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Securing rapid market access for proven medtech innovation in the NHS, delivering it efficiently through the various procurement options – and direct to providers in the case of tariff excluded high-risk devices – and getting it reimbursed adequately, comprises perhaps the most challenging of long-term, complex aims for the health care products industry selling into the UK market.

It is a task that has proved consistently tough for medtech manufacturers. In recent years, companies have improved their engagement with UK clinicians and understanding of their needs, but progress toward a system that readily rewards innovation is happening only slowly. And the market has become more complex: the patient has become the center around which all activity is happening, and value-based principles that promote quality over a sustained period now form the blueprint for delivering affordable care in the future in NHS England.

Luella Trickett

Tracking and making sense of this evolving picture from the medtech industry’s vantage point is Luella Trickett (pictured), who was appointed director of value and access at the UK Association of British HealthTech Industries (ABHI) in July 2019. (Also see "UK Medtech Readies For Wellness Era With Digital Role For Davies" - Medtech Insight, 4 Jul, 2019.) Speaking to Medtech Insight, she described the role as bringing together adoption and spread of innovation. But it is also about translating those principles into NHS procurement on a "value-based health care (VBHC)” basis, she said. Hers is a role that looks at how technology impacts the whole pathway of care.

Trickett comes with 25 years of medtech industry experience, but how much her job will be complicated by the distractions and sideshows of 2020 is impossible to say. Up ahead, UK medtech must adapt and react to the forthcoming Brexit trade negotiations, the new UK Medicines and Medical Devices (MMD) bill, and the drive by NHSX and the medtech industry to maximize the transition to digital, and leverage all the benefits that AI can deliver in transforming care and care pathways, among other things. (Also see "NHSX Brings A New Digital Dimension In UK " - In Vivo, 10 Sep, 2019.)

“Access” and “value” are elements that are clearly interlinked, said Trickett. "All companies are grappling with the same market access issues: they have great evidence, their product has a positive impact on patient pathways, and they can demonstrate outcomes for the system, the patient, and/or the clinicians," she said. But they are faced with a situation where systems are not in place to enable the NHS to buy the technologies in question.

A major part of Trickett’s work is around real-world evidence (RWE) – what it is and how it should be integrated in product development. While the ability to demonstrate a product’s value to the health system is vitally important, “sometimes it is only when technologies are in use that the hypothesis for what they can deliver can be demonstrated,” she said. Using RWE is “a different way of going to the market.”     


Procurement Focus

But her main focus, an area that ABHI chief executive Peter Ellingworth says is “front and center” of the association’s work, is procurement in the secondary care setting. This month, Trickett chaired a forum that included Supply Chain Coordination Ltd (SCCL), which is the management function of the NHS Supply Chain, and other NHS representatives. The forum’s aim was to clarify industry's needs for the NHS and clinical leaders, in all aspects of the procurement landscape. Procurement should be recognized as an “enabler” for improved patient care and efficiency gains, said the ABHI.

“We need to agree the outcomes that are to be achieved, and then set up metrics to demonstrate that the outcomes have been achieved,” said Trickett.  A value-based procurement system is the direction of travel, and not just in UK. Some UK companies are working with SCCL on pilots, but there is much room for growth. “We can support that more,” said Trickett, recognizing that it is easy to say, “let’s buy for outcomes,” but harder to define what that actually means for the system, patients and clinicians.

Difficult though the task may be, it must start somehow and somewhere. The key is to build momentum towards value-based procurement, support it, engage with the process, be inclusive and identify where industry can bring its expertise, said the ABHI director. “Unless we collaborate, we’ll never get the best out of it.” Many companies support the initiative, and together with the ABHI, are trying to address the various pinch points.

Given its financial situation, NHS England is at present very focused on achieving cash-releasing savings. Expenditure has been withheld, and a lot of hospitals need to use CapEx simply to keep what they’ve got functioning. But the NHS certainly has yet bigger, higher-priority challenges to face, said Trickett. It should be focusing more on integrating technologies that support the workforce and optimizing utilization of resources. “These technologies should be embraced, given that the UK does not have enough nurses or hospital beds.”


Supply Chain Changes

Within the value-based scenario, bringing the NHS Supply Chain into a more central position in secondary care procurement is often described as a big and ambitious project. NHS Supply Chain has historically accounted for around only 40% of medical consumables and associated products in the system. Medical consumables used in secondary care and by community providers amount to £5.6bn ($7.3bn) annually, according the Carter review on eliminating NHS variation in five years to 2020-21.

The recent UK procurement system changes went live in May 2018. (Also see "UK Must Break The Cycle Of Pricing Pressure And Face Up To Medtech Value Needs" - Medtech Insight, 3 Jul, 2018.) The goal for NHS Supply Chain is to grow its share from 40% to 80%, and, with an increased share of 53% last autumn, it has already “moved the needle.” It is expected that there will still be some local procurement, by NHS Trusts and community trusts, etc, too. And some voice the fear that local nuances would be lost if procurement became too centralized.

“Value-based procurement is about changing the types of procurement that will be undertaken,” said Trickett. There will always be straightforward procurement frameworks for certain cohorts of products. “But there are also plenty of technologies that can deliver more than merely ‘a device’,” she added.

The first step to increasing value is taken when NHS England commissions a treatment pathway; the second step is to procure the appropriate technology. And they both need a reimbursement mechanism. Unofficial value-based agreements are already in place in the UK, while Managed Equipment Services, which are seen as a type of VBHC, have long been in place.

But the reality is that NHS England is still far away from the goal of generalized value-based procurement. The NHS, like a giant franchise, is often described as a single organization, but in reality it is a whole raft of organizations. There may be “excellent procurement” within certain NHS Trusts, but these examples are not yet being replicated across England, said Trickett. This is because all Trusts face very different problems, and as their resources vary, and so do their procurement options.

In the best of all worlds, medtech manufacturers would like the NHS to work on an informed and collaborative partnership basis whereby the national provider can approach the commercial sector as a partner to discuss the technology that needs to be procured to deliver the necessary outcomes for the patients, clinicians and the system. Clinical involvement is crucial in this exercise: procurement, finance and clinical people should work together with industry to reach the best solution, Trickett advised.


“Value-based procurement is still a work in progress, but the general direction of travel is positive.” – Luella Trickett


“I am optimistic, but very realistic. We’ve got to believe that we can make it work.” ABHI is seeing increased engagement on, and greater awareness of, value-based procurement from a wider cohort of medtech companies. The association is helping SMEs to get involved.

The NHS has committed to issue more guidelines on value-based procurement. “It’s never going to be a one-size-fits-all. We need agreed outcomes and a definition of which steps are going to be undertaken by which party, and what the payment mechanism is,” said Trickett.” It’s still a work in progress, but the general direction of travel is positive, she stressed.


Innovation Landscape Becoming Clearer

There are three clear routes for getting innovation into the NHS at present: via the Academic Health Science Networks (AHSNs); through the new National Institute for Health and Care Excellence (NICE) body HealthTech Connect, which aim to identify health technologies that offer measurable benefits to patients and/or the UK health and care system (Also see "UK Plugs Into ‘Golden Period’ For Medtech Innovation" - Medtech Insight, 17 Jun, 2019.); and the Accelerated Access Collaborative (ACC). These three will very much “talk to each other” in the future, said Trickett.

“The AAC – a slow journey, but better than no journey.”

At the AAC, where Mark McIntyre of Boston Scientific and Neil Mesher of Philips have seats on the board, “a lot of great stuff going on,” but the AAC is only as good as the resource provided to execute it, Trickett said. In Dr. Sam Roberts, the director of innovation and life sciences at NHS England & Improvement, the group has “purposeful chief executive who wants to get things done.”

The journey from the Accelerated Access Review, in 2014, to the AAC now has admittedly been slow, but “rather a slow journey than no journey,” said Trickett. The AAC is now in the second year after its “boost,” and has taken on a new level of energy since mid-2019. “Let’s see where we are when we come up to planning for the financial year 2021-22, when we’ll really be able to see what can be delivered,” she said.

NICE’s HealthTech Connect, previously an AAC initiative, came out of the NHS Long Term Plan (LTP) and aims to support selected technologies by getting the right evidence and clinical engagement in place. This would give greater visibility to a technology and boost its adoption. The NHS Supply Chain is also looking at ways that “innovative procurement” can identify innovations, but there are no details on that plan yet.


NICE Role Elevated

It is understood that there will be no further Innovation and Technology Payment (ITP) schemes from NHS England: the medtech funding mandate set out in the LTP, and mooted in March 2019, will be the mechanism by which innovative devices, diagnostics and digital tools will be supported in the system. This is tantamount to a “NICE approval.” The medtech funding mandate applies only to technologies that have gone through NICE medical technology guidance, and have demonstrated in-year savings. The medtech mandate comes into force in April 2020.

NICE is undertaking a methods review at present, and is also doing a study of the data analytics that it will take into account when reviewing technologies, recognizing that not all technologies will have or will require the same evidence base to demonstrate that they are effective and cost effective, said Trickett. “Evidence is one area where we all need a better common understanding of what is really necessary.”

Under its current processes, the methods to secure a NICE Technology Appraisal are clear; but the processes around HealthTech Connect are not clear, said Trickett. And how NICE is funded is an issue, but ABHI is is "working with NICE to ensure industry is aware of the support they offer," she said.


Cultural Change And Change Management Challenge

There are many positives relating to the direction of healthtech adoption in the UK. The biggest improvement is a work-in-progress: the fostering of a positive, collaborative approaches on wider scale in the NHS. “It’s a cultural thing in many ways, and industry has many things to bring to the table.” The bigger challenge is the way the patients is managed in the system, and the barriers to change are not usually financial, but change management.

NHS England’s procurement transition should be centered around value and achieving outcomes for patients, clinicians and the system. Securing the changes requires pragmatism and a drive to achieve results. Despite the evident complexities, industry wants to be fully engaged in this in an open and transparent way, said Trickett.

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