All patients need faster access to useful medical innovations
6 June 2016
A new draft publication from the Accelerated Access Review (AAR) sets out a pathway for the adoption of innovative new products in the NHS in England.
Produced by Deloitte for the Office of Life Sciences, Accelerating NHS patient access to medical innovations is aimed particularly at small and medium sized enterprises (SMEs) – which presumably have less scope for attempts to change the NHS to fit their product and need an alternative route from conception to ‘adoption and uptake by the NHS’.
This guide is just the sort of thing that the Accelerated Access Review should be doing alongside wider policies to support swift NHS uptake of innovations. It is intended for potential pharmaceutical or biological treatments, vaccines, medical devices or digital health products and covers issues from ideas generation and development to regulation, reimbursement and ‘endorsement (including health technology assessments)’, right through to commissioning and adoption in the NHS. It also provides key contacts and considerations for each stage of the process, and stresses that it is only a ‘high-level overview’, and a preliminary version at that; feedback may be provided to the Accelerated Access team. Here’s mine.
Navigating the NHS: full speed ahead
The guide recommends that innovators find an unmet clinical need and develop a potential solution (seems obvious, but there you are), testing the concept with patients, healthcare professionals and regulators’ before deciding on further development. There is useful information provided on the various regulatory bodies and an invaluable guide to the NHS structure in England, including four regional offices, 37 area teams and 211 clinical commissioning groups (CCGs), along with the corresponding guide from the Kings Fund. Indeed, the general advice provided on development, regulation and reimbursement seems reasonable; it is the commissioning and adoption section that falls short of utility – or at least, of reality.
From bench to bedside - or not
Spot what is wrong with this sentence: ‘Once a service has been commissioned…it will be available to healthcare professionals, resulting in patient access’. This is a nice idea, but dangerously simplistic, even naïve. The theoretical availability of an innovative product within the NHS – achievement though that is – still falls far short of patient access. Healthcare professionals need to know it exists and how to obtain and use it, and decide to do so in appropriate circumstances, before patients can be said to have access. For comprehensive, equitable access, the decision-making clinician for each and every patient in the country who might benefit from the innovation needs to be genuinely ready, willing and able to use it. That’s a lot to cram into the cheery QED of ‘resulting in patient access’.
The theoretical availability of an innovative product within the NHS – achievement though that is – still falls far short of patient access
To be fair, the commissioning and adoption process is unpacked a bit more than this, with innovators urged to develop a clear business case to demonstrate clinical and health economic benefits to commissioners and providers, including consideration of how it might change current care pathways (very important). It is also recommended that they should engage with stakeholders from ‘multiple functions’, adoption support bodies and possibly also patients and health professionals. Listening to feedback from clinical champions on the product or even (if desperate?) undertaking some form of patient and clinician awareness and education is advocated.
In the case of digital health and wellness products, it is suggested that innovators could also consider selling directly to patients, as well as individual hospitals and GP practices, which is an interesting proposal – it may help developers turn a profit, but could also take up NHS time as users bring findings to their GPs, appropriately or otherwise.
Altogether, the guide suggests that the process of national reimbursement and commissioning for a new product should take 6 months - 2 years, and local commissioning and adoption ‘2+ years’. There is no distinction made between adoption in one or more locations, and widespread equitable patient access from every location. Of course, with the move towards local commissioning, ensuring effective national availability of an innovation is difficult, but patient access does mean at least theoretical accessibility irrespective of where they are in the country.
The limitations of AHSNs as drivers of NHS uptake
Innovators are urged to turn to NHS vanguards, test beds and Academic Health Science Networks (AHSNs) for assistance with commissioning and adoption. AHSNs were of course pushed as the crucial mediator in accelerated adoption of innovations in the NHS in the preliminary version of the AAR, and this seems likely to continue. AHS centres and networks are great initiatives, and most do genuinely good work in developing and piloting medical innovations with academic clinicians who have appropriate incentives to assist – typically supporting their own research efforts (including securing funding) and making new products available to their own patients. There are rather fewer incentives for them to assist with efforts to push an innovation into practice elsewhere, however.
The need for (more) speed
It seems as though the PHG Foundation recommendations to the AAR – to distinguish between development and trial of innovative new products and services (typically involving specialist NHS clinicians), and the NHS-wide implementation of innovative products and services of proven value (by all front-line health professionals) – have probably fallen on deaf ears. This may be because we called for dedicated funding to support this second stage of clinical implementation, but it is in the interests of both innovators and patients to ensure that this takes place, and the sooner the better. There is also the question of support for adoption of innovations that could benefit patients or save the NHS money, but which are not clearly defined, commercially developed ‘products’.
As Foundation Director Dr Hilary Burton has already said: “We want to see the g overnment give health professionals and commissioners the resources, time and incentives to support the national implementation of innovations via collaborative, strategic policy development. Let’s not waste the brilliance behind great British science by failing to harness it for the NHS”.