The digital therapeutics market is forecast to grow from $1.7 billion in 2016 to $9.4 billion by 2025, according to Grand View Research Inc. The increase is driven by improving technology and data algorithms, the openness of patients using and wearing technology, and research showing the effectiveness of technology in improving health.
An aging population means more health care will be needed. Technology can ease some of that demand if patients use it to cut down on office visits, says Kvedar. A congestive heart failure patient, for instance, can be monitored remotely and then check in by phone with nurses, reducing both medical expenses and hospital visits.
“Mobile adoption, cloud computing and our willingness to give information as consumers, has created a sweet spot” for digital therapeutics, says Erez Gavish, co-founder and CEO of 2breathe Technologies Ltd. in Tel Aviv. That doesn’t mean replacing all doctor visits. Gavish says, “Digital therapeutics is helping you comply with the regimen a physician has supplied.”
Digital therapeutics refers to technology that improves a person’s health similarly to a drug but without the costs and side effects of pharmaceuticals. They can be used in combination with drugs or instead of them. “It covers everything from an app to augmented virtual reality,” says Kinsey Fabrizio, CTA senior director of member engagement.
A patient with dementia, for instance, could benefit from a virtual reality walk in the park. Dr. Michael Hodgkins, chief medical officer of the American Medical Association agrees that technology can help doctors reach patients “in the wild” since office visits only provide a brief snapshot. With hypertension, for instance, success rates of controlling blood pressure through traditional approaches have been too low.
“The challenge is finding the right balance between the use of these technologies and the care people expect from physicians and their health care team,” Hodgkins says.
For digital therapeutics to reach its potential, innovators need to overcome a few challenges. The biggest is: Who pays both for the devices and for time to review the data?
Gavish predicts that businesses will spring up to analyze the data for doctors. In January, the Centers for Medicare and Medicaid Services (CMS) began offering reimbursement to doctors with Medicare and Medicaid patients for reviewing data from digital therapeutics.
Insurance companies also are beginning to offer incentives to patients for using technology to improve their health. But CMS has not done the same for the devices themselves. Without a code from CMS for the software and devices, patients often can’t get reimbursed by their insurance companies. Buyers of RESPeRate, a blood pressure device made by the same people as 2breathe, generally pay out of pocket, though some Veterans Affairs hospitals cover it.
User friendliness is another challenge. Touch and voice improvements in technology have helped, Kvedar says, but the industry needs to continue to make the products easier for patients to use, Hodgkins adds. For doctors, the challenge is to make the data they receive work with their existing technology, and to help them wring meaning out of vast piles of information.
Amar Kendale, senior vice president of product management and design at Livongo Health, says it takes doctors about 10 years to publish scientific results and adopt new solutions as part of clinical practice. The products need to be designed well enough to keep chronic disease patients’ interest over the long haul, Hodgkins says.
But people from the technology and health worlds believe digital therapeutics can change the face of medicine. “The episodic care people get from the current health care system is “sick care,” whereas what people really need is “well care” – that will keep them healthy in the real world and the time between [doctor] visits,” says Kendale.
But the market needs to find ways to get their offerings covered by insurance and employers, make them technologically accessible to both patients and doctors, and get the medical community to buy in to their benefits. Showing scientific outcomes for the effectiveness and value of digital therapeutics will be key for winning reimbursement and getting support from the medical community.
People respond to personalization in ads and games so why not in how they battle diabetes?
Livongo, located in Mountain View, CA, offers a wireless blood glucose meter. Instead of scribbling readings on a log, the data zips to a cloud to be analyzed. Livongo then offers advice, like a message notifying the patient that their blood sugar is too high, and recommending a 15-minute walk.
Livongo can offer personalized advice because it has medical information about the user and patients report how they are feeling along with the readings. “This [diabetes management] is a complicated topic so a 15-minute visit with a doctor is not enough information,” says Kendale.
When patients have a very high or very low reading, a diabetes educator calls them within three minutes. “It’s in-the-moment information and support so consumers can make good decisions,” he says. And patients can choose to have family, friends or doctors be notified if they have dangerous readings.
Livongo’s diabetes program is covered by hundreds of self-insured employers. A study by the consulting firm Mercer studied five companies using Livongo and found that the program brought blood glucose readings down about seven percent, cut health care costs six percent (compared with two percent for a control group of diabetics not using Livongo) and reduced the number of doctor and emergency room visits.
Digital therapeutics also can help create health solutions that cut across different diseases, Kendale says. His company recently added a product to help monitor hypertension.
That 60,000 mile track of small blood vessels in the human body gets narrower and more rigid under stress, causing the heart to pump harder and blood pressure to be raised dangerously. RESPeRate is a fitness plan for those blood vessels. Doctors commonly recommend drugs along with diet and exercise improvements for hypertension.
But pharmaceuticals have side effects, patients sometimes skip medications and the drugs don’t always work well enough, says 2breathe CEO, Gavish. Diet and exercise changes can be difficult for some patients. His device is the only over-the-counter, non-drug treatment for blood pressure leared by the FDA. It helps users regulate breathing by following musical tones they hear and adapts to each person’s breath patterns. Hypertension patients use the $299 device for 15 minutes several days a week.
On average, users decreased their systolic blood pressure by 14 points and diastolic by 18 points, Gavish says, allowing some people to reduce or eliminate prescription drugs. “Nobody likes to modify their life,” Gavish says. “Fifteen minutes of listening to a melody is not modifying your life.”
The device is so relaxing, he says, many initial users fell asleep during the treatment. Voices were added to wake up people if they fall asleep before the 15 minutes is up, Gavish says, and a second product called 2breathe was launched to use tones for other users, to help them fall asleep.
An opioid crisis is gripping the nation as the search for pain relief has turned into an addiction for many. “You’ve got people suffering and the easy approach was just to write a prescription. But there are a lot of side effects with medications,” says Frank McGillin, chief commercial officer of NeuroMetrix Inc., a Boston digital health and neurotechnology company that offers an alternative.
Quell is a wearable neurostimulator that uses electrodes to transfer current through a person’s skin to stimulate sensory nerves. That activates the body’s natural pain response, triggering production of enkephalin, a powerful natural opioid that blocks pain signals to the brain. About 100 million Americans (one out of three) have chronic pain, and half of them don’t get complete relief from medications, McGillin says. Others become addicted. “We’re basically enabling people to get on with their life,” he adds.
Quell looks like a strap worn to monitor heart rate during a workout but is worn on the upper calf where there are lots of sensory nerves. The device captures data from users so it can deliver an optimal dose of stimulation for each person. It even checks the weather to let people know if rain or cold is coming and gives them the option to increase their stimulation levels to compensate. The app lets users track their self-reported pain scores, sleep patterns, activity and gait (which is correlated with pain levels.)
Quell, with 150,000 customers, has reduced pain for 81 percent of patients with chronic pain. And 67 percent of users cut or eliminated their pain medications, McGillin says.
Kvedar says, “There’s an enormous amount of promise in digital therapeutics but we still have a few things to iron out.”
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