Now is the time to jump on the digital therapeutics bandwagon

We now have access to a number of digital tools to help us manage our health, from educational websites full of information, through podcasts created by patients sharing their stories, to apps in our smartphones that actively track our vital signs. It seems like we’re using as many digital healthcare interventions as we can possibly handle. But what if there was more? What if we could actually get digital treatment? 

Enter digital therapeutics. These do not belong in the realms of sci-fi but are actually in use right now, with the first therapy - reSET - receiving approval from the FDA in September 2017. reSET is a mobile medical app developed by Pear Therapeutics that can help treat substance use disorder as part of a 12-week program. The same company has also recently submitted Somryst, a prescription digital therapeutic to treat chronic insomnia and depression, for FDA approval. 

reSET and Somryst work by harnessing cognitive behavioural therapy (CBT), a type of treatment that focuses on changing the way people think and act. The theory behind CBT is that certain thoughts and attitudes are at the root of mental health issues, and that learning coping skills can help manage them and improve wellbeing. This approach is evidence-based and has been shown to help with the management of mental health issues like mild depression and anxiety, post-traumatic stress disorder (PTSD) and eating disorders. In combination with conventional therapies, it has also been shown to be effective for other conditions, such as severe obsessive compulsive disorder (OCD), major depressive disorder and bipolar disorder.

But CBT is not just effective at treating mental health issues: because it has the power to change behaviour, it can be used as an intervention in many chronic diseases that have their origin in unhealthy lifestyles, like cardiovascular disease and type 2 diabetes. For the same reasons, it can also be used to improve medication non-adherence, another major issue in patients with chronic disease. CBT is ideally suited for digital as it is scalable and can be delivered remotely in an effective way, providing quick care when needed. 

The CBT approach was used in the Twine platform, which provided a customisable approach to manage type 2 diabetes: it let patients set up treatment goals and develop health action plans, then sent reminders and provided analytics that helped track progress. The use of Twine together with conventional therapy resulted in a 3-fold reduction in blood sugar marker HbA1c compared to patients who used conventional therapy alone, showing that digital therapeutics can be just as effective as conventional approaches and even surpass them. Twine has since been acquired by wearable giant Fitbit, which has incorporated the platform into its other services. 

In terms of medication adherence, the Californian startup Proteus has developed a small radio tag that can be incorporated into pills and, once ingested, sends a signal to a wearable sensor patch located near the abdomen. The sensor can also track vital signs and provide a clear view of the impact the medication is having on patient wellbeing, further improving adherence.          

Clearly, digital therapeutics have the potential to become widespread in the near future. They are less costly than conventional medical interventions and can be self-administered, relieving the pressure on overwhelmed health services. This is particularly true in the case of mental health patients, who are often on long waiting lists for non-medication treatment. A further advantage in this scenario is that, unlike other non-medication approaches for the treatment of mental health, digital therapeutics can be standardised.

Digital therapeutics can also interact with other tools such as wearables and electronic patient records, generating and integrating large amounts of information which can then be used to improve patient care. They are of particular value to patients suffering from chronic diseases: in these cases, medication alone is not sufficient as standard of care, since patients also require education and support while making lifestyle changes that need to be long-lasting. These patients are also eager to actively participate in shared decision-making regarding their healthcare, and so self-administered digital tools allow them to take control of their treatment.

There are challenges as well, though. HCPs might very well favour the use of digital therapeutics by their patients on account of their effectiveness and their good safety profile, but first they have to be aware of them. They might also have concerns about insurance coverage, although some insurance payers have recognised the potential of digital therapeutics and are already providing reimbursements.  

So, digital therapeutics are great for patients, but why should pharmaceutical companies embrace them? Because they offer a unique opportunity to provide more holistic care to patients, care that doesn’t just mean giving them pills but helping with the day-to-day management of their condition and their lifestyle, supporting them on their journey. Digital therapeutics don’t only work as a standalone therapy, they can also be used to increase or complement the effectiveness of existing conventional therapies, adding value to these while helping to fulfil unmet needs. This will strengthen the relationship with patients, particularly if they are involved in design and development from an early stage.  

There are also revenue issues: because the FDA considers digital therapeutics as medical devices, pharmaceutical companies could be granted patent extensions when they use their drugs in combination with software. And of course, increases in compliance are expected to translate into increases in revenue.

And yet, pharmaceutical companies have been slow at taking up digital therapeutics. As an example, the entire digital therapeutics market was estimated at about 1.7 billion dollars in 2017. For comparison, in 2018 alone the sales of just one of AbbVie’s drugs (Humira) totalled 19 billion dollars. 

So why so cautious? Digital therapeutics have proven their efficacy, but their widespread use will probably require a paradigm shift for healthcare professionals, insurance payers and patients alike in terms of how healthcare is provided. For example, many potential reSET users are on Medicaid, but neither Medicaid nor Medicare are currently covering digital therapeutics.   

Another reason that might explain that reluctance is that it might be hard to distinguish digital therapeutics from digital wellness apps. Although digital therapeutics have demonstrated efficacy through clinical trials and many have obtained FDA approval, they may be considered to be on equal footing with apps aimed at tracking vital signs or sleep patterns. Strict definition criteria for digital therapeutics, together with mounting results for their effectiveness, could help overcome this issue.

It has never been easier to develop and market digital therapeutics, since the FDA has seen their potential and made it simpler to get them approved, providing easy and accelerated processing. However, FDA approval is only required for prescription-only digital therapeutics, which means that it is possible to develop direct-to-consumer therapeutics as well. Omada, a digital program designed to change behaviour in prediabetic, diabetic and cardiovascular patients, is not regulated by the FDA as a medical device, but can still be promoted directly to patients and employers as a tool to tackle chronic disease. This could be another one of the challenges the pharmaceutical industry faces when trying to market these therapies: traditionally, they have offered their products to healthcare providers, so they’ll have to change their ways.  

As with other digital therapeutics, clinical trials support the effectiveness of Omada: there is then a real possibility that these therapeutics might reduce and even replace the use of medication. This would mean that the companies developing these therapeutics would be in the best position to have a strong, close relationship with patients. It would also mean they would be the ones availing of large data sets regarding their healthcare management, using them to further improve their product to continuously provide solutions tailored to patient’s needs. Digital therapeutics would become the holistic treatment option, leaving pharmaceutical companies in the dust. 

For all these reasons, this is the time for pharmaceutical companies to get fully involved in developing digital therapeutics that add value and complement their existing services. It’s a great opportunity to have real impact in patient’s lives and keep them at the centre of cutting-edge healthcare.