Prescription Digital Therapeutics a New Frontier in Mental Health Care - A Personalized Treatment that Could Bridge the Access Gap

Addressing the Holistic Unmet Need in Mental Health

As many as 1 billion people are currently living with a chronic and complex mental health condition worldwide.¹ It is estimated that approximately half of the population will experience a mental illness in their lifetime,² and 1 in 20 adults experience a serious mental illness each year.³

There are a host of well-documented challenges in mental health that accompany these jarring statistics, including stigma, poor access to care, psychiatric provider shortages, and complex health systems, all of which contribute to delayed diagnosis through ongoing disease management to long-term support.^3,4,5,6 Treatments for mental illness also lack precision, and some patients report significant side effects, resulting in varying levels of symptom management and unpredictable outcomes.

With the growing role of technology in health care, a new class of treatments – prescription digital therapeutics or PDTs – are uniquely positioned to address some of these challenges and may offer an innovative solution for mental health conditions.^{7 8} Installed on a smartphone, PDTs are prescribed by healthcare professionals to deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.⁷

“Digital therapeutics, which can provide evidence-based psychological and behavioral treatment strategies through a smartphone, are well positioned to overcome many of the access barriers to treatment and may be an effective tool to help address the mental health care crisis," said David Mohr, Society for Digital Mental Health.

Can Prescription Digital Therapeutics Address Symptoms of Schizophrenia?

Schizophrenia is among the most challenging mental health conditions and one of the top 15 causes of disability worldwide.⁹ Current antipsychotic medications for schizophrenia largely work to relieve certain positive symptoms, such as hallucinations, disorganized speech, and behavior agitation.¹⁰ However, people being treated for schizophrenia still experience negative symptoms of decreased motivation, problems associated with socialization and inability to experience joy, as well as cognitive impairment issues associated with problem-solving, paying attention, and memory.¹¹ Individuals experiencing negative symptoms associated with schizophrenia often have limited access to psychotherapy and can be socially isolated or disconnected from everyday life.^{12 13} These symptoms can also impact their productivity, which has a societal and economic impact.¹² 

“Holistic treatments remain a major unmet need in the care of individuals living with schizophrenia. The potential for innovative solutions to address negative symptoms and support data driven clinical decisions could have a significant impact to individuals and families living with schizophrenia,” notes Gordon Lavigne, President and CEO of The Schizophrenia and Psychosis Action Alliance. 

The growing mental health crisis demands innovative solutions that can be customized to the individual’s symptoms and situation. PDTs may answer this call and contribute to shifting the paradigm of mental health care and psychiatry. 

Boehringer Ingelheim has made a generational commitment to transform the mental health landscape, and we are proud to partner with Click Therapeutics to investigate the applications of PDTs that have the potential to address gaps in care, reach a broad population, and introduce real-time care management to those who need it the most.⁷  

In 2023, we initiated the CONVOKE study (NCT05838625), a randomized, multicenter, 16-week study, which will evaluate the efficacy and safety of two prescription digital therapeutics in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescence and adults. As of January 2024, this device received Breakthrough Device designation by the Food and Drug Administration.

This prescription digital therapeutic (PDT) is investigational and has not been approved for use by any regulatory authority, including the U.S. Food and Drug Administration (FDA). The efficacy and safety of this digital intervention have not been established. 

“Boehringer Ingelheim and Click Therapeutics have a shared vision in our approach to prescription digital therapeutics,” said David Benshoof Klein, CEO, Click Therapeutics. “At the core of this is creating a patient centric design where our digital therapies are created both for and with patients. We believe this will result in an adaptive, personalized treatment to meet patients where they are, potentially leading to high engagement and long-term value.” 

As part of our extended collaboration with Click Therapeutics, we are developing additional prescription digital therapeutics after recognizing that a comprehensive treatment strategy for schizophrenia would benefit from a multi-product approach. 

Prescription digital therapeutics (PDTs) are software-based treatments that are evaluated for safety and efficacy in clinical trials by the U.S. Food and Drug Administration (FDA).⁷ Once FDA cleared, PDTs may be evaluated for reimbursement by health insurance companies if shown to be medically necessary.⁷ Ultimately, PDTs can expand accessibility to evidence-based treatments for people with mental health conditions and can work in concert with remote education, assessment and telehealth visits to further enable a holistic approach to care.

The Journey to Precision Psychiatry 

By bringing ‘precision’ approaches to psychiatry, we are developing holistic treatments that focus on the brain biology associated with specific symptoms. Our ultimate goal is to improve symptom control and offer people living with mental health conditions more predictable treatment outcomes. 

“Precision psychiatry requires a holistic approach and is only possible through collaborative and human-centric endeavors. This is why we believe in meaningful partnerships with like-minded stakeholders who share our ambitions, and together we share our collective findings to improve everyday mental health treatment practices,” said Lennart Jungersten, M.D., Ph.D., senior vice president, U.S. Medicine and Regulatory Affairs, U.S. Medical Director, Boehringer Ingelheim.

Together, we hope to deliver novel solutions to relieve the symptoms that most affect and derail the lives of people living with chronic and complex mental health conditions and support clinicians in providing timely care. With our partners, Boehringer Ingelheim will continue to innovate and push the boundaries of medicine and pursue holistic treatments for people with mental illness.
 

References:

1. World Health Organization. World Mental Health Report: Transforming mental health for all. Published online 2022.
2. Kessler, R. C., Angermeyer, M., Anthony, J. C., DE Graaf, R., Demyttenaere, K., et al. (2007). Lifetime prevalence and age-of-onset distributions of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World psychiatry: official journal of the World Psychiatric Association (WPA), 6(3), 168–176.
3. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2020 National Survey on Drug Use and Health. Published online 2020. https://www.samhsa.gov/data/sites/default/files/reports/rpt35325/NSDUHFFRPDFWHTMLFiles2020/2020NSDUHFFR1PDFW102121.pdf
4. Wainberg, M. L., Scorza, P., Shultz, J. M., Helpman, L., Mootz, J., et al. (2017). Challenges and Opportunities in Global Mental Health: a Research-to-Practice Perspective. Current psychiatry reports, 19(5), 28. https://doi.org/10.1007/s11920-017-0780-z
5. National Alliance on Mental Illness (NAMI). Mental Health by the Numbers. nami.org. Published June 2022. Accessed April 4, 2023. https://www.nami.org/mhstats
6. Ngui, E. M., Khasakhala, L., Ndetei, D., & Roberts, L. W. (2010). Mental disorders, health inequalities and ethics: A global perspective. International review of psychiatry (Abingdon, England), 22(3), 235–244. https://doi.org/10.3109/09540261.2010.485273
7. Brezing CA, Brixner DI. The Rise of Prescription Digital Therapeutics in Behavioral Health. Adv Ther. 2022;39(12):5301-5306. doi:10.1007/s12325-022-02320-0
8. Avalere. Prescription Digital Therapeutics Bring New Treatments to Healthcare. Avalere Health. Published October 5, 2021. Accessed April 5, 2023. https://avalere.com/insights/prescription-digital-therapeutics-bring-new-treatments-to-healthcare
9. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators (2017). Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet (London, England), 390(10100), 1211–1259. https://doi.org/10.1016/S0140-6736(17)32154-2
10. Stahl SM. Stahl’s Essential Psychopharmacology, 4th ed., 2013. Cambridge University Press.
11. Kitchen, H., Rofail, D., Heron, L., & Sacco, P. (2012). Cognitive impairment associated with schizophrenia: a review of the humanistic burden. Advances in therapy, 29(2), 148–162. https://doi.org/10.1007/s12325-012-0001-4
12. Bowie, C. R., & Harvey, P. D. (2006). Cognitive deficits and functional outcome in schizophrenia. Neuropsychiatric disease and treatment, 2(4), 531–536. https://doi.org/10.2147/nedt.2006.2.4.531
13. World Health Organization (WHO). Schizophrenia. Published online 2022. Accessed here: https://www.who.int/news-room/fact-sheets/detail/schizophrenia

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