Defining Digital Therapeutics – Constructive ambiguity or detrimental disarray?

Digital therapeutics do not yet have a widely agreed definition, though the market for them is expected to reach $9 billion by 2025.

Their rise coincides with the intensification of the digital health market as a whole in recent years, which includes the widespread use of health and wellbeing technologies including fitness, sleep and diet trackers such as fitbit or myfitnesspal. Apps focused on health condition management and patient care now account for over 40% of the health and wellbeing app market, signifying a move to more targeted health technologies^[1].

Digital therapeutics can be distinguished from the rest of the digital healthcare market in that their primary goal is to use digital technology to complement or replace traditional therapeutics. On this basis they must show improved outcomes^[2]. There is however, little consensus on what constitutes a valid improvement, and what standards are needed to encourage adoption within wider clinical practice^[2]. For example, to what degree must digital therapeutics improve patient outcomes? What outcomes are deemed robust enough? How should the outcomes be collected? What evidence might be required to gain reimbursement?

Despite this lack of clarity, the US Department of Health & Human Services has been able to reimburse digital therapeutics since 2016^[3]. These include Pear Therapeutics’

reSET program for the treatment of patients with substance use disorder and Otsuka’s Abilify MyCite, which incorporates Proteus’ ingestion sensor into a drug for treating schizophrenia, bipolar disorder, and depression^[4].

In the UK, there has also been a push to encourage the development and adoption of digital therapeutics within clinical practice. This includes a £35 million fund made available over 4 years through the Digital Health Technology Catalyst^[5]. However, much of the digital therapeutic development in the US, UK and EU has until now been driven and funded by the pharmaceutical industry, which raises its own questions relating to access, ethics and sustainability.

A key benefit of digital therapeutics is their adaptability and their ability to respond to changes in a patient’s condition, in the absence of a healthcare professional. This is not to say we should be leaving the entire care of patients to unfettered algorithms but to allow scope for digital therapeutics to reduce the burden of tracking patient-reported outcomes (PROs) and to make minor, predefined amends to the complementary or replacement care they are providing.

More than 571 studies have been published since 2007, with approximately 140 of these being published in 2017 alone, which contain clinical evidence of digital health efficacy^[6]. The conversations have already been started, opening up debate as to the extent to which the lack of a unified definition is actually hindering innovation in this field. Projects such as the Evidence for Effectiveness (EfE) including NICE and DigitalHealth.London are already poised to provide support for innovators with the development of evidence, aiming to save time through the promotion of a ‘kill quick’ philosophy for any innovations that do not meet their standards.^[7]. But, if the real world evidence generated by digital therapeutics is what will ultimately define them, will stricter guidelines lead to more or less energy and meaningful innovation in this field?

For now, the ambiguity surrounding the definitions of digital therapeutics may be just what the landscape requires to allow this regimen disrupting innovation to change the healthcare landscape for the better. Meanwhile, there remains a unique opportunity to review and reflect on the bespoke, targeted evidence bases offered by this novel method of care, so as to evolve and maximise the many new prospects that digital therapeutics could offer.

1. Aitken, M; Clancy, B; Nass, D; The IQVIA Institute, The growing value of digital health in the United Kingdom: Evidence and Impact on Human Health and the Healthcare System; November 2017
2. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/digital-therapeutics-preparing-for-takeoff
3. https://www.fda.gov/medicaldevices/digitalhealth/
4. https://healthadvancesblog.com/2017/11/13/whos-really-first-in-fda-cleared-digital-therapeutics/
5. https://www.gov.uk/government/collections/leading-edge-healthcare-industrial-strategy-challenge-fund
6. https://digitalhealth.london/wp-content/uploads/2018/04/DigitalTherapeuticsNHS.pdf
7. http://www.medcityhq.com/wp-content/uploads/2018/07/Evidence-for-Effectiveness-for-website.pdf

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Please contact Sam Oliver samoliver@phassociates.com or Amanda Pulfer amandapulfer@phassociates.com, Joint Managing Directors, to arrange a meeting.