Which type of synthetic mesh should be procured for hernia repairs – standard flat polypropylene or a self-gripping composite? And which type of surgical glove should be worn while performing the procedure – powder-free latex or polyisoprene double gloves with a puncture indication system?
Within almost every mature medical device category the gap between the cheapest and most expensive options can be substantial but enduring, particularly among products in established use by the National Health Service (NHS) in England. However, thanks to a quiet but deliberate shift in how the National Institute for Health and Care Excellence (NICE) evaluates such technologies, device-makers demanding premium prices may now find themselves having to justify those premiums with evidence they do not have, against a timescale they cannot meet.
The lifecycle approach to HealthTech evaluation
In July 2025, NICE combined the former Diagnostics Assessment, Interventional Procedures and Medical Technologies Evaluation programmes into a single, integrated HealthTech programme in which the approach taken to developing guidance reflects the stage a technology has reached in its lifecycle. Early-use assessments rapidly evaluate products with regulatory approval that address an unmet need but require further evidence to support wider use. Routine-use assessment focuses on the clinical- and cost-effectiveness of technologies that may be suitable for widespread NHS adoption. At the other end of the lifecycle sits existing-use assessment – the rebranded successor to late-stage assessment – which evaluates groups of similar products already established in the NHS, particularly when there is uncertainty about whether price variations are justified.
The practical upshot of this revised approach is that a device category can now be pulled into a structured value-for-money review using cost-effectiveness methods that result in recommendations that apply across the entire category. Considering how consequential such an assessment could be, what should manufacturers of premium-priced devices be doing, right now, to ensure they are ready when NICE puts those prices on trial?
What’s different about existing-use assessment?
Existing-use assessment differs from its predecessor, late-stage assessment, in at least three distinct ways.
Firstly, as Ben McNally of Costello Medical has observed in his own thought-leadership piece, the door has been left open to single technology appraisals. However, most existing-use assessments are expected to be multi-product evaluations of a class of competing products – such as surgical mesh for treatment of primary ventral hernias – with a common use case, value proposition and population defined by the assessment scope. Although named technologies specified in identified studies may be included in the assessment report, recommendations will not be issued for individual technologies but for the whole class.
Secondly, with this shift to multi-tech appraisals comes the involvement of an External Assessment Group (EAG) and cost-effectiveness analysis as the analytical centre of gravity. This brings medical device evaluation closer to the methods long applied to pharmaceuticals, albeit without the mandatory funding status of a technology appraisal and with all the advantages and disadvantages of an EAG-led report. These assessments will lean heavily on real-world evidence and on reusing prior economic work where possible – drawing on literature reviews and company-submitted information rather than commissioning de novo modelling from scratch.
Thirdly, a unique feature of the existing-use pathway is the inclusion of formal user preference assessment alongside clinical and economic evaluation – reflecting that clinicians and patients often make highly informed choices about products that are in widespread use based on their own lived experiences.
This is not hypothetical
So what might be the consequences of this approach for device-makers that have historically enjoyed premium prices? The outcome of a recent late-stage assessment of 29 drug-eluting stents is informative. Published in May 2025, this assessment concluded there was insufficient evidence to justify price variation between different stents and instructed NHS trusts that, where more than one stent is clinically appropriate, the cheapest should be chosen. Any manufacturer that had, until then, enjoyed above-market prices, did not suffer because stents are poor value for money but because the value upon which their prices rested could not be substantiated.
Six actions to take right now
NICE’s forward view for 2026/27 continues its strategy of aligning guidance programmes with key clinical areas – including cancer, cardiovascular disease and mental health. However, given the time and resources required to generate clinical, economic and user preference studies, the prudent medtech company should be taking action now to ensure their evidence generation strategies for established, premium-priced products are ready for existing-use assessment. What does this mean in practice? Here are six strategic actions to take right away:
1. Audit the evidence as NICE will see it
Put yourself in NICE’s shoes and audit the existing evidence base on the entire device class, not just your product, then map which of your claims the evidence actually supports. Premium devices often have strong trial evidence for the lead indication and very thin evidence elsewhere, while cheaper comparators may have accumulated real-world data that looks persuasive in aggregate. NICE committees read everything, including the evidence you would rather they did not. Commission an independent systematic review if one does not already exist and do it now rather than in response to a scoping consultation because, once scoping begins, unpublished evidence will be locked out.
2. Define the subgroups where a price premium is genuinely deserved
Keep in mind that although existing-use recommendations are tied to the use case in scope, NICE’s scoping process explicitly considers different uses of a technology at different points in a care pathway. So do not claim a blanket premium across all patients and settings if you cannot justify it. Instead, define the specific subgroups, indications or care settings where your premium product is genuinely strong and delivers disproportionate value while remembering that heterogeneity arguments only work if subgroup evidence exists and is methodologically credible. Beware of making implausible post hoc subgroup claims using underpowered trials – they may damage the credibility of claims that would otherwise have held up.
3. Translate price premiums into measurable outcomes
Existing-use assessments focus on how technologies differ from each other and the impact those differences have on the outcomes that matter for the decision problem. For a product with a premium price tag this means converting claims like “easier to use” or “better workflow” into hard metrics such as procedure times and workforce productivity. Identify which two or three drivers do the heavy lifting in your cost-effectiveness case, then generate the evidence that demonstrates each one being delivered in an NHS setting.
4. Build a health economic model before NICE builds one for you
In HealthTech assessments, existing economic models that are applicable to the decision problem should be reused where possible. Premium device-makers with no model in the public domain are therefore ceding the analytical territory to the EAGs or to a lower-priced competitor. However, a credible, transparent, peer-reviewed economic model of the technology class – that uses NHS-relevant prices to explore whether any premium is justified at standard thresholds – will have a disproportionate influence on the framing of any subsequent assessment.
5. Generate real-world evidence deliberately and prospectively
NICE has explicitly stated that existing-use assessments will lean heavily on real-world data because the products under assessment are, by definition, already in use. This requires device-makers to flag registries and post-market surveillance data that can be mined or prospectively structured into evidence of relative differences in clinical outcomes and resource use. This is slow work, but a partnership with two or three high-volume NHS centres to build prospective comparative registries with proper outcome definitions and follow-up will eventually pay dividends.
6. Think hard about the user preference dimension
The collection of evidence of user preferences is a standout feature of existing-use assessments and is unusual in NICE methodology. It reflects the procurement-orientated nature of this assessment pathway and can be undertaken by either NICE itself or an appointed EAG. So although the resulting report will be subject to factual accuracy checking by manufacturers it will not be possible to challenge a genuinely held expert opinion about what is or is not important to them about a product.
User preference assessment is, however, a double-edged sword for premium device-makers. It may provide an opportunity to document types of value that are hard to capture in a model. But it may equally weaken the case for a price premium if a manufacturer has leaned on value criteria to which users are indifferent. Investing, right now, in a formal study of clinician and patient preferences – meaning properly conducted discrete choice experiments, not marketing surveys – can support the case that a device class is not commoditised. At the very least, premium manufacturers must map the stakeholder landscape and audit the strength of their relationships with clinical champions, professional societies and patient groups. This is a multi-year investment in the goodwill upon which success in user preference exercises will depend.
Prove it, or lose it
In the new HealthTech assessment environment for technologies in existing-use, above-market prices will only be safe if there is strong evidence of better patient outcomes, lower whole-pathway costs or other types of value that NICE can see are demonstrably real and important to users. The medtech companies that will successfully defend their premium prices will be those that began preparing early since, by the time a topic is scoped, the evidence generation window will be effectively closed. Although existing-use assessment cannot block access to devices already embedded in the NHS it can nonetheless direct purchasers and commissioners towards lower-cost alternatives. It will reward evidenced value, not incumbency.
