High time for change

At long last, the final recommendations of the Accelerated Access Review (AAR) that began almost two years ago have been released. Faster access for patients to the better care, better outcomes (and even, in some cases, greater efficiency) that scientific and digital innovations can offer is long overdue. Processes and systems for evaluating, approving, commissioning and funding such innovations currently lag far behind the pace at which the innovations themselves emerge – particularly given the rapid proliferation of useful technologies that fall outside traditional regulatory pathways for treatments and medical devices, or which combine more than one type of innovation.

The interim findings of the AAR were certainly inadequate; the PHG Foundation’s response outlined a number of areas of concern, and many others also provided submissions to the initial and interim consultation questions. In his introduction to the final report, external advisory group chair Prof Sir John Bell, notes: ‘Interestingly, we have not encountered anyone who believed that innovation adoption was not a problem that required a new solution’. But have these representations been heeded, and are the problems set to be solved?

The recommendations

  • Not unreasonably for such an important direction-setting review, the final report details eighteen specific recommendations for action, which are summarised here:
  • The NHS should develop new capacity for horizon scanning and prioritisation, with a new ‘transformative’ designation for innovations with the greatest potential impact
  • Assessment of emerging technologies should evolve to be ‘fit for the future’
  • A new Accelerated Access Pathway for strategically important, transformative products should coordinate regulatory, reimbursement, evaluation and diffusion processes and involve patients throughout 
  • This AA pathway should be versatile, fit for not only medicines and treatments but also other medical technologies, diagnostics and digital products
  • NHS digital infrastructure should be used to capture information on the use of innovations and patient outcomes
  • NHS England should set up a new ‘strategic commercial unit’ and should clarify NHS needs and local and national routes to market for innovative products
  • An Accelerated Access Partnership should be set up immediately to ‘align national bodies around accelerating innovation’ and should lead implementation of the AAR recommendations alongside clinicians
  • AHSNs, teaching hospitals and ‘clinical leaders across the NHS’ should drive and support the evaluation and diffusion of innovative products, with incentives to support local uptake and spread
  • Regional and local ‘routes to market’ should be enhanced to operate consistently across the NHS

A partnership for transformation

The proposed Accelerated Access Partnership’s roles would include many of those specified above, including oversight of the new Accelerated Access Pathway, setting out NHS priorities and selection criteria for transformative innovations, and guiding and supporting innovators to bring products to the NHS market. The partnership would bring together multiple partners:

1. Core partners: NHS England, NHS Innovation

These two bodies, working with the Academic Health Science Networks (AHSNs) are seen as having primary responsibility for delivery, working alongside:

2. Other core partners: Department of Health, NICE, MHRA, NIHR, AHSNs

All these bodies clearly have major roles to play.

3. Independent members: Including an overall Chair and ‘patient voice’ representation

It is not stated whether patient voice and other independent members are expected to include charities, commercial interests, or both, but the overall partnership is explicitly expected to be further informed and directed by:

4. Influencers: Patients and charities, scientific and clinical experts, industrial and academic researchers and clinicians, local AHSNs

Politicians (and especially the relevant health ministers) would obviously also have an influencing role via the Office for Life Sciences.

Putting patients and clinicians front and centre

The PHG Foundation has for many years sought to see the NHS itself tasked with responsibility for the national uptake and availability of useful scientific innovations for health, and it is heartening to see that not only has this message finally hit home, but also that the crucial role of patients, the public and clinicians in ensuring that it takes place emphasised. The review makes it absolutely clear that patients, families and carers have a vital role to play across the whole process: influencing innovators on the sort of solutions they would like to see; greater say in determining which innovations are important to them; supporting NHS uptake and learning about outcomes from their use; and ‘holding the NHS to account for the adoption and spread of the best innovations’. 

The vital importance of involving clinicians at every stage and of consideration for commissioning needs to support national uptake have also been taken on board, as well as our message that innovations should always be ‘considered in relation to specific care pathways and clinical services’ rather than as isolated products. Pleasingly, the recommendations now specifically refer to accelerating ‘local and national spread of innovations by supporting the capacity and capability required to make the associated clinical pathway changes’.

Of course, the success in meeting these and other important challenges will lie very much in the execution. Our reservations about the inherent limitations of AHSNs with respect to national (as opposed to local) implementation remain, but given the right support (including resources) for national uptake they will no doubt function very well as a vital location for trialling and demonstrating the potential impact of innovations, and a stepping stone towards national adoption. 

We are delighted to see the final proposals refer explicitly to ‘adoption support and uptake incentives’ – a far cry from the passive ‘diffusion’ that dominated interim proposals, and much more promising. Whether these will be appropriate and sufficient to address the real-world barriers to widespread national adoption of innovations across the NHS remains to be seen, but the plans so far are definitely a step in the right direction.