Digital Therapeutics

Ann Meyer has had diabetes for twenty-two years, but it was only last year that her GP prescribed a treatment that changed her life. It has allowed her to bring her blood-sugar levels under control and lose weight. Yet this miracle of modern science is not a new type of medication. It is a smartphone app called BlueStar. ‘Can an app replace a pill?’ is the big question behind an emerging trend known as ‘digital therapeutics.’ The idea: software that can improve a person’s health as much as a drug can, but without the same costs and side- effects, something that medical professionals everywhere will be interested in.

Developing digital therapeutics, or ‘digiceuticals,’ as some call them, has become the ultimate quest in some quarters of Silicon Valley, where investors see the chance to deliver medicine through smartphones. One investment firm, Andreessen Horowitz, even predicts that digital drugs will become the third phase of medicine, meaning the successor to the chemical and protein drugs we currently prescribe, but without the billion-dollar cost of bringing one to market. ‘It’s going to seem like going backwards and even barbaric that our solution to everything was just giving out pills,’ partner Vijay Pande wrote on the company’s blog.

But defining exactly what a digital therapeutic actually is can be tricky. ‘It’s still a fluid space that everyone is trying to categorize,’ says Peter Hames, the British CEO of a start-up called Big Health, which offers an online therapy program for insomnia suffers called sleep.io that, it claims, can replace ‘pills or potions’ with visualization exercises. Hames personally believes that digital therapies fall into two groups, which he calls ‘medication augmentation’ and ‘medication replacement.’ He says sleep.io is in the latter category because it actually makes sleeping pills unnecessary. ‘We’ve been able to show through multiple peer-reviewed studies that the outcomes are better than drugs,’ he says.

Digital therapeutics providers are careful to distance themselves from the rest of the digital health market of ‘wellness’ gadgets such as activity monitors and sleep trackers. Consequently, they have striven to mimic the drug industry’s practices and standards, including carrying out clinical tests and sometimes seeking regulatory approvals. Welldoc, the makers of BlueStar, describe it as the ‘first FDA-cleared mobile prescription therapy’ (although digital therapeutics don’t usually need approval by the U.S. Food and Drug Administration, since they often promote lifestyle or dietary changes that are deemed to be low-risk). And Big Health successfully opted to test a placebo version of its insomnia app against the real thing. The digital treatment ‘absolutely spanked the placebo,’ says Hames.

Whether a digital therapeutic involves a tracking sensor or coaching through an app, the acid test is whether they provide a distinct, measurable medical benefit to patients, and so can be recommended by the medical profession. One that does is Virta Health, based in San Francisco. Its goal is to actually ‘reverse’ diabetes without drugs or surgery using online coaching to get people on a special diet high in fats and low on carbs. It has a study by Indiana State University to back up the claim—about half of the 262 people with type 2 diabetes enrolled in a ten-week trial were able to reduce their blood glucose levels to non- diabetic ranges.

Steve Kraus, an investor, says he thinks digital therapeutics will be a ‘real thing’, but he says it’s not clear how many people will succeed with lifestyle intervention in the long run. Instead, he says, digital therapeutics used ‘in combination’ with drugs, to make them work better, could be the idea’s sweet spot.’ Perhaps with that in mind, some digital companies are already allying with pharmaceutical makers. One, Propeller Health, worked with a major pharmaceutical company on what it calls a ‘digitally guided therapy’ platform, combining asthma medication with sensors that patients attach to their inhalers to monitor when they’re used. Patients getting feedback from Propeller’s app end up using the medication less.

Hames believes that someday digital therapeutics companies may even outstrip drug companies when it comes to evidence. ‘We’re digital, so we’re going to have a firehose of data,’ he says. Pharmaceutical companies don’t always track the real-world results of their pills once clinical trials are done. But digital therapeutics companies could easily keep on getting data. ‘It’s not in the drug company’s interest because they have already sold the drug,’ he says. ‘But, the insurance companies will say to us, ‘You have the data, so why don’t you just tell us?’’

Some drug company executives remain skeptical, however. Robert Plenge, vice president at Merck’s research labs, even had to look up ‘digital therapeutics’ when asked whether they were important. Plenge doesn’t think the idea would have much impact on drug development and questioned whether digital companies will ever be able to provide the value for money that conventional medicines do. But as some digital therapies are already much cheaper than drug-based equivalents – about $33 a month, to use Big Health insomnia software compared to $73 for six tablets for the sleeping pill Ambien – cost may be what tips the scales in favour of digital.