contributed by Chris Taylor
Sally’s story (and how it tells us DTx distribution is broken):
Sally has been looking forward to (for quite some time) her first granddaughter’s first birthday. You may be a parent or relative who has participated in this type of celebration and can attest to the fact that it is a memorable experience. For Sally, being around family, seeing her granddaughter open her first present, and experiencing the hilarity of watching her eat birthday cake for the first time, really brought her joy. That was until she bent over to pick up her granddaughter. That’s when the pain shot through her lower back.
Now you need to know that a decade prior, Sally got into a small car accident and sustained a minor injury to her left big toe. This injury caused a change in her walking gait, which put slight pressure on the iliotibial band (IT band) that runs on the outside of the thigh. This caused instability and a downward pull of the gluteus medius and Quadratus Lumborum (QL) muscles. It cascaded to create a pull on the lumbar region of her spine and a corresponding compression of the nerves—all resulting in lower back pain. The back pain didn’t start for almost eight years after the accident, and it never occurred to Sally or others that the pain she was experiencing was related to the wreck. Her body was experiencing a chain reaction of breakdowns.
As you would expect, she sought treatment through her employer group health plan. This meant she was going to an in-network physical therapist (PT). The specialist guided her through a standard series of lower back pain stretching and strength exercises. At first, these exercises seemed to help… until the birthday incident.
After that, her back pain escalated quickly. She was prescribed more intensive pain medications and was referred to both an orthopedic and neurosurgeon for surgery. A single-level posterior lumbar-fusion surgery was recommended that would have cost Sally her max $4,400 in total out of pocket spend and $26,000  to the self-funded group health plan that covered her procedure.
Still over a decade away from retirement, and desperate for alternatives to what she viewed as an “old person’s” surgery, she was introduced to a digital solution through a friend. This digital application incorporated motion capture technology with artificial intelligence and trained PT’s to look at whole body mechanics as a way to treat pain. It wasn’t covered by her group health policy, but Sally decided to pay the fee and give it a try. It was only through this solution that the core issue was identified, which tied her lower-back pain to the big toe injury she sustained 10 years ago. The outcome was a more appropriate and non-invasive treatment protocol to be prescribed and monitored through the digital application.
Within 60-days of being introduced, Sally was virtually pain-free and more productive. These results represented a big win for her and her employer. She avoided a major surgery, paid a fraction of the total out of pocket that was coming her way if the surgery was elected, and the employer avoided a major expense.
Unless you are cold hearted, it’s difficult to not feel a degree of empathy for Sally. For those of us in the healthcare industry, we are well aware of the unnecessary surgeries, over prescribing of pain medications, and excessive treatments for chronic medical needs. If it wasn’t for this digital therapeutic (DTx) solution, Sally was on this path. That path was not appropriate for Sally, and the unnecessary surgery would have added more cost pressure to an employer already sensitive to high healthcare prices.
As an industry, we aren’t doing enough to get the right solutions into the hands of the right people at the right time. This is a technology challenge just as much as it is a distribution problem. Read on to understand why distribution is the bigger and more meaningful issue we need to work on.
What do we mean when we say digital therapeutics? According to the Digital Therapeutics Alliance, “DTx delivers evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions. Digital therapeutics form an independent category of evidence-based products within the broader digital health landscape, and are distinct from pure-play adherence, diagnostic, and telehealth products” . This is a good working definition. The key is that these solutions are evidence based, which means they are all about outcomes.
DTx solutions are more than just a rebranding of digital health or health and wellbeing. A variety of the digital health solutions, of which there are many, have not delivered. Because some of these early tools have proliferated without being tied to evidence-based approaches, we think they are the ones most likely to disappear due to eroding the market’s trust by lack of provable efficacy. DTx approaches deliver a new level of rigor that proves the efficacy of treating, managing, or preventing a medical condition. Say it with your friends at m4… “Evidence is everything.” We’re in a skeptical, prove-it-to-me industry with those that are the gatekeepers to success. Some of the more successful DTx solutions in the market today have well established and proven claims like Proteus, Livongo, Akili, or Omada.
But we are still early. Omada’s study that concluded at the end of 2019 showed enrollment of less than 500 participants. This industry is still working through uncertainties on what constitutes a successful trial and how to measure digital results. There is yet to be a large scale RCT (randomized control trial) run on a broad population against a control group or “placebo”. We don’t even have a universal definition of “placebo” in digital health yet.
In addition, there has not yet been wide adoption by doctors, patients, and payers in real-world scenarios. This isn’t like a drug. There is an additional burden to prove efficacy beyond human physiology. For example, in the real world there are cultural dimensions to technology adoption and use. It goes beyond the simple task of popping a pill into your mouth and measuring the impact.
Despite the early stage of many of the solutions currently in the market, investors are viewing DTx in a very favorable light.
Globally, the DTx market was roughly $1.8bn in 2018. That is projected to grow to $7.1bn by 2025, which is a CAGR of 21.5% over that period . The amount of investment into digital health is projected to grow from $179.6bn in 2016 to $536.6bn by 2025 . This level of investment has driven a tremendous expansion in the number of solutions and clinical indications that they are treating. In the US alone, 2018 saw $8.1bn invested in digital health solutions, which represents a 42% increase over the prior year .
The number of health apps grew significantly leading into 2016. Since then that number has remained fairly steady. As of Q3 2019, there were 44,384 mHealth-defined apps in the Apple App store. This is a 4.5% decrease from the previous quarter . Remember what we said about long-term viability being tied to evidence.