Written evidence submitted by Ms Jessica Shull (DEL0207)
I serve as European Lead for the Digital Therapeutics Alliance, a non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics (simply put, digital treatments delivered remotely). We applaud the NHS for a superhuman effort in transforming to adapt to the current crisis and believe Primary Care must be able to broaden its use of technology-enabled care. More than 85% of consultations now managed remotely, and this letter provides evidence on how treatments can be provided remotely as well. We would also like to assist NHS commissioners and providers in preparing for an increase in demand for chronic disease care and mental health services.
COVID-19 continues to severely limit how people with chronic diseases, mental health conditions, and cognitive impairments receive the healthcare they will require both during, and following the immediate impacts, of this pandemic. Acute mental health support needs for patients will continue to escalate, with overall levels of anxiety, depression, and insomnia increasing. In terms of healthcare services, staffing will continue to be hampered throughout and immediately following the lockdown period, so clinicians may have trouble adjusting to ‘new normal’ clinical routines and working through the significant backlog of patients that has developed over the past few months. In terms of supporting technologies, many patients who have experienced the benefits of tele-consultations may now be unwilling to fully return to the prior analogue way of meeting with clinicians. Consequent to these factors, the NHS will need to integrate patient, clinician, and technology requirements into current workflows to not only accommodate for an increasingly digitally enabled workforce, but also scale to address healthcare needs post-pandemic.
NHS has already seen a notable rise in the use of digital technology, and the increased access these successful programmes provide should be built upon. The health tech sector in the UK has the highest levels of investment across Europe with more than 100 start-ups generating the potential to become £1billion businesses. Matthew Gould, CEO of NHSX states: “Tech can help the country deal with coronavirus. Digital tools are vital, whether they work to collect data or to connect patients with clinical staff. I’m delighted that so many startups and innovative tech businesses have offered their skills, talent and ideas to help us.”
Digital therapeutics (DTx) deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of behavioural, mental, and physical diseases and disorders. By providing interventions to patients in the safety of their homes and through patient-owned devices (such as smartphones and tablets), DTx products improve health outcomes and alleviate overburdened healthcare systems. They are safe, effective and highly differentiated from other digital health apps.
DTx products must maintain rigorous patient-centred core principles, ethical standards, and product development best practices to ensure product integrity, user-centred design, patient privacy/security, and validated clinical outcomes.
Digital therapeutics can be integrated across a number of distribution channels to enable scale and greatest impact. On a practical level, DTx products are usually prescribed to patients by GPs or made accessible to patients through validated clinical screening processes. Patients then receive instructions on how to download the associated app onto their device (e.g., smartphone, tablet), and use their patient-specific code to access clinical-grade content. For mental health DTx products, treatment regimens frequently consist of 10 to 12-week programs featuring interactive cognitive behavioural therapy offered through the patient’s device. For diabetes DTx products, programs may be responsible for dosing insulin or providing behavioural interventions based on patient-specific nutrition, medication use, daily behaviours, and activity in order to reduce dangerous fluctuations in blood sugar and improve HbA1c values. Regardless of the health condition being addressed, DTx products must undergo rigorous clinical tests to show that methods of care delivery are clinically effective.
The challenges for the healthcare system post-pandemic are two-fold; first, it is anticipated that there will be a steep rise in mental health and physical health needs due to the reduced access that resulted during the lockdown period; and second, clinical capacity across NHS will take time to return full complement, and even once it does, it is anticipated that healthcare services will be delivered via in-person and remote methods.
The digital nature of digital therapeutics means they can be deployed immediately and to millions of patients without potentially requiring an equivalent workforce expansion. DTx products can integrate into existing clinical systems and many, such as Sleepio and Silvercloud are UK-based and NICE evaluated. These types of products therefore have established protocols that are developed specifically for UK-based systems and existing integrations to enable rapid delivery to patients following clinical approval.
In order to rise to meet these challenges and be accepted as a new category of medicine that is safe, effective, and trusted, DTx products therefore:
Are clinically demonstrated as safe and effective through Randomised Control Trials, with results published in peer-reviewed journals.
Align with clinical guidelines, current medical care, and concurrent therapies.
Provide targeted care on a patient’s schedule and in the safety of their home environment.
Are scalable and used on patient-owned devices, with training available via the platform.
Deliver actionable, real world insights to patients, caregivers, General Practitioners, and other clinicians.
DTx products do not take the place of physicians or psychologists but serve as another tool in their arsenal to combat disease. DTx products can be prescribed or referred to by GPs, similar to medications and mental health counselling. Different from drugs or in-person therapy, DTx products are fully digital and provider clinicians with access to outcomes at different levels of granularity, including product use metrics and clinical outcomes. The potential of using these product-generated insights to directly benefit care are significant and may also be used by policy makers at the population health level to make better informed decisions for healthcare planning.
A study published in Health Affairs illustrates that the outcomes from using a DTx for asthma (Propeller) provided insights through real-world data on inhaler use, combined with environmental data. This led to population health policy recommendations including enhancing tree canopy, zoning for air pollution emission buffers, recommended truck routes, and developing a community asthma notification system.
The following list provides a short list of diseases that can be addressed with DTx products, an example product name, and a link to at least one published clinical trial.
Digital therapeutics are regulated as medical devices in Europe. DTx products provide treatment through software interventions that have been subject to Randomised Control Trials (RCT) and have been published clinically meaningful results in peer-reviewed scientific journals.
DTx Product, Company
Asthma and COPD
Propeller, Propeller Health
50% reduction of ED and related hospitalizations for asthma patients
35% improvement in symptom free days for COPD patients
Reduced annual hospitalizations from 3.9 to 2.3 visits.
Kaia, Kaia Health
Users suffering from chronic pain showed a 43% pain level decrease compared to controls in its latest randomized controlled trial (RCT).
Insomnia disorder and mental health
Sleepio, Big Health
Demonstrated in a placebo-controlled RCT and a further 11 published RCTs that 76% of users achieved healthy sleep levels.
Real world data from a large study of 3 million people showed that Sleepio was able to increase patient throughput with good clinical outcomes without requiring additional clinical resource in primary care and IAPT services.
SilverCloud, SilverCloud Health
46-60% recovery from depression and anxiety at 3 months
50% decrease in anxiety and depression symptoms at 12 months follow-up.
Type 1 and 2 diabetes
A retrospective study showed 100% of patients (1248) reduced their blood glucose average after 6 months. 31% (387) achieved blood glucose average of <140 mg/dL (eA1C<6.5) after 3 months.
Type 1 and 2 diabetes
A 6-month RCT involving 17 hospitals in France, showed the Diabeo system gave a 0.91% (0.60; 1.21) improvement in HbA1c over controls.
Type 2 diabetes
Insulia (Diabeo-BI), Voluntis (CE marked)
In a 13-month RCT, HbA1c reduction was significantly higher in the telemonitoring groups (G2: −1.44% and G3: −1.48% vs. G1: −0.92%; P < 0.002).
About DTA: Founded in 2017, the Digital Therapeutics Alliance (DTA) is a non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics. DTA has over 35 global members, located in 15 countries across four continents. DTA does not function as a certification, accreditation, or standard setting body. DTA does not endorse specific digital therapeutic (DTx) products, nor does information provided through DTA intend to serve as patient-specific medical advice. www.dtxalliance.org