Smartphones are increasingly delivering verified treatments for diabetes, addictions and ADHD
LUANN STOTTLEMYER has had diabetes for 23 years, but it was only in 2016 that her doctor 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 pill. It is a smartphone app called BlueStar.
The program is one of a growing number of apps that America’s Food and Drug Administration (FDA) has approved to treat everything from diabetes to substance abuse. The FDA has encouraged firms to join a scheme that aims to streamline the regulatory process for such treatments. There are many candidates: at least 150 firms globally are developing some form of “digital therapeutic” (“digiceutical” in the lingo), says Mark Sluijs, who advises Merck, a big American drugmaker.
Unlike other sorts of digital health apps, digiceuticals have been tested for efficacy, approved by regulatory agencies such as the FDA and are prescribed by a doctor. Most gather data, either by asking patients for information or by using sensors, and provide real-time guidance. Diabetes apps, for instance, work with connected monitors and use the information to manage symptoms. Apps that help users to stop smoking combine a breath sensor with coaching on how to quit. Addiction-fighting apps can be based on cognitive behavioural therapy.
Most apps are developed by startups, many of which are based in and around Boston. One such, Pear Therapeutics, has a pipeline of treatments at various stages of development, much like a conventional pharmaceutical firm. These apps are aimed at treating a range of conditions: opioid addiction, schizophrenia, anxiety, insomnia, post-traumatic stress disorder (PTSD), depression and chronic pain. Pear’s reSET app, for instance, which treats disorders involving the misuse of alcohol, cocaine and other stimulants, has been approved for sale and should be on the market in early 2018. The app will be more effective than conventional treatments, claims Corey McCann, Pear’s chief executive. It carefully trains patients to recognise daily triggers and cravings and to monitor and track these with their doctor.
Another area of attention is medication for attention-deficit hyperactivity disorder (ADHD), on which Americans spend $14bn annually. Akili Interactive, another startup, recently completed a trial showing that a computer game it has developed to treat ADHD can improve attention and inhibitory control in children. If approved, the game would be the first digital therapeutic for this disease. As well as competing with existing drugs, it may also appeal to parents who are reluctant to medicate their children for ADHD.
Some digiceuticals will work better alongside conventional drugs, rather than on their own—opening up possibilities for alliances between tech and pharma firms. Voluntis, a startup, develops companion software for specific medications or medical devices. These programs can monitor side-effects, help manage symptoms and connect patients with doctors and nurses.
Pharma firms and venture capitalists remain cautious, however. Only a few drugmakers have invested in startups, and VCs are waiting to see what happens with the current crop of businesses, says Nikhil Krishnan of CB Insights, a data provider. One reason for the reluctance is a lack of rules for prescribing and paying for these apps—a problem that a new lobbying group, the Digital Therapeutics Alliance, wants to tackle. Cultural hurdles have to be overcome, too: many patients will find it hard to believe that software can be as effective as a pill. Analysts estimate that the market for digiceuticals will be worth a modest $9bn by 2025.
Once accepted, however, digiceuticals should take off and may well be created by large pharma and tech firms as well. The apps make it possible both to measure whether patients are adhering to their treatment, and to collect evidence on outcomes. Barriers to entry for startups are lower than for drugmakers, which need access to costly laboratories and manufacturing facilities. So many apps will compete to treat the same disease, which should spark very rapid innovation—a rare phenomenon in medicine—and perhaps even to lower prices, a rarer one still.