Aug 14,2024 TOP STORY

Otsuka Precision Health launches first digital therapeutic for depression

Otsuka Precision Health has launched its first digital therapeutic for major depressive disorder, an app-based treatment called Rejoyn. The six-week program, available by prescription, is designed to supplement medication. It features cognitive behavioral therapy-based video lessons and exercises that help users identify and recall emotions from facial expressions, targeting neural connections involved in emotional processing. Rejoyn, developed with Click Therapeutics, received FDA clearance in March and has shown statistically significant improvement in depression symptoms during clinical trials. The app will initially be available for $50 on a cash-pay basis, with a future price of $200 for insurers.

PRODUCT

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Aug 19,2024

Digital Therapeutics Sector Sees Billing Codes as Key to Breaking Free of Reimbursement Rut

On August 19, 2024, it was announced that Medicare's physician fee schedule will now include billing codes for digital therapeutics for the first time, a significant development for the sector. The Centers for Medicare and Medicaid Services (CMS) has proposed three codes specifically for FDA-cleared digital mental health treatment devices, marking a shift in federal recognition of these technologies. This change is expected to address some of the reimbursement challenges that have plagued digital therapeutics, as seen with companies like Pear Therapeutics and Better Therapeutics, which faced difficulties securing payer coverage.

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Aug 08,2024 TOP STORY

Big Health receives FDA clearance for DTx for insomnia

Big Health has received FDA clearance for SleepioRx, a digital therapeutic designed to treat chronic insomnia and insomnia disorder in adults over 18. Based on its existing product, Sleepio, SleepioRx delivers self-directed cognitive behavioral therapy over 90 days, depending on the severity of the condition. This FDA approval enables healthcare providers to prescribe SleepioRx as an alternative to medication or therapy, which often involves long waiting times. The product’s effectiveness has been demonstrated in clinical trials, with up to 76% of users achieving long-term sleep improvements.The FDA clearance comes as Medicare is considering covering FDA-approved digital mental health treatments in 2025, which could expand access to SleepioRx.

REGULATORY FDA

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Jun 03,2024

Mika Health, Cancer Support Community partner on AI oncologic digital therapeutic

Mika Health, a digital therapeutics company focused on oncology, has partnered with the global nonprofit Cancer Support Community (CSC) to provide a free AI-enabled digital therapeutic to U.S. cancer patients and their caregivers. The app offers psychological support to reduce anxiety, depression, and stress, as well as tools for tracking medication side effects, receiving reminders, and coordinating care. Already certified in the EU, the therapeutic will now be available in North America. The partnership aims to expand access through CSC's network and develop multicultural components to improve health equity. Additionally, they will conduct research to enhance patient and caregiver outcomes.

COLLABORATION PARTNERSHIP

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Aug 08,2024 TOP STORY

U.S. Food and Drug Administration Grants Clearance for Big Health's SleepioRx

Big Health, a developer of digital mental health treatments, received FDA clearance for its flagship digital therapeutic, SleepioRx, designed to treat chronic insomnia in adults. SleepioRx, which delivers Cognitive Behavioral Therapy for Insomnia (CBT-I), can now be prescribed by licensed healthcare providers. The 90-day treatment has been proven effective in reducing sleep issues, with benefits lasting up to three years. With the proposed 2025 Medicare rule to reimburse FDA-cleared digital treatments, SleepioRx could see broader adoption.

REGULATORY FDA

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Jun 03,2024

Mika Health, Cancer Support Community partner on AI oncologic digital therapeutic

Mika Health, a digital therapeutics company focused on oncology, has partnered with the global nonprofit Cancer Support Community (CSC) to provide a free AI-enabled digital therapeutic to U.S. cancer patients and their caregivers. The app offers psychological support to reduce anxiety, depression, and stress, as well as tools for tracking medication side effects, receiving reminders, and coordinating care. Already certified in the EU, the therapeutic will now be available in North America. The partnership aims to expand access through CSC's network and develop multicultural components to improve health equity. Additionally, they will conduct research to enhance patient and caregiver outcomes.

COLLABORATION PARTNERSHIP

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Jun 19,2024 TOP STORY

Mika Health, AstraZeneca, and Daiichi Sankyo Partner on UNITE Program

Mika Health has partnered with AstraZeneca and Daiichi Sankyo on the "UNITE" program to enhance support for breast cancer patients in Switzerland. Mika Health, known for its digital therapeutic platform aiding over 100,000 cancer patients, will provide mental health coaching, AI-powered recommendations, and symptom monitoring through its app. The UNITE program, starting in German-speaking regions and expanding to French and Italian-speaking areas, integrates these digital solutions with prescribed medications. The Mika Health app, combining therapeutic methods and AI, offers educational content and support for depressive symptoms and fatigue.

COLLABORATION PARTNERSHIP

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Jul 18,2024

Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services

There is a substantial gap between demand for and availability of mental health services. Digital mental health interventions (DMHIs) are promising tools for bridging this gap, yet little is known about their comparative effectiveness. In this study, researchers aimed to assess whether patients randomized to a cognitive behavioral therapy (CBT)–based or mindfulness-based DMHI had greater improvements in mental health symptoms than patients randomized to the enhanced personalized feedback (EPF)–only DMHI. Participants were randomized to 1 of 5 intervention arms: (1) EPF only; (2) Silvercloud only; (3) Silvercloud plus EPF; (4) Headspace only; and (5) Headspace plus EPF. The results showed that the magnitude of change was not significantly different across the 5 arms. Additionally, the groups did not differ in decrease in anxiety or substance use symptoms. However, the Headspace arms reported significantly greater improvements on a suicidality measure subscale compared with the Silvercloud arms. The findings suggest that DMHIs may provide support for patients during waiting list–related delays in care. 

CLINICAL STUDY

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Jul 29,2024

Breakthrough study shows AI digital program as effective as human therapy for anxiety

A new study by ieso Digital Health in collaboration with the NHS and NIHR BioResource reveals that its AI-driven digital programme delivered results comparable to traditional human-led therapy for generalized anxiety.  Developed by expert clinicians and using the latest advances in AI, the ieso Digital Programme offers a six-module course facilitated by a conversational agent. It provides real-time, tailored interactions to teach users skills to manage their anxiety based on Cognitive Behavioral Therapy (CBT) principles. In ieso’s landmark study of 300 volunteers with mild to severe anxiety, 82% of participants who used the programme for up to nine weeks showed a clinically meaningful decrease in anxiety symptoms, which can include worry, sleeplessness and fatigue. Even those with severe anxiety benefited from marked improvements, and over half experienced a reduction in symptoms within two weeks, on average. The programme, benchmarked against carefully matched NHS patient data (n=767), proved as effective as human-led therapy. In the US, variants of the ieso digital programme are being piloted with payers and health systems. The program will be rolled out with selected UK partners in late 2024.

CLINICAL STUDY

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Jul 29,2024 TOP STORY

Otsuka and Oxford HIN collaborate to gather insights into digital therapeutics for mental health

Otsuka and Health Innovation Oxford & Thames Valley (Oxford HIN) have announced a collaboration to evaluate the implementation and integration of a new digital therapeutic (DTx), CARE for MDD, intended to treat major depressive disorder. The companies will combine Oxford HIN’s network and expertise in mental health treatment, with Otsuka’s experience in developing therapies for patients living with mental illness. Together, Otsuka and Oxford HIN intend to evaluate patient and healthcare practitioner feedback on real-world implementation of the DTx through a pilot that will initially run across four Primary Care sites in England. CARE for MDD is a regulated medical device delivered as a smartphone app, and was co-developed by Otsuka alongside Click Therapeutics.

COLLABORATION PARTNERSHIP

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