The U.S. healthcare industry has adopted the basic phone call, video call, and email with a healthcare professional as telemedicine. But telemedicine extends significantly farther than the synchronous healthcare delivery of a phone call or video session. Any type of software, connected device, or treatment prescribed and monitored by a healthcare professional and accessed by patients in their daily lives can be considered telemedicine, sometimes referred to as asynchronous telemedicine or virtual care.
Clinical trials are typically the only time a pharmaceutical company has direct insight into the individuals who use their medication. Once a medication is FDA approved, the main touchpoints between the patients and their medication are physicians, nurses, pharmacists, payers, and other licensed clinicians. The pharmaceutical company has to rely on the mediators and patients reaching out to the pharma company directly for any feedback about how their medication does in a real-world environment, or other routes, such as through the FDA if there are new adverse events or side effects.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
But technology is changing the way patients interact with pharmaceutical companies. With the advent of prescription and companion digital therapeutics, pharmaceutical companies are on the cusp of having significant access to how their medication is used on a daily basis, in patients’ everyday lives. Through these apps, pharmaceutical companies can actually influence patient adherence and mindset after that patient has been prescribed that company’s medication by their physician.
Digital therapeutics (DTx) are a whole new category in healthcare. The non-profit Digital Therapeutics Alliance was founded in 2017 to grow alongside the DTx industry, helping to define and educate about this new category. They define a DTx as a high-quality software app used “to prevent, manage, or treat a medical disorder or disease.” These software programs are typically by prescription only and used in conjunction with other medical interventions like medications and therapy. They are also known as Prescription Digital Therapeutics (PDT) or Medical Mobile Apps. A companion digital therapeutic is an app that is typically prescribed for a specific medication and used on a daily basis in conjunction with that specific medication. There are also a handful of direct-to-consumer digital therapeutics, including Headspace Health for meditation.
What most of these digital therapeutics are doing is leveraging CBT, cognitive behavior therapy. CBT is a gold standard, evidence-based technique used for behavior change. These apps typically have an educational component, a coaching component, a data tracking component, and an analytics component. Because these medical interventions are software, they can and are gamified with built-in reward systems, challenges, and a user interface designed to be sticky, meaning the patient wants to use it because it’s fun and interesting.
Many pharmaceutical companies have already partnered with software companies that are experts in creating apps. This is a smart move and an important point. Pharma companies are experts in medications, not software. But it’s not just pharma getting in on this new category, payers and even patient organizations are also launching their own partnerships and programs with digital therapeutic companies.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Click Therapeutics is a great example of a DTx company partnering with pharmaceutical companies to create prescription apps to be used alongside their medications as companion apps. Japan-based Otsuka Pharma is one of Click’s main milestone-based funders with $300M specifically for Click to develop a DTx app for Major Depressive Disorder, a condition Otsuka already treats. Germany-based pharma Boehringer Ingelheim is also a milestone-based funder with $500M for Click to develop a DTx app for schizophrenia, a condition they cover with an existing medication. Click has FDA clearance for a smoking cessation app, and a pipeline of future DTx apps for migraine, overactive bladder, obesity, chronic low back pain, and acute coronary syndrome in various stages of development, trials, FDA clearance, and launch.
Twill Health is another digital therapeutic company to watch. Twill has digital solutions for over 10 chronic conditions and is already globally distributed in 190 countries and 10 languages. Similar to Click Therapeutics, Twill partners with global pharmaceutical companies to create evidence-based, disease-specific digital solutions. They are also partnered with the American Heart Association to create an app for heart disease.
Twill Health’s latest digital solution is a digital therapeutic app called Ensemble to treat the symptoms of Generalized Anxiety Disorder (GAD) and Major Depression Disorder (MDD). In conjunction with therapy and/or medication, the 15-minute app-based exercises are led by an AI chatbot coach named Anna and completed once or twice a day. The app-based exercises work with the user to change negative thought patterns into more productive habits by focusing their attention on positive thoughts or goals, and then tracking their progress over a 10-week program. Like many of the other digital therapeutics, these new positive thought patterns aren’t just to help anxiety or depression today, they are meant to become life-long habits to help anxiety and depression long after the user stops interacting with Twill Health.
Elevance Health (formally called Anthem) has also started launching digital therapeutics. They’ve partnered with digital therapeutics company Sidekick Health to launch DTx apps for Crohn’s Disease, Covid-19, cancer, and diabetes. Currently, these apps are free for patients who qualify. Sidekick Health is also working with pharmaceutical companies on creating integrated combination therapeutics consisting of a digital therapeutic in conjunction with a specific medication. Sidekick has partnered with Bayer on one for peripheral artery disease (PAD).
These DTx prescription apps work in conjunction with pharmaceuticals and/or healthcare professionals such as therapists, psychologists, and psychiatrists. These partnerships also provide a channel for the pharmaceutical company, payer, or non-profit organization to understand exactly how a medication, treatment, or therapy is working on a day-to-day basis. As a major signal to the healthcare industry, CMS launched a new Medicare reimbursement code in the spring of 2022 that covers CBT-based digital therapeutics. CMS reimbursement is a major step towards widespread adoption and opens the door for more innovation in this area.
Telemedicine is maturing rapidly, going way beyond the standard synchronous phone or video call. Asynchronous telemedicine in the form of remote patient monitoring with devices like the Apple Watch, remotely monitored, digital point-of-care diagnostics with companies and reimbursable prescription digital therapeutics are changing the healthcare paradigm from sick care to continuous care 24/7, when and where the patient wants to receive their healthcare.
Photo: Who_I_am, Getty Images
Robin Farmanfarmaian is a Silicon Valley-based professional speaker and entrepreneur working in cutting-edge tech poised to impact 100M people or more. Robin has been involved with over 20 early-stage biotech and healthcare startups from curing cancer to medical devices and digital health and has written 4 books, most recently "How AI Can Democratize Healthcare: The Rise in Digital Care" with Michael Ferro.
