t listed as a collaborator or sponsor of this study that is now recruiting. The study looks at the Daylight app for GAD in an adult population with chronic MSK pain:
“The study contains two phases, with only Phase 2 being registered here. Following the achievement of benchmarks from Phase I, Phase 2 is a randomized clinical trial of Digital Cognitive Behavioral Therapy (dCBT) targeting worry and anxiety symptoms in a population with chronic pain and clinical levels of generalized anxiety disorder (GAD) symptoms. The dCBT under study is a commercially available smartphone application that provides weekly intervention sessions in 4 modules. An initial assessment drives an algorithm to personalize the program and individuals will have 10 weeks to complete the treatment. This randomized clinical trial calls for the recruitment and randomization of 80 individuals to either the dCBT program or a waitlist (control) condition. Specific aims for this project are:
- To show that dCBT leads to lower GAD symptoms relative to the control condition.
- To evaluate whether dCBT leads to greater changes in the secondary worry, mood, sleep, quality of life, and anxiety sensitivity outcomes than the control condition.
- To evaluate whether dCBT leads to lower pain distress and disability outcomes than the wait-list control condition.”
Cedars-Sinai Medical Center to study VR intervention for pain in GI cancer patients
Cedars says that past VR studies focused on cancer pain have not had a long enough duration:
“Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health-related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.”
“To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.”
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