On May 20, the National Institute of Health and Care (NICE) of the United Kingdom announced new guidelines recommending the use of Sleepio Digital Therapeutic (DTx) by Big Health to treat insomnia. According to the GlobalData Epidemiology and Market Size Database, there are currently almost 19 million insomnia cases in the UK, with NICE estimating that up to 800,000 people could benefit from Sleepio in England. Sleepio was approved for use in Scotland last October.
NICE recommends cognitive-behavioral therapy (CBT) as a first-line treatment for insomnia. However, CBT is not routinely offered by the National Health Service (NHS) due to a lack of trained therapists, so the current standard of care is sleep hygiene advice and sleep pills, which can be addictive. NICE’s new guide states that Sleepio is a safe and effective treatment option for people who typically offer the current standard of care by providing immediate access to CBT. Patients can receive Sleepio through self-referral or through their primary care provider.
The NICE Medical Technology Advisory Committee evaluated evidence for Sleepio based on 28 studies, including 12 randomized controlled trials (RCTs), which showed that Sleepio was more effective in reducing insomnia than sleep hygiene and sleeping pills. RCT data show that 76% of patients who used Sleepio achieved clinically significant improvements in sleep. The guide also emphasizes that Sleepio is a cost-saving option by reducing both primary care appointments and prescribing costs. The price of Sleepio for the NHS is £ 45 ($ 56), excluding value added tax (VAT), for each person. Cost models show that after one year, compared to standard treatment, Sleepio saves £ 4.52 per person, which increases to £ 90.08 per person after three years.
Sleepio is a fully automated and customized six-week program that uses an artificial intelligence (AI) algorithm to tailor behavioral interventions to each patient’s symptoms and needs. The weekly CBT sessions last approximately 20 minutes and include a virtual sleep expert who offers techniques and strategies to naturally improve sleep patterns by identifying thoughts, feelings and behaviors that contribute to insomnia symptoms. The program 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 such as Apple Watch or Fitbit. Patients will have full access to the program for 12 months, allowing them to complete the sessions at their own pace and review the sessions if necessary. Sleepio can be accessed via a smartphone or web browser.
Achieving NICE approval is a critical step in increasing access to DTx products such as Sleepio. Since 2020, the DTx landscape has expanded significantly in Europe, with several countries implementing cost recovery policies to increase access to these tools. Removing barriers to reimbursement is a key step in ensuring widespread adoption of DTx, as recent work in Europe and now in England shows that significant progress is being made. Areas such as mental health and neurology are particularly relevant to the use of digital health technologies and the availability of evidence-based, cost-effective digital technologies will help national health systems reduce elective care backlogs, which have increased significantly due to the Covid-19 pandemic.