Public Engagement on Building an Integrated, Rules-Based Medical Technology (MedTech) Pathway in England

The Value of MedTech is More Than What it Costs

The message at recent events, conferences and webinars seems to be: “the UK is excellent at innovation, and terrible at adoption into the NHS.” The need for change is therefore clear: to simplify and streamline evaluation of MedTech, whilst ensuring that the healthcare system is an attractive proposition for innovation.

As part of this, NHS England and the National Institute for Health and Care Excellence (NICE) shared a proposal for an integrated, rules-based pathway for medical technologies, with the engagement period running for 12 weeks from 23 May to 15 August 2024. This pathway aims to provide consistent rules for the evaluation of MedTech across the lifecycle of technologies to drive innovation and help minimise the barriers to adoption that manufacturers currently face in England.

The principles of the pathway are promising, and reflect its aims. However, in our response to the consultation we have highlighted a number of concerns with the current proposals, which we anticipate will limit the impact of such a pathway – for industry, for healthcare professionals, and most importantly, for patients. This article delves into a few of the key talking points.

An overview of the proposed pathway

The details can be found here, but, briefly, the pathway (Figure 1) will be governed by five Guiding Principles:

1. The pathway should be supported by evidence-based advice and guidance from the National Institute for Health and Care Excellence (NICE), focused on technologies with the greatest impact on patient outcomes and the most compelling cases for clinical and cost-effectiveness
2. The pathway requires a lifecycle approach to support new, early-stage technologies as well as driving greater value from existing technologies in widespread use
3. The pathway should lead to automatic identification of funding to support routine commissioning and adoption for clinically and cost-effective and affordable technologies
4. The pathway should support the transformation of clinical pathways and services
5. The pathway should drive up the quality and use of evidence, helping tackle ethnic and unfair biases in MedTech

These principles highlight a shift towards clearer, evidence-based evaluations of MedTech considering both clinical evidence and cost-effectiveness evaluations. They also demonstrate the need for flexibility in evaluation across a product’s lifecycle, which suggests an understanding that a one-size-fits-all approach to MedTech just isn’t feasible. Furthermore, automatic identification of funding to support routine commissioning would be a big step towards mitigating barriers to adoption faced by manufacturers in this country, if achievable.

Principles are one thing, though. When you lift the lid on this pathway, it’s the detail of the proposals that raises questions.

 

Figure 1: Integrated, rules-based MedTech pathway

 

Value is about far more than the cost of an intervention

The proposed plans state that “this pathway will build a foundation for more value-driven decision making across medtech procurement and adoption within the NHS.” The question is, though: what is meant by “value”? Traditionally, there has been a need to demonstrate cost-savings for MedTech to achieve adoption; cost-effectiveness has not been given the same weight as in the pharmaceutical world. However, this pathway is welcome in its clear shift towards cost-effectiveness evaluations, which could open the door to more technologies within the NHS. But it’s not all positive. The budget impact threshold has been set at £10 million, half that used for pharmaceutical evaluations, and that’s before you consider that there is an ongoing consultation on raising this threshold for drugs to £40 million. So why are the rules for MedTech going to be so different to those for pharmaceuticals? This has the potential to create barriers to devices with high upfront costs, and where value is realised over a longer time period. Looking at the detail of the proposed plans, it feels the definition of value here is just too focused on cost alone. And who loses out in this scenario? Patients, for one, but also the NHS – both the system and those that work within in it. Low cost does not necessarily equal high value in healthcare.

Beyond the budget impact test, discussion of the late-stage assessment seems almost entirely focused on the NHS attaining the lowest possible price for an intervention. Of course, money is tight in the NHS (an understatement, I know), but will this really maximise the true value of MedTech for the NHS? We still only have interim methods for this pathway, as well, and the consultation responses for LSA clearly highlight wider concerns around the consideration of costs versus true value.

The reason MedTech has such great potential for the NHS – the reason that there is a focus on developing these pathways in the first place – is the value that these interventions can have across multiple domains. A disproportionate focus on budget impact and price may blind to the potential of interventions improving efficiencies, releasing staff time or transforming a patient pathway. Furthermore, whilst LSA methodology indicates user preference will also be considered, how this feeds into the final decision remains unclear. Preference and usability are such key facets of a MedTech intervention, but a move to drive down price that leads to a monopoly removes that choice for users. For this pathway to be successful, evaluation methodologies must consider a holistic approach to value.

A pathway for the many or the few?

Whilst the principles suggest one pathway ready for almost any technology, the reality spelled out in the rest of the document is that there will only be a limited number of technologies assessed. The multi-tech guidance (MTG) pathway is anticipated to evaluate just 5 technologies early on. Surely there will be many more technologies left on the sidelines, not evaluated within this pathway? To me, this doesn’t suggest the improvement to market access indicated by the principles of the pathway. So what happens to those technologies that don’t meet the criteria of this pathway?

This feels like an unanswered question more generally, not just when thinking about the MTG pathway. For example, what happens to those technologies that do not meet the potentially quite limiting criteria around NHS priorities, but could have a clear patient benefit? The assumption must be that they will face the same barriers manufacturers come up against today. Perhaps, it will be even worse, with resource focused so heavily towards the qualifying technologies in this pathway. So will this dissuade companies from investing in or entering the UK, if it’s not clear how or if their technology will be assessed? Clarity is needed, with regards to both the capacity of this pathway, and the alternative routes to access for those that don’t meet the eligibility criteria.

Availability of funding is key to success

Funding has long been discussed as a key barrier to adoption for MedTech in the UK. The lack of direct reimbursement for the majority of MedTech evaluated by NICE drives the focus towards cost-savings over cost-effectiveness. The proposed pathway states that “For those technologies that are recommended by NICE as clinically and cost-effective and that meet an NHS affordability test, there will be a commitment to automatic identification of funding to support routine commissioning.” This is really promising, although we await further detail of the sources of these funds to be able to make a clear judgement on feasibility.

Beyond the pots of money to support implementation and adoption, the availability of funding through earlier parts of the pathway will also be essential, particularly considering implementation of the published evidence generation plan that is available as part of an Early Value Assessment. Otherwise, how do companies, particularly SMEs, fund what can be an extensive list of requirements within the required timeframe? Whilst we acknowledge a recent OLS/NIHR funding call did provide an opportunity for funding of evidence collection, the nature of a funding call means that some technologies miss out. Either they are unsuccessful during the application period, or in the instance of that particular funding call, timelines were so restrictive that unless you had adoption sites ready to go, it was too difficult to get a worthy application together in time. And now there is a wait to see when the next funding call might be. Instead, guaranteed, consistent, stable access to funding to support evidence generation plans is an absolute necessity. Funding for devices in use in the NHS would also remove a clear barrier to early implementation as part of evidence generation.

Engagement, engagement, engagement

If there’s one Guiding Principle missing from the list outlined in the proposed pathway, it’s that of engagement, although the details of the proposed pathway do acknowledge the importance of early and continued engagement. Demand signalling and horizon scanning components of this pathway indicate the need for bidirectional communication between stakeholders to ensure alignment between the NHS and industry on the areas that matter most. However, there needs to be far greater granularity on priority topics. This needs to go further than overarching areas such as “cancer” and “cardiovascular”, but consider relevant (sub)populations and specific diseases where there are the greatest unmet needs. It could also consider areas where healthcare disparities have the potential to be greatest.

Beyond demand signalling, engagement is also critical when looking to foster a more streamlined evaluation and adoption pathway for SMEs. Opportunities to engage at earlier phases of the technology’s life cycle to ensure appropriate design of relevant evidence programmes will be essential. There must also be consideration to providing more detail on the current areas that inform topic selection, especially given the eligibility criteria noting the need for “strong evidence.” What constitutes “strong evidence” for a medical technology, which as noted in the foreword to this pathway, is often associated with differing evidence standards? Whilst it is appreciated that describing precise evidence requirements across the diversity of medical technologies is challenging, further guidance here could be critical to provide transparency for companies of all sizes, but particularly SMEs looking to adequately distribute limited funds to priority activities. The requirements of the system, be it priorities via demand signalling, evidence requirements and funding opportunities, need to be completely transparent.

The call for engagement carries through to this consultation. There is no doubting the need for an improved pathway that streamlines and supports MedTech evaluation and adoption. This must be fit for purpose for all stakeholders, and so the next step to realising the potential of this pathway is meaningful engagement with responses from all interested parties to help better shape this pathway so that everyone stands to gain from its implementation. We look forward to seeing the proposals evolve and the subsequent implementation of a pathway that will improve MedTech adoption.