Digital therapeutics companies, citing clinical evidence, are promoting digital therapy wellness apps, in a new category known as Prescription Digital Therapeutics, for outpatient treatment of substance abuse. Do these DTx solutions have a place in traditional medicine?
In recent years, there has been talk in the health care industry about digital health products and digital medicine for the treatment of various mental health disorders. Using psychological tools, such as contingency management and cognitive behavioral therapy, these software tools are seeking FDA clearance to be prescribed by healthcare workers.
With Prescription Digital Therapeutics, also known as DTx solutions, there is no need for a dedicated medical device. The DTx product is essentially a smartphone app.
The user downloads the app from their smart device’s app store. However, to be able to use the app, the user must request authorization from a licensed clinician.
How can an iPhone prescription DTx app get FDA approval to treat a particular mental health disorder?
When we think about the Food and Drug Administration, we typically think about things like food and drugs. We want them to ensure that the food sold in grocery stores is safe and the medicines sold in pharmacies is safe as well.
How did the FDA get in the software app approval business? It does make sense when you think about the fact that the FDA also evaluates and approves many medical devices for use in healthcare. They provide regulatory approval for everything from surgical devices to laser hair removal technology.
When a doctor uses a medical device for any medical procedure, that device must first be evaluated by the FDA. To receive approval, each drug and device must undergo a randomized controlled trial to demonstrate that it can produce a positive therapeutic outcome for a particular health condition.
Since many devices in modern medicine are a combination of hardware and software, where software does much of the heavy lifting, it makes sense that the FDA has essentially been in the software approval business for many years now. For example, when a patient with heart failure goes to their cardiologist for an echocardiogram, the machine that is used to perform the test relies on highly sophisticated software to help the technician complete the test and to help the doctor to interpret it.
Consumer devices, such as smart phones and smart watches are now being used in healthcare for improved patient outcome.
In more recent years, consumer devices have entered the healthcare arena, providing screening tools for health conditions. For example, the Apple Watch has been approved by the FDA to provide screening for atrial fibrillation.
In fact, there is now an app on the Apple Watch that can assist in the treatment of post traumatic stress disorder (PTSD) by waking the user up from a traumatic nightmare. In order to use this particular smart watch app for stopping night terrors in PTSD patients, the patient must first download the app, install it on their Apple Watch, and then get approval from their doctor or other prescribing healthcare provider.
The approval from their doctor is essentially a prescription, just like a prescription for medication. The difference is that the prescription is sent to a software company instead of a pharmacy.
After the prescription is received and the software company processes payment reimbursement, either from the patient or from the patient’s healthcare insurance company, a code is provided to unlock the software for a period of time. Now, the patient may use the software on their own device as prescribed by their doctor.
Interestingly, the idea of a digital therapeutic app or device helping a person with a behavioral health condition is not a new idea. There have been apps for some time that help people to manage their eating habits to lose weight and eat healthier foods. And, there are apps and devices that can help to treat chronic insomnia.
There is even a mind machine device that claims to help with teenage ADHD symptoms and has at least one study to back up their claim. The pulsing light and sound machine uses binaural beats and flashing LED lights in specially designed glasses to entrain the brain and promote specific ranges of brain waves.
How does a prescription digital therapeutic product differ from other consumer software apps and devices that help with mental health conditions?
Prescription digital therapeutics are held to a higher standard compared to non-FDA authorized products. After undergoing a rigorous clinical trial the prescription digital therapeutic app must then await approval, similar to the same process used in clinical pharmacology products. Just like a pharmaceutical company, the PDT software company must prove that their product is both safe and effective.
In addition to having the backing of the FDA to provide additional public confidence in the product, insurance companies will be more willing to provide reimbursement for treatment with the product. In fact, with FDA approval or authorization, the insurance companies may eventually be obligated to cover treatment costs for the approved therapeutic area.
Why would digital therapeutics companies target addiction and substance use disorders as therapeutic areas to treat with their PDT apps?
Treating addiction is a hard problem. The healthcare industry has had difficulty coming to terms with the issue that some people who are in the midst of active addiction may not be ready to stop, no matter what treatment options are presented to them.
Often, providing harm reduction tools may be the best option, protecting the person with a substance use disorder from being harmed by their substance use. Examples of harm reduction tools include the opioid blocker, Narcan (naloxone nasal spray and injection) to reverse opioid overdoses, as well as naltrexone, another opioid blocker, which can be used to help alcoholics to reduce alcohol consumption.
Is a prescription digital therapeutic app considered to be in the realm of harm reduction? It could be used in this manner. If a patient expresses interest to their doctor in quitting an addictive drug, such as alcohol, opioids, or stimulants, such as meth or cocaine, the doctor could prescribe a DTx product.
Even if the patient is not completely ready to give up their addiction, they may get started with the app, which provides therapies such as CBT and contingency management, which is a system of providing rewards to encourage positive behavioral changes. The app may also provide a communication portal between the patient and physician, allowing for the clinician to monitor the patient’s progress and for the patient to be aware that their healthcare provider is involved.
Are DTx solutions being used in other areas of healthcare?
Products have been developed or proposed to help with conditions such as anxiety disorder, diabetes (particularly type 2 diabetes), and to monitor for suicidal ideation. Additionally, tools have been developed for contact tracing during the COVID 19 pandemic.
There are many possible applications of these new technologies. As smart phones, smart watches, and other high tech wearables become more advanced and accepted by society, there will be many more opportunities for developing better Digital therapeutics to better assist in healthcare.
Can we expect Prescription Digital Therapeutics to significantly change the direction of addiction medicine?
Unfortunately, many current therapies that are offered for treating addiction do not have high success rates. Rehab, Detox, counseling, and other commonly provided treatments are not highly successful in preventing relapses in addiction patients.
Medication assisted treatment for specific types of substance use disorders do have relatively high success rates, but there is a lack of public acceptance for these treatment modalities. For example, it has been very difficult for treatments such as Suboxone, ZubSolv, Bunavail, Sublocade, Brixadi, and others to gain acceptance as effective treatments for opioid use disorder.
People would like to see addiction treatments that do not rely on these medications, even though study after study has demonstrated their effectiveness. In a perfect world, we would have smart phone apps that can help with many types of addictions, from gambling, to work addiction, to binge eating, and of course, drug and alcohol addiction.
Part of the early success of prescription digital therapeutics will likely be based on the hopes of the public for a new form of therapy that does not involve the prescribing of a controlled drug, such as buprenorphine, or methadone dispensing at a methadone maintenance clinic. Additionally, there will be the hope that addictions experienced by larger segments of the population will be addressed by these new software tools.
It will remain to be seen if these DTx products will fulfill the promises of making a significant difference in addiction treatment outcomes. While clinical trials provide hope and the basis for FDA authorization, the real test of the success of prescription digital therapeutics will be in the outcomes of much larger studies and the clinical experience of doctors across the country who are willing to accept these new tools and prescribe them to their patients.
