Entrepreneurs are betting on apps that improve\u2014or just replace\u2014prescription medication.<\/b>
What if an app could replace a pill? That\u2019s the big question behind an emerging trend known as \u201cdigital therapeutics.\u201d The idea: software that can improve a person\u2019s health as much as a drug can, but without the same cost and side-effects.
Digital therapeutics, or \u201cdigiceuticals,\u201d as some call them, have become a Holy Grail in some quarters of Silicon Valley, where investors see the chance to deliver medicine through your smartphone. Andreessen Horowitz, the venture firm, even predicts digital drugs will become \u201cthe third phase\u201d of medicine, meaning the successor to the chemical and protein drugs we have now, but without the billion-dollar cost of bringing one to market.
\u201cIt\u2019s going to seem backwards and even barbaric that our solution to everything was just giving out pills,\u201d partner Vijay Pande wrote on the investment company\u2019s blog .
But defining exactly what a digital therapeutic actually is can be as elusive as finding the famous chalice. \u201cIt\u2019s still a fluid space that everyone is trying to categorize,\u201d says Peter Hames, the British CEO of a startup called Big Health, which offers an online therapy program for insomnia suffers called sleep.io that it claims can replace \u201cpills or potions\u201d with visualization exercises.
Hames says digital therapies fall into two groups, which he calls \u201cmedication augmentation\u201d and \u201cmedication replacement.\u201d He says sleep.io is in the latter category because it actually makes sleeping pills unnecessary. \u201cWe\u2019ve been able to show through multiple peer-reviewed studies that the outcomes are better than drugs,\u201d he says.
The term digital therapeutics began to circulate around 2013, in large part due to Sean Duffy, CEO of Omada Health. He began using it at conferences and in the company\u2019s marketing materials to describe its online coaching software to help pre-diabetics avoid getting sick by exercising more and losing weight.
About a dozen startups now call themselves digital therapeutics providers, and say they\u2019re distinct from the rest of the digital health market of activity monitors, smart scales, and sleep trackers.
To distinguish themselves from \u201cwellness\u201d gadgets, digital therapeutics companies tend to carry out clinical tests and sometimes seek regulatory approvals \u2013one company, Welldoc, offers a prescription-only version of its BlueStar phone app for managing diabetes, which it terms the \u201cfirst FDA-cleared mobile prescription therapy.\u201d But unlike drugs, digital therapeutics don\u2019t usually need approval by the U. S. Food and Drug Administration, since often they promote lifestyle or dietary changes that are deemed to be low-risk.
Whether a digital therapeutic involves a tracking sensor or coaching though an app, the biggest question is whether they provide a distinct, measureable medical benefit. One startup calling itself a digital therapeutics company is Virta Health, based in San Francisco. The company raised $37 million in March. Its goal is to actually \u201creverse\u201d 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\u2014about half of the 262 people with type 2 diabetes enrolled in a 10-week trial were able to reduce their blood glucose levels to non-diabetic ranges.
Steve Kraus, an investor at Bessemer Venture Partners, says he thinks digital therapeutics will be a \u201creal thing, I really do,\u201d but he says it\u2019s not clear how many people will succeed with lifestyle intervention in the long run. Instead, he says, digital therapeutics used \u201cin combination\u201d with drugs, to make them work better, could be the idea\u2019s sweet spot.
Some digital companies are already allying with pharmaceutical makers. One, Propeller Health, inked a deal with GlaxoSmithKline for what it calls a \u201cdigitally guided therapy\u201d platform. The approach combines Glaxo\u2019s asthma medications with sensors, made by Propeller, that patients attach to their inhalers to monitor when they\u2019re used. Patients who get feedback from Propeller\u2019s app end up using the medication less often.
To win adoption, digital therapeutics companies have striven to mimic the drug industry\u2019s practices and standards. Big Health, based in San Francisco, went as far as testing a placebo version of its insomnia app against the real thing. One group of insomnia-sufferers were given plausible-sounding, but fake, online visualization exercises; the other received the actual cognitive behavioral therapy that Big Health says works. The digital treatment \u201cabsolutely spanked the placebo,\u201d says Hames.
Hames believes that someday digital therapeutics companies may even outstrip drug companies when it comes to evidence. \u201cWe\u2019re digital, so we\u2019re going to have a firehose of data,\u201d he says. Drugmakers don\u2019t always track real-world results of their pills once clinical trials are done. But digital therapeutics companies could easily keep getting data. \u201cIt\u2019s not in the drug company\u2019s interest because they have already sold the drug,\u201d he says. \u201cMeanwhile, the insurance companies will say to us, \u2018You have the data, so why don\u2019t you just tell us?\u2019\u201d
Some drug company executives remain skeptical. Robert Plenge, vice president at Merck\u2019s research labs, had to look up \u201cdigital therapeutics\u201d when asked whether they were important. \u201cI don\u2019t totally understand what you mean,\u201d he says. \u201cWhich might in and of itself be your answer.\u201d Plenge doesn\u2019t think the idea would have much impact on drug development and questioned whether digital companies will be able to prove their offerings are worth the price.
But some digital therapies are already much cheaper than your average drug. At Big Health, people are charged $400 a year, or about $33 a month, to use the insomnia software. The sleeping pill Ambien, by contrast, costs $73 for six tablets, or six nights of shut-eye.
A notable difference is that insurance often pays most of the cost of drugs and insurers are still getting used to digital therapeutics. Omada Health, which bills employers and insurance plans $140 a month for the first four, then $20 per month, in 2016 again broke ground when Medicare agreed to reimburse the cost of its digital diabetes prevention program.
Ambar Bhattacharyya, with Maverick Ventures, says he thinks insurers are ready to talk about covering digital therapies more widely. \u201cThis is an imminent issue that I suspect will be figured out within a year,\u201d he says. If it\u2019s good news, he says, the space is poised to explode.<\/p>\n