Digital therapeutics (DTx) or digital health technologies (DHTs) are defined as products that deliver evidence-based therapeutic interventions to patients, which are driven by high quality software programs to prevent, manage, or treat conditions. DTx have become a hot topic in the life science field with the pace of development growing rapidly as a result of the heavy investment from venture capitalists and biotech companies. Similar to conventional drugs, prescription DTx need to undergo clinical trials to demonstrate efficacy and safety so they can be authorised from regulatory authorities and then seek reimbursement to ensure patients have access to their product1. The challenge is that the reimbursement landscape in many countries is still vague due to the innovative nature of DTx.
In the UK, the pricing and reimbursement (P&R) process for DHTs is decentralised. The National Institute for Health and Care Excellence (NICE) has developed an evidence standard framework to support the National Health Service (NHS) with determining the value of DHTs, but final P&R decisions are made at a clinical commissioning group (CCG) level, which have now been replaced by Integrated Care Systems (ICSs)2. However, NICE has recently published their first guidance from their assessment of a DTx called Sleepio, which may set a precedent in the UK in the way DTx are assessed and decisions on their reimbursement are made. This represents not only the increasing importance of DTx across the UK healthcare system but also NICE’s belief that they can bring real value to patients.
What is Sleepio and what is NICE’s recommendation on it?
Sleepio is a self-help sleep improvement programme based on cognitive behavioural therapy for insomnia (CBI-I). It is primarily accessed through a website, however, the app is also available for iOS and Android devices, which could be linked to a compatible wearable fitness tracker to monitor patients’ sleep. Sleepio’s programme centres around a sleep test, weekly interactive CBT-I sessions and regular sleep diary entries. The application aims to identify feelings and behaviours which are associated with symptoms of insomnia. Cognitive interventions aim to improve how people perceive sleep and behavioural interventions aim to advocate for a healthy sleep routine. The Sleepio programme is intended to be completed in 6 weeks, but people have access to it for 12 months upon their registration3.
On 20th May 2022, Sleepio became the first digital therapeutic to receive a positive appraisal from NICE. NICE recommended Sleepio as a cost saving option for treating insomnia and insomnia symptoms in primary care for people who would otherwise be offered sleep hygiene or sleeping pills. The digital therapeutic was assessed through NICE’s Medical Technologies Guidance (MTG) process. Clinical evidence has shown that Sleepio reduces insomnia symptoms compared with sleep hygiene and sleeping pills. According to NICE’s guidance, Sleepio represents a cost saving at a price of £45 per person compared with usual treatment in primary care, based on an analysis of primary care resource use data before and after Sleepio was introduced in 9 GP practices. NICE estimates that up to 800,000 patients in England could benefit from the app. The company, which has developed Sleepio will offer primary care training on prescribing, technical training and set up of the digital therapeutic3.
What evidence was incorporated in the submission package and how was it generated?
Clinical evidence demonstrates that Sleepio reduces insomnia symptoms compared with sleep hygiene and sleeping pills. This evidence comes from 28 studies, 12 of which are randomised controlled trials. NICE commissioned an external assessment centre (EAC) to review this evidence. They concluded that the quality of evidence on Sleepio’s effectiveness in improving sleep in people with self-reported insomnia symptoms is good. EAC also noted that the UK population is well represented in the evidence base for Sleepio, which incorporates seven UK studies and four multinational studies that included UK patients. Four of these studies conducted in the UK were randomised controlled trials and they all demonstrated that Sleepio was more effective in reducing insomnia symptoms than its comparator, which was standard of care (SoC), waiting list, placebo, or attention control3.
There is limited evidence of Sleepio’s effectiveness compared with face-to-face CBT‑I, so NICE recommended further research in this context.
Sleepio’s developer used a single cohort spreadsheet model to compare the cost of Sleepio with treatment as usual (hygiene sleep and sleep medication) and face-to-face CBT-I. The economic evidence on Sleepio was derived from 12 economic studies. The EAC considered just three of them met the decision problem. The model assumes that Sleepio is clinically equivalent to both comparators so considers only resource impact and no clinical outcomes3.
What were the key comments made by the NICE Committee?
Overall, the evidence presented by Sleepio’s developer was well accepted by the NICE committee. The committee also accepted relevance of the selected patient population to UK clinical practice and acknowledged that insomnia symptoms are a common problem and that Sleepio has the potential to help many people in the UK. The committee also concluded that Sleepio’s evidence base is robust, so it is effective at reducing insomnia symptoms compared with treatment as usual.
At the initially proposed price by the company (£90 per user), Sleepio was unlikely to be cost saving compared with treatment as usual. The EAC reduced the uptake rate from the company’s estimate of 1% to 0.58%, which increased Sleepio’s cost per user to £155.17. The Committee noted that the cost saving potential of the technology is highly dependent on its uptake rate. After the first committee discussion, the price per user was reduced to £66.11 and applied to EAC base case. This resulted in Sleepio becoming cost incurring by £16.59 per user at year 1 but cost saving by £68.97 at three years. However, the NICE committee did not agree that the company had sufficient evidence to extrapolate the data to three years and concluded there was uncertainty in Sleepio’s cost saving potential. At consultation, the company reduced its proposed price for Sleepio to £45 per user and the Committee noted that at this price the technology was likely to be at least cost neutral and very likely cost saving.
NICE committee members pointed out the app may be difficult to use for some people as it requires basic computer skills and currently it is available in English only. However, the company said that the programme will be available in other languages, too and acknowledged that the app will be harder to use for some people with computer/internet access restrictions3.
In conclusion, DTx are beginning to take an increasingly prominent role in the pharmaceutical industry. The rapid technology advancement in the past decade coupled with the Covid-19 pandemic was the strongest accelerator for the digitalisation of many industries, including pharma. As a consequence, there is an increasing number of DTx coming to the market and many of them will be seeking reimbursement. To be able to undergo the rigorous HTA assessment by NICE, developers of DTx would need to plan high quality clinical trials that would allow them to demonstrate clinical and cost-effectiveness of their digital therapy against the current SoC. Being the first digital therapeutic ever to be assessed by NICE, Sleepio will be used as an example by many other DTx developers, which can now benefit from NICE’s critical appraisal and update their evidence generation plans accordingly.
- Hargreaves, B., 2022. Digital therapeutics: a new frontier of medicine -. [online] Pharmaphorum.com. https://pharmaphorum.com/digital/digital-therapeutics-a-new-frontier-of-medicine/ [Accessed 3 August 2022].
- National Institute for Health and Care Excellence (NICE). Evidence standards framework for digital health technologies. https://www.nice.org.uk/corporate/ecd7 [Accessed 3 August 2022]
- National Institute for Health and Care Excellence (NICE). 2022. Overview | Sleepio to treat insomnia and insomnia symptoms | Guidance | NICE. Available at: https://www.nice.org.uk/guidance/mtg70 [Accessed 3 August 2022]