King’s led Multiple Sclerosis fatigue app receives funding as part of government’s £10M medtech investment

A digital therapy developed by researchers at King’s College London and Avegen, is one of eight innovative technologies to receive support from the government with the aim to accelerate the pathway for NHS and/or market approval.

The app, REFUEL-MS, helps patients manage Multiple Sclerosis (MS) fatigue symptoms. The funding is part of a new programme called The Innovative Devices Access Pathway (IDAP) which aims to bring state-of-the-art technologies and solutions to the forefront of the NHS. The government is investing £10 million in this pilot stage to test the new technologies for use on a large scale as quickly as possible.

MS is a chronic neurological condition which affects how the body functions and feels. MS directly affects around one in 500 people in the UK. Its symptoms include loss of sensation, trouble with balance and walking, and difficulties with thinking, memory and vision. One of the most challenging hidden symptoms is a persistent and particularly debilitating sense of fatigue and exhaustion, affecting more than 90 per cent of people with MS and significantly impacting their quality of life.  

The smartphone app REFUEL-MS, aims to reduce the severity of fatigue symptoms by improving accessibility to evidenced based NICE-recommended management programmes - these deliver cognitive behavioural therapy, targeted graded physical activity and balance exercises in a personally customisable format, with expert guidance from health psychologists, physiotherapists and occupational therapists.

Whilst some people receive medication for fatigue, evidence suggests that these behavioural approaches are more likely to help with fatigue; however, they are not offered to many patients due to limited NHS capacity. This funding will help speed up approval of the app to be used at scale and meet the gaps in NHS service provision.

The app is being developed by a team at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s, led by Professor Rona Moss-Morris, Professor of Psychology as Applied to Medicine, at the IoPPN and Theme Lead for Digital Therapies at the NIHR Maudsley BRC and built by Avegen, a digital health solutions company. A MS patient advisory group who come from a diverse range of backgrounds and have different severities of the illness have provided input into the app development throughout. It was funded by a grant awarded by the National Institute for Health and Care Research (NIHR) and co-funded by the Multiple Sclerosis Society as part of a larger programme of research including ensuring the app is acceptable to a diverse range of people (including currently underserved groups) and a trial which will allow the team to evaluate the effectiveness of the app and how well it can be implemented in routine care. 

Dr Kristina C Dietz, Research Associate at King’s IoPPN, employed on the NIHR Maudsley BRC Digital Therapies and Therapeutics theme, who led the IDAP application for the MS REFUEL team, said: “We are delighted to have been chosen for the Innovative Devices Access Pathway (IDAP) pilot scheme as part of a new multimillion pound government investment. This funding will help NHS patients get quicker access to REFUEL-MS, a smartphone app which is being developed in line with NICE-recommendations, based on the latest research, to make effective support for MS-related fatigue more widely available to people living with multiple sclerosis. We are confident that being part of IDAP will help us achieve this aim.”

Dr Clare Walton, Head of Research at the MS Society, said: "MS affects over 130,000 people in the UK. It is unpredictable and different for everyone, but around 90% of people living with the condition experience fatigue. And research shows fatigue in MS has a bigger impact on overall quality of life than any other symptom. “Treatment for fatigue is vital, and we’re proud to have co-funded the REFUEL-MS research project which has been recognised by the government as an innovative technology. We hope this will allow people with MS to access the app through the NHS as quickly as possible once the study completes.”

Dr Neha Gupta, Director of Platform, Avegen, said: “Scale and impact within Digital Health are influenced by pace of innovation within Regulatory pathways. As part of the first IDAP initiative, we at Avegen are thrilled to directly influence this pace to double-up on our scale and impact.”

IDAP pilot scheme

The Innovative Devices Application Pathway (IDAP) pilot scheme is a government initiative to develop a proportionate approval pathway (faster and easier) for all classes of medical devices (including, but not limited to, digital therapies, i.e. software and Artificial Intelligence as medical device) from conception to market approval/NHS adoption.

Vin Diwakar, Interim National Director of Transformation, NHS England, said: “This is an important milestone in our work to ensure the NHS continues to get the best new technologies and treatments to patients faster, having already rolled out more than 100 new treatments through the cancer drug fund and setting up a dedicated programme to prepare for new Alzheimer’s treatments once they are approved.

“We will be working closely with our partners to support those companies selected for the pilot so that more game-changing, life-saving technologies are introduced quickly and safely on the NHS.”

The pilot is part of a wider programme of work to accelerate access to medical technology. The programme is run by the Medicines and Healthcare products Regulatory Agency (MHRA), The National Institute for Health and Care Excellence (NICE), NHS England, Health Technology Wales, and Scottish Health Technology Group. They will be providing tailored, intensive advice on regulatory approval, health tech assessments and access to the NHS.

Dr Marc Bailey, Medicines and Healthcare products Regulatory Agency Chief Science and Innovation Officer, said: “The pilot criteria prioritises patient need in all aspects of decision-making and, by supporting innovative medical technologies, will ease pressure on the healthcare system. Most important, it’s an initiative which could be life-changing for many patients. We are committed to being a regulator that establishes the UK as a centre of medical innovation and look forward to working with the wider healthcare system to achieve this.”

Other medtech receiving funding include innovative devices which could identify and destroy liver cancer tumours using focused ultrasound waves, a blood test to detect Alzheimer’s, and a portable blood test to help paramedics quickly spot those at risk of stroke.