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The opportunity of EAMS – earlier guidance is only the start

Whether in health, education or finance, innovation isn’t simply about creating something new. To have impact, promising products, tools and services need to be identified, shared and taken up. So how do we get the best and most promising medicines, technologies and services to those who can benefit from them? Kathleen Stokes, senior researcher at innovation charity Nesta, discusses the Early Access to Medicines Scheme.

There’s little doubt that encouraging innovation in health is worthwhile, but it is also risky. While new products, procedures and ideas ideally offer some combination of positive outcomes and cost benefit, above all we want to them to be safe. In health, effort is rightly taken to manage risk through careful accreditation and licensing processes – particularly in the care of medicines. However many of these processes can take years, leaving a significant time before the new innovation is publicly available.

When the MHRA launched the Early Access to Medicines Scheme (EAMS) on 7 April, an important step was taken towards accelerating the safe take-up of innovative drugs within our healthcare system. Without replacing existing licencing procedures, this voluntary scheme helps patients with certain serious conditions have faster access to promising medicines when existing treatment options are limited (or non-existent). EAMS is particularly interesting as it has established a new designation for unlicensed yet promising innovative medicines (PIM). Once a proposed medicine is designated as a PIM and its clinical data and risks are assessed, it is listed on the MHRA website for a year – providing public information and guidance on the medicine years before it would otherwise be available.

With this new scheme and designation, the MHRA is speeding up patient access while also accounting for the risks that underpin innovation in health care. But these efforts can go further – moving from recognising and earmarking new ideas, tools and approaches to actively encouraging their take-up.

To make the most of EAMS, we need to consider two things: how will professionals and patients actually identify and make use of the scheme; and how can we develop similar efforts for a wider range of innovations?

How will NHS bodies spread innovations to professionals and patients, so they can take advantage of EAMS?

Involve communities instead of just transmitting information.

Health practitioners have access to an unprecedented amount of information and guidance. Central institutions like the MHRA and NICE play an invaluable role in assessing evidence and information, setting standards and offering guidance; but presenting information does not ensure people will find what they need, let alone act upon it. Spreading innovation to the frontline begins with creating information, but it’s disseminating and enacting such information that counts.

In Nesta’s exploratory report ‘Which doctors take up promising ideas? New insights from open data’, we set out to understand how innovations are taken up and spread across primary care. Mapping take-up of a small sample of innovations (including QOFs, IT tools and medicines), we were struck by the uneven levels of take-up among GP practices. Looking closer, we did find that many different stakeholders had important roles to play in whether an innovation was considered and eventually embedded in practice.

When it comes to spreading information and encouraging others to consider different innovations, informal professional networks and patients are two particularly important communities. Meanwhile, local intermediaries like CCGs and Academic  Health Science Networks (AHSNs) were identified as incredibly useful forces for supporting and championing their members  to take up of new and promising ideas and tools. These lessons are specific to primary care but they do make us wonder – how much consideration and effort is givento promotion and outreach for EAMS?

As the scheme goes forward, careful effort to engage and involve different communities throughout the process could make the difference between yet another information source and a collective opportunity that is taken up and owned by patients and professionals alike.

How can we develop similar efforts for the wider range of innovations in our healthcare system?

Learn from existing efforts and tailor our approaches.

Innovation covers a nebulous assortment in health, from medicines to technologies to management procedures. Each type needs to be distinguished and considered independently, as do different stages the adoption process – from the moment information about a new product or medicine is spread to when a practitioner or clinician decides to embed it within their practice.

EAMS only focuses on serious conditions with limited or no available adequate treatment. This strategic choice to address a gap in provision has helped to justify a more groundbreaking approach to accelerating innovation. However, the scheme also demonstrates the importance of knowing how to focus and tailor your approach to the type of innovation at hand.

While momentous, EAMS also is not an isolated attempt to accelerate and spread innovations. Indeed, adoption and dissemination has been a lasting priority for NHS England in recent years. Strategies like ‘Innovation, Health and Wealth: Accelerating Adoption and Diffusion in the NHS’ and the more recent ‘Everyone Counts: Planning for Patients 2014/15 to 2018/19’ have set the stage for a new crop of policies and initiatives – ranging from challenge prizes to Commissioning for Quality and the Innovation Scorecard. Equally, NICE’s recent Medtech Innovation Briefings (MIBs) now offer descriptions of early medtech innovations without providing explicit guidance. While efforts and enthusiasm in many cases, emphasis has been on creating more information and incentivising take up through financial means.

EAMS has the opportunity to build on existing lessons and inform other efforts looking to speed up and spread innovation in health. Yet for this to happen, we will need to see how the scheme develops in practice – are people making use of it? What challenges do they face? And what impact does it have?

While a challenging prospect, this is an exceptional opportunity to reflect upon and improve how promising medicines – and other innovations – are identified, spread and encouraged in the NHS.

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