On 20 May, the UK’s National Institute for Health and Care Excellence (NICE) announced new guidance that recommends the use of Big Health’s Sleepio digital therapeutic (DTx) for the treatment of insomnia. According to the GlobalData Epidemiology & Market Size Database, there are almost 19 million total prevalent cases of insomnia in the UK at present, with NICE estimating that up to 800,000 people could benefit from using Sleepio in England. Sleepio was approved for use in Scotland in October last year.

NICE recommends cognitive behavioural therapy (CBT) as a first-line treatment for insomnia. CBT is not, however, routinely available on the National Health Service (NHS) due to a lack of trained therapists, so the current standard of care is sleep hygiene advice and sleeping tablets, which can be dependency-forming. The new NICE guidance states that Sleepio is a safe and effective treatment option for people normally offered the current standard of care by providing instant access to CBT. Patients can get Sleepio through self-referral or through their primary care provider.

NICE’s Medical Technologies Advisory Committee evaluated evidence for Sleepio based on 28 studies, including 12 randomised controlled trials (RCTs), which showed that Sleepio is more effective at reducing insomnia than sleep hygiene and sleeping pills. RCT data shows that 76% of patients who used Sleepio achieved clinically significant sleep improvements. The guidance also highlighted that Sleepio is a cost-saving option, by reducing both primary care appointments and prescribing costs. The cost of Sleepio to the NHS is £45 ($56), excluding value-added tax (VAT), for each person. Cost models show that after one year, compared with standard treatment, Sleepio saves £4.52 for each person, which increases to £90.08 for each person after three years.

Sleepio is a fully automated and personalised six-week programme that uses an artificial intelligence (AI) algorithm to tailor behavioural interventions to each patient’s symptoms and needs. Weekly CBT sessions are approximately 20 minutes in length and involve a virtual sleep expert, which suggests techniques and strategies to naturally improve sleep patterns by identifying thoughts, feelings and behaviours that contribute to symptoms of insomnia. The programme also includes access to a community of users, a sleep diary, audio tools and articles. The sleep diary can be filled in manually or data can be uploaded from wearable devices like Apple Watch or Fitbit. Patients will have full access to the programme for 12 months, allowing them to complete sessions at their own pace and revisit sessions if needed. Sleepio can be accessed via a smartphone or web browser.

Achieving NICE approval is a critical step to increasing access to DTx products like Sleepio. Since 2020, the DTx landscape has expanded considerably in Europe, with several countries implementing reimbursement policies to increase access to these tools. Removing barriers to reimbursement is a key step in ensuring widespread adoption of DTx, with recent activity in Europe and now England demonstrating that significant progress is being made. Areas like mental health and neurology are particularly suited to the use of digital health technologies and the availability of evidence-based, cost-effective digital technologies will support national healthcare systems in reducing elective care backlogs, which have increased significantly due to the Covid-19 pandemic.

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