The Accelerated Access Review, part of the UK's renewed push to speed access to innovations for system efficiency, cost savings and outcomes improvements, strikes most of the right notes, but there is still room for improvement in the framework of innovation adoption by the NHS, according to an industry-commissioned response to the review.
Will the latest drive to create a UK environment that rewards medtech innovation with swift adoption and appropriate reimbursement solve the problems that the industry has been highlighting for a decade or more? The fervent hope is that the mechanisms and support offered in recent government initiatives, including the Accelerated Access Review (AAR), will provide lasting answers and represent more than good intentions, well written.
The Association of British Healthcare Industries (ABHI) has commissioned a report that dissects the AAR, and weighs the value that it offers to UK medtech manufacturers as they seek to secure NHS adoption of products and procedures. (Also see "UK Medtech To Leverage Accelerated Access Opportunity, Regardless Of The 'B' Word" - Medtech Insight, 6 Nov, 2017.) Co-author of the report Sophie Castle-Clarke, health policy fellow at the Nuffield Trust, said her research – which included case studies, interviews with AHSNs and the new Innovation National Networks (INNs) – found that in an otherwise impressive review, long-identified problems are still present or have been overlooked.
Need: Identify Solutions On The NHS Demand Side
Speaking on the day of the report's release, she said the NHS remains too supply-focused. And yet the AAR encourages NHS organizations to adopt existing innovations, rather than enabling the NHS to identify its most pressing problems and find solutions for them.
In addition, there remains little clarity over just who is responsible for innovation at the provider level, in terms of establishing what evidence is needed to support a medtech innovation. Clinicians' time is at a premium, so value pathways are not always uppermost in their minds, and indeed, innovation can too often be viewed as a "luxury," rather than a routine part of operational management.
Instead, the release of cash for procurement remains a day-to-day priority. But innovation uptake needs a clear attribution of responsibility, which should be embedded in roles. Chief innovation officers with board oversight of the innovation process could make a fundamental difference.
AHSNs Moved To Center-Stage
The 15 England-wide Academic Health Science Networks (AHSNs) are getting a wider remit under the AAR as the main delivery vehicle for driving innovation. Crucially, they are being given the role of overseeing the new Innovation Exchanges. The AHSNs are "high value" but are not joined up, in the view of NHS England strategy director Ian Dodge. As a group, they need to engage in more networking, and more plagiarizing of "best of breeds."
Dodge added that the AHSNs, which have so far supported 226 innovations, are all different. However, they are now coming together more and moving towards a core offering. A bigger problem, according to Dodge, is the failure of the NHS to address cost, and the need for a change in the way the NHS does research so as not to supply larger costs. He also mooted a "whole systems demonstrator," using digital methods to reduce unit costs.
On the theme of money flows, Castle-Clarke said that while a lot of responsibility is being invested in the AHSNs, including in their nine new INNs and the Innovation Exchanges that they will coordinate, there is need for more support and infrastructure to bring industry and adopters together.
The AHSNs will be getting some £39m ($52.4m) over two years of the £86m granted so far under the AAR, but stakeholders say it falls short of what is needed to for deeply transformative activity. (Also see "UK Device, IVD Sector Cheered By New Funding Pledge For Accelerated Access Program" - Medtech Insight, 14 Jul, 2017.) Caroline Fenwick, the UK Office for Lifesciences' head of AAR implementation, said that more cash had been recommended, and that this is seen as just a first step. In fact, the AAR had initially suggested an additional £10-20m basic structure funding, and up to £30m per annum for change management support.
Charlie Davie, head of the AHSNs Network, noted that the AHSNs will enter their next licensing cycle in April 2018, and their roles had been clarified under the AAR. He felt there had always been some confusion over their remit in the past.
Obscuring Real Needs?
Castle-Clarke returned to some of the perceived weaker elements of the AAR. The Accelerated Access Collaborative (AAC) is the new forum for bringing together stakeholders to select and promote transformative innovation via the Accelerated Access Pathway. But this may become focused on horizon scanning and merely bringing products to market swiftly. There is a risk that the demand-side needs – helping the NHS to become more problem-driven in its approach to innovation – may be obscured.
Fenwick said the first breakthrough products will be identified from April through September 2018. She agreed that they would be identified as quickly as possible, by looking mainly at products with already-strong evidence bases, but also doing horizon scans.
"There needs to be a shift from focusing on cost to focusing on value – but there are cultural and system issues that make this very difficult to achieve," says Sophie Castle-Clarke on NHS innovation culture.
As to evidence, Castle-Clarke suggested the need to think about new ways of testing innovation locally, in particular, asking if randomized controlled trials are always appropriate. Clinicians and others need to be willing to look at different types of evidence and understand how to interpret it, she said.
The report also observed that judging procurement departments on short-term cash-releasing savings has negative effects over time; large multi-year service contracts can stifle competition and the taking up of innovation; and the NHS' short-term approach to adopting innovation creates a missed opportunity for realizing the significant efficiencies that come from long-term transformational projects, with appropriate funding to support them.
"There needs to be a shift from focusing on cost to focusing on value – but there are cultural and system issues that make this very difficult to achieve," the report stated.
AAR Is Just A First Step
Despite the contention that it shoots a little wide of the mark, the aim now is to get the AAR in place and in use, and then to work towards making NHS medtech innovation more demand-driven.
Fenwick said the AAR, as it stands, is first step, "not the answer to everything and not the final story." This theme was picked up by Andrew Davies, ABHI market access director, who expressed the UK industry's wish for a robust, simple, and joined-up system for the adoption of medtech, with multiple appropriate routes to market.