Digital therapies are evidence-based clinical approaches powered by software applications designed to prevent, control, or treat a particular disease or condition. Digital therapy takes a research and development course close to drug development, as opposed to health and wellness devices. While this emerging type of medicine continues to be incorporated into the healthcare environment, digital therapeutic (DTx) products can profoundly affect the distribution and use of healthcare around the world.
While advances in technology-assisted therapies evolve, digital therapy is evolving as a tool for treating mental well-being and addiction. Digital therapies have the ability to close patient care gaps, minimize time demands for providers, and increase the effectiveness of pharmaceuticals, offering stakeholders hope across the healthcare delivery spectrum.
Examples of Digital Therapeutics in Mental Health
The first two automated treatments approved by the FDA are the Reset Mobile Medical Application of Pear Therapeutics for Substance Use Disorders and Reset-O, which is specifically for Opioid Use Disorder. Both instruments require a prescription and provide cognitive behavioral therapy under a clinician's supervision as an adjunct to outpatient treatment. They are also intended for use in conjunction with pharmacotherapy.
Digital treatments use interactive approaches to improve patient behavior and lifestyle, usually using a smartphone and accessed through an app. Numerous chronic conditions such as type II diabetes, obesity, and depression have been successfully treated using automated therapies. In June 2020, the FDA permitted the marketing of the first Game-Based Digital Therapeutic to improve attention function in children with ADHD.
Benefits of Digital Therapeutics in Mental Health
- Provide secure, evidence-based therapies with good quality control and improve access to treatments scientifically shown to be safe and successful
- Offer tailored treatment based on the needs and skills of specific patients
- Administer behavioral therapies in a relaxed and engaging manner
- Facilitate a treatment regimen independent of the schedule of a patient and in the privacy of their own home, and help tackle fear of stigma associated with certain conventional therapies
- Provide patients, caregivers, and selected healthcare providers with secure progress updates on personalized goals and outcomes
Mental Health as a Target for Digital Therapeutics
Digital therapeutics make use of various digital solutions to monitor and change the patient’s behavior and lifestyle, usually with the help of an app or a smartphone. Digital therapy has been widely used to treat many chronic conditions such as type II diabetes and obesity, and now it has also revolutionized the treatment for depression.
A survey conducted by the WHO, in January 2020, showed that 300 million people suffer every day from depression and mental health related disorders, which are the leading cause of disability and suicides. Despite the availability of relatively successful depression therapies such as antidepressants, there are not enough health care services to address the rising number of people with depression. With the rise of digital therapy, healthcare professionals can easily connect to the patient on an online platform and enable personalized and real-time treatment methods.
Akili Pharma has created several video games for patients with CNS disorders and mental disabilities. Akili Pharma is leading the development of medicines intended to have direct therapeutic effect, delivered not through a traditional pill, but through a video game experience with high-quality results.
Key Products of Digital Therapeutics in Mental Health
Pear Therapeutics and Akili have introduced digital behavioral health treatment into the market, and other companies are making strides in this area.
In June 2020, Akili announced that the U.S. Food and Drug Administration (FDA) has granted clearance to EndeavorRxTM (AKLT01) to be used as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD).
Global Reach of Digital Therapeutics
Digital therapeutic products should follow the core standards of each industry and integrate best practices in product quality, design, manufacturing, health, clinical validation, and regulatory oversight.
- Organizations preparing to launch DTx products in multiple regions and countries will consider, in addition to country-specific regulatory criteria, a variety of factors ranging from language and cultural significance to optimum incorporation into the existing healthcare landscape.
- For this new class of medicine, it is necessary for consensus to build on a set of internationally accepted standards. These standards should ensure continuity in the way patients, providers and payers understand, evaluate, and trust digital therapies.
- Collaborations within countries between digital therapeutic companies, technology and service providers, pharmaceutical manufacturers, national health systems, academic, institutions, patients, and provider groups can lead to the creation of local, regional, and national road maps to better operationalize and commercialize digital therapeutics.
The Future of Digital Therapeutics in Mental Health
A patient or caregiver with any type of mental illness should expect digital therapy to offer innovative treatment options for a wide variety of neurological conditions and to provide highly engaging and immersive therapeutic approaches while at the same time offering actionable feedback.
Digital therapeutics in mental health will help improve existing care pathways and help payers, employers, and national providers cover neurological diseases. It will help integrate value-added therapies into official clinical guidelines and existing care management pathways. It will also help improve patient safety and improve practice efficiency. It will help demonstrate safety, efficacy, and cost effectiveness based on the principles and practices of evidence-based medicine.
Digital therapeutics in mental health disorders will also help deliver clinical, service efficiency, and health economic benefits. It will also help demonstrate improved clinical and health economic outcomes at patient and population levels.
In addition, it will also be a medium to receive similar coverage to existing medicine and therapies in mental health disorders and help the companies working in the domain to gain partnerships with DTx companies and industry partners. These will also help incorporate globally recognized principles and best practices related to product design, price, manufacture, and privacy and will be acknowledged as an independent class of medicine similar to or as an important alternative to pharmaceuticals and other treatments.
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