Expert: Chris Wasden, Head of DTx , Happify Health

Chris leads Happify's digital therapeutics effort to take its world-leading digital mental health and wellbeing platform to the pharmaceutical and healthcare industry. He also serves as a board member for the Digital Therapeutics Alliance. Connect with Chris to get his perspective on how digital therapeutics are shaping the future of mental health and psychiatric care. https://www.linkedin.com/in/chriswasden/ 

Snapshot of the story

This month, digital therapeutics (DTx) company Happify Health announced their first prescription DTx to treat patients with both major depressive disorder (MDD) and generalized anxiety disorder (GAD). The therapy, dubbed Ensemble, includes a 10-week cognitive behavioral therapy (CBT) program to help teach patients how to change negative thought patterns. It also includes a dashboard doctors can use to monitor patients. It is the first transdiagnostic PDT for MDD and GAD available in the U.S. 

Why is it notable:

• With the exception of Pear Therapeutics, few of Happify Health’s competitors have launched prescription digital mental health therapies and it is expected that a doctor’s stamp of approval will significantly influence adoption when compared to its competitive counterparts such as Orexo, which currently only offer direct-to-consumer platforms.
• Ensemble has not been cleared by the FDA. However, patients diagnosed with MDD or GAD will be eligible to participate in an investigational device research study released under FDA’s Enforcement policy. Happify Health will use the data collected for regulatory and commercial purposes.
• Ensemble focuses on teaching patients how to identify and change unhelpful patterns of thinking and behaving using an evidence-based CBT programme. CBT is a clinically recognised intervention for those living with a broad spectrum of mental health disorders. Digital CBT however, offers enhanced benefits in that it removes stigma, geographic limitations, wait times, and high cost associated with mental health care and has demonstrated effectiveness in alleviating symptoms of depression, stress, anxiety and ADHD in a range of clinical studies..

Industry Implications:

• Doctors will be more likely to recommend digital therapies if they’re covered by insurance. In turn, DTx vendors will need to garner enough data to demonstrate that their platform can reduce costs to attain payers buy-in. Happify Health has been well primed for this challenge. Being a long-time partner of massive payer Cigna, Happify has offered its non-prescription digital app to patients to help manage conditions like stress and anxiety.

• Demonstrating the effectiveness of DTx in clinical trials is imperative and slowly becoming the norm, especially in the behavioural space. Last November, we saw Koa team up with Johnson & Johnson’s Janssen Pharmaceuticals to research the delivery of digital CBT to treat treatment-resistant major depressive disorder. And in February of this year, Click Therapeutics partnered with Otsuka to evaluate the effectiveness of a DTx for the treatment of depression.
• What’s next for DTx? A wave of M&A - experts say especially with big pharma or telehealth giants. PDT plays to pharma's regulatory strengths while cutting down on the 10-plus years it can take to develop a chemical drug, while experts in the field also predict that DTx vendors teaming up with a specialised telehealth company will be a next big move.

‍

Read the full story here.

Expert: Paul Feldheausen, Director Of Strategic Partnerships, Holmusk

Paul is the Director of Growth Operations & Partnerships at Holmusk, where he is working to build the world's largest real-world evidence platform for behavioral health and chronic diseases. He has extensive expertise in leading complex health engagements in the US and Asia, and over the past 15 years Paul has worked to drive behavioral and structural changes in the way patients interact and participate within the health ecosystems. Connect with Paul to get his perspective on leveraging real-world data for improving outcomes.

https://www.linkedin.com/in/paul-feldhausen/ 

Snapshot of the story

This week Otsuka announced the signing of a three-year collaboration with global data science company Holmusk to enhance digital health and data analytics for global behavioral health programs. One of Holmusk’s main focuses is on building a real-world evidence (RWE) platform for behavioral health. Together, Otsuka and Holmusk will work to drive a deeper understanding of unmet patient needs and real-world outcomes by employing proprietary analytics and artificial intelligence (AI) on multiple real-world data sources. 

Why it is notable

• These insights have application across Otsuka’s portfolio and the collaboration will help strengthen Otsuka’s capabilities in serving people living with complex, chronic diseases and utilize real-world evidence to improve clinical development and improve patient outcomes. 
• Otsuka continues to place its stamp on being a frontrunner in embarking on new and interesting partnerships in digital health. This also shows the success of a company like Holmusk that started life in Singapore and is rapidly expanding its footprint around the globe, as previously seen with Biofourmis. 

Industry Implications

• This move syncs with a wider focus on levering RWD to improve patients outcomes and healthcare utilisation. In February of this year Ipsen Pharmaceuticals partnered with Mendelian to leverage the MendelScan software for the identification of people with rare diseases. The software, which is designated a Class 1 Medical Device, scans patients’ electronic health records and alerts GPs to high-risk patients for referral and diagnosis.
• With an increasing awareness of the benefits and opportunities of RWD, pharma is increasingly looking in its direction to help support post-market surveillance and speed up go-to-market strategies. Furthermore, with a growing focus on building value-based care models, the generation of pragmatic, real-world evidence is essential to demonstrate that digital solutions and pharmacotherapy are linked to healthcare cost savings.

• All said and done, the lack of standardization and guidelines surrounding the collection and analysis of RWE means that it does not hold up as a comparison to the highly regulated RCT. When assessing RWE, the plethora of variables make it impossible to definitely say whether or not the treatment being tested was the sole contributor to the observed results.

‍

Read the full story here.

Expert: Murray Brozinskly, Conversa Health

Murray is a creative entrepreneur who has started, run, and served as a senior executive at numerous companies. He has extensive experience in leadership, strategy, bringing new products to market, generating revenue, building strategic relationships, as well as M&A. In addition to working as a digital health leader in automated care management at Conversa Health he works as a Board member and advisor to other promising technology start-ups in various industries. Connect with Murray to get his perspective on how M&As will shape the strategy of telemedicine companies in the future. https://www.linkedin.com/in/murraybrozinsky/ 

Snapshot of the story 

This week telehealth giant Amwell announced the acquisition of SilverCloud Health and Conversa Health in a bid to enhance its virtual care platform. Their acquisition will broaden Amwells offersings differentiating it among competitors. We are super proud of our friends at Conversa Health & Silvercloud Health on this milestone!'. Covid-19 has cut through the red tape that initially restricted telehealth adoption, forcing the healthcare world to do a 180° on digital health, and these acquisitions offer a clear example to how telehealth is innovatively responding.

Why is it notable:

• By adding the technology of these two companies to its virtual care platform, Amwell is greatly enhancing the differentiated value it can bring to current and future clients. The acquisition of SilverCloud Health, a leading digital mental health platform, and Conversa Health, a leader in automated virtual healthcare will position Amwell to materially advance the reach and impact of care teams on patients’ lives through the use of interactive tools that align physical and virtual care.
• This move will help Amwell realize value in a number of key ways, specifically in terms of advancing platform offerings and accelerating growth in new markets. The geographical footprint of SilverCloud Health in particular will help Amwell to accelerate its global growth plans, specifically within the United Kingdom and Ireland.
• SilverCloud Health and Conversa Health have already demonstrated that they can enable a more efficient blend of in-person, virtual and digital care, resulting in lower operational and healthcare costs, and advanced care outcomes in alignment with a shift to a future, hybrid-based care approach .

Industry Implications

• Over the past few years, health plans, pharma giants and medtech companies have been forming partnerships with telehealth companies right and left, in recognition of their impact on user, client and patient reach. But this move represents a slight vertical in the telehealth partnership playing field by following in the footsteps of Teladoc and Livongo. It highlights M&As a key part of Amwell’s strategy and an opportunity for telehealth companies to differentiate themselves through expanded offerings and speciality services.
• The acquisition also highlights a focus on leveraging digital to offer patients care and support that is omnipresent and moves beyond the usual supply and demand constraints in healthcare.
• This activity is testament to the beginning of a new chapter in telehealth. As the coronavirus pandemic evolves, telehealth companies can no longer rely solely on their own technology to stay competitive. Instead, they will have to develop an omnichannel presence by connecting telehealth visits to other digital solutions to fortify their value proposition.

‍

Read the full story here.