This blog is the output from HealthXLs’ meeting series that explored DTx in the Mental Health space. Collective inputs from:

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Jeff Weness (Head of Digital Opportunities and Business Intelligence at Otsuka), Krys Zaluski (Director, Frontier Business Office at Sumitomo Dainippon Pharma America), Francesca Wutkke (Chief Digital Officer at Almirall) , Azran Osman-Rani (CEO and Co-Founder at Naluri), Laura Stella Korcik (Founder & Managing Director at Vila Health UG), Aahuti Rai (Strategic Advisor | Healthcare Innovation at Four Points Consulting Ltd), Maria Arbiter (Behavioural Scientist at Ampersand Health), Eric Gastfriend (Founder and CEO at DynamiCare Health), Ivan Jurisic (Business Analyst for Digital Therapeutics at Roche), Arthur Bretonnet (Global Digital Innovation Immunology at UCB), Chandana Fitzgerald (GM & CMO at HealthXL), Meaghan Schedel (Digital Health Consultant at HealthXL) & Judit Faus (Community Manager at HealthXL) 

*All opinions are participants’ own and do not reflect the stance of their respective employers. 

Introduction:

Mental health is an area ripe for DTx given the lack of pharmacological treatments available and evidence showing that therapies are more effective than drugs for certain indications (e.g. anxiety). Poor accessibility to services, psychiatrist shortages, lack of objective tests and stigma, make mental health one of the most promising areas for digital health companies. This is especially pertinent now that the pandemic has boosted the demand for mental health services. In this series of 2 meetings we discussed the current state of DTx in mental health, what indications are best suited to such interventions, and the commercial opportunities that they present. 

Status Quo: Current solutions & Unmet Needs 

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Mental health is a broad term that covers a vast number of conditions and diseases with different presentations and varying levels of extremity. It includes not only effective treatments for managing or alleviating the suffering from mental disorders but also strategies for preventing their onset. 

Most solutions in the digital mental health space address depression, anxiety, substance use disorder, and ADHD. However, tackling mental health comorbidities presents one of the biggest opportunities for DTx companies operating in this space. The bi-directional relationship between primary conditions and mental health impacts have spurred solutions aimed at mental health conditions that coexist with chronic diseases like cancer, psoriasis, and others. 

We have yet to see many companies create groundbreaking modes of action using digital products with most solutions simply offering a digitized version of Cognitive Behavioral Therapy (CBT). Beyond the R&D complexity of developing a more novel product, this is also likely due to the fact that it is more complicated to pursue FDA approval or payer reimbursement for a new mode of action vs. a digitized version of a well recognized and used therapy. 

A couple of areas that are purely digital and that are being explored, include the use of Virtual Reality (VR) or digital neuromodulation with clinician support and experience. However these treatments may be perceived as more expensive and the product delivery more complicated making adoption a challenge. Often these approaches need to be administered as part of a clinical visit rather than in lieu of. 

Unmet Need and Opportunities: 

• Severe mental health conditions: There are a limited number of solutions that address more complex conditions like schizophrenia or bipolar disorder and those that do have not seen remarkable results. While there is an opportunity to build products that can complement drug treatments, the market size is smaller and it can be more difficult to generate evidence for these rare and complex conditions. Developing these solutions may require pre-competitive collaborations between research, academia, hospitals, pharma and tech companies in order to break this barrier.
  
  
• Children’s Mental Health: Though solution’s like Akili’s EndeavorRx have shown great success in treating children with ADHD, children are still often an underdiagnosed and underserved segment of mental health patients. While younger populations are experiencing anxiety and depression at higher rates, there is still much discussion regarding the right way to diagnose or treat this population.
  
  
• Diagnosis: Getting an early and accurate diagnosis is one of the biggest challenges in mental health. Though DTx focus on treatment rather than diagnosis, there’s an opportunity for solutions that find innovative ways to tackle this problem. Digital phenotyping is a promising alternative in the mental health space, as it can provide objective measures (e.g voice, level of activity, social interactions, etc) that can help get a more objective diagnosis. Face and voice recognition technologies have advanced to a point of potential triage or even diagnosis and could be leveraged passively in patients of interest or concern.

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Commercialisation models for DTx companies in mental health

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There is no true one-route to market and the right approach seems to combine more than one path. While others exist, like the direct to hospital route used by Big Health in Scotland, we explored the following four distinct routes to market in this meeting: 

• Going D2C

In the US in particular many mental health DTx solutions are offered D2C. An advantage of this is that a D2C model can help to build a customer base. With this model less clinical evidence is also needed, lowering the barrier to market entry. Companies that first take a D2C strategy can build evidence by collecting real world data and use this evidence to approach other commercialisation strategies. D2C solutions often gain more traction when they are physician recommended. 

• Pharma Partnerships 

For mental health DTx in particular, pharma partnerships may not yet be the best commercialisation model since the business model for pharma in this space is still very much in development. In the case of mental health in particular consideration is needed for the type of condition as well as how and if the DTx works together with a drug. These partnerships will be necessary for both DTx and pharma companies with success from this type of alliance likely to follow in the future. 

• Payer and employer route

The payer and employer route can also be a successful commercialisation model for solutions that treat broad or large populations but perhaps less so for niche products. DTx that prevent mental health comorbidities in patients with chronic diseases might be interesting to payers and employers, as they mean cost savings. However, like the pharma route, long-term data and studies are highly desired and can be difficult for small start-ups to deliver on their own. Additionally, in the US there is a lack of payers consistency around where they want a DTx product to be i.e. medical benefits vs. pharmacy benefits. 

• Partnerships with other digital health companies

Some DTx in the space are also choosing partnerships with other digital health companies. For example, Silvercloud was acquired by Amwell and Ginger and Headspace merged. These types of partnerships can also be good options for mental health DTx. 

The right route to market for mental health DTx solutions will depend on the amount of evidence they have at the outset, what their long-term goals are, the condition they target, and also where they are geographically located. Location being a key factor particularly for the employer route which can be a great option in the US, but one that has not seen the same success in the EU. The EU is less familiar with a pay per service model and through programs like the DiGA in Germany, their regulatory and reimbursement paths are starting to be forged. 

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Adoption and last-mile delivery challenges

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Something which can and will affect adoption is the reality that with mental disorders people respond to treatments differently and there is a blurring of symptoms between one type of mental disorder vs. another. Typically if one type of therapy is not working for a patient, a psychiatrist may add another therapy to a patients’ treatment. However, many DTx solutions only offer one type of therapy which can limit adoption. Whilst each mental disorder may have its own clinical protocol in terms of diagnosis and treatment, there are synergies across them and so the more that approaches to mental health / mental disorder treatment can be 'aggregated', the higher the likelihood of success when it comes to DTx adoption.

Also important is more innovation from DTx manufacturers. DTx development needs to show that it can be more than the delivery of already proven treatments via software and that beyond this, DTx can offer a means to measure aspects of patient biology and behaviour in ways that were not previously possible. Particularly in mental health, this objective data collection will in turn allow better diagnosis and allow clinicians to adjust care as necessary. What may eventually be possible is the discovery of complex relationships between new forms of data and mental health conditions - i.e. being able to quantify complex concepts such as mood swings or binge eating that might underlie worsening mental health conditions. Therefore, educating clinicians on the power of the underlying data set that builds with DTx could motivate them beyond just seeing DTx as a software driven delivery of existing therapies.

Integration into HCPs systems and workflows can also help to facilitate prescriptions. Systems that rate different solutions like Orcha and the NHS library could make it easier for HCPs to prescribe these products. They make providers aware of the products and help them to assess their quality. They can also help them to sift through a crowded and noisy market of solutions claiming to be digital therapeutics. While these platforms can be beneficial, there are currently a number of them out there with inconsistencies in how solutions are identified. This can lead to discrepancies and make things more confusing and complicated for providers. 

This is where an increase in physician education will be critical. Better tools are needed to help show the value of DTx in mental health in order to increase adoption. Patient associations and/or digital KOLs can also help raise HCP awareness about mental health solutions and how they can enhance the diagnosis and treatment of mental health conditions.