We all know what 'conventional' prescribed medications are. These can range from antibiotics to pain relief. Tangible medications you can swallow, rub in or insert. Prescribed Digital therapeutics are however a novel class of therapy. Their active ingredient is code. Software code and a user interface.
A clinician prescribed product, device, app or other technology that primarily uses software and has received regulatory approval for the prevention, management or treatment of a medical disease, condition or disorder.
Instead of being prescribed a pill, a clinician would instead prescribe access to an app or website to treat diagnosed conditions. Prescribed Digital Therapeutics are evaluated for safety and effectiveness in trials, they need to be authorised by governmental regulatory bodies such as the US Food and Drug Administration (FDA), and are subject to the same post-marketing requirements similar to 'traditional' prescribed regulated pharmaceuticals.
Is this just science fiction, or fact?
Legislation
The Access to Prescription Digital Therapeutics Act of 2023 was introduced to the US Senate in March 2023. The purpose- to amend the Social Security Act to enable means of remuneration for prescribed digital therapeutics. This step is considered by many as an essential prequel to wider acceptance and use of prescribed digital therapeutics.
In Germany, the Digital Healthcare Act (Digitales Versorgungsgesetz, DVG) adopted in November 2019, paved the way for doctor prescribed apps to be remunerated by statutory health insurers. At the time of writing 45 apps had received permanent or provisional admittance to the German Digital Health Applications directory. The conditions these apps address range from breast cancer to irritable bowel syndrome and depression.
Benefits of Prescribed Digital Therapeutics
Clinical efficacy aside (more on that later), one can see the attraction of delivering prescribed 'treatments' digitally. Manufacturers supply chains become cloud storage and servers, rather than warehouses and pharmacies. Conventional analogue distribution channels such as ships, roads and haulage are replaced by the internet. Aside from obvious environmental benefits an equally important benefit becomes apparent. Digitally prescribed therapeutics could in theory reach any digitally connected person on earth.
Digital Prescribed Therapeutics have the potential to level the disparity in medicines availability for humanity as a whole.
The global disparity in COVID-19 vaccine availability lays bear the reality of medicine inequity. Presently, 11% of populations in low income countries have had a primary COVID-19 vaccine compared to 73% of those in high income countries according to the G20 Accelerating COVID-19 Vaccine Deployment report of 2022.
Let us for one moment indulge in science fiction. 97% of the world lives within reach of a mobile network according to the International Telecommunication Union.
Future pandemics will have significantly less global impact if digitally prescribed vaccines or treatment can be delivered to people via their mobile devices.
Instantaneous, global reach. Booster shots will be as easy to receive as software updates. So, whilst we are no where near realising this reality, present day prescribed digital therapeutics are potentially the first-step towards this.
So back to science-fact.
Do Prescribed Digital Therapies work?
So this is the key question. Do these digital prescriptions for therapy actually work? There have been numerous studies, but one catches the eye. A study published in the European Heart Journal, looked at 390 unmedicated Japanese patients with high blood pressure. They were split into 2 groups. Both groups had similar baseline characteristics (age, sex, body-mass index, smoking history, and blood pressure).
The first group were provided standard lifestyle modification advice. The second group got the same advice but were also prescribed the use of an app (HERB Mobile). They were closely followed-up. By 12 weeks the mobile app group had statistically significant lower blood pressure than those not using the app.
At 12 weeks anti-hypertensive (blood pressure lowering) drugs were prescribed for those in either group that needed them. 8% fewer patients needed 'conventional' drugs in the app group. Interestingly, even at 24 weeks those on medications and using the app still had a significantly greater blood pressure reduction (better) than those on medication not using the app.
For completeness the study was funded by the app makers and several of the authors have stock options in the company as disclosed in the paper.
How do these apps work?
Many of the apps use a variety of methods. These can be broadly summerised as-
Digital Cognitive Behavioural therapy (dCBT) which works by taking patients through a structured programme of psycho-education, tracking mood, monitoring and offering strategies for aberrant thought management to name a few.
Remote monitoring of symptoms / physiology allows patients to record contemporary information about their condition in order to track and be reactive to 'deviations'.
Personalised education gives patients curated timely information on their condition and may provide means and mechanisms to cope with any troublesome symptoms. Some, offer education and reminders for any prescribed traditional medicines.
The degree by which apps 'automate' and process the above information is variable. Some offer a standardised, pre-planned programme whilst others include algorithms that dynamically alter content dependent upon user responses.
Physician intervention is also offered by some apps. Physician intervention can occur at pre-planned time-points or when certain events or combination of events are 'recognised' by the app/platform.
Many currently available prescribed digital therapeutics currently complement traditional therapies or are used as adjuncts to conventional medicines. Some are used as a first-line (as in the Japanese study) with conventional medicines introduced dependent on outcome.
Outcome measures
Which brings us onto a final but important point. Response to treatment must be defined. What does an adequate response look like with a digital therapeutic? Should we use the same outcome measures as for conventional medicines? With blood pressure, objective measures are readily discernible. However not all pathologies benefit from such objective markers of treatment response. No doubt in time we will hear the phrase 'Digital Therapeutic Response' entering the medical lexicon.
Summary
Prescribed digital therapeutics are novel class of clinician prescribed, regulated, software-based treatments for an ever increasing basket of conditions. Prescribed digital therapeutics can be used as adjuncts to conventional therapy, but in the future, where proven, they may one day replace traditional pharmaceuticals.