Evolving Landscapes: Digital Therapeutics
From smart watches to mental health apps, will an app a day keep the doctor away in 2019?
If you’ve been out and about in a city recently you may have seen the Close Your Rings advert by Apple, loaded with the compulsive desire to please the observer embodied in the Activity app on the watches. You don’t need to own one to feel the pull of visualising the quantified self.
The graphical style is hypnotic, the reward mechanisms are feel good and the output is an incremental increase in the likelihood of an individual moving / exercising / standing for the required time in a day.
“It’s such a simple and fun way to live a healthier day that you’ll want to do it all the time” — Apple
It’s the lifestyle partner to get you where you want to be. Supposedly.
Honestly, it sounds creepy as hell. Like the robot voice over at the beginning of any movie where artificial intelligence lulls humanity into a false sense of security by providing them with easy chores and little treats.
If the carrot mechanism isn’t enough, there’s also a fair amount of stick. The app dislikes people who sit down all day, and ten minutes before every hour you will get a reminder of this. People fear letting others down, so a little guilt and a pinch of shame goes a long way to motivating a response, even when it’s not actually a ‘person’ we’re dealing with. It’s not angry, it’s just disappointed.
If carrot and stick get the donkey moving, there are acheivement badges for hitting your goals a thousand times, or for making it outside on Christmas day. Go you! The only cost is a vast amount of extremely personal data including your location, your routine and your general health. Oh, and the cost of the watch at $399 for the Series 4.
Tone so far: Cynical. But…
It seems to work. This study from Q3 2018, published in the Journal of the American Heart Association demonstrates that gamified activity trackers (the study used Fitbit + MapTrek) are an effective approach for increasing physical activity at a clinically meaningful level in sedentary office workers.
Push notifications that act as reminders are a key feature of success, (see study here), and these can limit the use decline over time that is a common characteristic of all such apps.
So, if the tech works, and it can continue to work, can it offer support in other ways?
This is where we move from mHealth and ‘wellness’ as a category to digital therapeutics as specific products. mHealth includes anything and everything that can be classed as ‘mobile health support’. Anyone can release an app that enables you to track your calorie consumption, record your mood or manage a pill schedule, because the life-style changes recommended are deemed to be low-risk.
It’s the ‘anyone’ that’s important here. If anyone can push an mHealth product it means that the products are, as a category, unregulated by medical authorities. Digital therapeutics are a more specific, emerging group, that are intended to be rigorously tested and regulatory body approved for use as a replacement for, or as a complement to, an existing disease therapy.
There are clear benefits. These products can save millions in drug testing, they can relieve the burden on health services by saving costs in drug management, and they can empower patients to take control of their own health.
However, at the moment there is no requirement for companies to seek approval before calling their product a ‘digital therapeutic’. Some seek regulatory approval, some use clinical studies, but there are no guidelines as to what exactly would constitute a sound process comparable to the trial phases of a drug release.
Forbes quotes Michael Levy, Vice President, Head of Quality Institute and Head of Research & Innovation at United State Phamacopeia as stating that;
“Without established standards and verifications, these products could be falsified by unscrupulous actors”. He states there are significant differences between the way chemical medicines and digital therapeutics are developed. “The act of designing software is difficult, just like developing medicine. The rigor should be analogous to Good Manufacturing Practices, which must be used for medicinal products.”
Currently, the market is, to some extent, self regulating as competitors and media outlets give negative reviews in response. Hopefully, as the landscape evolves, regulation will catch up and we will see stringent criteria and quality standards of this novel class of interventions. These structures would provide a foundation for trust between health care providers and software developers, enabling the former to feel confident in prescribing a treatment plan which utilises a digital therapeutic.
And the big players are getting in on the action
New entrants include Big Health who aim to displace sleeping and anxiety medication with their two apps respectively: sleep.io and Daylight. In the case of the former, their guided insomnia therapy was tested against fake, but plausible cognitive benhavioural therapy (CBT) exercises in randomized control trials.
The results showed that the Sleepio course helped around 75% of people with persistent sleep problems to improve their sleep to healthy levels, compared with the placebo and no treatment conditions which had relatively little impact.
Daylight is still in the trial phase but it will be fascinating to see if similarly significant results can be attained when tackling anxiety.
But this market isn’t only scrappy start-ups looking to take on the big encumbants. GlaxoSmithKline had an extended partnership with Propeller Health (2015–18) aiming to support patients with asthma and chronic obstructive pulmonary disease (COPD) by providing symptom comprehension, medication plans and doctor reviews.
Patients who get feedback from the app demonstrably end up using their inhalers less often because they have better understanding of when it is needed. In 2018, Propeller was purchased by ResMed for $225 million as part of their goal to become the global leader in digital health for COPD. In the same space, Teva Pharmaceuticals secured FDA approval for their ProAir Digihaler device, which is the first regulatory approval for a device of this type.
Sandoz (Novartis) have also thrown their hat into the ring, participating in every funding round for Pear Therapeutics in 2018, investing a total of $70 million. In January, they announced the release of reSET-O, cited as the first and only FDA-cleared mobile medical application to help treat opioid use disorder. They are aiming to create and dominate a specific niche ‘prescription digital therapeutics’ which are designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers.
“The reSET-O prescription digital therapeutic (PDT) is a 12-week cognitive behavioral therapy intended to be used in addition to outpatient treatment. It includes transmucosal buprenorphine, a commonly used medication to treat opioid addiction, and contingency management designed to provide incentives to reinforce positive behaviors. reSET-O is available by prescription only for patients 18 years or older under the care of a clinician. The randomized clinical trial showed that reSET-O therapeutic content had an overall retention rate of 82.4 percent through the end of 12 weeks of treatment compared with 68.4 percent overall retention rate for patients who did not use reSET-O.” — reSET-O
Business Insider lists the following health acquistions in 2018 in a handy infographic, and concludes that a combination of the FDA paving the way for innovative new treatment options, and deep-pocket investments from the big players, will make 2019 a break out year for digital therapeutics.
Where will it be successful?
Not all companies are so positive about the new software releases. Robert Plenge, vice president at Merck’s research labs, is cited as having had to look up “digital therapeutics” when asked whether they were important. He is among a number of company leaders that are sceptical of the potential of this space to be anything more than another bubble. The evidence of the studies listed above suggest there might be more to it.
In a review of 224 studies across a variety of mHealth apps, programs that proved most effective were those that incorporated goal setting and self-monitoring (such as recording how much you ate or weighed), and those that involved multiple forms of communication (like personal counseling and texts) and which carried individualized messages. This suggests that success for digital therapeutics will primarily come from personalised, engaging, adaptive support offerings.
‘Catch all’ products are unlikely to succeed, as personalisation will require focussing on the complexities of a particular illness and the unmet needs of patients diagnosed with it, however, the overarching theme of ‘CBT as applied to x’ seems likely to recur. This study, published in the Clinical Psychology Review, found that with CBT response across disorders averaged 49.5% at post-treatment and 53.6% at follow-up, but that response rates varied as a function of the properties used to define them. Standardised measures of success will be critical in demonstrating that new apps can be relied upon as interventions.
The other big win for products in this market is likely to be in the race for data. The nature of the digital therapeutics beast is that an individual patient continually provides consistent data regarding their state and their routine and the software tailors the program to them. This stands in stark contrast with companies offering traditional drug interventions which often do not have such a hoard of high quality, near real-time information on the patients they support.
Some of the challenges for the new software will include managing such intimate personal data under increasingly strict legislation, namely Europe’s General Data Protection Regulation and California’s AB 375, a piece of landmark legislation which they passed while no one was looking in Q3 2018. Equally, avoiding corruption of data on the patient end will be equally important. The software needs to support patients in being honest, rather than, say, attaching their activity tracker to their dog.
Two pennies worth
This market looks set for growth, this is a general consensus across reviewers, but specifically an RnR market review predicts that:
“The digital therapeutics market in terms of value is expected to reach USD 457.9 million by 2021 from USD 110 million in 2016, growing at a CAGR of 27.7% from 2016 to 2021.”
The new offerings are comparatively inexpensive, easily scalable and support health care providers in addressing the challenge of behavior change. Todd Hixon at Forbes writes that it is “vital to progress against two major challenges facing healthcare in developed countries: chronic diseases, which drive over 80% of U.S. healthcare spending, are strongly rooted in unhealthy behaviors, and poor drug compliance, a $300 billion problem in the U.S.” He holds that digital tools, which can demonstrate behaviour change, will go a long way in addressing the challenges.
If you’re working in healthcare, making like an ostritch and burying your head in the sand is roughly equivalent to standing on a mountain top, during a thunderstorm, in wet copper armour and shouting ‘all gods are bastards!’ (RIP Sir Terry Pratchett). No organisation is an island, and exploring opportunities for knowledge sharing, investment and partnerships will result in targeted, smart innovations that have the potential to transform the sector.
