Opinions on the NICE HealthTech Programme Consultation

On the 7th February 2025, NICE launched a 4-week consultation for the NICE HealthTech programme manual, outlining plans to simplify how NICE evaluates medical devices, diagnostics, digital health technologies and procedures.

So what’s changing?

The overall aim here is simplification, reducing the number of pathways and the divergence in methods across them, with NICE now taking a life cycle approach to HealthTech evaluation. The biggest change is the shift to cost-effectiveness evaluations, as part of efforts to bring methods into line with appraisals of pharmaceuticals. Furthermore, the majority of assessments will now consider multiple technologies together, rather than single technology appraisals, with reports developed by an external assessment group (EAG); there will be no company submissions.

In this article, I look at the proposals in a bit more detail and focus in on changes to economic evaluations, the continued move towards multi-tech appraisals and some of the blurred lines around the life cycle approach to evaluation, namely uncertainty around eligibility for the Early Value Assessment (EVA).

When three become one

HealthTech Programme figure. 3 stages of the life cycle: Early use, Routine use, Existing use

Let’s start with the basics – what is being consulted on? The NICE HealthTech programme is aiming to bring evaluation of devices, diagnostics, digital health technologies and procedures under one umbrella, where previously they were considered under three separate programmes: the Diagnostics Assessment Programme, Medical Technologies Evaluation Programme and Interventional Procedures Guidance. The motivation is one of simplification, consolidating three programmes into one governed by the same methods. It’s long overdue, and great to see NICE start to focus on addressing issues with HealthTech evaluation more widely.

However, considering this as just one programme is not quite true. The approach that NICE is planning to take for HealthTech products is now focused more on life cycle than type of technology. This is not a new announcement, rather this consultation gives us more of the “how” for some parts of this life cycle approach. So, gone are different pathways for devices and diagnostics; instead, we now have different approaches to evaluation depending on the stage in a technology’s life cycle, namely:

  • Early use, also known as EVA: for technologies with limited use in the NHS, requiring further evidence for adoption. A more pragmatic evaluation that can lead to a conditional recommendation for use in the NHS, providing further evidence is developed in line with a published evidence generation plan.
  • Routine use, previously referred to as multi-tech guidance (MTG): for technologies that may be suitable for routine widespread adoption. Evaluations will primarily focus on multiple technologies, with methods broadly in line with pharmaceutical technology appraisals.
  • Existing use, also known as the late-stage assessment (LSA): for technologies already in widespread or established use within the NHS. A programme focused on procurement and commissioning for the NHS, unlike any other NICE programme and currently guided by interim methods only.

As well as setting out this realignment as part of the new HealthTech programme, the consultation also sets out methods for technologies ready for “Early use” (replacing the interim EVA methods) and “Routine adoption and scale.” Late-stage assessment methods seem to be for another day, and so another article…

Cost-effectiveness at last, but does this fit with NHS targets?

The biggest headline as part of the consultation on the HealthTech programme is finally the widespread introduction of cost-effectiveness evaluations. This is not new for diagnostics; our own research presented at ISPOR Europe 2024 demonstrated that of 22 recently published diagnostic guidance, 20 included de novo cost-effectiveness models. However, the story was very different for medical devices, with part of the eligibility criteria for the MTEP being that devices must be cost-saving, ultimately limiting patient access to cost-effective devices in the NHS.

So, the shift to cost-effectiveness evaluation is a good thing, puts HealthTech on more of an even keel with pharmaceuticals, and may increase access to a broader range of technologies. I say “may” because we need to place these changes in the context of the NHS. At the moment, there is huge pressure on integrated care boards (ICBs) to cut costs and balance the books. Even if NICE recommends cost-effective technologies (that are not cost saving), will the NHS actually commission them?

This leaves me pondering affordability and funding more broadly. For example, this consultation does not address if HealthTech evaluations will be subject to the same budget impact test threshold as pharmaceuticals, recently raised to £40 million following consultation. Last year’s consultation on the rules-based pathway proposed a smaller threshold of £10 million, so questions remain as to why MedTech may be subject to different rules and in particular what will happen with technologies that come with high up-upfront costs. It feels like a real barrier to access.

More importantly, the implication remains that line 5.10.1 of the Health Technology Evaluation Manual (PMG36), which specifies the expectation that health boards provide funding within 3 months of recommendation, applies to pharmaceuticals only, indicating that there remains no funding mandate for MedTech. I’m not sure I necessarily expected one to magically appear, and updates to the rules-based pathway may seek to clarify this instead. However, again it highlights that whilst a shift to cost-effectiveness is welcome, it must be matched by appropriate funding otherwise barriers to access for cost-effective technologies will remain.

Finally, let’s bear in mind that cost-effectiveness is just one measure of value for HealthTech; the impact of these technologies is so much broader. There is a nod to this in the consultation in 2.1.21 that suggests that an EVA should capture potential impacts of technology use beyond model results, such as healthcare efficiencies. The nod is appreciated, but this needs more detail within the methods to ensure it’s best captured and evaluated.

EAG-led multi-tech submissions will be the new normal

The door has been left open to single technology appraisals, but the gist of this consultation is that NICE expect the vast majority of evaluations within the HealthTech programme to be of multiple technologies. From a pragmatic perspective, it makes sense. It is likely to be the most efficient use of limited NICE resources. However, whilst the potential for single technology appraisals remain, you fear that they may not be prioritised above indications that present for multi-tech appraisals, and this could limit access to truly innovative/disruptive technologies that are first to market. Equally, I’m not sure I see how multi-tech appraisals will always work in practice when taking a lifecycle approach to appraisals. The assumption is that all technologies will be at similar points of the life cycle, but how will it work when some have a much more limited evidence base than others. Can they piggy back off the evidence base for their more established comparators? Or will appraisal of more established technologies be delayed, whilst the evidence base for newer entrants catches up? Or, of course, perhaps late entrants will ultimately just be disadvantaged, emphasising the need to build that evidence base quickly.

The other aspect of multi-tech appraisals is that all submissions will be developed by an EAG; there will be no company submissions. On paper, maybe this makes it easier for companies; submissions aren’t exactly short dossiers. The reality could be a bit different though. It means the experts in their technology are not the ones presenting the evidence and the value proposition that supports it. It does raise the risk that important evidence could be missed, or aspects of the value of a technology overlooked or underplayed. Of course, there are opportunities for companies to contribute via requests for information and during consultation phases. Company-developed cost-effectiveness models can be submitted too. However, with it noted that consultation responses should focus on factual accuracy, the limitations of an EAG-led report need to be acknowledged. EAG-led reports may be the best solution for multi-tech appraisals, but to ensure the most accurate evaluation of a technology, those consultation responses must be listened to, and sufficient time provided to ensure that companies can provide everything required to make a fair, informed decision.

Is the Early Value Assessment truly focused on “early use”?

The other area I remain a little confused on is the criteria that guide the routing of technologies to different evaluation types. More specifically, which technologies are considered ready for “early use” and which are ready for “routine adoption and scale”? The consultation document indicates that this is based on the evidence base as well as actual adoption within the NHS. So how much evidence is enough evidence to be considered for “routine adoption and scale”? Honestly, 12 months ago, I think I felt more comfortable with this delineation, but the recent EVAs focused on soft tissue and orthopaedic robotic-assisted surgery have thrown me. Intuitive Surgical launched their first robot in 2000, with the first install in St. Mary’ hospital, London in 2001, almost 25 years ago. In 2023, Guy’s and St Thomas’ celebrated 10,000 cases with the da Vinci system. NHS Wales has already partnered with CMR Surgical to deliver the All-Wales National Robotic Assisted Surgery Programme, and has passed 500 cases. If robotic-assisted soft tissue surgery is not considered ready for “routine adoption and scale” then does this set quite a high bar? Up until this point, the EVA had been focused on technologies much earlier on in their lifecycle.

There are, I’m sure, nuances to this, and this does not mean the EVA is a bad idea; it could offer great value for early-stage technologies that need support with early adoption and evidence generation. However, I think it highlights the need for more clarity on how technologies might be appraised, and what might be deemed eligible for multi-tech guidance, especially as evaluation via the EVA can only lead to a conditional positive recommendation providing evidence is generated in adherence with the evidence generation plan.

What next?

This consultation is a step in the right direction. The end of multiple programmes with differing methods is welcome. The shift towards cost-effectiveness is great to see. The move towards more multi-tech appraisals understandable. How some of this plays out in practice remains to be seen though, particularly in the context of financial pressures within the NHS. What this likely precedes is further communication and updates to last year’s proposed rules-based pathway; NICE’s HealthTech Programme will be one cog in that wheel, and there’s no doubt continued change is required if the UK is going to be an appealing market for HealthTech.

If you would like any further information on our MedTech services, please do not hesitate to contact Ben McNally, Head of MedTech (LinkedIn). This article was written by Ben McNally who is an employee at Costello Medical. The views/opinions expressed are his own and do not necessarily reflect those of Costello Medical or Costello Medical’s clients/affiliated partners.

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