Big Health, a US-based company that offers digital mental health solutions, has launched Sleepio, an evidence-based digital therapeutic that delivers cognitive behavioural therapy for insomnia (CBTi), but it is widely unavailable to NHS patients in England despite being recommended by the National Institute for Health and Care Excellence (NICE) two years ago.
In the US, FDA clearance of SleepioRx (the US version of the treatment) comes alongside a proposal by the Government’s Centers for Medicare & Medicaid Services (CMS) to introduce new reimbursement codes for FDA-approved digital mental health therapies paving the way for millions of patients to be offered help consistent with clinical guidelines in 2025.
Meanwhile in England, although NICE recommends CBTi as the first-line treatment for insomnia - either delivered face-to-face by a qualified therapist or digitally through Sleepio - in practice neither option is available to most people. Face-to-face CBTi is very limited due to a shortage of trained therapists⁵,⁶,⁷, and NHS England has still not funded digital CBTi through Sleepio.
Calls for access to the recommended first-line treatment are growing, with three in four GPs saying they would recommend a NICE-approved, clinically effective CBT-based treatment if it was available to them
When NICE recommended Sleepio in May 2022, it outlined its potential to increase access to the clinically recommended first-line treatment and stated that funding it nationally would deliver in-year cost savings for the health service by reducing GP appointments and prescription medication costs.
However, while CBTi could be made available to patients in the US within just a few months of its FDA clearance, and has been accessible across Scotland since 2021, stalled NHS England procurement efforts mean that Sleepio is still unavailable to most patients in England 28 months after it received NICE guidance. This is despite the NHS Constitution stating that patients have a right to access treatments that have been recommended by NICE for use in the NHS.
Calls for access to the recommended first-line treatment are growing, with three in four GPs saying they would recommend a NICE-approved, clinically effective CBT-based treatment if it was available to them. Sleepio’s creators, Big Health, have received thousands of requests for access to their digital CBTi treatment from concerned GPs and patients who need help to manage their insomnia, and so are hoping for a swift resolution to the stalled NHS England procurement.
The UK has ambitions to be a life sciences and medical technology powerhouse, leveraging the single-payer NHS model to rapidly adopt proven innovations that deliver exceptional care to patients at exceptional value for taxpayers
Will Goddard, UK Managing Director for Big Health, said: "The UK has ambitions to be a life sciences and medical technology powerhouse, leveraging the single-payer NHS model to rapidly adopt proven innovations that deliver exceptional care to patients at exceptional value for taxpayers.
"However, despite Sleepio being recommended by NICE, proven within the NHS, and cost-saving in-year, patients in England still don’t have access. This begs the question: what’s the use in NICE guidelines that clinicians cannot follow, and that patients cannot benefit from?
“In contrast, FDA clearance in the US is a significant milestone and we are delighted that clinically-effective digital CBTi will soon be available to patients. We just hope that, as is already the case in Scotland, patients in England will soon be able to access this guideline-recommended treatment, too."