Last month at the DTx Europe Summit in London, MedCity, along with the Oxford Academic Health Science Network (Oxford AHSN) and NHSX, hosted a roundtable to discuss routes to entry to the UK and current learning from best practice in this emerging area. Here we share some of the key points arising from the discussion, which took place between companies attending from Europe and the US and our expert hosts, Neelam Patel, Chief Operating Officer MedCIty, Nicki Bromwich, Head of Commercial Development, Oxford AHSN, Leanne Summers, Digital Strategy Delivery Lead, NHSX

When it comes to scaling digital technology development, data generation and analytical capability, there are few that would deny we are on the cusp of something great. The opportunities being presented for digital therapeutics in the UK are on a scale not seen before, and clinicians, innovators and regulators alike are excited by the potential benefits for both patients and health care providers.

But how do we all get on the same page, especially when it comes to navigating the complexities of the landscape and the needs of our national health service?

A lot of work is being done to help companies access the market, and the infrastructure and policy environment is already much more supportive than it has been. For example, the newly boosted Accelerated Access Collaborative (AAC) programme will fast-track promising digital services, medicines and diagnostic tools to NHS patients. As a single payer the NHS is looking to implement digital interventions that deliver improved outcomes supported by a proportionate level of evidence demonstrating effectiveness. Equally, companies ultimately want to produce technologies that deliver these requirements. It’s all about partnership – working together to produce better, more efficient, more cost-effective healthcare.

What was really highlighted was the ongoing importance of co-production and collaboration between industry, clinicians and academics in developing and adopting technologies that can demonstrate improved patient outcomes and value to the health and social care system.

So, here’s a recap of some of the main discussion points.

The role of organisations such as AHSNs, NHSX and MedCity, where they fit into the landscape and their role in supporting companies to access the healthcare system

The UK benefits from a forward-thinking government and policy framework and is investing heavily in innovation development and uptake. This has enabled initiatives at multiple levels. The NHS Long Term Plan has been drawn up by frontline staff, patient groups, and national experts to secure a health system fit for the future, including a focus on making better use of data and digital technologies. And the second Life Sciences Sector Deal, published in December 2018, announced £1.2 billion of new investment to strengthen the UK as a world-leading science base. The newly formed NHSX has been established to provide a policy framework, standards and APIs for digital technologies aimed at the NHS. Similarly, a newly re-licensed network of 15 Academic Health Science Networks, covering England as the innovation arm of the NHS, is focusing on evaluation, adoption and scaling of digital innovations.

MedCity, one of several regional cluster organisations across the UK, provides a much-needed front door for companies and acts as an impartial and independent connection point between the NHS, academia and industry. With its core focus on supporting the growth of the life sciences sector in London and the Greater South East, MedCity works with partners including the AHSNs, Academia, the National Institute for Health Research and others, providing an independent access point to companies.

The common perception that the UK is a hard market to enter – why should international companies choose the UK above Europe and beyond

Safe access for digital technologies is emerging as a key theme in global health policy, not only here in the UK, and that requires technologies to be evidenced. Far from being hard to enter, the UK market is accessible and there is a lot of support available to help companies navigate it.

For early stage digital therapeutics companies wishing to develop products and business models, the UK is a fantastic place for research collaborations, design support and evaluation and grant funding. The convergence of expertise, funding and a data-rich healthcare system is compelling for trialling and evidence generation.

For later stage companies wishing to access the NHS, the organisations already mentioned are well equipped to support and signpost resources.  Importantly, the AAC has been formed to speed up the pathway to adoption. The ambition of the AAC is to launch a single web-portal from across organisations to enable easier navigation for innovators by the end of 2019.

For non-UK companies, MedCity works with organisations such as N-Site and London and Partners that can signpost support with respect to tax and legal considerations.

Case-study

Sleepio is a clinically validated (9 RCTs and over 37 published papers), personalised, fully automated digital programme based on cognitive behavioural therapy (CBT) that enables whole populations to improve their sleep, mental health and quality of life. It is the first digital therapeutic developed by parent company, Big Health.

The problem

Difficulty sleeping is the most common mental health complaint in the UK, yet also the most poorly managed. Poor sleep affects one in three adults and, as a chronic disorder, insomnia affects 10-12% of working adults. It is a known risk-factor for chronic conditions such as depression, anxiety, diabetes, and heart disease.

The solution

Sleepio targets users with poor sleep as a non-stigmatised route to tackle poor mental health. Its validated sleep test directs people to the appropriate level of care. Those with insomnia symptoms receive tailored sleep hygiene information, akin to GP advice. Those with insomnia disorder can access gold standard treatment with digital Cognitive Behavioural Therapy (dCBT). Sleepio is fully automated, scalable and in the world’s first placebo-controlled randomized trial for a digital sleep intervention, Sleepio helped 76% of poor sleepers achieve healthy sleep levels – an effect that was maintained 8 weeks later at follow-up1. Leading scientific publisher, Nature magazine, indicated this was an outcome “comparable in effect to in-person therapy.”2

The project

Oxford AHSN is partnering with Big Health on a £1m, 2 year Innovate UK grant. Real-world evidence data is being collected from participants in the Thames Valley region.

Since October 2018 over 8000 people have accessed the Sleepio programme and are sleeping an additional 5 hours each week, experiencing improved workplace productivity (less stress, improved productivity, reduced absenteeism), reporting improved mental health (reduced anxiety and depression symptoms -GAD-2 and PHQ-2) and reduced usage of sleeping tablets.

The objective of the project is to develop a blueprint for commissioning and adoption of Sleepio at scale.

Evidence and data – what these mean for digital therapeutics

Until March 2019, there were no standards available anywhere on what good evidence looks like for demonstrating clinical effectiveness and cost effectiveness for digital health technologies. Prior to this there were significant challenges in evaluating technologies being put forward for NHS adoption. In reality, there was insufficient evidence to assess effectiveness for the majority of technologies, and this was one of the major reasons that there was poor and inconsistent adoption.

The Evidence Standards for Digital Health Technologies framework, first published in December 2018, has introduced the means for industry and commissioners to have a dialogue on evidence and use a framework for that dialogue. Since its publication, the framework has been shared with countries in Europe and beyond interested in following this best practice and raising the quality bar for digital health technologies. NHSX, NICE and a range of stakeholders including AHSNs and MedCity, are working on how this evolving set of standards is used in practice and providing practical examples of the type of evidence that will be required. We are also working to align adherence with the evidence standards to NHS Funding Mandates to support the adoption of innovations in the NHS.

Collecting real-world data

We expect digital health companies to work with local organisations and AHSNs to develop plans that support the evaluation of their products with real-people in relevant care settings. This is a partnership approach, as we work to mature the health and care system so that it’s ready to adopt the technologies that meet the standards and principles of the tech vision. These include user need, privacy and security, interoperability and openness and inclusion. We want to signal to the market where there are needs to support alignment between local health and care objectives.

Q&A spotlight

Q: As a non-UK company where should I start? 

Information governance and data protection are paramount for the delivery of good digital technologies. The information governance toolkit that NHS organisations require providers to be compliant with has recently been updated to the Data Security and Protection Toolkit and provides guidance.

Q: I have a technology that’s responding to a specific national need, is evidenced and is an improvement on current solutions – how do I get this into the NHS system?

The best route is to start with the AHSNs. Across the AHSN network they understand needs of the system and can act as a matchmaker between NHS organisations and local authorities and suppliers. A good place to start is with the recently released AHSN Network Impact Report. 

Q: How far away are we from having specific digital therapeutics for specific interactive care pathways?

Some of the Global Digital Exemplars (GDEs) and more digitally mature Integrated Care Systems (ICS) across the NHS are modelling new ways of delivering care. The challenge we all face is how this is then scaled across the health and care landscape. This is within the remit of the Accelerated Access Collaborative and we would be delighted to work with innovators to work through the evidence generation that will support with spread and scale in this transforming NHS. 

 

For more information on any of the discussion points contact office@medcityhq.com.